[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1074 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 1074
To improve the health of Americans and reduce health care costs by
reorienting the Nation's health care system toward prevention,
wellness, and self care.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 18, 2005
Mr. Harkin introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To improve the health of Americans and reduce health care costs by
reorienting the Nation's health care system toward prevention,
wellness, and self care.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Healthy Lifestyles
and Prevention America Act'' or the ``HeLP America Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
TITLE I--HEALTHIER KIDS AND SCHOOLS
Sec. 101. Fresh fruit and vegetable program.
Sec. 102. Child nutrition promotion and school lunch protection.
Sec. 103. School nutrition environment enhancement grants.
Sec. 104. Grants for the integration of schools and mental health
systems.
Sec. 105. Baby friendly hospital-center for breastfeeding excellence.
Sec. 106. Intervention to strengthen families and build children's
resilience.
Sec. 107. Reservations for early head start programs.
TITLE II--HEALTHIER COMMUNITIES AND WORKPLACES
Subtitle A--Incentives for a Healthy Workforce
Sec. 201. Short title.
Sec. 202. Tax credit to employers for costs of implementing wellness
programs.
Sec. 203. Income exclusion for employer-provided off-premises health
club services.
Sec. 204. CDC and employer-based wellness programs.
Subtitle B--Healthy Communities
Sec. 211. Healthy community grants.
Sec. 212. Living well with a disability and working well with a
disability programs.
Sec. 213. Enhanced standards for roads and intersection controls.
Sec. 214. National assessment of mental health needs.
Sec. 215. Preventive medicine and public health training grant program.
Sec. 216. Task force for the promotion of breastfeeding in the
workplace.
Sec. 217. Lactation accomodation and breastfeeding promotion at work.
Subtitle C--Family Smoking Prevention and Control
Sec. 221. Short title.
Sec. 222. Findings.
Sec. 223. Purpose.
Sec. 224. Scope and effect.
Sec. 225. Severability.
Part I--Authority of the Food and Drug Administration
Sec. 231. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 232. Interim final rule.
Sec. 233. Conforming and other amendments to general provisions.
Part II--Tobacco Product Warnings; Constituent and Smoke Constituent
Disclosure
Sec. 235. Cigarette label and advertising warnings.
Sec. 236. Authority to revise cigarette warning label statements.
Sec. 237. State regulation of cigarette advertising and promotion.
Sec. 238. Smokeless tobacco labels and advertising warnings.
Sec. 239. Authority to revise smokeless tobacco product warning label
statements.
Sec. 240. Tar, nicotine, and other smoke constituent disclosure to the
public.
Part III--Prevention of Illicit Trade in Tobacco Products
Sec. 241. Labeling, recordkeeping, records inspection.
Sec. 242. Study and report.
TITLE III--RESPONSIBLE MARKETING AND CONSUMER AWARENESS
Subtitle A--General Provisions
Sec. 301. Nutrition labeling of restaurant foods.
Sec. 302. Rulemaking authority for advertising to children.
Sec. 303. Label and disclosure requirements for infant formulas.
Sec. 304. Food advertising in schools.
Sec. 305. Disallowance of deductions for advertising and marketing
expenses relating to tobacco product use.
Sec. 306. Federal-State tobacco counter-advertising programs.
Subtitle B--Penalties for Failure to Reduce Teen Smoking
Sec. 311. Child cigarette use surveys.
Sec. 312. Cigarette use reduction goal and noncompliance.
Sec. 313. Enforcement.
TITLE IV--REIMBURSEMENT AND COVERAGE OF PREVENTIVE SERVICES
Sec. 401. Coverage of substance use (other than tobacco), diet,
exercise, injury prevention, and dental
health counseling.
Sec. 402. Preventive mental health screenings.
Sec. 403. Encouragement of cessation of tobacco use.
Sec. 404. Recognition of school-based health centers as model for
delivery of primary care for children under
the medicaid and State children's health
insurance programs.
Sec. 405. Preventive health care demonstration program.
Sec. 406. Preventive health services for women.
TITLE V--HELP (HEALTHY LIFESTYLES AND PREVENTION) AMERICA TRUST FUND
Sec. 501. HeLP (healthy lifestyles and prevention) America Trust Fund.
TITLE VI--RESEARCH
Sec. 601. Expansion of research regarding obesity.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Health care costs in the United States are rising
rapidly. Per capita health spending in the United States is 56
percent higher than the median country that is a member of the
Organization for Economic Cooperation and Development.
(2) According to the Centers for Medicare and Medicaid
Services, total health care spending in the United States in
2004 was $1,800,000,000,000 and is expected to rise to
$3,600,000,000,000 by 2014. Furthermore, chronic disease
accounts for approximately 75 percent of health care costs
annually.
(3) The United States spends less than 5 percent of annual
health care expenditures on prevention
(4) Reducing and preventing the incidence of chronic
disease is one means by which to reduce health care costs in
the United States.
(5) More than 1,700,000 Americans die of a chronic disease
each year, accounting for nearly 70 percent of all deaths in
the United States.
(6) The economic impact of chronic disease can be seen in
the annual costs associated with cardiovascular disease and
stroke ($352,000,000,000), obesity ($117,000,000,000), cancer
($171,600,000,000), and diabetes ($132,000,000,000).
(7) Obesity related health conditions cost employers nearly
$13,000,000,000 in health care and other indirect costs.
(8) Health promotion investments by employers on average
yield a return of $3 for every $1 invested in a program.
(9) Being overweight or obese increase the risk of
diabetes, heart disease, stroke, several types of cancer and
other health problems.
(10) An estimated 65 percent of adults and 15 percent of
children and adolescents in the United States are overweight or
obese.
(11) The rates of obesity have doubled in children and
tripled in teens since the 1980's.
(12) Almost 40 percent of Americans are sedentary. More
than \1/3\ of young people in grades 9 through 12 do not
regularly engage in vigorous-intensity physical activity.
(13) Only 1 in 5 young people eat the recommended 5 daily
servings of fruits and vegetables.
(14) Food and beverage advertisers collectively spend
$10,000,000,000 to $12,000,000,000 a year to reach children and
youth.
(15) Between 1977 and 1995, trips made by walking declined
by 40 percent for adults while driving trips increased to
almost 90 percent of the total.
(16) Virtually all-new users of tobacco products are under
the minimum legal age to purchase such products. Every day in
America, more than 4,000 kids try their first cigarette.
Another 2,000 children become new daily smokers.
(17) In 2002, nearly a quarter of American adults,
46,000,000 people, smoked cigarettes, including almost 40
percent of college-aged students.
(18) Research consistently shows that smoking cessation
services offered as a combination of tobacco medication therapy
and counseling can be one of the most cost-effective health
interventions and can reduce smoking-related health care costs.
(19) Physical and mental health are interconnected.
Physical conditions often result in mental health complications
and depression can manifest itself through physical symptoms.
(20) The Surgeon General reported that mental disorders
collectively account for over 15 percent of the overall burden
of disease from all causes, slightly more than the burden
associated with all forms of cancer.
(21) One of every 2 people who need mental health treatment
in the United States does not receive it. Of children and
adolescents 6 to 17 years old who need mental health services,
nearly 80 percent do not receive it.
(22) Early screening and prevention programs in the schools
can detect high risk children that are vulnerable to developing
mental illness and assist in accessing appropriate services.
(23) Children are at greater risk for mental health
problems when they experience stressful family circumstances
such as social or economic disadvantage, severe marital
discord, divorce, family violence, parental substance abuse or
other mental disorder or physical illness, and parental absence
due to military service, imprisonment, or death.
(24) The 2003 President's New Freedom Commission on Mental
Health urged a transformation of the approach to mental health
in the United States, including improving the mental health of
children and promoting resilience and prevention.
(25) People with disabilities report substantial
disparities in health compared with people without
disabilities. These disparities are caused by a number of
factors, including less access to health care than individuals
without disabilities. People with disabilities report more days
of pain, depression, and anxiety and they have higher rates of
obesity.
(26) Evidence shows that health promotion programs with
exercise, nutrition, and wellness components targeting people
with disabilities can significantly reduce the incidence of
these conditions and lead to healthy outcomes for people with
disabilities, as well as save money by reducing the frequency
of medical visits.
TITLE I--HEALTHIER KIDS AND SCHOOLS
SEC. 101. FRESH FRUIT AND VEGETABLE PROGRAM.
(a) Additional Funding for Fresh Fruit and Vegetable Program.--
Section 18(g)(6)(B) of the Richard B. Russell National School Lunch Act
(42 U.S.C. 1769(g)(6)(B)) is amended--
(1) by redesignating clause (ii) as clause (iv); and
(2) by inserting after clause (i) the following:
``(ii) Additional mandatory funding.--Out
of any funds in the Treasury not otherwise
appropriated, the Secretary of the Treasury
shall transfer to the Secretary of Agriculture
to carry out and expand the program under this
subsection, to remain available until
expended--
``(I) on October 1, 2005,
$1,000,000,000; and
``(II) on October 1, 2006, and on
each October 1 thereafter, the amount
made available for the previous fiscal
year, as adjusted under clause (iii).
``(iii) Adjustment.--On October 1, 2006,
and on each October 1 thereafter of a fiscal
year the amount made available under subclause
(I) of clause (ii) shall be calculated by
adjusting the amount made available for the
previous fiscal year to reflect changes in the
Consumer Price Index of the Bureau of Labor
Statistics for fresh fruits and vegetables,
with the adjustment--
``(I) rounded down to the nearest
dollar increment; and
``(II) based on the unrounded
amounts for the preceding 12-month
period.''.
(b) Healthy Cooking Pilot Program.--Section 18(g) of the Richard B.
Russell National School Lunch Act (42 U.S.C. 1769(g)) is amended--
(1) by redesignating paragraphs (4), (5), and (6) as
paragraphs (5), (6), and (7), respectively; and
(2) by inserting after paragraph (3) the following:
``(4) Healthy cooking pilot program.--
``(A) In general.--As part of the program conducted
under this subsection, the Secretary shall carry out a
pilot program under which the Secretary shall make
competitive grants to selected elementary and secondary
schools to teach children--
``(i) how to eat a nutritious diet;
``(ii) how to select foods to make a
healthy meal; and
``(iii) how to prepare healthy meals.
``(B) Selection of schools.--In selecting schools
to participate in the pilot program, the Secretary
shall ensure that--
``(i) only schools participating in the
fruit and vegetable program under this
subsection are eligible to receive funds under
this paragraph;
``(ii) to the maximum extent practicable,
at least 75 percent of schools selected are
schools in which at least 50 percent of the
students enrolled are eligible for free or
reduced price meals under this Act; and
``(iii) there is appropriate
representation, as determined by the Secretary,
of--
``(I) rural, urban, and suburban
schools; and
``(II) elementary, middle, and
secondary schools.
``(C) Priority consideration.--In awarding
competitive grants under this paragraph, the Secretary
shall give priority consideration to schools that
submit an application that includes the participation
of the parents or families of the children enrolled in
the school.''.
SEC. 102. CHILD NUTRITION PROMOTION AND SCHOOL LUNCH PROTECTION.
Section 10 of the Child Nutrition Act of 1966 (42 U.S.C. 1779) is
amended--
(1) by striking the section heading and all that follows
through ``(a) The Secretary'' and inserting the following:
``SEC. 10. REGULATIONS.
``(a) In General.--The Secretary''; and
(2) by striking subsections (b) and (c) and inserting the
following:
``(b) Food of Minimal Nutritional Value.--
``(1) Proposed regulations.--
``(A) In general.--Not later than 180 days after
the date of enactment of this paragraph, the Secretary
shall promulgate proposed regulations--
``(i) to revise the definition of `food of
minimal nutritional value' that is used to
carry out this Act and the Richard B. Russell
National School Lunch Act (42 U.S.C. 1751 et
seq.); and
``(ii) to rename the term `food of poor
nutritional value'.
``(B) Requirements.--In revising the definition,
the Secretary shall--
``(i) cover all foods made available--
``(I) outside the school meal
programs;
``(II) on the school campus; and
``(III) at any time during the
school day;
``(ii) shall consider both the positive and
negative contributions of nutrients,
ingredients, and foods (including calories,
portion size, saturated fat, trans fat, sodium,
and added sugars) to the diets of children;
``(iii) consider evidence concerning the
relationship between consumption of certain
nutrients, ingredients, and foods to both
preventing and promoting the development of
overweight, obesity, and other chronic
illnesses; and
``(iv) consider recommendations made by
authoritative scientific organizations
concerning appropriate nutritional standards
for foods sold outside of the reimbursable meal
programs in schools.
``(2) Implementation.--
``(A) Effective date.--
``(i) In general.--Except as provided in
clause (ii), the proposed regulations shall
take effect at the beginning of the school year
following the date on which the regulations are
finalized.
``(ii) Exception.--If the regulations are
finalized on a date that is not more than 60
days before the beginning of the school year,
the proposed regulations shall take effect at
the beginning of the following school year.
``(B) Failure to promulgate.--If, on the date that
is 1 year after the date of enactment of this
paragraph, the Secretary has not promulgated final
regulations, the proposed regulations shall be
considered to be final regulations.''.
SEC. 103. SCHOOL NUTRITION ENVIRONMENT ENHANCEMENT GRANTS.
Section 18 of the Richard B. Russell National School Lunch Act (42
U.S.C. 1769) is amended by adding at the end the following:
``(l) Healthy School Nutrition Environment Incentive Grants.--
``(1) In general.--Following the publication of the
recommendations of the Institute of Medicine study carried out
using funds made available for public health improvement and
leadership under the heading `Centers for Disease Control and
Prevention' in the Department of Labor Appropriations Act, 2005
(title I of division F of Public Law 108-447; 118 Stat. 3124)
regarding appropriate nutritional standards for the
availability, sale, content, and consumption of food at school,
with particular attention given to foods offered in competition
with federally reimbursed meals and snacks, the Secretary may
carry out a grant program to--
``(A) provide schools with technical assistance in
implementing the recommendations of the Institute of
Medicine regarding appropriate school nutrition
standards; and
``(B) assess the impact of implementing the
recommendations on the health and well-being of
children enrolled in the schools.
``(2) Selection of schools.--In selecting schools to
receive incentive grants under this subsection, the Secretary
shall--
``(A) ensure that not less than 75 percent of
schools selected to participate in the program
established under this subsection are schools in which
not less than 50 percent of the students enrolled in
each school are eligible for free or reduced price
meals under this Act;
``(B) ensure that, of the schools selected to
participate in the program, there is appropriate
representation of rural, urban, and suburban schools,
as determined by the Secretary;
``(C) ensure that, of the schools selected to
participate in the program, there is appropriate
representation of elementary, middle, and secondary
schools, as determined by the Secretary;
``(D) ensure that schools selected to receive a
grant under this subsection meet the requirements of
paragraph (3);
``(E) give priority to schools that develop
comprehensive plans that include the involvement of a
broad range of community stakeholders in achieving
healthy school nutrition environments; and
``(F) give priority to schools that develop
comprehensive plans that include a strategy for
maintaining healthy school nutrition environments in
the years following the fiscal years for which the
schools receive grants under this subsection.
``(3) Requirements.--
``(A) Criteria for healthy school environments.--
The Secretary shall establish criteria, based upon the
recommendations of the Institute of Medicine described
in paragraph (1), under which schools may receive
grants under this section.
``(B) Plan.--To be eligible to receive a grant
under this subsection, a school shall--
``(i) submit to the Secretary a healthy
school nutrition environment plan that
describes the actions the school will take to
meet the criteria established under
subparagraph (A); and
``(ii) take the actions described in the
plan.
``(4) Grants.--For each of fiscal years 2007 through 2011,
the Secretary shall make a grant to each school selected under
paragraph (2).
``(5) Evaluations.--
``(A) In general.--The Secretary, acting through
the Administrator of the Food and Nutrition Service,
shall conduct an evaluation of a representative sample
of schools that receive grants under this subsection.
``(B) Content.--The evaluation shall measure, at a
minimum, the effects of a healthy school nutrition
environment on--
``(i) overweight children and obesity;
``(ii) dietary intake;
``(iii) nutrition education and behavior;
``(iv) parental and student attitudes and
participation; and
``(v) related funding issues, including the
cost of maintaining a healthy school nutrition
environment.
``(C) Reports.--The Secretary shall submit to the
Committee on Education and the Workforce of the House
of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate--
``(i) an interim report on the activities
of schools evaluated under this subsection; and
``(ii) a final report on the activities of
schools evaluated under this subsection.
``(6) Authorization of appropriations.--
``(A) In general.--There are authorized to be
appropriated such sums as are necessary to carry out
this subsection for fiscal year 2007 and each
subsequent fiscal year, to remain available until
expended.
``(B) Evaluations.--The Secretary may use not more
than 10 percent of the total funds made available for a
fiscal year under subparagraph (A) to carry out
paragraph (5).''.
SEC. 104. GRANTS FOR THE INTEGRATION OF SCHOOLS AND MENTAL HEALTH
SYSTEMS.
Section 5541 of the Elementary and Secondary Education Act of 1965
(20 U.S.C. 7269) is amended--
(1) in subsection (c), by adding at the end the following:
``(7) To support schools that work with families and
appropriate community partners to implement school-wide
prevention strategies, based on mental health research, that
will support early and intensive interventions.
``(8) To provide necessary training and support to school
personnel on how to recognize and seek needed support for
children exhibiting early warning signs of behavioral and
academic problems.''; and
(2) in subsection (d)--
(A) in paragraph (4)--
(i) in subparagraph (C), by striking
``and'' after the semicolon;
(ii) in subparagraph (D), by striking the
period and inserting ``; and''; and
(iii) by adding at the end the following:
``(E) mental health services provided under this
section by schools will be evidence-based or promising
early interventions.''; and
(B) by adding at the end the following:
``(7) An explanation of how the applicant will carry out
public education programs in support of mental health promotion
and prevention by collaborating with--
``(A) an institution of higher education (including
a graduate program in psychology, social work, or
education at an institution of higher education); and
``(B) private nonprofit community-based
organizations that have experience in public education
programs relating to mental health promotion and
prevention.''.
SEC. 105. BABY FRIENDLY HOSPITAL-CENTER FOR BREASTFEEDING EXCELLENCE.
(a) Establishment of Program.--The Director of the Office on
Women's Health of the Department of Health and Human Services (referred
to in this section as the ``Director'') shall establish a program to be
known as the ``Baby-Friendly Hospital Initiative'' (referred to in this
section and the ``Initiative'').
(b) Certification Process.--Under the Initiative, the Director
shall establish a certification process under which a hospital can
apply for a certification as a ``baby friendly hospital/center for
breastfeeding excellence''. Such certification process shall be based
upon the international guidelines of the Baby-Friendly Hospital
Initiative established by the World Health Organization and United
Nations Children's Fund.
(c) Requirements.--
(1) In general.--To be certified as a baby friendly
hospital/center for breastfeeding excellence, a hospital (as
defined for purposes of this section by the Director, and which
may include birth centers) shall carry out the following:
(A) The hospital shall maintain a written
breastfeeding policy that is routinely communicated to
all of the healthcare staff of the hospital.
(B) The hospital shall provide training for all
healthcare staff in the skills necessary to implement
the policy described in subparagraph (A).
(C) The hospital shall ensure that all pregnant
women who are patients at the hospital are informed
about the benefits and management of breastfeeding.
(D) The hospital shall help mothers initiate
breastfeeding within one hour of birth.
(E) The hospital shall demonstrate to mothers how
to breastfeed and how to maintain lactation, even if
the mother is separated from her infant.
(F) The hospital shall give infants no food or
drink other than breastmilk, unless medically
indicated.
(G) The hospital shall implement a ``rooming in''
policy by allowing mothers and infants to remain
together 24 hours a day in the same hospital room.
(H) The hospital shall encourage unrestricted
breastfeeding.
(I) The hospital shall provide no pacifiers or
artificial nipples to breastfeeding infants.
(J) The hospital shall foster the establishment of
breastfeeding support groups and refer mothers to such
groups on discharge from the hospital.
(2) Inspection.--A hospital shall be certified as a baby
friendly hospital/center for breastfeeding excellence only upon
the completion of an on-site assessment by the Director through
which the Director has determined that the hospital is in
compliance with the guidelines used for certification under
subsection (b).
(3) Verification.--Upon being certified as a baby friendly
hospital/center for breastfeeding excellence, a hospital shall
agree to permit the Director to conduct on-site assessments to
verify the continued compliance of the hospital with the
requirements of paragraph (1).
(d) Authority for Automatic Certification.--The Director may
automatically certify a hospital as a baby friendly hospital/center of
breastfeeding excellence if such hospital has been designated as a
baby-friendly hospital under the Baby-Friendly USA program.
(e) Limitation.--A hospital shall not make any claim that such
hospital is a baby friendly hospital/center of breastfeeding excellence
unless such hospital has been certified by the Director in accordance
with this section.
(f) Technical Assistance.--The Director shall provide, at the
request of a hospital seeking a certification as a baby friendly
hospital/center of breastfeeding excellence, such technical assistance
as appropriate to assist the requesting hospital to achieve such
certification.
(g) Certification Costs.--Subject to the availability of
appropriations, the Director may provide to a hospital that has
successfully been certified as a baby friendly hospital/center of
breastfeeding excellence under this Act, a one time award of up to
$20,000 to offset the cost to such hospital of being certified as a
baby friendly hospital/center of breastfeeding excellence.
(h) Recommendations for Accrediting Entities.--Not later than 12
months after certifying the first baby friendly hospital/center for
breastfeeding excellence under this section, the Director shall provide
to the appropriate organizations or entities that are engaged in the
accreditation of healthcare organizations, recommendations concerning
steps that such accrediting entities may take to integrate the baby
friendly hospital requirements used in the Baby Friendly Hospital
Initiative into healthcare organization accreditation procedures and
requirements.
(i) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section.
SEC. 106. INTERVENTION TO STRENGTHEN FAMILIES AND BUILD CHILDREN'S
RESILIENCE.
Part B of title V of the Public Health Service Act (42 3 U.S.C.
290bb et seq.) is amended by adding at the end the following:
``SEC. 520K. INTERVENTIONS TO STRENGTHEN FAMILIES AND BUILD CHILDREN'S
RESILIENCE.
``(a) In General.--The Secretary shall award grants to eligible
entities for the purpose of implementing programs that strengthen
families of children at risk for emotional or behavioral problems due
to family distress.
``(b) Eligible Entity.--Entities eligible to receive funds under
this section may include--
``(1) a local public entity, including a health department
or local education agency;
``(2) an Indian tribal organization or agency;
``(3) a federally qualified health center;
``(4) a community-based organization; or
``(5) any other entity determined appropriate by the
Secretary, including a consortia or partnership of entities
eligible to receive funds under this section.
``(c) Use of Funds.--
``(1) In general.--An eligible entity that receives a grant
under this section shall use the funds made available through
the grant to carry out home-based, school-based, and community-
based activities that--
``(A) promote strong, supportive families and child
resilience through parenting skills training and
supports, or skill-building services with children, as
well as provide other consultative services and support
for family and other caregivers, such as child care
providers, educators, and after-school program staff;
``(B) enhance mental health promotion activities in
domains where children live, play, and learn; and
``(C) enhance community wellness, and reduce the
incidence of preventable mental health problems among
children.
``(2) Intervention activities.--Intervention activities
funded under this section shall--
``(A) be consumer and family driven, and use
strengths-based approaches;
``(B) be designed to promote social and emotional
competencies and increase children's ability to
successfully cope with stressful life circumstances;
``(C) be designed to strengthen children and their
families by enhancing the knowledge, social, emotional,
and other life or work skills, and support of, parents
or other significant caregivers;
``(D) emphasize and model a positive, supportive
approach to working with children;
``(E) be evidence-based and provide in-depth and
ongoing training and consultation in the adoption and
use of evidence-based interventions by schools,
communities, and families;
``(F) include a rigorous evaluation component,
including outcome measures suited to the intervention
and the overall goals of the grant, as well as use of
comparison groups and moderating and meditating process
variables whenever possible;
``(G) involve partnerships between communities or
schools and universities where possible to support
effective implementation and evaluation of the
intervention activities;
``(H) provide facilitated referrals for parents and
other family members who need mental health, substance
abuse, or social work services, and coordinate a
referral network of professionals with affordable fees;
and
``(I) emphasize local capacity-building to use
evidence-based intervention, promote linkages among
individuals and groups that serve children and
families, and develop community outreach to support
coalition-building.
``(3) Target populations.--Families targeted by these
activities shall include those with children at risk for
increased mental health problems due to stressful family
circumstances, including--
``(A) social or economic disadvantage;
``(B) severe marital discord;
``(C) divorce;
``(D) family violence;
``(E) parental substance abuse or other mental
disorder or physical illness;
``(F) parental death;
``(G) parental absence due to military service;
``(H) parental absence due to imprisonment; and
``(I) other family disruption determined
appropriate by the Secretary.
``(d) Priority Funding.--In awarding grants under subsection (a),
the Secretary shall give priority to the following:
``(1) Entities that provide non-Federal contributions,
either in cash or in kind.
``(2) Entities with demonstrated experience with community-
based partnerships.
``(3) Entities with demonstrated experience and success
with such interventions.
``(4) Entities with demonstrated experience working with
families.
``(5) Entities that develop comprehensive plans that
include a strategy for extending program activities developed
under this section in the years following the fiscal years for
which they receive grants under this section.
``(6) Entities that submit plans that exhibit cooperative
plans that include the involvement of a broad range of
stakeholders, including the following:
``(A) Community-based organizations.
``(B) Local governments.
``(C) Local educational agencies.
``(D) Local business and community associations.
``(E) Accredited colleges, universities, and
community colleges.
``(F) Other entities determined appropriate by the
Secretary.
``(e) Evaluation.--Of the funds appropriated to carry out this
section, the Secretary may reserve up to 5 percent for each fiscal year
for the purpose of carrying out evaluations of the activities carried
out under this section, including a national cross-site evaluation.
Within 90 days of the completion of any evaluations, they shall be
provided to the relevant authorizing committees and to the Committees
on Appropriations of the Senate and the House of Representatives.
``(f) Duration.--The Secretary shall award grants under this
section for a period of not more than 5 years.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $25,000,000 for fiscal year
2006, and such sums as may be necessary for each of fiscal years 2007
to 2010.''.
SEC. 107. RESERVATIONS FOR EARLY HEAD START PROGRAMS.
Section 640(a)(6)(A) of the Head Start Act (42 U.S.C.
9835(a)(6)(A)) is amended by striking ``7.5 percent'' and all that
follows and inserting ``12 percent for fiscal year 2006, 14 percent for
fiscal year 2007, 16 percent for fiscal year 2008, 18 percent for
fiscal year 2009, and 20 percent for fiscal year 2010, of the amount
appropriated pursuant to section 639(a).''.
TITLE II--HEALTHIER COMMUNITIES AND WORKPLACES
Subtitle A--Incentives for a Healthy Workforce
SEC. 201. SHORT TITLE.
This subtitle may be cited as the ``Healthy Workforce Act of
2005''.
SEC. 202. TAX CREDIT TO EMPLOYERS FOR COSTS OF IMPLEMENTING WELLNESS
PROGRAMS.
(a) In General.--Subpart D of part IV of subchapter A of chapter 1
of the Internal Revenue Code of 1986 (relating to business related
credits) is amended by adding at the end the following:
``SEC. 45J. WELLNESS PROGRAM CREDIT.
``(a) Allowance of Credit.--
``(1) In general.--For purposes of section 38, the wellness
program credit determined under this section for any taxable
year is--
``(A) in the case of a small business employer, an
amount equal to 50 percent of the costs paid or
incurred by the small business employer in connection
with a qualified small business wellness program during
the taxable year, and
``(B) in the case of any other employer, an amount
equal to 50 percent of the costs paid or incurred by
the employer in connection with a qualified wellness
program during the taxable year.
``(2) Limitation.--The amount of credit allowed under
paragraph (1) for any taxable year shall not exceed the product
of $200 and the number of employees of the employer or small
business employer, as the case may be.
``(b) Qualified Wellness Program; Qualified Small Business Wellness
Program.--For purposes of this section--
``(1) Qualified wellness program.--The term `qualified
wellness program' means a program which consists of all of the
wellness program components described in subsection (c) and
which is certified by the Secretary of Health and Human
Services, in consultation with persons who have expertise in
employer health promotion and wellness programs, as a qualified
wellness program under this section.
``(2) Qualified small business wellness program.--The term
`qualified small business wellness program' means a program
which consists of any 2 of the components described in
subsection (c) and which is certified by the Secretary of
Health and Human Services, in consultation with persons who
have expertise in employer health promotion and wellness
programs, as a qualified small business wellness program under
this section.
``(c) Wellness Program Components.--For purposes of this section,
the wellness program components described in this subsection are the
following:
``(1) Health awareness component.--A health awareness
component which provides for the following:
``(A) Health education.--The dissemination of
health information which addresses the specific needs
and health risks of employees.
``(B) Health screenings.--The opportunity for
periodic screenings for health problems and referrals
for appropriate follow up measures.
``(2) Behavioral change component.--A behavioral change
component which provides for altering employee lifestyles to
encourage healthy living through counseling, seminars, on-line
programs, or self-help materials. Such component shall include
programs relating to--
``(A) smoking,
``(B) obesity,
``(C) stress management,
``(D) physical fitness,
``(E) nutrition,
``(F) substance abuse,
``(G) depression,
``(H) mental health promotion (including anxiety),
and
``(I) sleep (including sleep disorders and the
consequences of sleep deprivation).
``(3) Supportive environment component.--A supportive
environment component which includes the following:
``(A) On-site policies.--Policies and services at
the worksite which promote a healthy lifestyle,
including policies relating to--
``(i) smoking at the worksite,
``(ii) the nutrition of food available at
the worksite through cafeterias and vending
options,
``(iii) minimizing stress in the workplace,
``(iv) where applicable, accessible and
attractive stairs,
``(v) the encouragement of physical
activity during work hours,
``(vi) the promotion of fatigue
countermeasures.
``(B) Participation incentives.--
``(i) In general.--Qualified incentive
benefits for each employee who participates in
the health screenings described in paragraph
(1)(B) or the behavioral change programs
described in paragraph (2).
``(ii) Qualified incentive benefit.--For
purposes of clause (i), the term `qualified
incentive benefit' means any benefit which is
approved by the Secretary of Health and Human
Services. Such benefit may include an
adjustment in health insurance premiums or co-
pays.
``(C) Employee input.--The opportunity for
employees to participate in the management of any
qualified wellness program or qualified small business
wellness program to which this section applies.
``(d) Participation Requirement.--
``(1) In general.--No credit shall be allowed under
subsection (a) unless the Secretary of Health and Human
Services certifies, as a part of any certification described in
subsection (b), that each wellness program component of the
qualified wellness program or qualified small business wellness
program applies to all qualified employees of the employer.
``(2) Qualified employee.--For purposes of paragraph (1),
the term `qualified employee' means an employee who works an
average of not less than 25 hours per week during the taxable
year.
``(e) Other Definitions and Special rules.--For purposes of this
section--
``(1) Employee and employer.--
``(A) Partners and partnerships.--The term
`employee' includes a partner and the term `employer'
includes a partnership.
``(B) Certain rules to apply.--Rules similar to the
rules of section 52 shall apply.
``(2) Small business employer.--
``(A) In general.--The term `small business
employer' means, with respect to any taxable year, an
employer who employed an average of 200 or fewer
employees on business days during such taxable year.
``(B) Controlled groups.--For purposes of
subparagraph (A), all persons treated as a single
employer under subsection (b), (c), (m), or (o) of
section 414 shall be treated as a single employer.
``(3) Certain costs not included.--Costs paid or incurred
by an employer or small business employer for food or health
insurance shall not be taken into account under subsection (a).
``(4) No credit where grant awarded.--No credit shall be
allowable under subsection (a) to any person who receives a
grant under section 201 of the Health Workforce Act of 2005.
``(f) Portion of Credit Made Refundable.--
``(1) In general.--In the case of an eligible employer of
an employee, the aggregate credits allowed to a taxpayer under
subpart C shall be increased by the lesser of--
``(A) the credit which would be allowed under this
section without regard to this subsection and the
limitation under section 38(c), or
``(B) the amount by which the aggregate amount of
credits allowed by this subpart (determined without
regard to this subsection) would increase if the
limitation imposed by section 38(c) for any taxable
year were increased by the amount of employer payroll
taxes imposed on the taxpayer during the calendar year
in which the taxable year begins.
The amount of the credit allowed under this subsection shall
not be treated as a credit allowed under this subpart and shall
reduce the amount of the credit otherwise allowable under
subsection (a) without regard to section 38(c).
``(2) Eligible employer.--For purposes of this subsection,
the term `eligible employer' means an employer or small
business employer which is--
``(A) a State or political subdivision thereof, the
District of Columbia, a possession of the United
States, or an agency or instrumentality of any of the
foregoing, or
``(B) any organization described in section 501(c)
of the Internal Revenue Code of 1986 which is exempt
from taxation under section 501(a) of such Code.
``(3) Employer payroll taxes.--For purposes of this
subsection--
``(A) In general.--The term `employer payroll
taxes' means the taxes imposed by--
``(i) section 3111(b), and
``(ii) sections 3211(a) and 3221(a)
(determined at a rate equal to the rate under
section 3111(b)).
``(B) Special rule.--A rule similar to the rule of
section 24(d)(2)(C) shall apply for purposes of
subparagraph (A).
``(g) Termination.--This section shall not apply to any amount paid
or incurred after December 31, 2015.''.
(b) Treatment as General Business Credit.--Subsection (b) of
section 38 of the Internal Revenue Code of 1986 (relating to general
business credit) is amended by striking ``plus'' at the end of
paragraph (18), by striking the period at the end of paragraph (19) and
inserting ``, plus'', and by adding at the end the following:
``(20) the wellness program credit determined under section
45J.''.
(c) Denial of Double Benefit.--Section 280C of the Internal Revenue
Code of 1986 (relating to certain expenses for which credits are
allowable) is amended by adding at the end the following new
subsection:
``(e) Wellness Program Credit.--
``(1) In general.--No deduction shall be allowed for that
portion of the costs paid or incurred for a qualified wellness
program (within the meaning of section 45J) or a qualified
small business wellness program (within the meaning of such
section) allowable as a deduction for the taxable year which is
equal to the amount of the credit allowable for the taxable
year under section 45J.
``(2) Similar rule where taxpayer capitalizes rather than
deducts expenses.--If--
``(A) the amount of the credit determined for the
taxable year under section 45J, exceeds
``(B) the amount allowable as a deduction for such
taxable year for a qualified wellness program or a
qualified small business wellness program,
the amount chargeable to capital account for the taxable year
for such expenses shall be reduced by the amount of such
excess.
``(3) Controlled groups.--In the case of a corporation
which is a member of a controlled group of corporations (within
the meaning of section 41(f)(5)) or a trade or business which
is treated as being under common control with other trades or
business (within the meaning of section 41(f)(1)(B)), this
subsection shall be applied under rules prescribed by the
Secretary similar to the rules applicable under subparagraphs
(A) and (B) of section 41(f)(1).''.
(d) Clerical Amendment.--The table of sections for subpart D of
part IV of subchapter A of chapter 1 of the Internal Revenue Code of
1986 is amended by adding at the end the following:
``Sec. 45J. Wellness program credit.''.
(e) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2005.
(f) Outreach.--
(1) In general.--The Secretary of the Treasury, in
conjunction with the Director of the Centers for Disease
Control and members of the business community, shall institute
an outreach program to inform businesses about the availability
of the wellness program credit under section 45J of the
Internal Revenue Code of 1986.
(2) Authorization of appropriations.--There are authorized
to be appropriated such sums as are necessary to carry out the
outreach program described in paragraph (1).
(g) Restoration of Highest Income Tax Rate to Pre-2001 Level.--
Section 1(i)(2) of the Internal Revenue Code of 1986 (relating to
reductions in rates after June 30, 2001) is amended by adding at the
end the following new flush sentence:
``In the case of taxable years beginning after 2005, the last
item in the fourth column in the preceding table shall be
applied by substituting `39.6%' for `35.0%'.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after December 31, 2004.
SEC. 203. INCOME EXCLUSION FOR EMPLOYER-PROVIDED OFF-PREMISES HEALTH
CLUB SERVICES.
(a) Treatment as Fringe Benefit.--Subparagraph (A) of section
132(j)(4) of the Internal Revenue Code of 1986 (relating to on-premises
gyms and other athletic facilities) is amended to read as follows:
``(A) In general.--Gross income shall not include--
``(i) the value of any on-premises athletic
facility provided by an employer to its
employees, and
``(ii) fees or membership expenses paid by
an employer to an athletic or fitness facility
described in subparagraph (C) on behalf of its
employees, but only to the extent that such
fees or expenses do not exceed $900.
The preceding sentence shall apply with respect to any
highly compensated employee only if access to the
facility is available on substantially the same terms
to each member of a group of employees which is defined
under a reasonable classification set up by the
employer which does not discriminate in favor of highly
compensated employees.''.
(b) Athletic Facilities Described.--Paragraph (4) of section 132(j)
of such Code is amended by adding at the end the following new
subparagraph:
``(C) Certain athletic or fitness facilities
described.--For purposes of subparagraph (A)(ii), an
athletic or fitness facility described in this
subparagraph is a facility--
``(i) providing instruction in a program of
physical exercise or offering facilities for
the preservation, maintenance, encouragement,
or development of physical fitness,
``(ii) which is not a private club owned
and operated by its members,
``(iii) which does not offer golf, hunting,
sailing, or riding facilities,
``(iv) whose health or fitness facility is
not incidental to its overall function and
purpose, and
``(v) which is fully compliant with the
State of jurisdiction and Federal anti-
discriminations laws.''.
(c) Employer Deduction for Dues to Certain Athletic Facilities.--
(1) In general.--Paragraph (3) of section 274(a) of such
Code (relating to denial of deduction for club dues) is
amended--
(A) by striking ``Notwithstanding'' and inserting
the following:
``(A) In general.--Notwithstanding'', and
(B) by adding at the end the following new
subparagraph:
``(B) Exception for athletic facilities.--This
paragraph shall not apply to fees or dues paid to
athletic or fitness facilities (within the meaning of
section 132(j)(4)(C)) to the extent that such fees or
dues do not exceed $900 for any membership.''.
(2) Conforming amendment.--Section 274(e)(4) of such Code
is amended by striking ``subsection (a)(3)'' and by inserting
``subsection (a)(3)(A)''.
(d) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 204. CDC AND EMPLOYER-BASED WELLNESS PROGRAMS.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by adding at the end the following:
``PART R--CDC AND EMPLOYER-BASED WELLNESS PROGRAMS
``SEC. 399Z-1. EMPLOYER-BASED WELLNESS BEST PRACTICES.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention shall conduct a study that analyzes employer-based
wellness programs and determines--
``(1) best practices of such programs that impact and
sustain behavior change in employees;
``(2) the impact that such programs have on reducing health
risk prevalence and improving absenteeism of employees; and
``(3) the return to employers on the investment made by
such employers in such programs.
``(b) Report.--After completing the study under subsection (a), the
Director of the Centers for Disease Control and Prevention shall submit
to Congress not later than 1 year after the date of enactment of this
part--
``(1) a report that includes recommendations of effective
employer-based wellness programs; and
``(2) an Employer Wellness Model that is supported by the
Centers for Disease Control and Prevention.
``SEC. 399Z-2. WORKPLACE WELLNESS EDUCATION CAMPAIGN FOR EMPLOYERS.
``The Director of the Centers for Disease Control and Prevention,
in coordination with relevant worksite health promotion organizations,
shall conduct an educational campaign to make employers, employer
groups, and other interested parties aware of the benefits of employer-
based wellness programs. Such campaign shall include information about
the Employer Wellness Model described in section 399Z-1(b)(2) and
information on developing, implementing, and maintaining a program
based on such model.
``SEC. 399Z-3. EVALUATION OF EMPLOYER-BASED WELLNESS PROGRAMS.
``The Director of the Centers for Disease Control and Prevention
shall enter into contracts with entities to--
``(1) provide employers with technical assistance in
evaluating such employers' employer-based wellness programs;
and
``(2) train employers on how to evaluate such employers'
employer-based wellness programs.
``SEC. 399Z-4. REQUIREMENTS BASED ON APPROPRIATED FUNDS.
``The Director of the Centers for Disease Control and Prevention
shall be required to carry out the activities in sections 399Z-1, 399Z-
2, and 399Z-3 only if funds are appropriated to carry out such
sections.''.
Subtitle B--Healthy Communities
SEC. 211. HEALTHY COMMUNITY GRANTS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399P. HEALTHY COMMUNITY GRANTS.
``(a) Establishment.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination with
the Directors of other appropriate Federal agencies, shall award
competitive grants to eligible entities for the purpose of planning and
implementing programs that seek to promote individual and community
health and to prevent the incidence of chronic disease.
``(b) Eligibility.--
``(1) In general.--To be eligible to receive a grant under
this section an entity shall--
``(A) be--
``(i) a city, county, or Indian tribe;
``(ii) a local or tribal educational
agency;
``(iii) an accredited university, college,
or community college;
``(iv) a federally qualified health center;
``(v) a local health department;
``(vi) a health care provider;
``(vii) a community-based organization; or
``(viii) any other entity determined
appropriate by the Secretary, including a
consortia or partnership of entities described
in any of clauses (i) through (vii);
``(B) prepare and submit an application in
accordance with paragraph (2); and
``(C) provide assurances that the entity will
contribute the non-Federal share as required under
paragraph (3) to the cost of the activities carried out
under the grant.
``(2) Application.--
``(A) In general.--An entity desiring a grant under
this section shall submit an application to the
Secretary at such time, in such manner, and containing
such information as the Secretary may require,
including a plan that meets the requirements of
subparagraph (B).
``(B) Plan.--A plan meets the requirements of this
subparagraph if such plan, at a minimum, includes
information regarding--
``(i)(I) programs or community-based
activities that the applicant proposes to carry
out with funds received under this section and
which seek to prevent and reduce the incidence
of--
``(aa) overweight and obesity, or
chronic diseases associated with
overweight and obesity;
``(bb) tobacco use; or
``(cc) mental illness; or
``(II) other such activities, as determined
appropriate by the Secretary, that are
consistent with the goals of promoting
individual and community health and preventing
chronic disease; and
``(ii) the manner in which the applicant
will evaluate the effectiveness of the program
or activities carried out under this section.
``(3) Non-federal share.--To be eligible to receive a grant
under this section, an entity shall provide a non-Federal
contribution, in cash or in kind, to the costs of activities
under the grant in an amount that is equal to not less than 25
percent of the costs of such activities.
``(c) Use of Funds.--An entity that receives a grant under this
section shall use the amount made available under the grant to carry
out community-based activities, including--
``(1) activities that seek to promote individual health and
community wellness and to prevent and reduce the incidence of
health problems and chronic diseases associated with--
``(A) being overweight or obese;
``(B) tobacco use; or
``(C) mental illness; or
``(2) other activities undertaken with the goals of health
promotion and chronic disease prevention, as determined
appropriate by the Secretary.
``(d) Priority.--In awarding grants under subsection (a), the
Secretary shall give priority to--
``(1) entities that demonstrate that they have previously
applied successfully for funds to carry out activities that
seek to promote individual and community health and to prevent
the incidence of chronic disease and that can cite published
and peer-reviewed research demonstrating that the activities
that the entity proposes to carry out under this subsection are
effective;
``(2) entities that will carry out programs or activities
that seek to accomplish a goal or goals set by the State in the
Healthy People 2010 plan of the State;
``(3) entities that provide non-Federal contributions,
either in cash or in kind, to the costs of funding activities
under the grant;
``(4) entities that develop comprehensive plans that
include a strategy for extending program activities developed
under this section in the years following the fiscal years for
which they receive grants under this section;
``(5) entities located in communities that are medically
underserved, as determined by the Secretary;
``(6) entities located in areas where the average poverty
rate is 150 or higher than the average poverty rate in the
State involved, as determined by the Secretary; and
``(7) entities that submit plans that exhibit
multisectoral, cooperative conduct that includes the
involvement of a broad range of stakeholders, including--
``(A) community-based organizations;
``(B) local governments;
``(C) local educational agencies;
``(D) the private sector;
``(E) State or local departments of health;
``(F) accredited colleges, universities, and
community colleges;
``(G) health care providers;
``(H) State and local departments of transportation
and city planning; and
``(I) other entities determined appropriate by the
Secretary.
``(e) Technical Assistance.--From amounts appropriated to carry out
this section, the Secretary may reserve not more than 10 percent for
each fiscal year to provide entities receiving grants under this
section with technical assistance in the implementation of the plans
required under subsection (b)(2)(B).
``(f) Evaluation.--From amounts appropriated to carry out this
section, the Secretary may reserve not to exceed 5 percent for each
fiscal year for the purpose of carrying out evaluations of the
activities carried out under this section. Not later than 90 days after
the completion of any such evaluation, the results of such evaluation
shall be submitted to the relevant authorizing committees of Congress
and to the Committee on Appropriations of the Senate and the Committee
on Appropriations of the House of Representatives.
``(g) Limitation on Administrative Costs.--An entity may not use
more than 10 percent of amounts received under a grant under this
section for administrative expenses.
``(h) Supplement Not Supplant.--Amounts provided under a grant
under this section shall be used to supplement, and not supplant, other
amounts provided for activities of the type to be carried out under
this section.
``(i) Authorization of Appropriations.--There is authorized to be
appropriated such sums as may be necessary to carry out this
section.''.
SEC. 212. LIVING WELL WITH A DISABILITY AND WORKING WELL WITH A
DISABILITY PROGRAMS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.), as amended by section 211, is further amended by adding
at the end the following:
``SEC. 399Q. LIVING WELL WITH A DISABILITY PROGRAMS.
``(a) Definitions.--In this section:
``(1) Center for independent living.--The term `center for
independent living' means a center described in part C of title
VII of the Rehabilitation Act of 1973 (29 U.S.C. 796f et seq.).
``(2) Disability.--The term `disability' has the meaning
given the term in section 3 of the Americans with Disabilities
Act of 1990 (42 U.S.C. 12102).
``(3) Independent living services.--The term `independent
living services' has the meaning given the term in section 7 of
the Rehabilitation Act of 1973 (29 U.S.C. 705).
``(b) Grants.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may make grants to eligible
entities on a competitive basis, to assist the entities in implementing
Living Well With a Disability Programs, designed--
``(1) to increase health-promoting behavior, such as
engaging in exercise, eating nutritious food, and using stress
management techniques, among individuals with disabilities; and
``(2) to reduce the limitations of secondary conditions for
such individuals.
``(c) Eligibility.--To be eligible to receive a grant under this
section, an entity--
``(1) shall be a nonprofit organization that serves
individuals with disabilities;
``(2) shall be a community-based organization that has
experience in providing consumer-directed independent living
services; and
``(3) may be a center for independent living.
``(d) Application.--To be eligible to receive a grant under this
section for a program, an entity shall submit an application to the
Secretary at such time, in such manner, and containing such information
as the Secretary may require, including information on--
``(1) the number of individuals with disabilities who will
be trained in the program;
``(2) the entity's capacity to collect data and information
on outcomes of the program; and
``(3) the entity's experience implementing similar training
programs.
``(e) Preference and Distribution.--
``(1) Preference.--In making grants under this section, the
Secretary shall give preference to eligible entities who--
``(A) are currently (as of the date of submission
of the application) serving individuals with
disabilities and implementing training and peer support
programs;
``(B) indicate a commitment and ability to continue
to train participants over several years; and
``(C) have not previously provided training through
a Living Well With a Disability Program.
``(2) Distribution.--In making grants under this section,
the Secretary shall, to the extent practicable, ensure an
equitable geographic distribution of the grants.
``(f) Curriculum, Training, and Technical Assistance.--An entity
that receives a grant under this section may use funds made available
through the grant to acquire a curriculum, training, or technical
assistance for the program carried out through the grant from an entity
qualified to implement, and train participants in, a Living Well With a
Disability program.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $2,000,000 for each of fiscal
years 2005 through 2009.
``SEC. 399R. WORKING WELL WITH A DISABILITY PROGRAMS.
``(a) Definitions.--In this section, the terms `center for
independent living', `disability', and `independent living services'
have the meanings given the terms in section 399Q.
``(b) Authorization.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may establish a
demonstration program promoting the health and wellness of individuals
with disabilities in the workplace.
``(c) Grants.--In carrying out the program, the Secretary shall
make grants to an eligible entity, to assist the entity in preparing
for the implementation of, or implementing, Working Well With a
Disability Programs, which may include--
``(1) gathering data on the positive effects of healthy
behaviors on retention and productivity of individuals with
disabilities who are employees or potential employees;
``(2) building relationships between vocational
rehabilitation programs and health promotion programs;
``(3) adapting a Living Well With a Disability program to
meet the needs of individuals seeking or entering employment;
``(4) training individuals in methods of implementing the
program;
``(5) implementing the program; and
``(6) measuring the impact of the program on health and
employment outcomes.
``(d) Eligibility.--To be eligible to receive a grant under this
section, an entity shall--
``(1) have experience in implementing a Living Well With a
Disability Program; and
``(2) demonstrate that the entity is qualified and able to
adapt the program to establish a Working Well With a Disability
Program, and implement the program.
``(e) Partnership.--An entity that receives a grant under this
section shall carry out the activities funded through the grant through
a partnership with 1 or more entities that--
``(1) shall be nonprofit organizations that serve
individuals with disabilities;
``(2) shall be community-based organizations that have
experience in providing consumer-directed independent living
services; and
``(3) may be centers for independent living.
``(f) Application.--To be eligible to receive a grant under this
section for a program, an entity shall submit an application to the
Secretary at such time, in such manner, and containing such information
as the Secretary may require.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $1,000,000 for the period of
fiscal years 2005 through 2007.''.
SEC. 213. ENHANCED STANDARDS FOR ROADS AND INTERSECTION CONTROLS.
(a) Enhanced Standards for Roads and Intersection Controls.--
Section 133 of title 23, United States Code, is amended by adding at
the end the following:
``(g) Enhanced Standards for Roads and Intersection Controls.--
``(1) In general.--Not later than 18 months after the date
of enactment of this subsection, the Secretary, in coordination
with the American Association of State Highway and
Transportation Officials and the Institute of Transportation
Engineers, shall develop recommended enhanced standards for the
design of roads and intersection controls (including associated
bicycle paths, bicycle lanes, and walkways) to improve
pedestrian and bicycle safety.
``(2) Accommodation of bicycles and pedestrians.--The
standards under paragraph (1) shall--
``(A) cover all common types of facilities where
pedestrians or bicycles are allowed on a road or on
associated walkways and bicycle paths or lanes; and
``(B) specify that generally, when the increased
cost is not excessive, as an element of good highway
design for new construction or reconstruction
facilities on which bicycles or pedestrians are
permitted, the design shall include appropriate
provisions to accommodate bicycles or pedestrians.
``(3) Increased apportionment.--
``(A) In general.--Beginning with the first fiscal
year that begins after the date that is 2 years after
the date of enactment of this subsection, if a State
accepts the recommended enhanced standards for the
State and local units of government to meet, the State
shall receive a 4 percent increase in the amount of
funds made available to the State under this section
for each fiscal year, if, at least 10 days before the
beginning of the fiscal year, the State--
``(i) agrees to follow the enhanced
standards; or
``(ii) establishes an alternative enhanced
standard that the Secretary approves.
``(B) Significant commitment.--In determining the
significance of the required commitment of funds under
subparagraph (A), the Secretary shall take into
consideration the effectiveness of the criteria
required and an estimation of increased costs.
``(4) Construction requirements.--The Secretary and a State
may establish differing requirements for the construction of
new facilities, for the rehabilitation of facilities, and for
modifications specifically to improve safety and for facilities
based on the level of expected pedestrian and bicycle
traffic.''.
(b) Nonmotorized Transportation Safety.--Section 120(c) of title
23, United States Code, is amended--
(1) in the first sentence, by striking ``The Federal'' and
inserting the following:
``(2) Federal share.--The Federal'';
(2) in the second sentence, by striking ``In this
subsection, the term'' and inserting the following:
``(1) Definitions.--In this subsection:
``(A) Bicycle and pedestrian safety.--The term
`bicycle and pedestrian safety' means any improvement
that--
``(i) promotes the safety of bicyclists and
pedestrians (including people with
disabilities); and
``(ii) is consistent with sections 134 and
135.
``(B) Safety rest area.--The term'';
(3) by moving paragraph (1) (as added by paragraph (2)) so
as to appear before paragraph (2) (as added by paragraph (1));
and
(4) by adding at the end the following:
``(3) Statement of policy by state transportation
departments.--
``(A) In general.--Each State transportation
department shall adopt a statement of policy ensuring
that the needs and safety of all road users (including
the need for pedestrian and bicycle safety) are fully
integrated into the planning, design, operation and
maintenance of the transportation system of the State
transportation department.
``(B) Basis.--In the case of bicycle and pedestrian
safety, the statement of policy shall be based on the
design guidance on accommodating bicyclists and
pedestrians of the Federal Highway Administration
adopted in February 2000.
``(C) Reports.--Not later 1 year after the date of
enactment of this paragraph, and each year thereafter,
the Secretary shall submit to Congress a report on the
statements of policy adopted under this paragraph.
``(4) Nonmotorized transportation goal.--
``(A) In general.--The Secretary shall take such
actions as are necessary to, to the maximum extent
practicable, double the percentage of trips made by
foot or bicycle while simultaneously reducing crashes
involving bicyclists and pedestrians by 10 percent, in
a manner consistent with the goals of the national
bicycling and walking study conducted during 1994.
``(B) Administration.--Not later than 1 year after
the date of enactment of this paragraph, the Secretary
shall establish such baseline and completion dates as
are necessary to carry out subparagraph (A).
``(5) Research for nonmotorized users.--
``(A) Findings.--Congress finds that--
``(i) it is in the national interest to
meet the goals of the national bicycling and
walking study by the completion date
established under paragraph (4)(B);
``(ii) research into the safety and
operation of the transportation system for
nonmotorized users is inadequate, given that
almost 1 in 10 trips are made by foot or
bicycle and 1 in 8 traffic fatalities involves
a bicyclist or pedestrian; and
``(iii) inadequate data collection,
especially on exposure rates and infrastructure
needs, are hampering efforts to improve bicycle
and pedestrian safety and use to meet local
transportation needs.
``(B) Allocation of research funds for nonmotorized
users.--
``(i) In general.--The Secretary shall
submit to Congress an annual report on the
percentage of research funds that are allocated
(for the most recent fiscal year for which data
are available) to research that directly
benefits the planning, design, operation, and
maintenance of the transportation system for
nonmotorized users--
``(I) by the Department of
Transportation; and
``(II) by State transportation
departments.
``(ii) National cooperative highway
research program.--The Transportation Research
Board of the National Academy of Sciences shall
submit to Congress an annual report on the
percentage of research funds under the National
Cooperative Highway Research Program that are
allocated (for the most recent fiscal year for
which data are available) to research that
directly benefits the planning, design,
operation, and maintenance of the
transportation system for nonmotorized users.
``(iii) Department of transportation
allocation.--Effective beginning with the third
full fiscal year that begins after the date of
enactment of this paragraph, the Secretary
shall allocate at least 10 percent of the
research funds that are allocated by the
Department of Transportation for each fiscal
year to research that directly benefits the
planning, design, operation, and maintenance of
the transportation system for nonmotorized
users.
``(6) Metropolitan planning organizations.--
``(A) Bicycle/pedestrian coordinators.--A
metropolitan planning organization shall a designate a
bicycle/pedestrian coordinator to coordinate bicycle
and pedestrian programs and activities carried out in
the area served by the organization.
``(B) Certification.--A metropolitan planning
organization shall certify to the Secretary, as part of
the certification review, that--
``(i) the needs of bicyclists and
pedestrians (including people who use
wheelchairs and people with vision impairment)
have been adequately addressed by the long-
range transportation plan of the organization;
and
``(ii) the bicycle and pedestrian projects
to implement the plan in a timely manner are
included in the transportation improvement
program of the organization.
``(C) Long-range transportation plans.--
``(i) In general.--Except as provided in
clause (ii), a metropolitan planning
organization shall develop and adopt a long-
range transportation plan that--
``(I) includes the most recent data
available on the percentage of trips
made by foot and by bicycle in each
jurisdiction;
``(II) includes a target level for
bicycle and pedestrian trips that is
commensurate with the national goal of
doubling the percentage of trips made
by foot and bicycle established under
paragraph (4); and
``(III) identify the contribution
made by each project under the
transportation improvement program of
the organization toward meeting the
goal of doubling the percentage of
trips made by foot and bicycle.
``(ii) Application.--Clause (i) does not
apply to a metropolitan planning organization
that adopts the design guidance described in
paragraph (3)(B) for all transportation
projects carried out by the organization.
``(D) Local jurisdictions.--A metropolitan planning
organization shall strongly encourage local
jurisdictions that are served by the organization to
maximize the efforts of the local jurisdictions to
include sidewalks, bikepaths, and road intersections
that maximize bicycle and pedestrian safety in the
local transportation systems of the local
jurisdictions.''.
(c) Safe Routes to Schools Program.--
(1) In general.--Subchapter I of chapter I of title 23,
United States Code, is amended by inserting after section 149
the following:
``Sec. 150. Safe routes to schools program
``(a) Definitions.--In this section:
``(1) In the vicinity of schools.--The term `in the
vicinity of schools' means, with respect to primary and middle
schools, the area within bicycling and walking distance of the
primary and middle schools (approximately 2 miles).
``(2) Primary and middle schools.--The term `primary and
middle schools' means schools providing education from
kindergarten through eighth grade.
``(b) Establishment.--The Secretary shall establish and carry out a
safe routes to schools program for the benefit of children in primary
and middle schools.
``(c) Purposes.--The purposes of the program are--
``(1) to enable and encourage children, including children
with disabilities, to walk and bicycle to primary and middle
schools;
``(2) to make bicycling and walking to primary and middle
schools a safer and more appealing transportation alternative,
thereby encouraging a healthy and active lifestyle from an
early age; and
``(3) to facilitate the planning, development, and
implementation of projects and activities that will improve
safety and reduce traffic, fuel consumption, and air pollution
in the vicinity of primary and middle schools.
``(d) Apportionment of Funds.--
``(1) In general.--Subject to paragraphs (2) and (3),
amounts made available to carry out this subsection for a
fiscal year shall be apportioned among the States in the ratio
that--
``(A) the total student enrollment in primary and
middle schools in each State; bears to
``(B) the total student enrollment in primary and
middle schools in all the States.
``(2) Minimum apportionment.--No State shall receive an
apportionment under this section for a fiscal year of less than
$2,000,000.
``(3) Set-aside.--Before apportioning amounts made
available to carry out this section under this subsection for a
fiscal year, the Secretary shall set aside not more than 2
percent of those amounts to pay the administrative expenses
incurred by the Secretary in carrying out this section.
``(4) Determination of student enrollments.--Determinations
under this subsection concerning student enrollments shall be
made by the Secretary.
``(e) Administration of Amounts.--Amounts apportioned to a State
under this section shall be administered by the applicable State
transportation department.
``(f) Eligible Recipients.--Amounts apportioned to a State under
this section shall be used by the State to provide financial assistance
to State, local, and regional agencies, including nonprofit
organizations, that demonstrate an ability to meet the requirements of
this section.
``(g) Eligible Projects and Activities.--
``(1) Infrastructure-related projects.--
``(A) In general.--Amounts apportioned to a State
under this section may be used for the planning,
design, and construction of infrastructure-related
projects that will substantially improve the ability of
students to walk and bicycle to primary and middle
schools in the vicinity of primary and middle schools,
including--
``(i) sidewalk improvements;
``(ii) traffic calming and speed reduction
improvements;
``(iii) pedestrian and bicycle crossing
improvements;
``(iv) on-street bicycle facilities;
``(v) off-street bicycle and pedestrian
facilities;
``(vi) secure bicycle parking facilities;
and
``(vii) traffic diversion improvements.
``(B) Location of projects.--An infrastructure-
related project under subparagraph (A) may be carried
out on any public road or any bicycle or pedestrian
pathway or trail in the vicinity of a primary or middle
school.
``(2) Noninfrastructure-related activities.--
``(A) In general.--In addition to projects
described in paragraph (1), amounts apportioned to a
State under this section may be used for
noninfrastructure-related activities to encourage
walking and bicycling to primary and middle schools,
including--
``(i) public awareness campaigns and
outreach to press and community leaders;
``(ii) traffic education and enforcement in
the vicinity of primary and middle schools;
``(iii) student sessions on bicycle and
pedestrian safety, health, and environment; and
``(iv) funding for training, volunteers,
and managers of safe routes to schools
programs.
``(B) Allocation.--Not less than 10 percent and not
more than 30 percent of the amount apportioned to a
State under this subsection for a fiscal year shall be
used for noninfrastructure-related activities under
this paragraph.
``(3) Safe routes to school coordinator.--Each State
receiving an apportionment under this section for a fiscal year
shall use a sufficient amount of the apportionment to fund a
full-time position of coordinator of the safe routes to schools
program of the State.
``(h) Clearinghouse.--
``(1) In general.--The Secretary shall make grants to a
national nonprofit organization engaged in promoting safe
routes to schools to--
``(A) operate a national safe routes to school
clearinghouse;
``(B) develop information and educational programs
on safe routes to schools; and
``(C) provide technical assistance and disseminate
techniques and strategies used for successful safe
routes to schools programs.
``(2) Funding.--The Secretary shall carry out this
subsection using amounts set aside for administrative expenses
under subsection (d)(3).
``(i) Task Force.--
``(1) In general.--The Secretary shall establish a national
safe routes to schools task force composed of leaders in
health, transportation, and education, including
representatives of appropriate Federal agencies, to study and
develop a strategy for advancing safe routes to schools
programs nationwide.
``(2) Report.--Not later than March 31, 2006, the Secretary
shall submit to Congress a report containing--
``(A) the results of the study conducted, and a
description of the strategy developed, under paragraph
(1); and
``(B) information regarding the use of funds for
infrastructure-related and noninfrastructure-related
activities under paragraphs (1) and (2) of subsection
(g).
``(3) Funding.--The Secretary shall carry out this
subsection using amounts set aside for administrative expenses
under subsection (d)(3).
``(j) Applicability.--
``(1) In general.--Except as otherwise provided in this
subsection, funds made available to carry out this section
shall be available for obligation in the same manner as funds
apportioned under this chapter.
``(2) Availability.--Funds made available to carry out this
section shall not be transferable and shall remain available
until expended.
``(3) Federal share.--The Federal share of the cost of a
project or activity under this section shall be 100 percent.
``(4) Federal-aid system.--Notwithstanding any other
provision of law, a project assisted under this section shall
be treated as a project on a Federal-aid system under this
chapter.''.
(2) Authorizations of appropriations.--There are authorized
to be appropriated from the Highway Trust Fund (other than the
Mass Transit Account) for the safe routes to schools programs
under section 150 of title 23, United States Code (as added by
paragraph (1))--
(A) $175,000,000 for fiscal year 2006;
(B) $200,000,000 for fiscal year 2007;
(C) $200,000,000 for fiscal year 2008;
(D) $200,000,000 for fiscal year 2009; and
(E) $225,000,000 for fiscal year 2010.
(3) Conforming amendments.--The analysis for subchapter I
of chapter 1 of title 23, United States Code is amended by
inserting after the item relating to section 149 the following:
``150. Safe routes to schools program.''.
(d) Nonmotorized Transportation Pilot Program.--
(1) Establishment.--The Secretary of Transportation shall
establish and carry out a nonmotorized transportation pilot
program to construct, in 4 communities selected by the
Secretary, a network of nonmotorized transportation
infrastructure facilities (including sidewalks, bicycle lanes,
and pedestrian and bicycle trails) that connect directly with
transit stations, schools, residences, businesses, recreation
areas, and other community activity centers.
(2) Purpose.--The purpose of the program shall be to
demonstrate the extent to which bicycling and walking can ease
the burden on transportation systems, and represent a major
portion of the transportation needs that are met, within
selected communities.
(3) Grants.--
(A) In general.--In carrying out the program, the
Secretary may make grants to State, local, and regional
agencies that the Secretary determines are suitably
equipped and organized to carry out the objectives and
requirements of this subsection.
(B) Suballocation.--An agency that receives a grant
under this section may suballocate grant funds to a
nonprofit organization to carry out the program under
this subsection.
(4) Applicability of title 23.--
(A) In general.--Except as otherwise provided in
this paragraph, funds made available to carry out this
subsection shall be available for obligation in the
same manner as if the funds were apportioned under
chapter 1 of title 23, United States Code.
(B) Availability.--Funds made available to carry
out this subsection shall not be transferable and shall
remain available until expended.
(C) Federal share.--The Federal share of the cost
of a project carried out under this subsection shall be
80 percent.
(5) Statistical information.--In carrying out the program,
the Secretary shall--
(A) develop statistical information on changes in
motor vehicle, nonmotorized transportation, and public
transportation usage in communities participating in
the program; and
(B) assess how the changes--
(i) decrease congestion and energy usage;
(ii) increase the frequency of biking and
walking; and
(iii) promote better health and a cleaner
environment.
(6) Reports.--The Secretary shall submit to Congress an
interim report not later than September 30, 2007, and a final
report not later than September 30, 2010, on the results of the
program.
(7) Authorizations of appropriations.--There is authorized
to be appropriated from the Highway Trust Fund (other than the
Mass Transit Account) to carry out the nonmotorized pilot
program under this subsection $25,000,000 for each of fiscal
years 2006 through 2010.
SEC. 214. NATIONAL ASSESSMENT OF MENTAL HEALTH NEEDS.
Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.)
is amended by inserting after section 506B (42 U.S.C. 290aa-5b) the
following:
``SEC. 506C. NATIONAL ASSESSMENT OF MENTAL HEALTH NEEDS.
``(a) In General.--The Secretary, acting through the Administrator,
and in consultation with the Centers for Disease Control and Prevention
and the Director of the National Institutes of Health, shall establish
and implement public health monitoring measures to address the mental
and behavioral health needs of the population of the United States and
other populations served by the Administration, that include--
``(1) monitoring the mental health status of the
population, including incidence and prevalence rates of mental
and behavioral health problems throughout the lifespan;
``(2) monitoring mental and behavioral health risks;
``(3) enhancing existing public health monitoring systems
to include data on mental and behavioral health status and
risks; and
``(4) monitoring the immediate and long-term impact of
environmental factors to collect data on the prevalence of
mental and behavioral health problems throughout the lifespan
with the aim of encouraging early intervention and treatment.
``(b) Distinguishing Among Age Groups.--In designing and
implementing the measures described in subsection (a) the Secretary
shall ensure that methods of monitoring and reporting data distinguish
among different age groups, including when identifying groups of
children, and very young children under age 3, together with their
parents.
``(c) Report.--Not later than 1 year after the date of enactment of
this section, the Secretary shall submit a report to Congress that
describes the progress on the implementation of the monitoring measures
described in subsection (a).
``(d) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for fiscal year 2006
and such sums as may be necessary for each of the following fiscal
years.''.
SEC. 215. PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAINING GRANT PROGRAM.
Part C of title VII of the Public Health Service Act is amended by
inserting after section 747 (42 U.S.C. 293k) the following:
``SEC. 747A. PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAINING GRANT
PROGRAM.
``(a) Grants.--The Secretary may award grants to, or enter into
contracts with, eligible entities to provide training to graduate
medical residents in preventive medicine and public health.
``(b) Eligibility.--To be eligible to receive a grant or contract
under subsection (a), an entity shall--
``(1) be a school of public health, public health
department, school of medicine or osteopathic medicine, public
or private hospital, or public or private non-profit entity;
and
``(2) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may require.
``(c) Preference and Special Consideration.--
``(1) Preference.--In awarding grants or contracts under
this section, the Secretary shall give preference to one or
more eligible entities that have a record of training providers
who practice preventive medicine or public health as compared
to other eligible entities.
``(2) Special consideration.--In awarding grants or
contracts under this section, the Secretary shall give special
consideration to eligible entities that will carry out projects
under the grant or contract that train physicians in community-
based approaches to combating the incidence rates of obesity,
diabetes, heart disease, cancer, and other chronic diseases,
and institutions that have a record of training qualified
individuals from disadvantaged backgrounds.
``(d) Use of Funds.--Amounts received under a grant or contract
under this section shall be used to--
``(1) to plan, develop, and operate residency programs for
preventive medicine or public health;
``(2) provide financial assistance, including tuition and
stipends, to resident physicians (MD or DO) who plan to
specialize in preventive medicine or public health;
``(3) defray the costs associated with the planning,
development, and operation of preventive medicine or public
health programs, including the development of curriculum to be
used in such program; and
``(4) provide for the improvement of academic
administrative units.
``(e) Duration of Award.--A grant or contract under this section
shall be for a term not to exceed 5 years.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $43,000,000 for fiscal year
2006, and such sums as may be necessary for each succeeding fiscal
year.''.
SEC. 216. TASK FORCE FOR THE PROMOTION OF BREASTFEEDING IN THE
WORKPLACE.
(a) Establishment.--The Secretary of Health and Human Services and
the Secretary of Labor, or their designees, shall convene a task force
for the purpose of promoting breastfeeding among working mothers
(referred to in this section as the ``Task Force'').
(b) Membership.--The Task Force shall be composed of members who
are--
(1) expert staff from the Department of Labor with
expertise in workforce issues;
(2) expert staff from the Department of Health and Human
Services with expertise in the areas of breastfeeding and
breastfeeding promotion;
(3) members of the United States Breastfeeding Committee;
(4) expert staff from the Department of Agriculture; and
(5) appointed by the Secretary of Health and Human Services
and the Secretary of Labor, including--
(A) working mothers who have experience in working
and breastfeeding; and
(B) representatives of the human resource
departments of both large and small employers that have
successfully promoted breastfeeding and breastmilk
pumping support at work.
(c) Period of Appointment; Vacancies.--Members shall be appointed
for the life of the Task Force. Any vacancy in the Task Force shall not
affects its powers, but shall be filled in the same manner as the
original appointment.
(d) Chair.--The Task Force shall be chaired jointly by the
Secretary of Health and Human Services and the Secretary of Labor, or
their designees.
(e) Duties of the Task Force.--
(1) Examination.--Consistent with the Department of Health
and Human Services Blueprint for Action on Breastfeeding
(2000), the Task Force shall examine the following issues:
(A) The challenges that mothers face with
continuing breastfeeding when the mothers return to
work after giving birth.
(B) The challenges that employers face in
accommodating mothers who seek to continue to
breastfeed or to express milk when the mothers re-enter
the workforce, including different challenges that
mothers of varying socio-economic status and in
different professions may face.
(C) The benefits that accrue to mothers, babies,
and to employers when mothers are able to continue to
breastfeed or to express breastmilk at work after the
mothers have re-entered the workforce.
(D) Federal and State statutes that may have the
effect of reducing breastfeeding and breastfeeding
retention rates among working mothers.
(2) Reports.--
(A) In general.--Not later than 1 year after the
date of enactment of this section, the Task Force shall
issue a public report with recommendations on the
following:
(i) Steps that can be taken to promote
breastfeeding among working mothers and to
remove barriers to breastfeeding among working
mothers.
(ii) Potential ways in which the Federal
Government can work with employers to promote
breastfeeding among working mothers.
(iii) Areas in which changes to existing
Federal, State, or local laws would likely have
the effect of making it easier for working
mothers to breastfeed or would remove
impediments to breastfeeding that currently
exist in such laws.
(iv) Whether or not increased rates of
breastfeeding among working mothers would
likely have the result of reducing health care
costs among such mothers and their children,
and, in particular, whether increased rates of
breastfeeding would be likely to result in
lower Federal expenditures on health care for
such mothers and their children.
(v) Areas in which the Federal Government,
through additional appropriations, increased
efforts by Federal agencies, or changes to
existing Federal law, can and should increase
the Federal Government's efforts to promote
breastfeeding among working mothers.
(B) Copy to congress.--Upon completion of the
report described in subparagraph (A), the Task Force
shall submit a copy of the report to the Committee on
Health, Education, Labor, and Pensions of the Senate,
the Committee on Appropriations of the Senate, the
Committee on Education and the Workforce of the House
of Representatives, and the Committee on Appropriations
of the House of Representatives.
(f) Powers of the Task Force.--
(1) Hearings.--The Task Force may hold such hearings, sit
and act at such times and places, take such testimony, and
receive such evidence as the Task Force considers advisable to
carry out this section.
(2) Information from federal agencies.--The Task Force may
secure directly from any Federal department or agency such
information as the Task Force considers necessary to carry out
this section. Upon request of the Chair of the Task Force, the
head of such department or agency shall furnish such
information to the task Force.
(3) Postal services.--The Task Force may use the United
States mails in the same manner and under the same conditions
as other departments and agencies of the Federal Government.
(4) Gifts.--The Task Force may accept, use, and dispose of
gifts or donations of services or property.
(g) Operating Expenses.--The operating expenses of the Task Force,
including travel expenses for members of the Task Force, shall be paid
for from the general operating expenses funds of the Secretary of
Health and Human Services and the Secretary of Labor.
SEC. 217. LACTATION ACCOMMODATION AND BREASTFEEDING PROMOTION AT WORK.
(a) Breastfeeding at Work General Requirements.--The Family and
Medical Leave Act of 1993 (29 U.S.C. 2611 et seq.) is amended by
inserting after title IV the following:
``TITLE V--LACTATION PERIODS AND FACILITIES
``SEC. 501. DEFINITIONS.
``In this title:
``(1) Eligible child.--The term `eligible child', used with
respect to an eligible employee, means a son or daughter (as
defined in section 101) who is a child of the employee.
``(2) Eligible employee.--The term `eligible employee' has
the meaning given the term in section 101, except that the
limitations established in clauses (i) and (ii) of section
101(2)(A) shall not apply. The term `eligible employee' does
not include any Federal officer or employee covered under
subchapter VII of chapter 63 of title 5, United States Code,
but does include a State employee described in section 304(a)
of the Government Employee Rights Act of 1991 (42 U.S.C. 2000e-
16c(a)).
``(3) Employer.--The term `employer' has the meaning given
the term in section 101, and includes an entity employing a
State employee described in section 304(a) of the Government
Employee Rights Act of 1991.
``(4) Undue hardship.--The term `undue hardship' means an
action requiring significant difficulty or expense.
``SEC. 502. LACTATION PERIODS.
``(a) In General.--An employer shall provide an appropriate number
of lactation periods, of reasonable length, for an eligible employee
during each workday, to permit the employee to express milk for, or
breastfeed, an eligible child.
``(b) Break Time.--
``(1) Unpaid break periods.--Except as provided in
paragraph (2), the lactation periods may consist of unpaid
break periods.
``(2) Combined break periods.--To the extent practicable,
an employer shall combine break periods by providing the
lactation periods for an eligible employee at the same time as
the employer provides other break periods for the employee. If
the employer combines the break periods, the employee shall
receive the same compensation for a combined break period as
the employee would have received for an original break period.
``(c) Limitation.--
``(1) Undue hardship.--An employer shall not be required to
provide a lactation period under this section if the employer
demonstrates that providing the period would impose an undue
hardship on the employer, subject to paragraph (2).
``(2) Reasonable efforts.--An employer who maintains that
an undue hardship would result from providing a lactation
period to an eligible employee shall demonstrate that the
employer made reasonable efforts to comply with subsections (a)
and (b).
``SEC. 503. LACTATION FACILITIES.
``(a) In General.--An employer shall provide an appropriate
lactation facility for an eligible employee, within a reasonable
distance from the employee's usual work location, to permit the
employee to express milk for, or breastfeed, an eligible child.
``(b) Limitation.--
``(1) Undue hardship.--An employer shall not be required to
provide a lactation facility under this section if the employer
demonstrates that providing the facility would impose an undue
hardship on the employer, subject to paragraph (2).
``(2) Reasonable efforts.--An employer who maintains that
an undue hardship would result from providing a lactation
facility to an eligible employee shall demonstrate that the
employer made reasonable efforts to comply with subsection (a).
``SEC. 504. ENFORCEMENT AND REMEDIES.
``(a) Enforcement Process.--The Secretary of Labor shall establish
or designate a process through which--
``(1) an individual may file a complaint regarding a
violation of this title; and
``(2) an office designated by the Secretary in the
Department of Labor shall receive, investigate, make
determinations regarding, and administer remedies with respect
to such complaints.
``(b) Remedies.--The Secretary of Labor shall establish remedies
for violations of this title.
``(c) Government Accountability Office and Library of Congress.--In
the case of the Government Accountability Office and the Library of
Congress, the authority of the Secretary of Labor under this title
shall be exercised respectively by the Comptroller General of the
United States and the Librarian of Congress.
``SEC. 505. REGULATIONS.
``The Secretary of Labor shall issue regulations to carry out this
title, including provisions prescribing--
``(1) an appropriate number and reasonable length of
lactation periods, for purposes of section 502;
``(2) an appropriate lactation facility (which shall not be
a restroom or a portion of a restroom) and a reasonable
distance from a usual work location, for purposes of section
503; and
``(3) the process and remedies described in section 504.''.
(b) Breastfeeding at Work for Civil Service Employees.--Chapter 63
of title 5, United States Code, is amended by adding at the end:
``SUBCHAPTER VII--LACTATION PERIODS AND FACILITIES
``Sec. 6392. Definitions
``For the purpose of this subchapter--
``(1) the term `eligible child', used with respect to an
employee, means a son or daughter (as defined in section 6381)
who is a child of the employee;
``(2) the term `employee' means any individual who is an
`employee', as defined by section 6301(2), including any
individual employed in a position referred to in clause (v) or
(ix) of section 6301(2), but excluding any individual employed
by the government of the District of Columbia, any individual
employed on a temporary or intermittent basis, and any employee
of the General Accounting Office or the Library of Congress;
and
``(3) the term `undue hardship' means an action requiring
significant difficulty or expense.
``Sec. 6392A. Lactation periods
``(a) An employing agency shall provide an appropriate number of
lactation periods, of reasonable length, for an employee during each
workday, to permit the employee to express milk for, or breastfeed, an
eligible child.
``(b)(1) Except as provided in paragraph (2), the lactation periods
may consist of unpaid break periods.
``(2) To the extent practicable, an employing agency shall combine
break periods by providing the lactation periods for an employee at the
same time as the employing agency provides other break periods for the
employee. If the employing agency combines the break periods, the
employee shall receive the same compensation for a combined break
period as the employee would have received for an original break
period.
``(c)(1) An employing agency shall not be required to provide a
lactation period under this section if the employing agency
demonstrates that providing the period would impose an undue hardship
on the employing agency, subject to paragraph (2).
``(2) An employing agency who maintains that an undue hardship
would result from providing a lactation period to an employee shall
demonstrate that the employing agency made reasonable efforts to comply
with subsections (a) and (b).
``Sec. 6392B. Lactation facilities
``(a) An employing agency shall provide an appropriate lactation
facility for an employee, within a reasonable distance from the
employee's usual work location, to permit the employee to express milk
for, or breastfeed, an eligible child.
``(b)(1) An employing agency shall not be required to provide a
lactation facility under this section if the employing agency
demonstrates that providing the facility would impose an undue hardship
on the employing agency, subject to paragraph (2).
``(2) An employing agency who maintains that an undue hardship
would result from providing a lactation facility to an employee shall
demonstrate that the employing agency made reasonable efforts to comply
with subsection (a).
``Sec. 6392C. Remedies
``(a) The Office of Personnel Management shall establish or
designate a process through which--
``(1) an individual may file a complaint regarding a
violation of this subchapter; and
``(2) an office designated by the Director of the Office of
Personnel Management shall receive, investigate, make
determinations regarding, and administer remedies with respect
to such complaints.
``(b) The Office of Personnel Management shall establish remedies
for violations of this subchapter.
``Sec. 6392D. Regulations
``(a) The Office of Personnel Management shall issue regulations to
carry out this subchapter, including provisions prescribing--
``(1) an appropriate number and reasonable length of
lactation periods, for purposes of section 6392A;
``(2) an appropriate lactation facility (which shall not be
a restroom or a portion of a restroom) and a reasonable
distance from a usual work location, for purposes of section
6392B; and
``(3) the process and remedies described in section 6392C.
``(b) The regulations prescribed under this subchapter shall, to
the extent appropriate, be consistent with the regulations prescribed
by the Secretary of Labor to carry out title V of the Family and
Medical Leave Act of 1993.''.
(c) Breastfeeding at Work for Congressional Employees.--
(1) Application of laws.--Section 102(a) of the
Congressional Accountability Act of 1995 (2 U.S.C. 1302(a)) is
amended--
(A) in paragraph (5), by striking ``The'' and
inserting ``Title I of the''; and
(B) by adding at the end the following:
``(12) Title V of the Family and Medical Leave Act of
1993.''.
(2) Extension of rights and protections.--Part A of title
II of the Congressional Accountability Act of 1995 (2 U.S.C.
1311 et seq.) is amended--
(A) in section 202 (2 U.S.C. 1312), by striking the
title and inserting the following:
``SEC. 202. RIGHTS AND PROTECTIONS UNDER TITLE I OF THE FAMILY AND
MEDICAL LEAVE ACT OF 1993.'';
(B) by redesignating section 207 as section 208;
and
(C) by inserting after section 206 the following:
``SEC. 207. RIGHTS AND PROTECTIONS UNDER TITLE V OF THE FAMILY AND
MEDICAL LEAVE ACT OF 1993.
``(a) Breastfeeding Rights and Protections Provided.--
``(1) In general.--The rights and protections established
by sections 501 through 503 of the Family and Medical Leave Act
of 1993 shall apply to covered employees.
``(2) Definition.--For purposes of the application
described in paragraph (1)--
``(A) the term `employer' as used in the Family and
Medical Leave Act of 1993 means any employing office;
and
``(B) the term `eligible employee' as used in the
Family and Medical Leave Act of 1993 means a covered
employee who has been employed in any employing office.
``(b) Remedy.--The remedy for a violation of subsection (a) shall
be such remedy as would be appropriate if awarded under section 504 of
the Family and Medical Leave Act of 1993.
``(c) Regulations.--
``(1) In general.--The Board shall, pursuant to section
304, issue regulations to implement the rights and protections
under this section.
``(2) Agency regulations.--The regulations issued under
paragraph (1) shall be the same as substantive regulations
promulgated by the Secretary of Labor to implement the
statutory provisions referred to in subsections (a) and (b),
except insofar as the Board may determine, for good cause shown
and stated together with the issued regulations, that a
modification of such promulgated regulations would be more
effective for the implementation of the rights and protections
under this section.''.
(3) Table of contents.--The table of contents for the
Congressional Accountability Act of 1995 is amended by striking
the item relating to section 207 and inserting the following:
``Sec. 207. Rights and protections under title V of the Family and
Medical Leave Act of 1993.
``Sec. 208. Prohibition of intimidation or reprisal.''.
(d) Breastfeeding at Work for Employees in Presidential Offices.--
(1) Application of laws.--Section 402 of title 3, United
States Code, is amended--
(A) in paragraph (5), by striking ``The'' and
inserting ``Title I of the''; and
(B) by adding at the end the following:
``(12) Title V of the Family and Medical Leave Act of
1993.''.
(2) Extension of rights and protections.--Subchapter II of
chapter 5 of title 3, United States Code, is amended--
(A) in section 412, by striking the title and
inserting the following:
``SEC. 412. RIGHTS AND PROTECTIONS UNDER TITLE I OF THE FAMILY AND
MEDICAL LEAVE ACT OF 1993.'';
(B) by redesignating section 417 as section 418;
and
(C) by inserting after section 416 the following:
``SEC. 417. RIGHTS AND PROTECTIONS UNDER TITLE V OF THE FAMILY AND
MEDICAL LEAVE ACT OF 1993.
``(a) Breastfeeding Rights and Protections Provided.--
``(1) In general.--The rights and protections established
by sections 501 through 503 of the Family and Medical Leave Act
of 1993 shall apply to covered employees.
``(2) Definition.--For purposes of the application
described in paragraph (1)--
``(A) the term `employer' as used in the Family and
Medical Leave Act of 1993 means any employing office;
and
``(B) the term `eligible employee' as used in the
Family and Medical Leave Act of 1993 means a covered
employee.
``(b) Remedy.--The remedy for a violation of subsection (a) shall
be such remedy as would be appropriate if awarded under section 504 of
the Family and Medical Leave Act of 1993.
``(c) Regulations.--
``(1) In general.--The President, or the designee of the
President, shall issue regulations to implement this section.
``(2) Agency regulations.--The regulations issued under
paragraph (1) shall be the same as substantive regulations
promulgated by the Secretary of Labor to implement the
statutory provisions referred to in subsections (a) and (b)--
``(A) except to the extent that the President or
designee may determine, for good cause shown and stated
together with the issued regulations, that a
modification of such promulgated regulations would be
more effective for the implementation of the rights and
protections under this section; and
``(B) except that the President or designee may, at
the discretion of the President or designee, issue
regulations to implement a provision of subchapter VII
of chapter 63 of title 5, United States Code, that
applies to employees in the executive branch of the
Federal Government in lieu of an analogous statutory
provision referred to in subsection (a) or (b), if the
issuance of such regulations--
``(i) would be equally effective for the
implementation of the rights and protections
under this section; and
``(ii) would promote uniformity in the
application of Federal law to employees in the
executive branch of the Federal Government.''.
(3) Conforming amendment.--Section 411(e) of title 3,
United States Code, is amended by striking ``417'' and
inserting ``418''.
(4) Table of contents.--The table of contents for chapter 5
of title 3, United States Code, is amended by striking the item
relating to section 417 and inserting the following:
``417. Rights and protections under title V of the Family and Medical
Leave Act of 1993.
``418. Prohibition of intimidation or reprisal.''.
(e) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), this
section and the amendments made by this section take effect 18
months after the date of enactment of this Act.
(2) Regulations.--Section 505 of the Family and Medical
Leave Act of 1993 (as added by subsection (a)), section 6392D
of title 5, United States Code (as added by subsection (b)),
section 207(c) of the Congressional Accountability Act of 1995
(as added by subsection (c)), and section 417(c) of title 3,
United States Code (as added by subsection (d)) take effect on
the date of enactment of this Act.
Subtitle C--Family Smoking Prevention and Control
SEC. 221. SHORT TITLE.
This subtitle may be cited as the ``Family Smoking Prevention and
Tobacco Control Act''.
SEC. 222. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results in
new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous and
cause cancer, heart disease, and other serious adverse health
effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems caused
by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold, marketed,
advertised, and distributed in interstate commerce on a
nationwide basis, and have a substantial effect on the Nation's
economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the use
of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration with
the authority to regulate tobacco products and the advertising
and promotion of such products. The benefits to the American
people from enacting such legislation would be significant in
human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in
the United States each year and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of them
from premature death due to tobacco induced disease. Such a
reduction in youth smoking would also result in approximately
$75,000,000,000 in savings attributable to reduced health care
costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young persons
to use tobacco products and these efforts have resulted in
increased use of such products by youth. Past efforts to
oversee these activities have not been successful in adequately
preventing such increased use.
(16) In 2002, the tobacco industry spent more than
$12,466,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-term
attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and
healthful to minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products including
tobacco use by young people.
(23) Children are more influenced by tobacco advertising
than adults, they smoke the most advertised brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price-sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for education
about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a greater
impact on overall tobacco use and young people's use than
weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of the
Federal Register (61 Fed. Reg. 44615-44618) for inclusion as
part 897 of title 21, Code of Federal Regulations, are
consistent with the First Amendment to the United States
Constitution and with the standards set forth in the amendments
made by this subtitle for the regulation of tobacco products by
the Food and Drug Administration and the restriction on the
sale and distribution, including access to and the advertising
and promotion of, tobacco products contained in such
regulations are substantially related to accomplishing the
public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are
minors and become addicted to the nicotine in those products
before reaching the age of 18. Tobacco advertising and
promotion plays a crucial role in the decision of these minors
to begin using tobacco products. Less restrictive and less
comprehensive approaches have not and will not be effective in
reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of
tobacco products contained in such regulations will lead to a
significant decrease in the number of minors using and becoming
addicted to those products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are
narrowly tailored to restrict those advertising and promotional
practices which are most likely to be seen or heard by youth
and most likely to entice them into tobacco use, while
affording tobacco manufacturers and sellers ample opportunity
to convey information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-term
or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help them
quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks or
exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks,
those products can cause substantial harm to the public health
to the extent that the individuals, who would otherwise not
consume tobacco products or would consume such products less,
use tobacco products purporting to reduce risk. Those who use
products sold or distributed as modified risk products that do
not in fact reduce risk, rather than quitting or reducing their
use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The
costs to society of the widespread use of products sold or
distributed as modified risk products that do not in fact
reduce risk or that increase risk include thousands of
unnecessary deaths and injuries and huge costs to our health
care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce risk
are so high that there is a compelling governmental interest in
insuring that statements about modified risk tobacco products
are complete, accurate, and relate to the overall disease risk
of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to provide
clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would be
detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be approved in advance of
marketing, and to require that the evidence relied on to
support approval of these products is rigorous.
SEC. 223. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by
recognizing it as the primary Federal regulatory authority with
respect to the manufacture, marketing, and distribution of
tobacco products;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young people
and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are not
sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.
SEC. 224. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment made by
this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Secretary to take
certain actions with regard to tobacco and tobacco products shall not
be construed to affect any authority of the Secretary of Agriculture
under existing law regarding the growing, cultivation, or curing of raw
tobacco.
SEC. 225. SEVERABILITY.
If any provision of this Act, the amendments made by this Act, or
the application of any provision of this Act to any person or
circumstance is held to be invalid, the remainder of this Act, the
amendments made by this Act, and the application of the provisions of
this Act to any other person or circumstance shall not be affected and
shall continue to be enforced to the fullest extent possible.
PART I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 231. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products.--Section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at
the end the following:
``(nn)(1) The term `tobacco product' means any product made or
derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product).
``(2) The term `tobacco product' does not mean--
``(A) a product in the form of conventional food (including
water and chewing gum), a product represented for use as or for
use in a conventional food, or a product that is intended for
ingestion in capsule, tablet, softgel, or liquid form; or
``(B) an article that is approved or is regulated as a drug
by the Food and Drug Administration.
``(3) The products described in paragraph (2)(A) shall be subject
to chapter IV or chapter V of this Act and the articles described in
paragraph (2)(B) shall be subject to chapter V of this Act.
``(4) A tobacco product may not be marketed in combination with any
other article or product regulated under this Act (including a drug,
biologic, food, cosmetics, medical device, or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 907 as sections
1001 through 1007; and
(3) by inserting after section 803 the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 900. DEFINITIONS.
``In this chapter:
``(1) Additive.--The term `additive' means any substance
the intended use of which results or may reasonably be expected
to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco
product (including any substances intended for use as a
flavoring, coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or
holding), except that such term does not include tobacco or a
pesticide chemical residue in or on raw tobacco or a pesticide
chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, or
packaging, logo, registered trademark or brand name,
identifiable pattern of colors, or any combination of such
attributes.
``(3) Cigarette.--The term `cigarette' has the meaning
given that term by section 3(1) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1332(1)), but also
includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of tobacco
used in the filler, or its packaging and labeling, is likely to
be offered to, or purchased by, consumers as a cigarette or as
roll-your-own tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements for cigarettes shall also apply to
cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1332(2)).
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization, bears
the trademark, trade name, or other identifying mark, imprint
or device, or any likeness thereof, of a tobacco product listed
in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the distribution
of a tobacco product, whether domestic or imported, at any
point from the original place of manufacture to the person who
sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors
for purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution, sale,
or purchase of tobacco products including any practice or
conduct intended to facilitate such activity.
``(9) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self
Determination and Education Assistance Act (25 U.S.C. 450b(e)).
``(10) Little cigar.--The term `little cigar' has the
meaning given that term by section 3(7) of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
``(11) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(12) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container, any
wrapping (including cellophane), in which a tobacco product is
offered for sale, sold, or otherwise distributed to consumers.
``(13) Retailer.--The term `retailer' means any person who
sells tobacco products to individuals for personal consumption,
or who operates a facility where self-service displays of
tobacco products are permitted.
``(14) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco which, because of its appearance,
type, packaging, or labeling, is suitable for use and likely to
be offered to, or purchased by, consumers as tobacco for making
cigarettes.
``(15) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by
the combustion or heating of tobacco, additives, or other
component of the tobacco product.
``(16) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
``(17) State.--The term `State' means any State of the
United States and, for purposes of this chapter, includes the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, Johnston Atoll, the Northern Mariana
Islands, and any other trust territory or possession of the
United States.
``(18) Tobacco product manufacturer.--Term `tobacco product
manufacturer' means any person, including any repacker or
relabeler, who--
``(A) manufactures, fabricates, assembles,
processes, or labels a tobacco product; or
``(B) imports a finished cigarette or smokeless
tobacco product for sale or distribution in the United
States.
``(19) United states.--The term `United States' means the
50 States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco products shall be regulated by the
Secretary under this chapter and shall not be subject to the provisions
of chapter V, unless--
``(1) such products are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease (within
the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
``(2) a claim is made for such products under section
201(g)(1)(C) or 201(h)(3);
other than modified risk tobacco products approved in
accordance with section 911.
``(b) Applicability.--This chapter shall apply to all tobacco
products subject to the regulations referred to in section 232 of the
Family Smoking Prevention and Tobacco Control Act, and to any other
tobacco products that the Secretary by regulation deems to be subject
to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or the Family
Smoking Prevention and Tobacco Control Act, shall be construed
to affect the Secretary's authority over, or the regulation of,
products under this Act that are not tobacco products under
chapter V or any other chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter
shall not apply to tobacco leaf that is not in the
possession of a manufacturer of tobacco products, or to
the producers of tobacco leaf, including tobacco
growers, tobacco warehouses, and tobacco grower
cooperatives, nor shall any employee of the Food and
Drug Administration have any authority to enter onto a
farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding any other
provision of this subparagraph, if a producer of
tobacco leaf is also a tobacco product manufacturer or
controlled by a tobacco product manufacturer, the
producer shall be subject to this chapter in the
producer's capacity as a manufacturer.
``(C) Rule of construction.--Nothing in this
chapter shall be construed to grant the Secretary
authority to promulgate regulations on any matter that
involves the production of tobacco leaf or a producer
thereof, other than activities by a manufacturer
affecting production.
``SEC. 902. ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that may
render the product injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health;
``(4) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product standard
established under section 907 unless such tobacco product is in
all respects in conformity with such standard;
``(5)(A) it is required by section 910(a) to have premarket
approval and does not have an approved application in effect;
or
``(B) it is in violation of the order approving such an
application;
``(6) the methods used in, or the facilities or controls
used for, its manufacture, packing or storage are not in
conformity with applicable requirements under section 906(e)(1)
or an applicable condition prescribed by an order under section
906(e)(2); or
``(7) it is in violation of section 911.
``SEC. 903. MISBRANDED TOBACCO PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco
product manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical
count;
``(C) an accurate statement of the percentage of
the tobacco used in the product that is domestically
grown tobacco and the percentage that is foreign grown
tobacco; and
``(D) the statement required under section 921(a),
except that under subparagraph (B) reasonable
variations shall be permitted, and exemptions as to
small packages shall be established, by regulations
prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by the
Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or adequate
warnings against use by children, that are necessary for the
protection of users unless its labeling conforms in all
respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in any State in an establishment not
duly registered under section 905(b), 905(c), 905(d), or
905(h), if it was not included in a list required by section
905(i), if a notice or other information respecting it was not
provided as required by such section or section 905(j), or if
it does not bear such symbols from the uniform system for
identification of tobacco products prescribed under section
905(e) as the Secretary by regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of
regulations prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the manufacturer,
packer, or distributor thereof includes in all advertisements
and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect
to that tobacco product--
``(A) a true statement of the tobacco product's
established name as described in paragraph (4), printed
prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and
relevant warnings, precautions, side effects,
and contraindications; and
``(ii) in the case of specific tobacco
products made subject to a finding by the
Secretary after notice and opportunity for
comment that such action is appropriate to
protect the public health, a full description
of the components of such tobacco product or
the formula showing quantitatively each
ingredient of such tobacco product to the
extent required in regulations which shall be
issued by the Secretary after an opportunity
for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it bears
such labeling as may be prescribed in such tobacco product
standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed
under section 904 or 908; or
``(B) to furnish any material or information
required under section 909.
``(b) Prior Approval of Label Statements.--The Secretary may, by
regulation, require prior approval of statements made on the label of a
tobacco product. No regulation issued under this subsection may require
prior approval by the Secretary of the content of any advertisement,
except for modified risk tobacco products as provided in section 911.
No advertisement of a tobacco product published after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act
shall, with respect to the language of label statements as prescribed
under section 4 of the Cigarette Labeling and Advertising Act and
section 3 of the Comprehensive Smokeless Tobacco Health Education Act
of 1986 or the regulations issued under such sections, be subject to
the provisions of sections 12 through 15 of the Federal Trade
Commission Act (15 U.S.C. 52 through 55).
``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.
``(a) Requirement.--Not later than 6 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act,
each tobacco product manufacturer or importer, or agents thereof, shall
submit to the Secretary the following information:
``(1) A listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such date,
added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in
each brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(a)(4) of the Federal
Cigarette Labeling and Advertising Act.
``(3) A listing of all constituents, including smoke
constituents as applicable, identified by the Secretary as
harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco
product, by brand and by quantity in each brand and subbrand.
Effective beginning 2 years after the date of enactment of this
chapter, the manufacturer, importer, or agent shall comply with
regulations promulgated under section 916 in reporting
information under this paragraph, where applicable.
``(4) All documents developed after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act that
relate to health, toxicological, behavioral, or physiologic
effects of current or future tobacco products, their
constituents (including smoke constituents), ingredients,
components, and additives.
``(b) Data Submission.--At the request of the Secretary, each
tobacco product manufacturer or importer of tobacco products, or agents
thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health, toxicological,
behavioral, or physiologic effects of tobacco products and
their constituents (including smoke constituents), ingredients,
components, and additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products can
occur upon the employment of technology available or known to
the manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco
manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States
shall supply the information required of a tobacco product manufacturer
under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the manufacturer of
such product shall provide the information required under
subsection (a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new tobacco
additive or increases the quantity of an existing tobacco
additive, the manufacturer shall, except as provided in
paragraph (3), at least 90 days prior to such action so advise
the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has by
regulation been designated by the Secretary as an additive that
is not a human or animal carcinogen, or otherwise harmful to
health under intended conditions of use, the manufacturer shall
within 60 days of such action so advise the Secretary in
writing.
``(d) Data List.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, and annually thereafter, the Secretary shall publish in a
format that is understandable and not misleading to a lay
person, and place on public display (in a manner determined by
the Secretary) the list established under subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not later
than 5 years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall submit
to the appropriate committees of Congress a report on the
results of such research, together with recommendations on
whether such publication should be continued or modified.
``(e) Data Collection.--Not later than 12 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall establish a list of harmful and potentially harmful
constituents, including smoke constituents, to health in each tobacco
product by brand and by quantity in each brand and subbrand. The
Secretary shall publish a public notice requesting the submission by
interested persons of scientific and other information concerning the
harmful and potentially harmful constituents in tobacco products and
tobacco smoke.
``SEC. 905. ANNUAL REGISTRATION.
``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding,
or processing' shall include repackaging or otherwise changing
the container, wrapper, or labeling of any tobacco product
package in furtherance of the distribution of the tobacco
product from the original place of manufacture to the person
who makes final delivery or sale to the ultimate consumer or
user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before December
31 of each year every person who owns or operates any establishment in
any State engaged in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products shall register with
the Secretary the name, places of business, and all such establishments
of that person.
``(c) Registration of New Owners and Operators.--Every person upon
first engaging in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products in any
establishment owned or operated in any State by that person shall
immediately register with the Secretary that person's name, place of
business, and such establishment.
``(d) Registration of Added Establishments.--Every person required
to register under subsection (b) or (c) shall immediately register with
the Secretary any additional establishment which that person owns or
operates in any State and in which that person begins the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary may by
regulation prescribe a uniform system for the identification of tobacco
products and may require that persons who are required to list such
tobacco products under subsection (i) shall list such tobacco products
in accordance with such system.
``(f) Public Access to Registration Information.--The Secretary
shall make available for inspection, to any person so requesting, any
registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--Every
establishment in any State registered with the Secretary under this
section shall be subject to inspection under section 704, and every
such establishment engaged in the manufacture, compounding, or
processing of a tobacco product or tobacco products shall be so
inspected by 1 or more officers or employees duly designated by the
Secretary at least once in the 2-year period beginning with the date of
registration of such establishment under this section and at least once
in every successive 2-year period thereafter.
``(h) Foreign Establishments Shall Register.--Any establishment
within any foreign country engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products,
shall register under this section under regulations promulgated by the
Secretary. Such regulations shall require such establishment to provide
the information required by subsection (i) of this section and shall
include provisions for registration of any such establishment upon
condition that adequate and effective means are available, by
arrangement with the government of such foreign country or otherwise,
to enable the Secretary to determine from time to time whether tobacco
products manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the United
States, shall be refused admission on any of the grounds set forth in
section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at the
time of registration under any such subsection, file with the
Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that person
for commercial distribution and which has not been included in
any list of tobacco products filed by that person with the
Secretary under this paragraph or paragraph (2) before such
time of registration. Such list shall be prepared in such form
and manner as the Secretary may prescribe and shall be
accompanied by--
``(A) in the case of a tobacco product contained in
the applicable list with respect to which a tobacco
product standard has been established under section 907
or which is subject to section 910, a reference to the
authority for the marketing of such tobacco product and
a copy of all labeling for such tobacco product;
``(B) in the case of any other tobacco product
contained in an applicable list, a copy of all consumer
information and other labeling for such tobacco
product, a representative sampling of advertisements
for such tobacco product, and, upon request made by the
Secretary for good cause, a copy of all advertisements
for a particular tobacco product; and
``(C) if the registrant filing a list has
determined that a tobacco product contained in such
list is not subject to a tobacco product standard
established under section 907, a brief statement of the
basis upon which the registrant made such determination
if the Secretary requests such a statement with respect
to that particular tobacco product.
``(2) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June of
each year and once during the month of December of each year
the following:
``(A) A list of each tobacco product introduced by
the registrant for commercial distribution which has
not been included in any list previously filed by that
person with the Secretary under this subparagraph or
paragraph (1). A list under this subparagraph shall
list a tobacco product by its established name and
shall be accompanied by the other information required
by paragraph (1).
``(B) If since the date the registrant last made a
report under this paragraph that person has
discontinued the manufacture, preparation, compounding,
or processing for commercial distribution of a tobacco
product included in a list filed under subparagraph (A)
or paragraph (1), notice of such discontinuance, the
date of such discontinuance, and the identity of its
established name.
``(C) If since the date the registrant reported
under subparagraph (B) a notice of discontinuance that
person has resumed the manufacture, preparation,
compounding, or processing for commercial distribution
of the tobacco product with respect to which such
notice of discontinuance was reported, notice of such
resumption, the date of such resumption, the identity
of such tobacco product by established name, and other
information required by paragraph (1), unless the
registrant has previously reported such resumption to
the Secretary under this subparagraph.
``(D) Any material change in any information
previously submitted under this paragraph or paragraph
(1).
``(j) Report Preceding Introduction of Certain Substantially-
Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for human
use that was not commercially marketed (other than for test
marketing) in the United States as of June 1, 2003, shall, at
least 90 days prior to making such introduction or delivery,
report to the Secretary (in such form and manner as the
Secretary shall prescribe)--
``(A) the basis for such person's determination
that the tobacco product is substantially equivalent,
within the meaning of section 910, to a tobacco product
commercially marketed (other than for test marketing)
in the United States as of June 1, 2003, that is in
compliance with the requirements of this Act; and
``(B) action taken by such person to comply with
the requirements under section 907 that are applicable
to the tobacco product.
``(2) Application to certain post june 1, 2003 products.--A
report under this subsection for a tobacco product that was
first introduced or delivered for introduction into interstate
commerce for commercial distribution in the United States after
June 1, 2003, and prior to the date that is 15 months after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act shall be submitted to the Secretary not later than
15 months after such date of enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may by regulation,
exempt from the requirements of this subsection tobacco
products that are modified by adding or deleting a
tobacco additive, or increasing or decreasing the
quantity of an existing tobacco additive, if the
Secretary determines that--
``(i) such modification would be a minor
modification of a tobacco product authorized
for sale under this Act;
``(ii) a report under this subsection is
not necessary to ensure that permitting the
tobacco product to be marketed would be
appropriate for protection of the public
health; and
``(iii) an exemption is otherwise
appropriate.
``(B) Regulations.--Not later than 9 months after
the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall issue
regulations to implement this paragraph.
``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.
``(a) In General.--Any requirement established by or under section
902, 903, 905, or 909 applicable to a tobacco product shall apply to
such tobacco product until the applicability of the requirement to the
tobacco product has been changed by action taken under section 907,
section 910, section 911, or subsection (d) of this section, and any
requirement established by or under section 902, 903, 905, or 909 which
is inconsistent with a requirement imposed on such tobacco product
under section 907, section 910, section 911, or subsection (d) of this
section shall not apply to such tobacco product.
``(b) Information on Public Access and Comment.--Each notice of
proposed rulemaking under section 907, 908, 909, 910, or 911 or under
this section, any other notice which is published in the Federal
Register with respect to any other action taken under any such section
and which states the reasons for such action, and each publication of
findings required to be made in connection with rulemaking under any
such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including the
need therefore) orally or in writing, which period shall be at
least 60 days but may not exceed 90 days unless the time is
extended by the Secretary by a notice published in the Federal
Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any information
reported to or otherwise obtained by the Secretary or the Secretary's
representative under section 903, 904, 907, 908, 909, 910, 911, or 704,
or under subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5, United
States Code, by reason of subsection (b)(4) of that section shall be
considered confidential and shall not be disclosed, except that the
information may be disclosed to other officers or employees concerned
with carrying out this chapter, or when relevant in any proceeding
under this chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco product,
including restrictions on the access to, and the advertising
and promotion of, the tobacco product, if the Secretary
determines that such regulation would be appropriate for the
protection of the public health. The Secretary may by
regulation impose restrictions on the advertising and promotion
of a tobacco product consistent with and to full extent
permitted by the first amendment to the Constitution. The
finding as to whether such regulation would be appropriate for
the protection of the public health shall be determined with
respect to the risks and benefits to the population as a whole,
including users and non-users of the tobacco product, and
taking into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
No such regulation may require that the sale or distribution of
a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the Secretary
may in such regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph
(1) may--
``(i) prohibit the sale of any tobacco
product in face-to-face transactions by a
specific category of retail outlets; or
``(ii) establish a minimum age of sale of
tobacco products to any person older than 18
years of age.
``(B) Matchbooks.--For purposes of any regulations
issued by the Secretary, matchbooks of conventional
size containing not more than 20 paper matches, and
which are customarily given away for free with the
purchase of tobacco products shall be considered as
adult written publications which shall be permitted to
contain advertising. Notwithstanding the preceding
sentence, if the Secretary finds that such treatment of
matchbooks is not appropriate for the protection of the
public health, the Secretary may determine by
regulation that matchbooks shall not be considered
adult written publications.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) In general.--The Secretary may, in accordance
with subparagraph (B), prescribe regulations (which may
differ based on the type of tobacco product involved)
requiring that the methods used in, and the facilities
and controls used for, the manufacture, pre-production
design validation (including a process to assess the
performance of a tobacco product), packing and storage
of a tobacco product, conform to current good
manufacturing practice, as prescribed in such
regulations, to assure that the public health is
protected and that the tobacco product is in compliance
with this chapter. Good manufacturing practices may
include the testing of raw tobacco for pesticide
chemical residues regardless of whether a tolerance for
such chemical residues has been established.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation
under subparagraph (A), afford the Tobacco
Products Scientific Advisory Committee an
opportunity to submit recommendations with
respect to the regulation proposed to be
promulgated;
``(ii) before promulgating any regulation
under subparagraph (A), afford opportunity for
an oral hearing;
``(iii) provide the advisory committee a
reasonable time to make its recommendation with
respect to proposed regulations under
subparagraph (A); and
``(iv) in establishing the effective date
of a regulation promulgated under this
subsection, take into account the differences
in the manner in which the different types of
tobacco products have historically been
produced, the financial resources of the
different tobacco product manufacturers, and
the state of their existing manufacturing
facilities, and shall provide for a reasonable
period of time for such manufacturers to
conform to good manufacturing practices.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any
requirement prescribed under paragraph (1) may petition
the Secretary for a permanent or temporary exemption or
variance from such requirement. Such a petition shall
be submitted to the Secretary in such form and manner
as the Secretary shall prescribe and shall--
``(i) in the case of a petition for an
exemption from a requirement, set forth the
basis for the petitioner's determination that
compliance with the requirement is not required
to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a
variance from a requirement, set forth the
methods proposed to be used in, and the
facilities and controls proposed to be used
for, the manufacture, packing, and storage of
the tobacco product in lieu of the methods,
facilities, and controls prescribed by the
requirement; and
``(iii) contain such other information as
the Secretary shall prescribe.
``(B) Referral to the tobacco products scientific
advisory committee.--The Secretary may refer to the
Tobacco Products Scientific Advisory Committee any
petition submitted under subparagraph (A). The Tobacco
Products Scientific Advisory Committee shall report its
recommendations to the Secretary with respect to a
petition referred to it within 60 days after the date
of the petition's referral. Within 60 days after--
``(i) the date the petition was submitted
to the Secretary under subparagraph (A); or
``(ii) the day after the petition was
referred to the Tobacco Products Scientific
Advisory Committee, whichever occurs later, the
Secretary shall by order either deny the
petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines that compliance with such
requirement is not required to assure that the
tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a
tobacco product from a requirement if the
Secretary determines that the methods to be
used in, and the facilities and controls to be
used for, the manufacture, packing, and storage
of the tobacco product in lieu of the methods,
controls, and facilities prescribed by the
requirement are sufficient to assure that the
tobacco product will be in compliance with this
chapter.
``(D) Conditions.--An order of the Secretary
approving a petition for a variance shall prescribe
such conditions respecting the methods used in, and the
facilities and controls used for, the manufacture,
packing, and storage of the tobacco product to be
granted the variance under the petition as may be
necessary to assure that the tobacco product will be in
compliance with this chapter.
``(E) Hearing.--After the issuance of an order
under subparagraph (B) respecting a petition, the
petitioner shall have an opportunity for an informal
hearing on such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the period ending 3
years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter into
contracts for research, testing, and demonstrations respecting tobacco
products and may obtain tobacco products for research, testing, and
demonstration purposes without regard to section 3324(a) and (b) of
title 31, United States Code, and section 5 of title 41, United States
Code.
``SEC. 907. TOBACCO PRODUCT STANDARDS.
``(a) In General.--
``(1) Special rule for cigarettes.--A cigarette or any of
its component parts (including the tobacco, filter, or paper)
shall not contain, as a constituent (including a smoke
constituent) or additive, an artificial or natural flavor
(other than tobacco or menthol) or an herb or spice, including
strawberry, grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, or coffee, that is
a characterizing flavor of the tobacco product or tobacco
smoke. Nothing in this subparagraph shall be construed to limit
the Secretary's authority to take action under this section or
other sections of this Act applicable to menthol or any
artificial or natural flavor, herb, or spice not specified in
this paragraph.
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (b).
``(3) Tobacco product standards.--The Secretary may adopt
tobacco product standards in addition to those in paragraph (1)
if the Secretary finds that a tobacco product standard is
appropriate for the protection of the public health. This
finding shall be determined with respect to the risks and
benefits to the population as a whole, including users and non-
users of the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate
for the protection of the public health, including
provisions, where appropriate--
``(i) for the reduction of nicotine yields
of the product;
``(ii) for the reduction or elimination of
other constituents, including smoke
constituents, or harmful components of the
product; or
``(iii) relating to any other requirement
under (B);
``(B) shall, where appropriate for the protection
of the public health, include--
``(i) provisions respecting the
construction, components, ingredients,
additives, constituents, including smoke
constituents, and properties of the tobacco
product;
``(ii) provisions for the testing (on a
sample basis or, if necessary, on an individual
basis) of the tobacco product;
``(iii) provisions for the measurement of
the tobacco product characteristics of the
tobacco product;
``(iv) provisions requiring that the
results of each or of certain of the tests of
the tobacco product required to be made under
clause (ii) show that the tobacco product is in
conformity with the portions of the standard
for which the test or tests were required; and
``(v) a provision requiring that the sale
and distribution of the tobacco product be
restricted but only to the extent that the sale
and distribution of a tobacco product may be
restricted under a regulation under section
906(d); and
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the
proper use of the tobacco product.
``(5) Periodic re-evaluation of tobacco product
standards.--The Secretary shall provide for periodic evaluation
of tobacco product standards established under this section to
determine whether such standards should be changed to reflect
new medical, scientific, or other technological data. The
Secretary may provide for testing under paragraph (4)(B) by any
person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other
technical support available in other Federal agencies;
``(B) consult with other Federal agencies concerned
with standard-setting and other nationally or
internationally recognized standard-setting entities;
and
``(C) invite appropriate participation, through
joint or other conferences, workshops, or other means,
by informed persons representative of scientific,
professional, industry, agricultural, or consumer
organizations who in the Secretary's judgment can make
a significant contribution.
``(b) Establishment of Standards.--
``(1) Notice.--
``(A) In general.--The Secretary shall publish in
the Federal Register a notice of proposed rulemaking
for the establishment, amendment, or revocation of any
tobacco product standard.
``(B) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a
tobacco product standard for a tobacco product shall--
``(i) set forth a finding with supporting
justification that the tobacco product standard
is appropriate for the protection of the public
health;
``(ii) set forth proposed findings with
respect to the risk of illness or injury that
the tobacco product standard is intended to
reduce or eliminate; and
``(iii) invite interested persons to submit
an existing tobacco product standard for the
tobacco product, including a draft or proposed
tobacco product standard, for consideration by
the Secretary.
``(C) Standard.--Upon a determination by the
Secretary that an additive, constituent (including
smoke constituent), or other component of the product
that is the subject of the proposed tobacco product
standard is harmful, it shall be the burden of any
party challenging the proposed standard to prove that
the proposed standard will not reduce or eliminate the
risk of illness or injury.
``(D) Finding.--A notice of proposed rulemaking for
the revocation of a tobacco product standard shall set
forth a finding with supporting justification that the
tobacco product standard is no longer appropriate for
the protection of the public health.
``(E) Consideration by secretary.--The Secretary
shall consider all information submitted in connection
with a proposed standard, including information
concerning the countervailing effects of the tobacco
product standard on the health of adolescent tobacco
users, adult tobacco users, or non-tobacco users, such
as the creation of a significant demand for contraband
or other tobacco products that do not meet the
requirements of this chapter and the significance of
such demand, and shall issue the standard if the
Secretary determines that the standard would be
appropriate for the protection of the public health.
``(F) Comment.--The Secretary shall provide for a
comment period of not less than 60 days.
``(2) Promulgation.--
``(A) In general.--After the expiration of the
period for comment on a notice of proposed rulemaking
published under paragraph (1) respecting a tobacco
product standard and after consideration of such
comments and any report from the Tobacco Products
Scientific Advisory Committee, the Secretary shall--
``(i) promulgate a regulation establishing
a tobacco product standard and publish in the
Federal Register findings on the matters
referred to in paragraph (1); or
``(ii) publish a notice terminating the
proceeding for the development of the standard
together with the reasons for such termination.
``(B) Effective date.--A regulation establishing a
tobacco product standard shall set forth the date or
dates upon which the standard shall take effect, but no
such regulation may take effect before 1 year after the
date of its publication unless the Secretary determines
that an earlier effective date is necessary for the
protection of the public health. Such date or dates
shall be established so as to minimize, consistent with
the public health, economic loss to, and disruption or
dislocation of, domestic and international trade.
``(3) Power reserved to congress.--Because of the
importance of a decision of the Secretary to issue a regulation
establishing a tobacco product standard--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than
little cigars, all pipe tobacco, or all roll your own
tobacco products; or
``(B) requiring the reduction of nicotine yields of
a tobacco product to zero,
Congress expressly reserves to itself such power.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the
Secretary's own initiative or upon petition of an
interested person may by a regulation, promulgated in
accordance with the requirements of paragraphs (1) and
(2)(B), amend or revoke a tobacco product standard.
``(B) Effective date.--The Secretary may declare a
proposed amendment of a tobacco product standard to be
effective on and after its publication in the Federal
Register and until the effective date of any final
action taken on such amendment if the Secretary
determines that making it so effective is in the public
interest.
``(5) Reference to advisory committee.--The Secretary may--
``(A) on the Secretary's own initiative, refer a
proposed regulation for the establishment, amendment,
or revocation of a tobacco product standard; or
``(B) upon the request of an interested person
which demonstrates good cause for referral and which is
made before the expiration of the period for submission
of comments on such proposed regulation, refer such
proposed regulation to the Tobacco Products Scientific
Advisory Committee, for a report and recommendation
with respect to any matter involved in the proposed
regulation which requires the exercise of scientific
judgment. If a proposed regulation is referred under
this paragraph to the Tobacco Products Scientific
Advisory Committee, the Secretary shall provide the
advisory committee with the data and information on
which such proposed regulation is based. The Tobacco
Products Scientific Advisory Committee shall, within 60
days after the referral of a proposed regulation and
after independent study of the data and information
furnished to it by the Secretary and other data and
information before it, submit to the Secretary a report
and recommendation respecting such regulation, together
with all underlying data and information and a
statement of the reason or basis for the
recommendation. A copy of such report and
recommendation shall be made public by the Secretary.
``SEC. 908. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial harm
to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk, the
Secretary may issue such order as may be necessary to assure
that adequate notification is provided in an appropriate form,
by the persons and means best suited under the circumstances
involved, to all persons who should properly receive such
notification in order to eliminate such risk. The Secretary may
order notification by any appropriate means, including public
service announcements. Before issuing an order under this
subsection, the Secretary shall consult with the persons who
are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with an order
issued under this section shall not relieve any person from liability
under Federal or State law. In awarding damages for economic loss in an
action brought for the enforcement of any such liability, the value to
the plaintiff in such action of any remedy provided under such order
shall be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall issue
an order requiring the appropriate person (including the
manufacturers, importers, distributors, or retailers of the
tobacco product) to immediately cease distribution of such
tobacco product. The order shall provide the person subject to
the order with an opportunity for an informal hearing, to be
held not later than 10 days after the date of the issuance of
the order, on the actions required by the order and on whether
the order should be amended to require a recall of such tobacco
product. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to
support the actions required by the order, the Secretary shall
vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph
(1), the Secretary determines that the order should be
amended to include a recall of the tobacco product with
respect to which the order was issued, the Secretary
shall, except as provided in subparagraph (B), amend
the order to require a recall. The Secretary shall
specify a timetable in which the tobacco product recall
will occur and shall require periodic reports to the
Secretary describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph
(A)--
``(i) shall not include recall of a tobacco
product from individuals; and
``(ii) shall provide for notice to persons
subject to the risks associated with the use of
such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be
identified, the Secretary shall notify such persons
under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a) of this section.
``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish and
maintain such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure that
such tobacco product is not adulterated or misbranded and to otherwise
protect public health. Regulations prescribed under the preceding
sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of information
that reasonably suggests that one of its marketed tobacco
products may have caused or contributed to a serious unexpected
adverse experience associated with the use of the product or
any significant increase in the frequency of a serious,
expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information required
under this subsection unless required for the medical welfare
of an individual, to determine risks to public health of a
tobacco product, or to verify a record, report, or information
submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall
have due regard for the professional ethics of the medical profession
and the interests of patients. The prohibitions of paragraph (6)
continue to apply to records, reports, and information concerning any
individual who has been a patient, irrespective of whether or when he
ceases to be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by such
manufacturer or importer if the removal or correction was
undertaken--
``(A) to reduce a risk to health posed by the
tobacco product; or
``(B) to remedy a violation of this chapter caused
by the tobacco product which may present a risk to
health.
A tobacco product manufacturer or importer of a tobacco product
who undertakes a corrective action or removal from the market
of a tobacco product which is not required to be reported under
this subsection shall keep a record of such correction or
removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is required
and has been submitted under subsection (a).
``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.
``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products
in test markets) that was not commercially marketed in
the United States as of June 1, 2003; or
``(B) any modification (including a change in
design, any component, any part, or any constituent,
including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified
product was commercially marketed in the United States
after June 1, 2003.
``(2) Premarket approval required.--
``(A) New products.--Approval under this section of
an application for premarket approval for any new
tobacco product is required unless--
``(i) the manufacturer has submitted a
report under section 905(j); and
``(ii) the Secretary has issued an order
that the tobacco product--
``(I) is substantially equivalent
to a tobacco product commercially
marketed (other than for test
marketing) in the United States as of
June 1, 2003; and
``(II)(aa) is in compliance with
the requirements of this Act; or
``(bb) is exempt from the
requirements of section 905(j) pursuant
to a regulation issued under section
905(j)(3).
``(B) Application to certain post june 1, 2003
products.--Subparagraph (A) shall not apply to a
tobacco product--
``(i) that was first introduced or
delivered for introduction into interstate
commerce for commercial distribution in the
United States after June 1, 2003, and prior to
the date that is 15 months after the date of
enactment of the Family Smoking Prevention and
Tobacco Control Act; and
``(ii) for which a report was submitted
under section 905(j) within such 15-month
period, until the Secretary issues an order
that the tobacco product is not substantially
equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section
905(j), the terms `substantially equivalent' or
`substantial equivalence' mean, with respect to the
tobacco product being compared to the predicate tobacco
product, that the Secretary by order has found that the
tobacco product--
``(i) has the same characteristics as the
predicate tobacco product; or
``(ii) has different characteristics and
the information submitted contains information,
including clinical data if deemed necessary by
the Secretary, that demonstrates that it is not
appropriate to regulate the product under this
section because the product does not raise
different questions of public health.
``(B) Characteristics.--In subparagraph (A), the
term `characteristics' means the materials,
ingredients, design, composition, heating source, or
other features of a tobacco product.
``(C) Limitation.--A tobacco product may not be
found to be substantially equivalent to a predicate
tobacco product that has been removed from the market
at the initiative of the Secretary or that has been
determined by a judicial order to be misbranded or
adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under
section 905(j) respecting a tobacco product, the person
required to file a premarket notification under such
section shall provide an adequate summary of any health
information related to the tobacco product or state
that such information will be made available upon
request by any person.
``(B) Required information.--Any summary under
subparagraph (A) respecting a tobacco product shall
contain detailed information regarding data concerning
adverse health effects and shall be made available to
the public by the Secretary within 30 days of the
issuance of a determination that such tobacco product
is substantially equivalent to another tobacco product.
``(b) Application.--
``(1) Contents.--An application for premarket approval
shall contain--
``(A) full reports of all information, published or
known to, or which should reasonably be known to, the
applicant, concerning investigations which have been
made to show the health risks of such tobacco product
and whether such tobacco product presents less risk
than other tobacco products;
``(B) a full statement of the components,
ingredients, additives, and properties, and of the
principle or principles of operation, of such tobacco
product;
``(C) a full description of the methods used in,
and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing
and installation of, such tobacco product;
``(D) an identifying reference to any tobacco
product standard under section 907 which would be
applicable to any aspect of such tobacco product, and
either adequate information to show that such aspect of
such tobacco product fully meets such tobacco product
standard or adequate information to justify any
deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably
require;
``(F) specimens of the labeling proposed to be used
for such tobacco product; and
``(G) such other information relevant to the
subject matter of the application as the Secretary may
require.
``(2) Reference to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant, refer
such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission
(within such period as the Secretary may establish) of
a report and recommendation respecting approval of the
application, together with all underlying data and the
reasons or basis for the recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in
no event later than 180 days after the receipt of an
application under subsection (b), the Secretary, after
considering the report and recommendation submitted
under paragraph (2) of such subsection, shall--
``(i) issue an order approving the
application if the Secretary finds that none of
the grounds for denying approval specified in
paragraph (2) of this subsection applies; or
``(ii) deny approval of the application if
the Secretary finds (and sets forth the basis
for such finding as part of or accompanying
such denial) that 1 or more grounds for denial
specified in paragraph (2) of this subsection
apply.
``(B) Restrictions on sale and distribution.--An
order approving an application for a tobacco product
may require as a condition to such approval that the
sale and distribution of the tobacco product be
restricted but only to the extent that the sale and
distribution of a tobacco product may be restricted
under a regulation under section 906(d).
``(2) Denial of approval.--The Secretary shall deny
approval of an application for a tobacco product if, upon the
basis of the information submitted to the Secretary as part of
the application and any other information before the Secretary
with respect to such tobacco product, the Secretary finds
that--
``(A) there is a lack of a showing that permitting
such tobacco product to be marketed would be
appropriate for the protection of the public health;
``(B) the methods used in, or the facilities or
controls used for, the manufacture, processing, or
packing of such tobacco product do not conform to the
requirements of section 906(e);
``(C) based on a fair evaluation of all material
facts, the proposed labeling is false or misleading in
any particular; or
``(D) such tobacco product is not shown to conform
in all respects to a tobacco product standard in effect
under section 907, compliance with which is a condition
to approval of the application, and there is a lack of
adequate information to justify the deviation from such
standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to place such application in approvable form
(which measures may include further research by the applicant
in accordance with 1 or more protocols prescribed by the
Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether approval of a tobacco product is
appropriate for the protection of the public health shall be
determined with respect to the risks and benefits to the
population as a whole, including users and nonusers of the
tobacco product, and taking into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph
(2)(A), whether permitting a tobacco product to be
marketed would be appropriate for the protection of the
public health shall, when appropriate, be determined on
the basis of well-controlled investigations, which may
include 1 or more clinical investigations by experts
qualified by training and experience to evaluate the
tobacco product.
``(B) Other evidence.--If the Secretary determines
that there exists valid scientific evidence (other than
evidence derived from investigations described in
subparagraph (A)) which is sufficient to evaluate the
tobacco product the Secretary may authorize that the
determination for purposes of paragraph (2)(A) be made
on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from an
advisory committee, and after due notice and opportunity for
informal hearing to the holder of an approved application for a
tobacco product, issue an order withdrawing approval of the
application if the Secretary finds--
``(A) that the continued marketing of such tobacco
product no longer is appropriate for the protection of
the public health;
``(B) that the application contained or was
accompanied by an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for
maintaining records, or has repeatedly or
deliberately failed to maintain records or to
make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or
copying or verification of, such records as
required by section 704; or
``(iii) has not complied with the
requirements of section 905;
``(D) on the basis of new information before the
Secretary with respect to such tobacco product,
evaluated together with the evidence before the
Secretary when the application was approved, that the
methods used in, or the facilities and controls used
for, the manufacture, processing, packing, or
installation of such tobacco product do not conform
with the requirements of section 906(e) and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from
the Secretary of nonconformity;
``(E) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was approved, that
the labeling of such tobacco product, based on a fair
evaluation of all material facts, is false or
misleading in any particular and was not corrected
within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was approved, that
such tobacco product is not shown to conform in all
respects to a tobacco product standard which is in
effect under section 907, compliance with which was a
condition to approval of the application, and that
there is a lack of adequate information to justify the
deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing approval of the
application may, by petition filed on or before the 30th day
after the date upon which such holder receives notice of such
withdrawal, obtain review thereof in accordance with subsection
(e).
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an approved application
would cause serious, adverse health consequences or death, that
is greater than ordinarily caused by tobacco products on the
market, the Secretary shall by order temporarily suspend the
approval of the application approved under this section. If the
Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary under
this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the case of any tobacco
product for which an approval of an application filed under
subsection (b) is in effect, the applicant shall establish and
maintain such records, and make such reports to the Secretary,
as the Secretary may by regulation, or by order with respect to
such application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or
temporarily suspending such approval.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge or
custody thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at
all reasonable times to have access to and copy and verify such
records.
``(g) Investigational Tobacco Product Exemption for Investigational
Use.--The Secretary may exempt tobacco products intended for
investigational use from the provisions of this chapter under such
conditions as the Secretary may by regulation prescribe.
``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco product
unless approval of an application filed pursuant to subsection (d) is
effective with respect to such product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold or
distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco
product, the term `sold or distributed for use to
reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products'
means a tobacco product--
``(i) the label, labeling, or advertising
of which represents explicitly or implicitly
that--
``(I) the tobacco product presents
a lower risk of tobacco-related disease
or is less harmful than one or more
other commercially marketed tobacco
products;
``(II) the tobacco product or its
smoke contains a reduced level of a
substance or presents a reduced
exposure to a substance; or
``(III) the tobacco product or its
smoke does not contain or is free of a
substance;
``(ii) the label, labeling, or advertising
of which uses the descriptors `light', `mild',
or `low' or similar descriptors; or
``(iii) the tobacco product manufacturer of
which has taken any action directed to
consumers through the media or otherwise, other
than by means of the tobacco product's label,
labeling or advertising, after the date of
enactment of the Family Smoking Prevention and
Tobacco Control Act, respecting the product
that would be reasonably expected to result in
consumers believing that the tobacco product or
its smoke may present a lower risk of disease
or is less harmful than one or more
commercially marketed tobacco products, or
presents a reduced exposure to, or does not
contain or is free of, a substance or
substances.
``(B) Limitation.--No tobacco product shall be
considered to be `sold or distributed for use to reduce
harm or the risk of tobacco-related disease associated
with commercially marketed tobacco products', except as
described in subparagraph (A).
``(c) Tobacco Dependence Products.--A product that is intended to
be used for the treatment of tobacco dependence, including smoking
cessation, is not a modified risk tobacco product under this section
and is subject to the requirements of chapter V.
``(d) Filing.--Any person may file with the Secretary an
application for a modified risk tobacco product. Such application shall
include--
``(1) a description of the proposed product and any
proposed advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product to
reduce risk or exposure and relating to human health;
``(6) data and information on how consumers actually use
the tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary shall make the
application described in subsection (d) publicly available (except
matters in the application which are trade secrets or otherwise
confidential, commercial information) and shall request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to an advisory
committee any application submitted under this subsection.
``(2) Recommendations.--Not later than 60 days after the
date an application is referred to an advisory committee under
paragraph (1), the advisory committee shall report its
recommendations on the application to the Secretary.
``(g) Approval.--
``(1) Modified risk products.--Except as provided in
paragraph (2), the Secretary shall approve an application for a
modified risk tobacco product filed under this section only if
the Secretary determines that the applicant has demonstrated
that such product, as it is actually used by consumers, will--
``(A) significantly reduce harm and the risk of
tobacco-related disease to individual tobacco users;
and
``(B) benefit the health of the population as a
whole taking into account both users of tobacco
products and persons who do not currently use tobacco
products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may approve an
application for a tobacco product that has not been
approved as a modified risk tobacco product pursuant to
paragraph (1) if the Secretary makes the findings
required under this paragraph and determines that the
applicant has demonstrated that--
``(i) the approval of the application would
be appropriate to promote the public health;
``(ii) any aspect of the label, labeling,
and advertising for such product that would
cause the tobacco product to be a modified risk
tobacco product under subsection (b)(2) is
limited to an explicit or implicit
representation that such tobacco product or its
smoke contains or is free of a substance or
contains a reduced level of a substance, or
presents a reduced exposure to a substance in
tobacco smoke;
``(iii) scientific evidence is not
available and, using the best available
scientific methods, cannot be made available
without conducting long-term epidemiological
studies for an application to meet the
standards set forth in paragraph (1); and
``(iv) the scientific evidence that is
available without conducting long-term
epidemiological studies demonstrates that a
measurable and substantial reduction in
morbidity or mortality among individual tobacco
users is anticipated in subsequent studies.
``(B) Additional findings required.--In order to
approve an application under subparagraph (A) the
Secretary must also find that the applicant has
demonstrated that--
``(i) the magnitude of the overall
reductions in exposure to the substance or
substances which are the subject of the
application is substantial, such substance or
substances are harmful, and the product as
actually used exposes consumers to the
specified reduced level of the substance or
substances;
``(ii) the product as actually used by
consumers will not expose them to higher levels
of other harmful substances compared to the
similar types of tobacco products then on the
market unless such increases are minimal and
the anticipated overall impact of use of the
product remains a substantial and measurable
reduction in overall morbidity and mortality
among individual tobacco users;
``(iii) testing of actual consumer
perception shows that, as the applicant
proposes to label and market the product,
consumers will not be misled into believing
that the product--
``(I) is or has been demonstrated
to be less harmful; or
``(II) presents or has been
demonstrated to present less of a risk
of disease than 1 or more other
commercially marketed tobacco products;
and
``(iv) approval of the application is
expected to benefit the health of the
population as a whole taking into account both
users of tobacco products and persons who do
not currently use tobacco products.
``(C) Conditions of approval.--
``(i) In general.--Applications approved
under this paragraph shall be limited to a term
of not more than 5 years, but may be renewed
upon a finding by the Secretary that the
requirements of this paragraph continue to be
satisfied based on the filing of a new
application.
``(ii) Agreements by applicant.--
Applications approved under this paragraph
shall be conditioned on the applicant's
agreement to conduct post-market surveillance
and studies and to submit to the Secretary the
results of such surveillance and studies to
determine the impact of the application
approval on consumer perception, behavior, and
health and to enable the Secretary to review
the accuracy of the determinations upon which
the approval was based in accordance with a
protocol approved by the Secretary.
``(iii) Annual submission.--The results of
such post-market surveillance and studies
described in clause (ii) shall be submitted
annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the
applicant; and
``(B) scientific evidence and other information
that is available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1) and
(2), the Secretary shall take into account--
``(A) the relative health risks to individuals of
the tobacco product that is the subject of the
application;
``(B) the increased or decreased likelihood that
existing users of tobacco products who would otherwise
stop using such products will switch to the tobacco
product that is the subject of the application;
``(C) the increased or decreased likelihood that
persons who do not use tobacco products will start
using the tobacco product that is the subject of the
application;
``(D) the risks and benefits to persons from the
use of the tobacco product that is the subject of the
application as compared to the use of products for
smoking cessation approved under chapter V to treat
nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Approval.--
``(1) Modified risk products.--The Secretary shall require
for the approval of an application under this section that any
advertising or labeling concerning modified risk products
enable the public to comprehend the information concerning
modified risk and to understand the relative significance of
such information in the context of total health and in relation
to all of the diseases and health-related conditions associated
with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for
the approval of an application under this subsection
that a claim comparing a tobacco product to 1 or more
other commercially marketed tobacco products shall
compare the tobacco product to a commercially marketed
tobacco product that is representative of that type of
tobacco product on the market (for example the average
value of the top 3 brands of an established regular
tobacco product).
``(B) Quantitative comparisons.--The Secretary may
also require, for purposes of subparagraph (A), that
the percent (or fraction) of change and identity of the
reference tobacco product and a quantitative comparison
of the amount of the substance claimed to be reduced
shall be stated in immediate proximity to the most
prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the
disclosure on the label of other substances in the
tobacco product, or substances that may be produced by
the consumption of that tobacco product, that may
affect a disease or health-related condition or may
increase the risk of other diseases or health-related
conditions associated with the use of tobacco products.
``(B) Conditions of use.--If the conditions of use
of the tobacco product may affect the risk of the
product to human health, the Secretary may require the
labeling of conditions of use.
``(4) Time.--The Secretary shall limit an approval under
subsection (g)(1) for a specified period of time.
``(5) Advertising.--The Secretary may require that an
applicant, whose application has been approved under this
subsection, comply with requirements relating to advertising
and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require that an
applicant under subsection (g)(1) conduct post market
surveillance and studies for a tobacco product for which an
application has been approved to determine the impact of the
application approval on consumer perception, behavior, and
health, to enable the Secretary to review the accuracy of the
determinations upon which the approval was based, and to
provide information that the Secretary determines is otherwise
necessary regarding the use or health risks involving the
tobacco product. The results of post-market surveillance and
studies shall be submitted to the Secretary on an annual basis.
``(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph (1)
shall, within 30 days after receiving notice that the applicant
is required to conduct such surveillance, submit, for the
approval of the Secretary, a protocol for the required
surveillance. The Secretary, within 60 days of the receipt of
such protocol, shall determine if the principal investigator
proposed to be used in the surveillance has sufficient
qualifications and experience to conduct such surveillance and
if such protocol will result in collection of the data or other
information designated by the Secretary as necessary to protect
the public health.
``(j) Withdrawal of Approval.--The Secretary, after an opportunity
for an informal hearing, shall withdraw the approval of an application
under this section if the Secretary determines that--
``(1) the applicant, based on new information, can no
longer make the demonstrations required under subsection (g),
or the Secretary can no longer make the determinations required
under subsection (g);
``(2) the application failed to include material
information or included any untrue statement of material fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid, including
if--
``(A) a tobacco product standard is established
pursuant to section 907;
``(B) an action is taken that affects the risks
presented by other commercially marketed tobacco
products that were compared to the product that is the
subject of the application; or
``(C) any postmarket surveillance or studies reveal
that the approval of the application is no longer
consistent with the protection of the public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or (i); or
``(5) the applicant failed to meet a condition imposed
under subsection (h).
``(k) Chapter IV or V.--A product approved in accordance with this
section shall not be subject to chapter IV or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of modified
risk tobacco products. Such regulations or guidance shall--
``(A) establish minimum standards for scientific
studies needed prior to approval to show that a
substantial reduction in morbidity or mortality among
individual tobacco users is likely;
``(B) include validated biomarkers, intermediate
clinical endpoints, and other feasible outcome
measures, as appropriate;
``(C) establish minimum standards for post market
studies, that shall include regular and long-term
assessments of health outcomes and mortality,
intermediate clinical endpoints, consumer perception of
harm reduction, and the impact on quitting behavior and
new use of tobacco products, as appropriate;
``(D) establish minimum standards for required
postmarket surveillance, including ongoing assessments
of consumer perception; and
``(E) require that data from the required studies
and surveillance be made available to the Secretary
prior to the decision on renewal of a modified risk
tobacco product.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with the
Institute of Medicine, and with the input of other appropriate
scientific and medical experts, on the design and conduct of
such studies and surveillance.
``(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on a regular basis as new
scientific information becomes available.
``(4) New tobacco products.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue a regulation or
guidance that permits the filing of a single application for
any tobacco product that is a new tobacco product under section
910 and for which the applicant seeks approval as a modified
risk tobacco product under this section.
``(m) Distributors.--No distributor may take any action, after the
date of enactment of the Family Smoking Prevention and Tobacco Control
Act, with respect to a tobacco product that would reasonably be
expected to result in consumers believing that the tobacco product or
its smoke may present a lower risk of disease or is less harmful than
one or more commercially marketed tobacco products, or presents a
reduced exposure to, or does not contain or is free of, a substance or
substances.
``SEC. 912. JUDICIAL REVIEW.
``(a) Right to Review.--
``(1) In general.--Not later than 30 days after--
``(A) the promulgation of a regulation under
section 907 establishing, amending, or revoking a
tobacco product standard; or
``(B) a denial of an application for approval under
section 910(c), any person adversely affected by such
regulation or denial may file a petition for judicial
review of such regulation or denial with the United
States Court of Appeals for the District of Columbia or
for the circuit in which such person resides or has
their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition
filed under paragraph (1) shall be transmitted by the
clerk of the court involved to the Secretary.
``(B) Record of proceedings.--On receipt of a
petition under subparagraph (A), the Secretary shall
file in the court in which such petition was filed--
``(i) the record of the proceedings on
which the regulation or order was based; and
``(ii) a statement of the reasons for the
issuance of such a regulation or order.
``(C) Definition of record.--In this section, the
term `record' means--
``(i) all notices and other matter
published in the Federal Register with respect
to the regulation or order reviewed;
``(ii) all information submitted to the
Secretary with respect to such regulation or
order;
``(iii) proceedings of any panel or
advisory committee with respect to such
regulation or order;
``(iv) any hearing held with respect to
such regulation or order; and
``(v) any other information identified by
the Secretary, in the administrative proceeding
held with respect to such regulation or order,
as being relevant to such regulation or order.
``(b) Standard of Review.--Upon the filing of the petition under
subsection (a) for judicial review of a regulation or order, the court
shall have jurisdiction to review the regulation or order in accordance
with chapter 7 of title 5, United States Code, and to grant appropriate
relief, including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be reviewed in
accordance with section 706(2)(A) of title 5, United States Code.
``(c) Finality of Judgment.--The judgment of the court affirming or
setting aside, in whole or in part, any regulation or order shall be
final, subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of title 28,
United States Code.
``(d) Other Remedies.--The remedies provided for in this section
shall be in addition to, and not in lieu of, any other remedies
provided by law.
``(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review, a regulation or order issued under section
906, 907, 908, 909, 910, or 916 shall contain a statement of the
reasons for the issuance of such regulation or order in the record of
the proceedings held in connection with its issuance.
``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that retail
establishments for which the predominant business is the sale of
tobacco products comply with any advertising restrictions applicable to
retail establishments accessible to individuals under the age of 18.
``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE
COMMISSION.
``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as limiting
or diminishing the authority of the Federal Trade Commission to
enforce the laws under its jurisdiction with respect to the
advertising, sale, or distribution of tobacco products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in
section 232 of the Family Smoking Prevention and Tobacco
Control Act, is an unfair or deceptive act or practice under
section 5(a) of the Federal Trade Commission Act (15 U.S.C.
45(a)) and shall be considered a violation of a rule
promulgated under section 18 of that Act (15 U.S.C. 57a).
``(b) Coordination.--With respect to the requirements of section 4
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333)
and section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 (15 U.S.C. 4402)--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or smokeless
tobacco; and
``(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.
``SEC. 915. CONGRESSIONAL REVIEW PROVISIONS.
``In accordance with section 801 of title 5, United States Code,
Congress shall review, and may disapprove, any rule under this chapter
that is subject to section 801. This section and section 801 do not
apply to the regulations referred to in section 232 of the Family
Smoking Prevention and Tobacco Control Act.
``SEC. 916. REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than 24 months
after the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary, acting through the Commissioner of
the Food and Drug Administration, shall promulgate regulations under
this Act that meet the requirements of subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a) shall require testing and reporting of tobacco product
constituents, ingredients, and additives, including smoke constituents,
by brand and sub-brand that the Secretary determines should be tested
to protect the public health. The regulations may require that tobacco
product manufacturers, packagers, or importers make disclosures
relating to the results of the testing of tar and nicotine through
labels or advertising or other appropriate means, and make disclosures
regarding the results of the testing of other constituents, including
smoke constituents, ingredients, or additives, that the Secretary
determines should be disclosed to the public to protect the public
health and will not mislead consumers about the risk of tobacco related
disease.
``(c) Authority.--The Food and Drug Administration shall have the
authority under this chapter to conduct or to require the testing,
reporting, or disclosure of tobacco product constituents, including
smoke constituents.
``SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) In General.--
``(1) Preservation.--Nothing in this chapter, or rules
promulgated under this chapter, shall be construed to limit the
authority of a Federal agency (including the Armed Forces), a
State or political subdivision of a State, or the government of
an Indian tribe to enact, adopt, promulgate, and enforce any
law, rule, regulation, or other measure with respect to tobacco
products that is in addition to, or more stringent than,
requirements established under this chapter, including a law,
rule, regulation, or other measure relating to or prohibiting
the sale, distribution, possession, exposure to, access to,
advertising and promotion of, or use of tobacco products by
individuals of any age, information reporting to the State, or
measures relating to fire safety standards for tobacco
products. No provision of this chapter shall limit or otherwise
affect any State, Tribal, or local taxation of tobacco
products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--Except as provided in paragraph
(1) and subparagraph (B), no State or political
subdivision of a State may establish or continue in
effect with respect to a tobacco product any
requirement which is different from, or in addition to,
any requirement under the provisions of this chapter
relating to tobacco product standards, premarket
approval, adulteration, misbranding, labeling,
registration, good manufacturing standards, or modified
risk tobacco products.
``(B) Exception.--Subparagraph (A) does not apply
to requirements relating to the sale, distribution,
possession, information reporting to the State,
exposure to, access to, the advertising and promotion
of, or use of, tobacco products by individuals of any
age, or relating to fire safety standards for tobacco
products. Information disclosed to a State under
subparagraph (A) that is exempt from disclosure under
section 554(b)(4) of title 5, United States Code, shall
be treated as trade secret and confidential information
by the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall be
construed to modify or otherwise affect any action or the liability of
any person under the product liability law of any State.
``SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 1 year after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall establish an 11-member advisory committee, to be known
as the `Tobacco Products Scientific Advisory Committee'.
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as
members of the Tobacco Products Scientific Advisory
Committee individuals who are technically qualified by
training and experience in the medicine, medical
ethics, science, or technology involving the
manufacture, evaluation, or use of tobacco products,
who are of appropriately diversified professional
backgrounds. The committee shall be composed of--
``(i) 7 individuals who are physicians,
dentists, scientists, or health care
professionals practicing in the area of
oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant
specialty;
``(ii) 1 individual who is an officer or
employee of a State or local government or of
the Federal Government;
``(iii) 1 individual as a representative of
the general public;
``(iv) 1 individual as a representative of
the interests in the tobacco manufacturing
industry; and
``(v) 1 individual as a representative of
the interests of the tobacco growers.
``(B) Nonvoting members.--The members of the
committee appointed under clauses (iv) and (v) of
subparagraph (A) shall serve as consultants to those
described in clauses (i) through (iii) of subparagraph
(A) and shall be nonvoting representatives.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary may
appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members of the Advisory Committee to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory Committee
shall provide advice, information, and recommendations to the
Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed the daily equivalent of the
rate in effect for level 4 of the Senior Executive Schedule
under section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per diem
in lieu of subsistence, as authorized by section 5703 of title
5, United States Code, for persons in the Government service
employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act (5 U.S.C. App.) does not apply to the
Advisory Committee.
``(e) Proceedings of Advisory Panels and Committees.--The Advisory
Committee shall make and maintain a transcript of any proceeding of the
panel or committee. Each such panel and committee shall delete from any
transcript made under this subsection information which is exempt from
disclosure under section 552(b) of title 5, United States Code.
``SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
``The Secretary shall--
``(1) at the request of the applicant, consider designating
nicotine replacement products as fast track research and
approval products within the meaning of section 506;
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco dependence;
and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.
``SEC. 920. USER FEE.
``(a) Establishment of Quarterly User Fee.--The Secretary shall
assess a quarterly user fee with respect to every quarter of each
fiscal year commencing fiscal year 2005, calculated in accordance with
this section, upon each manufacturer and importer of tobacco products
subject to this chapter.
``(b) Funding of FDA Regulation of Tobacco Products.--The Secretary
shall make user fees collected pursuant to this section available to
pay, in each fiscal year, for the costs of the activities of the Food
and Drug Administration related to the regulation of tobacco products
under this chapter.
``(c) Assessment of User Fee.--
``(1) Amount of assessment.--Except as provided in
paragraph (4), the total user fees assessed each year pursuant
to this section shall be sufficient, and shall not exceed what
is necessary, to pay for the costs of the activities described
in subsection (b) for each fiscal year.
``(2) Allocation of assessment by class of tobacco
products.--
``(A) In general.--Subject to paragraph (3), the
total user fees assessed each fiscal year with respect
to each class of importers and manufacturers shall be
equal to an amount that is the applicable percentage of
the total costs of activities of the Food and Drug
Administration described in subsection (b).
``(B) Applicable percentage.--For purposes of
subparagraph (A) the applicable percentage for a fiscal
year shall be the following:
``(i) 92.07 percent shall be assessed on
manufacturers and importers of cigarettes;
``(ii) 0.05 percent shall be assessed on
manufacturers and importers of little cigars;
``(iii) 7.15 percent shall be assessed on
manufacturers and importers of cigars other
than little cigars;
``(iv) 0.43 percent shall be assessed on
manufacturers and importers of snuff;
``(v) 0.10 percent shall be assessed on
manufacturers and importers of chewing tobacco;
``(vi) 0.06 percent shall be assessed on
manufacturers and importers of pipe tobacco;
and
``(vii) 0.14 percent shall be assessed on
manufacturers and importers of roll-your-own
tobacco.
``(3) Distribution of fee shares of manufacturers and
importers exempt from user fee.--Where a class of tobacco
products is not subject to a user fee under this section, the
portion of the user fee assigned to such class under subsection
(d)(2) shall be allocated by the Secretary on a pro rata basis
among the classes of tobacco products that are subject to a
user fee under this section. Such pro rata allocation for each
class of tobacco products that are subject to a user fee under
this section shall be the quotient of--
``(A) the sum of the percentages assigned to all
classes of tobacco products subject to this section;
divided by
``(B) the percentage assigned to such class under
paragraph (2).
``(4) Annual limit on assessment.--The total assessment
under this section--
``(A) for fiscal year 2005 shall be $85,000,000;
``(B) for fiscal year 2006 shall be $175,000,000;
``(C) for fiscal year 2007 shall be $300,000,000;
and
``(D) for each subsequent fiscal year, shall not
exceed the limit on the assessment imposed during the
previous fiscal year, as adjusted by the Secretary
(after notice, published in the Federal Register) to
reflect the greater of--
``(i) the total percentage change that
occurred in the Consumer Price Index for all
urban consumers (all items; United States city
average) for the 12-month period ending on June
30 of the preceding fiscal year for which fees
are being established; or
``(ii) the total percentage change for the
previous fiscal year in basic pay under the
General Schedule in accordance with section
5332 of title 5, United States Code, as
adjusted by any locality-based comparability
payment pursuant to section 5304 of such title
for Federal employees stationed in the District
of Columbia.
``(5) Timing of user fee assessment.--The Secretary shall
notify each manufacturer and importer of tobacco products
subject to this section of the amount of the quarterly
assessment imposed on such manufacturer or importer under
subsection (f) during each quarter of each fiscal year. Such
notifications shall occur not earlier than 3 months prior to
the end of the quarter for which such assessment is made, and
payments of all assessments shall be made not later than 60
days after each such notification.
``(d) Determination of User Fee by Company Market Share.--
``(1) In general.--The user fee to be paid by each
manufacturer or importer of a given class of tobacco products
shall be determined in each quarter by multiplying--
``(A) such manufacturer's or importer's market
share of such class of tobacco products; by
``(B) the portion of the user fee amount for the
current quarter to be assessed on manufacturers and
importers of such class of tobacco products as
determined under subsection (e).
``(2) No fee in excess of market share.--No manufacturer or
importer of tobacco products shall be required to pay a user
fee in excess of the market share of such manufacturer or
importer.
``(e) Determination of Volume of Domestic Sales.--
``(1) In general.--The calculation of gross domestic volume
of a class of tobacco product by a manufacturer or importer,
and by all manufacturers and importers as a group, shall be
made by the Secretary using information provided by
manufacturers and importers pursuant to subsection (f), as well
as any other relevant information provided to or obtained by
the Secretary.
``(2) Measurement.--For purposes of the calculations under
this subsection and the information provided under subsection
(f) by the Secretary, gross domestic volume shall be measured
by--
``(A) in the case of cigarettes, the number of
cigarettes sold;
``(B) in the case of little cigars, the number of
little cigars sold;
``(C) in the case of large cigars, the number of
cigars weighing more than 3 pounds per thousand sold;
and
``(D) in the case of other classes of tobacco
products, in terms of number of pounds, or fraction
thereof, of these products sold.
``(f) Measurement of Gross Domestic Volume.--
``(1) In general.--Each manufacturer and importer of
tobacco products shall submit to the Secretary a certified copy
of each of the returns or forms described by this paragraph
that are required to be filed with a Government agency on the
same date that those returns or forms are filed, or required to
be filed, with such agency. The returns and forms described by
this paragraph are those returns and forms related to the
release of tobacco products into domestic commerce, as defined
by section 5702(k) of the Internal Revenue Code of 1986, and
the repayment of the taxes imposed under chapter 52 of such
Code (ATF Form 500.24 and United States Customs Form 7501 under
currently applicable regulations).
``(2) Penalties.--Any person that knowingly fails to
provide information required under this subsection or that
provides false information under this subsection shall be
subject to the penalties described in section 1003 of title 18,
United States Code. In addition, such person may be subject to
a civil penalty in an amount not to exceed 2 percent of the
value of the kind of tobacco products manufactured or imported
by such person during the applicable quarter, as determined by
the Secretary.
``(g) Effective Date.--The user fees prescribed by this section
shall be assessed in fiscal year 2005, based on domestic sales of
tobacco products during fiscal year 2004 and shall be assessed in each
fiscal year thereafter.''.
SEC. 232. INTERIM FINAL RULE.
(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--Not later than 30 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register an interim final
rule regarding cigarettes and smokeless tobacco, which is
hereby deemed to be in compliance with the Administrative
Procedures Act and other applicable law.
(2) Contents of rule.--Except as provided in this
subsection, the interim final rule published under paragraph
(1), shall be identical in its provisions to part 897 of the
regulations promulgated by the Secretary of Health and Human
Services in the August 28, 1996, issue of the Federal Register
(61 Fed. Reg., 44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional
authority that is in accordance with this subsection;
(B) strike Subpart C--Labeling and section
897.32(c); and
(C) become effective not later than 1 year after
the date of enactment of this Act.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with the
Administrative Procedures Act.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with the
Administrative Procedures Act, the regulation promulgated
pursuant to this section.
(b) Limitation on Advisory Opinions.--As of the date of enactment
of this Act, the following documents issued by the Food and Drug
Administration shall not constitute advisory opinions under section
10.85(d)(1) of title 21, Code of Federal Regulations, except as they
apply to tobacco products, and shall not be cited by the Secretary of
Health and Human Services or the Food and Drug Administration as
binding precedent:
(1) The preamble to the proposed rule in the document
entitled ``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco Products to Protect Children
and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
(2) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document entitled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318
(August 28, 1996)).
SEC. 233. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as
otherwise expressly provided, whenever in this section an amendment is
expressed in terms of an amendment to, or repeal of, a section or other
provision, the reference is to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e), by striking ``515(f), or 519'' and
inserting ``515(f), 519, or 909'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j), by striking ``708, or 721'' and
inserting ``708, 721, 904, 905, 906, 907, 908, 909, or section
921(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section 510 or
905, the failure to provide any information required by section 510(j),
510(k), 905(i), or 905(j), or the failure to provide a notice required
by section 510(j)(2) or 905(i)(2).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b)(8), or 908, or condition prescribed
under section 903(b)(6)(B)(ii)(II);
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904, 909,
or section 921; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after ``device'' each time that it appears; and
(13) by adding at the end the following:
``(aa) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
``(bb) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
``(cc)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification
device upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
``(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch, die,
plate, stone, or other item that is designed to print, imprint,
or reproduce the trademark, trade name, or other identifying
mark, imprint, or device of another or any likeness of any of
the foregoing upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
``(3) The doing of any act that causes a tobacco product to
be a counterfeit tobacco product, or the sale or dispensing, or
the holding for sale or dispensing, of a counterfeit tobacco
product.
``(dd) The charitable distribution of tobacco products.
``(ee) The failure of a manufacturer or distributor to
notify the Attorney General of their knowledge of tobacco
products used in illicit trade.''.
(c) Section 303.--Section 303 (21 U.S.C. 333(f)) is amended in
subsection (f)--
(1) by striking the subsection heading and inserting the
following:
``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
(2) in paragraph (1)(A), by inserting ``or tobacco
products'' after ``devices'';
(3) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(4) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), and inserting after paragraph (2)
the following:
``(3) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1).'';
(5) in paragraph (4) as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time
it appears and inserting ``assessed, or a no-
tobacco-sale order may be imposed,''; and
(ii) by striking ``penalty'' and inserting
``penalty, or upon whom a no-tobacco-order is
to be imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the
following: ``or the period to be covered by a
no-tobacco-sale order,''; and
(ii) by adding at the end the following:
``A no-tobacco-sale order permanently
prohibiting an individual retail outlet from
selling tobacco products shall include
provisions that allow the outlet, after a
specified period of time, to request that the
Secretary compromise, modify, or terminate the
order.''; and
(C) by adding at the end, the following:
``(D) The Secretary may compromise, modify, or
terminate, with or without conditions, any no-tobacco-
sale order.'';
(6) in paragraph (5) as so redesignated--
(A) by striking ``(3)(A)'' as redesignated, and
inserting ``(4)(A)'';
(B) by inserting ``or the imposition of a no-
tobacco-sale order'' after ``penalty'' the first 2
places it appears; and
(C) by striking ``issued.'' and inserting ``issued,
or on which the no-tobacco-sale order was imposed, as
the case may be.''; and
(7) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the
following: ``, (E) Any adulterated or misbranded
tobacco product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after ``device'' each place it appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device'' each place it appears.
(e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
(1) by inserting ``(1)'' after ``(a)''; and
(2) by adding at the end thereof the following:
``(2) For a tobacco product, to the extent feasible, the Secretary
shall contract with the States in accordance with paragraph (1) to
carry out inspections of retailers within that State in connection with
the enforcement of this Act.''.
(f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after ``device,''
each place it appears; and
(2) by inserting ``tobacco products,'' after ``devices,''
each place it appears.
(g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after ``devices,'' each place it appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
product'' after ``restricted devices'' each place it appears;
and
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''.
(h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by
inserting ``tobacco products,'' after ``devices,''.
(i) Section 709.--Section 709 (21 U.S.C. 379) is amended by
inserting ``or tobacco product'' after ``device''.
(j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after
``devices,'' the first time it appears;
(B) by inserting ``or section 905(j)'' after
``section 510''; and
(C) by striking ``drugs or devices'' each time it
appears and inserting ``drugs, devices, or tobacco
products'';
(2) in subsection (e)(1), by inserting ``tobacco product,''
after ``device,''; and
(3) by adding at the end the following:
``(p)(1) Not later than 2 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, and annually
thereafter, the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives, a report
regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco product
standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact; and
``(C) recommendations or assessments of policy alternatives
available to Congress and the Executive Branch to reduce any
negative public health impact caused by such exports.
``(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this subsection.''.
(k) Section 1003.--Section 1003(d)(2)(C) (as redesignated by
section 231(a)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting a comma and ``and tobacco products'' after
``devices''.
(l) Guidance and Effective Dates.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance--
(A) defining the term ``repeated violation'', as
used in section 303(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)) as amended by
subsection (c), by identifying the number of violations
of particular requirements over a specified period of
time at a particular retail outlet that constitute a
repeated violation;
(B) providing for timely and effective notice to
the retailer of each alleged violation at a particular
retail outlet;
(C) providing for an expedited procedure for the
administrative appeal of an alleged violation;
(D) providing that a person may not be charged with
a violation at a particular retail outlet unless the
Secretary has provided notice to the retailer of all
previous violations at that outlet;
(E) establishing a period of time during which, if
there are no violations by a particular retail outlet,
that outlet will not be considered to have been the
site of repeated violations when the next violation
occurs; and
(F) providing that good faith reliance on the
presentation of a false government issued photographic
identification that contains a date of birth does not
constitute a violation of any minimum age requirement
for the sale of tobacco products if the retailer has
taken effective steps to prevent such violations,
including--
(i) adopting and enforcing a written policy
against sales to minors;
(ii) informing its employees of all
applicable laws;
(iii) establishing disciplinary sanctions
for employee noncompliance; and
(iv) requiring its employees to verify age
by way of photographic identification or
electronic scanning device.
(2) General effective date.--The amendments made by
subsection (c), other than the amendment made by paragraph (2)
of such subsection, shall take effect upon the issuance of
guidance described in paragraph (1).
(3) Special effective date.--The amendments made by
paragraph (2) of subsection (c) shall take effect on the date
of enactment of this Act.
PART II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 235. CIGARETTE LABEL AND ADVERTISING WARNINGS.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333) is amended to read as follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
```WARNING: Cigarettes are addictive'.
```WARNING: Tobacco smoke can harm your children'.
```WARNING: Cigarettes cause fatal lung disease'.
```WARNING: Cigarettes cause cancer'.
```WARNING: Cigarettes cause strokes and heart disease'.
```WARNING: Smoking during pregnancy can harm your baby'.
```WARNING: Smoking can kill you'.
```WARNING: Tobacco smoke causes fatal lung disease in non-
smokers'.
```WARNING: Quitting smoking now greatly reduces serious
risks to your health'.
``(2) Placement; typography; etc.--
``(A) In general.--Each label statement required by
paragraph (1) shall be located in the upper portion of
the front and rear panels of the package, directly on
the package underneath the cellophane or other clear
wrapping. Except as provided in subparagraph (B), each
label statement shall comprise at least the top 30
percent of the front and rear panels of the package.
The word `WARNING' shall appear in capital letters and
all text shall be in conspicuous and legible 17-point
type, unless the text of the label statement would
occupy more than 70 percent of such area, in which case
the text may be in a smaller conspicuous and legible
type size, provided that at least 60 percent of such
area is occupied by required text. The text shall be
black on a white background, or white on a black
background, in a manner that contrasts, by typography,
layout, or color, with all other printed material on
the package, in an alternating fashion under the plan
submitted under subsection (b)(4).
``(B) Hinged lid boxes.--For any cigarette brand
package manufactured or distributed before January 1,
2000, which employs a hinged lid style (if such
packaging was used for that brand in commerce prior to
June 21, 1997), the label statement required by
paragraph (1) shall be located on the hinged lid area
of the package, even if such area is less than 25
percent of the area of the front panel. Except as
provided in this paragraph, the provisions of this
subsection shall apply to such packages.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not
manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging that
is supplied to the retailer by a tobacco product manufacturer,
importer, or distributor and is not altered by the retailer in
a way that is material to the requirements of this subsection
except that this paragraph shall not relieve a retailer of
liability if the retailer sells or distributes tobacco products
that are not labeled in accordance with this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a) of this section.
``(2) Typography, etc.--Each label statement required by
subsection (a) of this section in cigarette advertising shall
comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and (where
applicable) any required statement relating to tar, nicotine,
or other constituent (including a smoke constituent) yield
shall comprise at least 20 percent of the area of the
advertisement and shall appear in a conspicuous and prominent
format and location at the top of each advertisement within the
trim area. The Secretary may revise the required type sizes in
such area in such manner as the Secretary determines
appropriate. The word `WARNING' shall appear in capital
letters, and each label statement shall appear in conspicuous
and legible type. The text of the label statement shall be
black if the background is white and white if the background is
black, under the plan submitted under paragraph (4) of this
subsection. The label statements shall be enclosed by a
rectangular border that is the same color as the letters of the
statements and that is the width of the first downstroke of the
capital `W' of the word `WARNING' in the label statements. The
text of such label statements shall be in a typeface pro rata
to the following requirements: 45-point type for a whole-page
broadsheet newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point type for a
whole-page tabloid newspaper advertisement; 27-point type for a
half-page tabloid newspaper advertisement; 31.5-point type for
a double page spread magazine or whole-page magazine
advertisement; 22.5-point type for a 28 centimeter by 3 column
advertisement; and 15-point type for a 20 centimeter by 2
column advertisement. The label statements shall be in English,
except that in the case of--
``(A) an advertisement that appears in a newspaper,
magazine, periodical, or other publication that is not
in English, the statements shall appear in the
predominant language of the publication; and
``(B) in the case of any other advertisement that
is not in English, the statements shall appear in the
same language as that principally used in the
advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be printed
on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States Code,
adjust the format and type sizes for the label statements
required by this section or the text, format, and type sizes of
any required tar, nicotine yield, or other constituent
(including smoke constituent) disclosures, or to establish the
text, format, and type sizes for any other disclosures required
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et. seq.). The text of any such label statements or disclosures
shall be required to appear only within the 20 percent area of
cigarette advertisements provided by paragraph (2) of this
subsection. The Secretary shall promulgate regulations which
provide for adjustments in the format and type sizes of any
text required to appear in such area to ensure that the total
text required to appear by law will fit within such area.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas
of the United States in which the product is marketed in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(B) assures that all of the labels required under
this section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the
same time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required under
this section except that this paragraph shall not relieve a
retailer of liability if the retailer displays, in a location
open to the public, an advertisement that is not labeled in
accordance with the requirements of this subsection and
subsection (b).''.
SEC. 236. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by section 235, is further amended by adding
at the end the following:
``(d) Change in Required Statements.--The Secretary may, by a
rulemaking conducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the label
requirements, require color graphics to accompany the text, increase
the required label area from 30 percent up to 50 percent of the front
and rear panels of the package, or establish the format, type size, and
text of any other disclosures required under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary finds that
such a change would promote greater public understanding of the risks
associated with the use of tobacco products.''.
SEC. 237. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1334) is amended by adding at the end the following:
``(c) Exception.--Notwithstanding subsection (b), a State or
locality may enact statutes and promulgate regulations, based on
smoking and health, that take effect after the effective date of the
Family Smoking Prevention and Tobacco Control Act, imposing specific
bans or restrictions on the time, place, and manner, but not content,
of the advertising or promotion of any cigarettes.''.
SEC. 238. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 (15 U.S.C. 4402) is amended to read as follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any smokeless tobacco
product unless the product package bears, in accordance with
the requirements of this Act, one of the following labels:
```WARNING: This product can cause mouth cancer'.
```WARNING: This product can cause gum disease and tooth
loss'.
```WARNING: This product is not a safe alternative to
cigarettes'.
```WARNING: Smokeless tobacco is addictive'.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of
the package, and each label statement shall comprise at
least 30 percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and
in black text on a white background, or white text on a
black background, in a manner that contrasts by
typography, layout, or color, with all other printed
material on the package, in an alternating fashion
under the plan submitted under subsection (b)(3),
except that if the text of a label statement would
occupy more than 70 percent of the area specified by
subparagraph (A), such text may appear in a smaller
type size, so long as at least 60 percent of such
warning area is occupied by the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within the
United States.
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that is supplied
to the retailer by a tobacco products manufacturer, importer,
or distributor and that is not altered by the retailer unless
the retailer offers for sale, sells, or distributes a smokeless
tobacco product that is not labeled in accordance with this
subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable) any
required statement relating to tar, nicotine, or other
constituent yield shall--
``(A) comprise at least 20 percent of the area of
the advertisement, and the warning area shall be
delineated by a dividing line of contrasting color from
the advertisement; and
``(B) the word `WARNING' shall appear in capital
letters and each label statement shall appear in
conspicuous and legible type. The text of the label
statement shall be black on a white background, or
white on a black background, in an alternating fashion
under the plan submitted under paragraph (3).
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period, in
as equal a number of times as is possible on each brand of the
product and be randomly distributed in all areas of the United
States in which the product is marketed in accordance with a
plan submitted by the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraph (B) and approve it if the plan--
``(i) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(ii) assures that all of the labels required
under this section will be displayed by the tobacco
product manufacturer, importer, distributor, or
retailer at the same time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays in a location
open to the public, an advertisement that is not labeled in
accordance with the requirements of this subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic communications
subject to the jurisdiction of the Federal Communications
Commission.''.
SEC. 239. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL
STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 (15 U.S.C. 4402), as amended by section 237, is further
amended by adding at the end the following:
``(d) Authority To Revise WARNING Label Statements.--The Secretary
may, by a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of the label
requirements, require color graphics to accompany the text, increase
the required label area from 30 percent up to 50 percent of the front
and rear panels of the package, or establish the format, type size, and
text of any other disclosures required under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary finds that
such a change would promote greater public understanding of the risks
associated with the use of smokeless tobacco products.''.
SEC. 240. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE
PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and Advertising Act
(15 U.S.C. 1333 (a)), as amended by section 235, is further amended by
adding at the end the following:
``(4)(A) The Secretary shall, by a rulemaking conducted
under section 553 of title 5, United States Code, determine (in
the Secretary's sole discretion) whether cigarette and other
tobacco product manufacturers shall be required to include in
the area of each cigarette advertisement specified by
subsection (b) of this section, or on the package label, or
both, the tar and nicotine yields of the advertised or packaged
brand. Any such disclosure shall be in accordance with the
methodology established under such regulations, shall conform
to the type size requirements of subsection (b) of this
section, and shall appear within the area specified in
subsection (b) of this section.
``(B) Any differences between the requirements established
by the Secretary under subparagraph (A) and tar and nicotine
yield reporting requirements established by the Federal Trade
Commission shall be resolved by a memorandum of understanding
between the Secretary and the Federal Trade Commission.
``(C) In addition to the disclosures required by
subparagraph (A) of this paragraph, the Secretary may, under a
rulemaking conducted under section 553 of title 5, United
States Code, prescribe disclosure requirements regarding the
level of any cigarette or other tobacco product constituent
including any smoke constituent. Any such disclosure may be
required if the Secretary determines that disclosure would be
of benefit to the public health, or otherwise would increase
consumer awareness of the health consequences of the use of
tobacco products, except that no such prescribed disclosure
shall be required on the face of any cigarette package or
advertisement. Nothing in this section shall prohibit the
Secretary from requiring such prescribed disclosure through a
cigarette or other tobacco product package or advertisement
insert, or by any other means under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
required under this section, except that this paragraph shall
not relieve a retailer of liability if the retailer sells or
distributes tobacco products that are not labeled in accordance
with the requirements of this subsection.''.
PART III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 241. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as added by
section 231, is further amended by adding at the end the following:
``SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.
``(a) Origin Labeling.--The label, packaging, and shipping
containers of tobacco products for introduction or delivery for
introduction into interstate commerce in the United States shall bear
the statement `sale only allowed in the United States.'
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--Not later than 9 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall promulgate regulations
regarding the establishment and maintenance of records by any
person who manufactures, processes, transports, distributes,
receives, packages, holds, exports, or imports tobacco
products.
``(2) Inspection.--In promulgating the regulations
described in paragraph (1), the Secretary shall consider which
records are needed for inspection to monitor the movement of
tobacco products from the point of manufacture through
distribution to retail outlets to assist in investigating
potential illicit trade, smuggling or counterfeiting of tobacco
products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the purpose
of tracking or tracing the tobacco product through the
distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to individual
purchasers of tobacco products for personal consumption.
``(c) Records Inspection.--If the Secretary has a reasonable belief
that a tobacco product is part of an illicit trade or smuggling or is a
counterfeit product, each person who manufactures, processes,
transports, distributes, receives, holds, packages, exports, or imports
tobacco products shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or employee, at
reasonable times and within reasonable limits and in a reasonable
manner, upon the presentation of appropriate credentials and a written
notice to such person, to have access to and copy all records
(including financial records) relating to such article that are needed
to assist the Secretary in investigating potential illicit trade,
smuggling or counterfeiting of tobacco products.
``(d) Knowledge of Illegal Transaction.--
``(1) In general.--If the manufacturer or distributor of a
tobacco product has knowledge which reasonably supports the
conclusion that a tobacco product manufactured or distributed
by such manufacturer or distributor that has left the control
of such person may be or has been--
``(A) imported, exported, distributed or offered
for sale in interstate commerce by a person without
paying duties or taxes required by law; or
``(B) imported, exported, distributed or diverted
for possible illicit marketing, the manufacturer or
distributor shall promptly notify the Attorney General
of such knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or
distributor means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would
have had under like circumstances or which would have
been obtained upon the exercise of due care.''.
SEC. 242. STUDY AND REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study of cross-border trade in tobacco products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent or
eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Comptroller General of the United States shall submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report on the study described in subsection (a).
TITLE III--RESPONSIBLE MARKETING AND CONSUMER AWARENESS
Subtitle A--General Provisions
SEC. 301. NUTRITION LABELING OF RESTAURANT FOODS.
Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(q)(5)(A)(i)) is amended--
(1) in clause (A)--
(A) in subclause (i), by inserting ``except as
provided in clauses (H) and (I),'' before ``which'' the
first place it appears; and
(B) in subclause (ii), by inserting ``except as
provided in clauses (H) and (I),'' before ``which'' the
first place it appears; and
(2) by adding at the end the following:
``(H) Restaurants and retail food establishments.--
``(i) In general.--Except for food described in subclause
(iii), in the case of food that is served, processed, or
prepared in a restaurant or similar retail food establishment
that is part of a chain with 20 or more locations doing
business under the same trade name (regardless of the type of
ownership of the locations), the restaurant or establishment
shall disclose the information described in subclause (ii).
``(ii) Information required to be disclosed.--Except as
provided in subclause (iii), the establishment shall disclose--
``(I)(aa) in a statement adjacent to the name of
the food on any menu listing the food for sale, or by
any other means deemed equivalent by the Secretary, the
number of calories, grams of saturated fat plus trans
fat, and milligrams of sodium contained in a standard
serving of the food, as usually offered for sale, in a
clear and conspicuous manner; and
``(bb) information, specified by the Secretary by
regulation, designed to enable the public to
understand, in the context of a total daily diet, the
significance of the nutrition information that is
provided; and
``(II) in a statement adjacent to the name of the
food on any menu board or other sign listing the food
for sale, or by any other means deemed equivalent by
the Secretary--
``(aa) the number of calories contained in
a serving of the food, as usually offered for
sale, in a clear and conspicuous manner; and
``(bb) notification that the information
required by subitems (aa) and (bb) of item (I)
shall be provided in writing at the request of
a prospective purchaser.
``(iii) Nonapplicability to certain food.--This clause does
not apply to--
``(I) items that are not listed on a menu or menu
board (such as condiments and other items placed on the
table or counter for general use); or
``(II) daily specials, temporary menu items, or
other irregular menu items, as specified by the
Secretary by regulation.
``(iv) Self-service facilities.--In the case of food sold
at a salad bar, buffet line, cafeteria line, or similar self-
service facility, a restaurant or other establishment shall
place a sign that lists calories per standard serving adjacent
to each food offered.
``(v) Voluntary provision of nutrition information; state
regulation of nutrition information for restaurant food.--
``(I) Retail food establishments.--Nothing in this
clause precludes a restaurant or similar retail food
establishment from providing additional nutrition
information, voluntarily, if the information complies
with the nutrition labeling requirements contained in
this subparagraph.
``(II) State or local requirements.--Nothing in
this clause precludes a State or political subdivision
of a State from requiring that a restaurant or similar
food establishment provide nutrition information in
addition to that required under this clause.
``(vi) Regulations.--
``(I) Proposed regulation.--Not later than 1 year
after the date of enactment of this clause, the
Secretary shall promulgate proposed regulations to
carry out this clause.
``(II) Contents.--The regulations shall allow for
the variations in serving sizes and in food preparation
that can reasonably be expected to result from
inadvertent human error, training of food service
workers, and other factors.
``(III) Final regulations.--Not later than 2 years
after the date of enactment of this clause, the
Secretary shall promulgate final regulations to
implement this clause.
``(IV) Failure to promulgate final regulations by
required date.--If the Secretary does not promulgate
final regulations under item (III) by the date that is
2 years after the date of enactment of this clause--
``(aa) the proposed regulations issued in
accordance with item (I) shall become effective
as the final regulations on the day after that
date; and
``(bb) the Secretary shall publish in the
Federal Register notice of the final
regulations.
``(I) Vending machines.--
``(i) In general.--In the case of an article of food sold
from a vending machine that--
``(I) does not permit a prospective purchaser to
examine the article so as to be able to read a
statement affixed to the article before purchasing the
article; and
``(II) is operated by a person that is engaged in
the business of owning and operating 20 or more vending
machines;
the vending machine operator shall provide a conspicuous sign
in close proximity to the article that includes a statement
disclosing the number of calories contained in the article.
``(ii) Voluntary provision of nutrition information; state
regulation of nutrition information for vending machines.--
``(I) Vending machine operators.--Nothing in this
clause precludes a vending machine operator from
providing additional nutrition information,
voluntarily, if the information complies with the
nutrition labeling requirements contained in this
subparagraph.
``(II) State or local requirements.--Nothing in
this title precludes a State or political subdivision
of a State from requiring that a vending machine
operator provide nutrition information in addition to
that required under this clause.
``(iii) Regulations.--
``(I) Proposed regulations.--Not later than 1 year
after the date of enactment of this clause, the
Secretary shall promulgate proposed regulations to
carry out this clause.
``(II) Final regulations.--Not later than 2 years
after the date of enactment of this clause, the
Secretary shall promulgate final regulations to
implement this clause.
``(III) Failure to promulgate final regulations by
required date.--If the Secretary does not promulgate
final regulations under item (II) by the date that is 2
years after the date of enactment of this clause--
``(aa) the proposed regulations issued in
accordance with item (I) shall become effective
as the final regulations on the day after that
date; and
``(bb) the Secretary shall publish in the
Federal Register notice of the final
regulations.''.
SEC. 302. RULEMAKING AUTHORITY FOR ADVERTISING TO CHILDREN.
(a) Purpose.--The purpose of this section is to restore the
authority of the Federal Trade Commission to issue regulations that
restrict the marketing or advertising of foods and beverages to
children under the age of 18 years if the Federal Trade Commission
determines that there is evidence that consumption of certain foods and
beverages is detrimental to the health of children.
(b) Authority.--Section 18 of the Federal Trade Commission Act (15
U.S.C. 57a) is amended by striking subsection (h).
SEC. 303. LABEL AND DISCLOSURE REQUIREMENTS FOR INFANT FORMULAS.
Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a) is amended by adding at the end the following:
``(j) Label and Disclosure Requirements.--
``(1) Packaging label requirements.--
``(A) In general.--An infant formula shall be
deemed misbranded unless the label of such infant
formula contains the following statement: `The United
States Department of Health and Human Services has
determined that: (1) breast-feeding is the ideal method
of feeding and nurturing infants; (2) breast milk is
the most complete form of nutrition for infants; and
(3) breast milk is more beneficial to infants than
infant formula.'.
``(B) Specifications of label.--The label statement
required under subparagraph (A) shall be--
``(i) in conspicuous and legible type that
is not smaller than 12-point font;
``(ii) in black font on a white background,
or white font on a black background;
``(iii) with respect to typography and
layout, in contrast with the other printed
material on the package; and
``(iv) enclosed by a border that is the
same color as the letters of the statement.
``(2) Advertising regulations.--
``(A) In general.--The Secretary shall promulgate
regulations establishing labeling and disclosure
requirements for advertisements of infant formula.
``(B) Specifications of advertisements.--The
regulations promulgated under subparagraph (A) shall--
``(i) establish labeling and disclosure
requirements for all forms of media by which
infant formula is advertised, including print,
television, radio, and Internet marketing; and
``(ii) be at least as stringent as the
packaging label requirements under paragraph
(1).''.
SEC. 304. FOOD ADVERTISING IN SCHOOLS.
Section 10 of the Child Nutrition Act of 1966 (42 U.S.C. 1779) is
amended by adding at the end the following:
``(d) Food Advertising.--The Secretary may prohibit the advertising
of food in participating schools if the Secretary determines that
consumption of the advertised food has a detrimental effect on the
diets or health of children.''.
SEC. 305. DISALLOWANCE OF DEDUCTIONS FOR ADVERTISING AND MARKETING
EXPENSES RELATING TO TOBACCO PRODUCT USE.
(a) In General.--Part IX of subchapter B of chapter 1 of subtitle A
of the Internal Revenue Code of 1986 (relating to items not deductible)
is amended by adding at the end the following new section:
``SEC. 280I. DISALLOWANCE OF DEDUCTION FOR TOBACCO ADVERTISING AND
MARKETING EXPENSES.
``No deduction shall be allowed under this chapter for expenses
relating to advertising or marketing cigars, cigarettes, smokeless
tobacco, pipe tobacco, or any similar tobacco product. For purposes of
this section, any term used in this section which is also used in
section 5702 shall have the same meaning given such term by section
5702.''.
(b) Conforming Amendment.--The table of sections for such part IX
is amended by adding after the item relating to section 280H the
following new item:
``Sec. 280I. Disallowance of
deduction for tobacco
advertising and marketing
expenses.''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 306. FEDERAL-STATE TOBACCO COUNTER-ADVERTISING PROGRAMS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.), as amended in section 212, is further amended by adding
at the end the following:
``SEC. 399S. FEDERAL-STATE TOBACCO COUNTER-ADVERTISING PROGRAMS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall award grants to
and enter into contracts with eligible entities for the implementation
of national and local media (such as counter-advertising) and non-media
campaigns designed to reduce the use of tobacco products.
``(b) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity shall be--
``(1) a public entity, including a State public health
department; or
``(2) a private, nonprofit entity that--
``(A) is not affiliated with a manufacturer or
importer of a tobacco product;
``(B) has demonstrated a record of conducting a
national antitobacco public education campaign to
effectively reduce the use of tobacco products;
``(C) has expertise in conducting a multi-media
communications campaign; and
``(D) has expertise in developing strategies that
affect behavior changes in children and other targeted
populations.
``(c) Application.--An eligible entity shall submit an application
to the Secretary for a grant under this section at such time, in such
manner, and accompanied by such information as the Secretary may
require.
``(d) Use of Funds.--An eligible entity shall use amounts received
under a grant under this section to--
``(1) design and implement multimedia public education and
social marketing campaigns that--
``(A) discourage the use of tobacco products;
``(B) encourage the use of products designed to
enable tobacco use cessation; and
``(C) educate the public about the hazards of
environmental tobacco smoke exposure; or
``(2) conduct research related to the effectiveness of the
campaigns described in paragraph (1).
``(e) Allocation of Grants.--Of the amounts awarded under this
section, the Secretary shall award--
``(1) 50 percent of such amounts to eligible public
entities; and
``(2) 50 percent of such amounts to eligible private,
nonprofit entities.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated $200,000,000 to carry out this section.''.
Subtitle B--Penalties for Failure to Reduce Teen Smoking
SEC. 311. CHILD CIGARETTE USE SURVEYS.
(a) Annual Performance Survey.--
(1) In general.--Not later than August 31, 2006, and
annually thereafter, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
publish the results of an annual cigarette survey, to be
carried out after the date of enactment of this Act and
completed prior to August 21, 2006, and prior to August 21 of
each year thereafter, to determine--
(A) the percentage of all young individuals who
used a type of cigarette within the 30-day period prior
to the conduct of the survey involved; and
(B) the percentage of young individuals who
identify each brand of each type of cigarette as the
usual brand smoked within such 30-day period.
(2) Young individuals.--For the purposes of this subtitle,
the term ``young individuals'' means individuals who are under
18 years of age.
(b) Size and Methodology.--
(1) In general.--The survey referred to in subsection (a)
shall be comparable in size and methodology to the Monitoring
the Future survey that was completed in 1999 to measure the use
of cigarettes (by brand) by youths under 18 years of age within
the 30-day period prior to the conduct of the study.
(2) Conclusive accurateness.--A survey using the
methodology described in paragraph (1) shall be deemed
conclusively proper, correct, and accurate for purposes of this
section.
(3) Definition.--In this subtitle, the term ``Monitoring
the Future survey'' means the combined survey of 8th, 10th, and
12th grade students that was conducted at the Institute for
Social Research at the University of Michigan.
(c) Reduction.--The Secretary, based on a comparison of the results
of the first annual cigarette survey referred to in subsection (a) and
the Monitoring the Future survey referred to in subsection (b)(1),
shall determine the percentage reduction (if any) in youth cigarette
use for each manufacturer of cigarettes.
(d) Participation in Survey.--Notwithstanding any other provision
of law, the Secretary may conduct a survey under this section involving
minors if the results of such survey with respect to such minors are
kept confidential and not disclosed.
(e) Nonapplicability.--Chapter 35 of title 44, United States Code,
shall not apply to information required for the purposes of carrying
out this section.
(f) Definition.--In this subtitle the term ``cigarette'' has the
meaning given such term in section 3(1) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1332(1)).
SEC. 312. CIGARETTE USE REDUCTION GOAL AND NONCOMPLIANCE.
(a) Goal.--It shall be the cigarette use reduction goal that each
manufacturer reduce youth cigarette use by at least 15 percent during
the period between the Monitoring the Future survey referred to in
section 311(b)(1) and the completion of the first annual cigarette
survey (and such subsequent surveys as compared to the previous year's
survey) referred to in section 311(a).
(b) Noncompliance.--
(1) Industry-wide penalty.--If the Secretary determines
that the cigarette use reduction goal under subsection (a) has
not been achieved, the Secretary shall, not later than
September 10, 2006, and September 10 of each year thereafter,
impose an industry-wide penalty on the manufacturers of
cigarettes in an amount that is in the aggregate equal to--
(A) if youth cigarette use has been reduced by 5
percent or less, $6,000,000,000;
(B) if youth cigarette use has been reduced by at
least 6 percent but less than 10 percent,
$4,000,000,000; and
(C) if youth cigarette use has been reduced by at
least 11 percent but less than 15 percent,
$2,000,000,000.
(2) Payment.--The industry-wide penalty imposed under this
subsection shall be paid by each manufacturer based on the
percentage of cigarettes of each such manufacturer that are
used by youth (as determined under the Monitoring the Future
survey and compared to the cigarettes manufactured by all
manufacturers) as such percentage relates to the total amount
to be paid by all manufacturers.
(3) Final determination.--The determination of the
Secretary as to the amount and allocation of a surcharge under
this subtitle shall be final and the manufacturer shall pay
such surcharge within 10 days of the date on which the
manufacturer is assessed. Such payment shall be retained by the
Secretary pending final judicial review of what, if any, change
in the surcharge is appropriate.
(4) Compliance by certain manufacturers.--A manufacturer
that individually complies with the goal under subsection (a)
shall not be liable for the payment of any portion of the
penalty under this subsection.
(5) Limitation.--With respect to cigarettes, a manufacturer
with a market share of 1 percent or less of youth cigarette use
shall not be liable for the payment of a surcharge under this
section.
(c) Penalties Nondeductible.--The payment of penalties under this
subtitle shall not be considered to be an ordinary and necessary
expense in carrying on a trade or business for purposes of the Internal
Revenue Code of 1986 and shall not be deductible.
(d) Judicial Review.--
(1) After payment.--A manufacturer of cigarettes may seek
judicial review of any action under this subtitle only after
the assessment involved has been paid by the manufacturer to
the Department of the Treasury and only in the United States
District Court for the District of Columbia.
(2) Review by attorney general.--Prior to the filing of an
action by a manufacturer seeking judicial review of an action
under this subtitle, the manufacturer shall notify the Attorney
General of such intent to file and the Attorney General shall
have 30 days in which to respond to the action.
(3) Review.--The amount of any surcharge paid under this
subtitle shall be subject to judicial review by the United
States Court of Appeals for the District of Columbia Circuit,
based on the arbitrary and capricious standard of section 706
of title 5, United States Code. Notwithstanding any other
provision of law, no court shall have the authority to stay any
surcharge payment due to the Secretary under this subtitle
pending judicial review until the Secretary has made or failed
to make a compliance determination, as described under this
subtitle, that has adversely affected the person seeking the
review.
SEC. 313. ENFORCEMENT.
(a) Initial Penalty.--There is hereby imposed an initial penalty on
the failure of any manufacturer to make any payment required under this
subtitle within 10 days after the date on which such payment is due.
(b) Amount of Penalty.--The amount of the penalty imposed by
subsection (a) on any failure with respect to a manufacturer shall be
an amount equal to 2 percent of the penalty owed under section 312 for
each day during the noncompliance period.
(c) Noncompliance Period.--For purposes of this section, the term
``noncompliance period'' means, with respect to any failure to make the
surcharge payment required under this subtitle, the period--
(1) beginning on the due date for such payment; and
(2) ending on the date on which such payment is paid in
fall.
(d) Limitations.--No penalty shall be imposed by subsection (a)
on--
(1) any failure to make a surcharge payment under this
subtitle during any period for which it is established to the
satisfaction of the Secretary that none of the persons
responsible for such failure knew or, exercising reasonable
diligence, would have known, that such failure existed; or
(2) any manufacturer that produces less than 1 percent of
cigarettes used by youth in that year (as determined by the
annual survey).
TITLE IV--REIMBURSEMENT AND COVERAGE OF PREVENTIVE SERVICES
SEC. 401. COVERAGE OF SUBSTANCE USE (OTHER THAN TOBACCO), DIET,
EXERCISE, INJURY PREVENTION, AND DENTAL HEALTH
COUNSELING.
(a) Coverage.--
(1) In general.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)), as amended by section 642(a) of
the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (Public Law 108-173; 117 Stat. 2322), is amended--
(A) in subparagraph (Y), by striking ``and'' after
the semicolon at the end;
(B) in subparagraph (Z), by adding ``and'' after
the semicolon at the end; and
(C) by adding at the end the following new
subparagraph:
``(AA) substance use (other than tobacco), diet, exercise,
injury prevention, and dental health counseling (as defined in
subsection (bbb)(1));''.
(2) Conforming amendments.--(A) Section 1862(a)(12) of the
Social Security Act (42 U.S.C. 1395y(a)(12)) is amended by
inserting ``(except as otherwise allowed under subsection
1861(s)(2)(AA))'' after ``directly supporting teeth''.
(B) Clauses (i) and (ii) of section 1861(s)(2)(K) of the
Social Security Act (42 U.S.C. 1395x(s)(2)(K)), as amended by
section 611(d)(2) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-173;
117 Stat. 2304), are each amended by striking ``subsection
(ww)(1)'' and inserting ``subsections (ww)(1) and (bbb)''.
(b) Services Described.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x), as amended by section 706(b) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Public
Law 108-173; 117 Stat. 2339), is amended by adding at the end the
following new subsection:
``Substance Use (Other Than Tobacco), Diet, Exercise, Injury
Prevention, and Dental Health Counseling
``(bbb) The term `substance use (other than tobacco), diet,
exercise, injury prevention, and dental health counseling' means
therapy and counseling relating to substance use (other than tobacco),
diet, exercise, injury prevention, and dental health counseling that is
furnished--
``(1) by or under the supervision of a physician; or
``(2) by any other health care professional who--
``(A) is legally authorized to furnish such
services under State law (or the State regulatory
mechanism provided by State law) of the State in which
the services are furnished; and
``(B) is authorized to receive payment for other
services under this title or is designated by the
Secretary for this purpose.''.
(c) Payment and Elimination of Cost-Sharing.--
(1) Payment and elimination of coinsurance.--Section
1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)),
as amended by section 302(b)(2) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law
108-173; 117 Stat. 2229), is amended--
(A) in subparagraph (N), by inserting ``or
substance use (other than tobacco), diet, exercise,
injury prevention, and dental health counseling (as
defined in section 1861(bbb))'' after ``(as defined in
section 1848(j)(3))'';
(B) by striking ``and'' before ``(V)''; and
(C) by inserting before the semicolon at the end
the following: ``and (W) with respect to substance use
(other than tobacco), diet, exercise, injury
prevention, and dental health counseling (as defined in
section 1861(bbb) the amount paid shall be the lesser
of the actual charge for the services or the amount
determined under the payment basis determined under
section 1848''.
(2) Payment under physician fee schedule.--Section
1848(j)(3) of the Social Security Act (42 U.S.C. 1395w-
4(j)(3)), as amended by section 611(c) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003
(Public Law 108-173; 117 Stat. 2304), is amended by inserting
``(2)(AA),'' after ``(2)(W),''.
(3) Elimination of coinsurance in outpatient hospital
settings.--
(A) Exclusion from opd fee schedule.--Section
1833(t)(1)(B)(iv) of the Social Security Act (42 U.S.C.
1395l(t)(1)(B)(iv)), as amended by section 614(a) of
the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law 108-173; 117
Stat. 2306), is amended by striking ``and diagnostic
mammography'' and inserting ``, diagnostic mammography,
or substance use (other than tobacco), diet, exercise,
injury prevention, and dental health counseling (as
defined in section 1861(bbb))''.
(B) Conforming amendments.--Section 1833(a)(2) of
the Social Security Act (42 U.S.C. 1395l(a)(2)) is
amended--
(i) in subparagraph (F), by striking
``and'' after the semicolon at the end;
(ii) in subparagraph (G)(ii), by striking
the comma at the end and inserting
``; and''; and
(iii) by inserting after subparagraph
(G)(ii) the following new subparagraph:
``(H) with respect to substance use (other than
tobacco), diet, exercise, injury prevention, and dental
health counseling (as defined in section 1861(bbb))
furnished by an outpatient department of a hospital,
the amount determined under paragraph (1)(W),''.
(4) Elimination of deductible.--The first sentence of
section 1833(b) of the Social Security Act (42 U.S.C. 1395l(b))
is amended--
(A) by striking ``and'' before ``(6)''; and
(B) by inserting before the period at the end the
following: ``, and (7) such deductible shall not apply
with respect to substance use (other than tobacco),
diet, exercise, injury prevention, and dental health
counseling (as defined in section 1861(bbb))''.
(d) Application of Limits on Billing.--Section 1842(b)(18)(C) of
the Social Security Act (42 U.S.C. 1395u(b)(18)(C)) is amended by
adding at the end the following new clause:
``(vii) Any health care professional designated under
section 1861(bbb)(2)(B) to perform substance use (other than
tobacco), diet, exercise, injury prevention, and dental health
counseling that is not otherwise described in this
subparagraph.''.
(e) Effective Date.--The amendments made by this section shall take
effect as if included in the enactment of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173;
117 Stat. 2066) and shall apply to services furnished on and after
January 1, 2006.
SEC. 402. PREVENTIVE MENTAL HEALTH SCREENINGS.
(a) Coverage.--
(1) In general.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)), as amended by section 401(a)(1),
is amended--
(A) in subparagraph (Z), by striking ``and'' after
the semicolon at the end;
(B) in subparagraph (AA), by adding ``and'' after
the semicolon at the end; and
(C) by adding at the end the following new
subparagraph:
``(BB) screenings for clinical depression, anxiety, and
impaired cognitive functioning (as defined in subsection
(ccc)(1));''.
(2) Conforming amendments.--Clauses (i) and (ii) of section
1861(s)(2)(K) of the Social Security Act (42 U.S.C.
1395x(s)(2)(K)), as amended by section 401(a)(2)(B), are each
amended by striking ``and (bbb)'' and inserting ``(bbb), and
(ccc)''.
(b) Services Described.--Section 1861 of the Social Security Act
(42 U.S.C. 1395x), as amended by section 401(b), is amended by adding
at the end the following new subsection:
``Screenings for Clinical Depression, Anxiety, and Impaired Cognitive
Functioning
``(ccc)(1) The term `screening for clinical depression, anxiety,
and impaired cognitive functioning' means a consultation for the
purpose of detecting clinical depression, anxiety, and impaired
cognitive functioning during which a qualified health professional (as
defined in paragraph (2))--
``(A) uses a screening on the list established or
identified under paragraph (3);
``(B) assesses the individual's risk of clinical
depression, anxiety, and impaired cognitive functioning; and
``(C) if the qualified health professional determines that
the individual is at high risk for clinical depression,
anxiety, or impaired cognitive functioning, refers the
individual for a full diagnostic evaluation and such additional
treatment as may be required.
Nothing in subparagraph (C) shall be construed as prohibiting a
qualified health professional performing the screening for clinical
depression, anxiety, and impaired cognitive functioning with respect to
an individual from directly providing the diagnostic evaluation and
additional treatment described in such clause to such individual if
such professional is legally authorized to provide such an evaluation
and additional treatment under State law (or the State regulatory
mechanism provided by State law) of the State in which the screening is
performed.
``(2) For purposes of this subsection, the term `qualified health
professional' means an individual who--
``(A) is--
``(i) a physician (as defined in subsection
(r)(1));
``(ii) a nurse practitioner (as defined in
subsection (aa)(5)); or
``(iii) a mental health care professional
(including clinical psychologists (as defined by the
Secretary for purposes of section 1861(ii)) and
clinical social workers (as defined in subsection
1861(hh))) that is licensed or certified to perform
mental health services by the State in which the
screenings are performed; and
``(B) has an agreement in effect with the Secretary to
accept--
``(i) the amount determined under section
1833(a)(1)(W) as full payment for screenings for
clinical depression, anxiety, and impaired cognitive
functioning; and
``(ii) an assignment described in section
1842(b)(3)(B)(ii) with respect to payment for each
screening furnished by the professional to an
individual enrolled under part B.
``(3) The Secretary shall, in consultation with mental health
professionals and other stakeholders with experience in screening for
clinical depression, anxiety, and impaired cognitive functioning, shall
establish or identify a list of approved screenings to be used under
this paragraph. The Secretary, in consultation with such professionals
and stakeholders, shall review and update such list not less frequently
than once every 5 years.''.
(c) Payment and Elimination of Cost-Sharing.--
(1) Payment and elimination of coinsurance.--Section
1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)),
as amended by section 401(c)(1), is amended--
(A) in subparagraph (N), by striking ``or substance
use (other than tobacco), diet, exercise, injury
prevention, and dental health counseling (as defined in
section 1861(bbb))'' and inserting ``substance use
(other than tobacco), diet, exercise, injury
prevention, and dental health counseling (as defined in
section 1861(bbb)), or screenings for clinical
depression, anxiety, and impaired cognitive functioning
(as defined in section 1861(ccc))''; and
(B) in subparagraph (W), by inserting ``and
screenings for clinical depression, anxiety, and
impaired cognitive functioning (as defined in section
1861(ccc))'' after ``(as defined in section
1861(bbb))''.
(2) Payment under physician fee schedule.--Section
1848(j)(3) of the Social Security Act (42 U.S.C. 1395w-
4(j)(3)), as amended by section 401(c)(2), is amended by
inserting ``(2)(BB),'' after ``(2)(AA),''.
(3) Elimination of coinsurance in outpatient hospital
settings.--
(A) Exclusion from opd fee schedule.--Section
1833(t)(1)(B)(iv) of the Social Security Act (42 U.S.C.
1395l(t)(1)(B)(iv)), as amended by section
401(c)(3)(A), is amended by striking ``or substance use
(other than tobacco), diet, exercise, injury
prevention, and dental health counseling (as defined in
section 1861(bbb))'' and inserting ``substance use
(other than tobacco), diet, exercise, injury
prevention, and dental health counseling (as defined in
section 1861(bbb)), or screenings for clinical
depression, anxiety, and impaired cognitive functioning
(as defined in section 1861(ccc))''.
(B) Conforming amendment.--Section 1833(a)(2)(H) of
the Social Security Act (42 U.S.C. 1395l(a)(2)(H)), as
added by section 401(c)(3)(B)(iii), is amended by
inserting ``and screenings for clinical depression,
anxiety, and impaired cognitive functioning (as defined
in section 1861(ccc))'' after ``(as defined in section
1861(bbb))''.
(4) Elimination of deductible.--Section 1833(b)(7) of the
Social Security Act (42 U.S.C. 1395l(b)(7)), as amended by
section 401(c)(4), is amended by inserting ``or screenings for
clinical depression, anxiety, and impaired cognitive
functioning (as defined in section 1861(ccc))'' before the
period at the end.
(d) Application of Limits on Billing.--Section 1842(b)(18)(C) of
the Social Security Act (42 U.S.C. 1395u(b)(18)(C)), as amended by
section 401(d), is amended by adding at the end the following new
clause:
``(viii) A mental health care professional described in
section 1861(ccc)(2) that is authorized to perform screenings
for clinical depression, anxiety, and impaired cognitive
functioning (as defined in section 1861(ccc)(1)) that is not
otherwise described in this subparagraph.''.
(e) Frequency.--Section 1862(a)(1) of the Social Security Act (42
U.S.C. 1395y(a)(1)), as amended by section 613(c) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Public
Law 108-173; 117 Stat. 2306), is amended--
(1) in subparagraph (L), by striking ``and'' after the
comma at the end;
(2) in subparagraph (M), by striking the semicolon at the
end and inserting ``, and''; and
(3) by adding at the end the following new subparagraph:
``(N) in the case of screenings for clinical depression,
anxiety, and impaired cognitive functioning (as defined in
section 1861(ccc)(1)), which is performed more frequently than
is covered under such section;''.
(f) Effective Date.--The amendments made by this section shall take
effect as if included in the enactment of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173;
117 Stat. 2066) and shall apply to services furnished on and after
January 1, 2006.
SEC. 403. ENCOURAGEMENT OF CESSATION OF TOBACCO USE.
(a) Medicare Coverage of Counseling and Pharmacotherapy for
Cessation of Tobacco Use.--
(1) Coverage.--
(A) In general.--Section 1861(s)(2) of the Social
Security Act (42 U.S.C. 1395x(s)(2)), as amended by
section 402(a)(1), is amended--
(i) in subparagraph (AA), by striking
``and'' after the semicolon at the end;
(ii) in subparagraph (BB), by adding
``and'' after the semicolon at the end; and
(iii) by adding at the end the following
new subparagraph:
``(CC) counseling and pharmacotherapy for cessation of
tobacco use (as defined in subsection (ddd)(1));''.
(B) Conforming amendments.--Clauses (i) and (ii) of
section 1861(s)(2)(K) of the Social Security Act (42
U.S.C. 1395x(s)(2)(K)), as amended by section
402(a)(2), are each amended by striking ``and (ccc)''
and inserting ``(ccc), and (ddd)''.
(2) Services described.--Section 1861 of the Social
Security Act (42 U.S.C. 1395x), as amended by section 402(b),
is amended by adding at the end the following new subsection:
``Counseling and Pharmacotherapy for Cessation of Tobacco Use
``(ddd)(1) Subject to paragraphs (2) and (3), the term `counseling
and pharmacotherapy for cessation of tobacco use' means diagnostic,
therapy, and counseling services and pharmacotherapy (including the
coverage of prescription and nonprescription tobacco cessation agents
approved by the Food and Drug Administration) for cessation of tobacco
use for individuals who use tobacco products or who are being treated
for tobacco use which are furnished--
``(A) by or under the supervision of a physician; or
``(B) by any other health care professional who--
``(i) is legally authorized to furnish such
services under State law (or the State regulatory
mechanism provided by State law) of the State in which
the services are furnished; and
``(ii) is authorized to receive payment for other
services under this title or is designated by the
Secretary for this purpose.
``(2) Such term is limited to--
``(A) services recommended in `Treating Tobacco Use and
Dependence: A Clinical Practice Guideline', published by the
Public Health Service in June 2000, or any subsequent
modification of such Guideline; and
``(B) such other services that the Secretary recognizes to
be effective.
``(3) Each individual who is described in paragraph (1) and
enrolled under part B shall be eligible for the services described in
this subsection for up to 3 attempts to cease the use of tobacco.''.
(3) Payment and elimination of cost-sharing.--
(A) Payment and elimination of coinsurance.--
Section 1833(a)(1) of the Social Security Act (42
U.S.C. 1395l(a)(1)), as amended by section 402(c)(1),
is amended--
(i) in subparagraph (N) by striking ``or
screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc))'' and inserting ``,
screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc)), or counseling and
pharmacotherapy for cessation of tobacco use
(as defined in section 1861(ddd))''; and
(ii) in subparagraph (W), by striking ``and
screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc))'' and inserting
``screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc)), and counseling and
pharmacotherapy for cessation of tobacco use
(as defined in section 1861(ddd))''.
(B) Payment under physician fee schedule.--Section
1848(j)(3) of the Social Security Act (42 U.S.C. 1395w-
4(j)(3)), as amended by section 402(c)(2), is amended
by inserting ``(2)(CC) (with separate payment amounts
for pharmacotherapy, including prescription and
nonprescription tobacco cessation agents approved by
the Food and Drug Administration),'' after
``(2)(BB),''.
(C) Elimination of coinsurance in outpatient
hospital settings.--
(i) Exclusion from opd fee schedule.--
Section 1833(t)(1)(B)(iv) of the Social
Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)), as
amended by section 402(c)(3)(A), is amended by
striking ``or screenings for clinical
depression, anxiety, and impaired cognitive
functioning (as defined in section 1861(ccc))''
and inserting ``screenings for clinical
depression, anxiety, and impaired cognitive
functioning (as defined in section 1861(ccc)),
or counseling and pharmacotherapy for cessation
of tobacco use (as defined in section
1861(ddd))''.
(ii) Conforming amendment.--Section
1833(a)(2)(H) of the Social Security Act (42
U.S.C. 1395l(a)(2)(H)), as added by section
402(c)(3)(B), is amended by striking ``and
screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc))'' and inserting
``screenings for clinical depression, anxiety,
and impaired cognitive functioning (as defined
in section 1861(ccc)), and counseling and
pharmacotherapy for cessation of tobacco use
(as defined in section 1861(ddd))''.
(D) Elimination of deductible.--Section 1833(b)(7)
of the Social Security Act (42 U.S.C. 1395l(b)(7)), as
added by section 402(c)(4), is amended by striking ``or
screenings for clinical depression, anxiety, and
impaired cognitive functioning (as defined in section
1861(ccc))'' and inserting ``screenings for clinical
depression, anxiety, and impaired cognitive functioning
(as defined in section 1861(ccc)), or counseling and
pharmacotherapy for cessation of tobacco use (as
defined in section 1861(ddd))''.
(4) Application of limits on billing.--Section
1842(b)(18)(C) of the Social Security Act (42 U.S.C.
1395u(b)(18)(C)), as amended by section 402(d), is amended by
adding at the end the following new clause:
``(ix) Any individual designated by the Secretary under
section 1861(ddd)(1)(B)(ii).''.
(5) Frequency.--Section 1862(a)(1) of the Social Security
Act (42 U.S.C. 1395y(a)(1)), as amended by section 402(e), is
amended--
(A) in subparagraph (M), by striking ``and'' after
the comma at the end;
(B) in subparagraph (N), by striking the semicolon
at the end and inserting ``, and''; and
(C) by adding at the end the following new
subparagraph:
``(O) in the case of counseling and pharmacotherapy for
cessation of tobacco use (as defined in section 1861(ddd)),
which is performed with respect to more attempts to cease
tobacco use than is covered under such section;''.
(b) Promoting Cessation of Tobacco Use Under the Medicaid
Program.--
(1) Dropping exception from medicaid prescription drug
coverage for tobacco cessation medications.--Section 1927(d)(2)
of the Social Security Act (42 U.S.C. 1396r-8(d)(2)) is
amended--
(A) by striking subparagraph (E);
(B) by redesignating subparagraphs (F) through (J)
as subparagraphs (E) through (I), respectively; and
(C) in subparagraph (F) (as redesignated by
paragraph (2)), by inserting before the period at the
end the following: ``, except agents approved by the
Food and Drug Administration for purposes of promoting,
and when used to promote, tobacco cessation''.
(2) Requiring coverage of tobacco cessation counseling and
pharmacotherapy services for pregnant women.--Section
1905(a)(4) of the Social Security Act (42 U.S.C. 1396d(a)(4))
is amended--
(A) by striking ``and'' before ``(C)''; and
(B) by inserting before the semicolon at the end
the following: ``; and (D) counseling and
pharmacotherapy for cessation of tobacco use (as
defined in section 1861(ddd)) for pregnant women''.
(3) Removal of cost-sharing for tobacco cessation
counseling and pharmacotherapy services for pregnant women.--
Section 1916 of the Social Security Act (42 U.S.C. 1396o) is
amended in each of subsections (a)(2)(B) and (b)(2)(B), by
inserting ``, and counseling for cessation of tobacco use (as
defined in section 1861(ddd))'' after ``complicate the
pregnancy''.
(c) Coverage Under FEHBP.--The last sentence of section 8904(a) of
title 5, United States Code, is amended by striking ``both for costs
associated with care in a general hospital and for other health
services of a catastrophic nature'' and inserting ``for costs
associated with care in a general hospital, for other health services
of a catastrophic nature, and for counseling and pharmacotherapy for
cessation of tobacco use (as defined in section 1861(ddd)(1) of the
Social Security Act)''.
(d) Effective Date.--The amendments made by this section shall take
effect as if included in the enactment of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173;
117 Stat. 2066) and shall apply to services furnished on and after
January 1, 2006.
SEC. 404. RECOGNITION OF SCHOOL-BASED HEALTH CENTERS AS MODEL FOR
DELIVERY OF PRIMARY CARE FOR CHILDREN UNDER THE MEDICAID
AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS.
(a) In General.--Title XIX of the Social Security Act (42 U.S.C.
1396 et seq.) is amended by inserting after section 1911 the following:
``school-based health centers
``Sec. 1911A. Not later than 12 months after the date of enactment
of this section, the Secretary shall establish procedures to encourage
a State program established under this title, title XXI, or both, to
recognize school-based health centers as a model of delivery for
primary care for children who are eligible for medical assistance under
this title or child health assistance under title XXI. Such procedures
shall include the following:
``(1) Recognition of, and reimbursement for, services
provided through school-based health centers.--Procedures that
encourage a State to recognize as primary care providers under
this title and title XXI, providers who furnish physical or
mental health services that are available as medical assistance
under this title or child health assistance under title XXI to
children who are eligible for such assistance through school-
based health centers, and to reimburse such providers or
centers (as appropriate) for furnishing such services to such
children.
``(2) Exceptions to the `free care' rule.--Procedures that
allow a State the option to permit school-based health centers
to bill the State for physical or mental health services that
are available as medical assistance under this title or child
health assistance under title XXI and that are furnished to
children who are eligible for such assistance through such
centers without billing all children who are provided such
services.
``(3) Exceptions to the `third party liability' cost
avoidance policy.--Procedures that encourage a State to include
physical or mental health services that are available as
medical assistance under this title and that are provided
through school-based health centers in the list of diagnosis
billing codes for preventive pediatric care services that the
State will pay for under this title and then seek reimbursement
from any liable third party in accordance with the requirements
of section 1902(a)(25).
``(4) Assurance of payment for services covered by a
contract with a managed care entity.--Procedures that encourage
a State to include in any contract entered into with a managed
care entity (as defined in section 1932(a)(1)(B)) under this
title or title XXI provisions which ensure that the entity will
make prompt payment to a school-based health center for
furnishing physical or mental health services to a child who is
eligible for medical assistance under this title or child
health assistance under title XXI that are within the scope of
items and services for which benefits are available with
respect to the child under the contract between the entity and
the State (or to a provider who furnishes such services to such
a child through a school-based health center), regardless of
whether the center (or provider) is a participating provider
with respect to such entity, at a rate established by the
entity for such services that is not less than the level and
amount of payment which the entity would make for the services
if the services were furnished by a participating provider.''.
(b) Report to Congress.--Not later than 36 months after the date of
enactment of this section, the Secretary of Health and Human Services
shall submit a report to Congress on the effectiveness of the
procedures established in accordance with section 1911A of the Social
Security Act (as added by subsection (a)) in encouraging the use of
school-based health centers for the delivery of primary care physical
and mental health services to children who are eligible for medical
assistance under title XIX of the Social Security Act (42 U.S.C. 1396
et seq.) or child health assistance under title XXI of such Act (42
U.S.C. 1397aa et seq.), together with such recommendations for
administrative or legislative action as the Secretary determines to be
appropriate.
SEC. 405. PREVENTIVE HEALTH CARE DEMONSTRATION PROGRAM.
(a) Establishment.--
(1) In general.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall conduct a 5-year demonstration program under part B of
title XVIII of the Social Security Act under which the
Secretary establishes demonstration projects to contract with
appropriate entities to provide preventive health care to
eligible beneficiaries through the development and
implementation of a disease prevention plan (as described in
subsection (b)).
(2) Sites.--The Secretary shall designate at least 2 sites
at which to conduct the demonstration program under this
section, of which--
(A) 1 shall be in an urban area; and
(B) 1 shall be in a rural area.
(3) Number of eligible beneficiaries.--Each demonstration
project site under this section shall consist of at least 1,000
eligible beneficiaries representative of the population of
individuals entitled to benefits under part A of title XVIII of
the Social Security Act, and enrolled under part B of such
title. The Secretary may expand the population as needed to
measure statistical significance.
(4) Identifying eligible beneficiaries.--The Secretary
shall develop a method for identifying eligible beneficiaries
who may benefit from the demonstration program and communicate
with them regarding their eligibility.
(5) Voluntary participation.--Participation of health care
providers, and individual beneficiaries, in the demonstration
program shall be voluntary.
(b) Disease Prevention Plan.--
(1) In general.--The disease prevention plan described in
this subsection is a plan, developed in consultation with an
eligible beneficiary participating in the demonstration
program, to mitigate the risk factors associated with a
particular disease.
(2) Plan contents.--The disease prevention plan should
include the following:
(A) Point of contact.--The disease prevention plan
shall provide for a point of contact responsible for
communicating with the participating beneficiary and
with other health care providers on behalf of such
beneficiary.
(B) Personal health care.--The disease prevention
plan shall provide for instruction on personal health
care.
(C) Physician and health care provider training.--
The disease prevention plan shall provide for the
training of physicians or other health care providers
in the communication of relevant clinical information.
(D) Monitoring technology.--The disease prevention
plan may provide for necessary monitoring technology to
facilitate the exchange of information, including
information such as vital signs, symptoms, and health
self assessments.
(c) Program Standards and Criteria.--The Secretary shall establish
performance standards for the demonstration program under this section,
including best practices for the prevention of chronic diseases. Such
practices shall be standardized to the greatest extent possible. The
eligibility of entities or individuals to enter into a contract to
provide preventive health care under the demonstration program shall be
conditioned, at a minimum, on performance that meets or exceeds such
standards.
(d) Payment.--The Secretary shall develop a method and level of
payment for entities that participate in the program under this section
based on best practices, as determined by the Secretary.
(e) Waiver Authority.--The Secretary may waive such requirements of
titles XI and XVIII of the Social Security Act as may be necessary to
carry out the purposes of the demonstration program under this section.
(f) Evaluation and Report.--
(1) Evaluation.--The Secretary shall conduct evaluations
of--
(A) the benefits due to a reduction, if any, in
disease incidence for participants in the demonstration
projects compared to the medicare population as a
whole, as determined by the use of appropriate
statistical techniques;
(B) the long term cost effectiveness of the
demonstration projects to the medicare program in terms
of acute care costs avoided due to disease prevention;
and
(C) patient satisfaction under the demonstration
projects.
(2) Report.--Not later than 6 months after the date on
which the demonstration program under this section ends, the
Secretary shall prepare and submit to Congress a report on the
demonstration program together with--
(A) recommendations on whether the demonstration
program should be expanded in terms of its success in
disease prevention and the cost effectiveness of the
demonstration program; and
(B) such recommendations for legislation or
administrative action as the Secretary determines
appropriate.
(g) Funding.--The Secretary shall provide for the transfer from the
Federal Supplementary Medical Insurance Trust Fund under section 1841
of the Social Security Act (42 U.S.C. 1395t) of such funds, not to
exceed $50,000,000, as are necessary for the costs of carrying out the
demonstration program under this Act.
(h) Definitions.--In this section:
(1) Appropriate entity.--The term ``appropriate entity''
means--
(A) a chronic care improvement program;
(B) a hospital; and
(C) any other entity that the Secretary determines
appropriate based on clinical, financial, or other
requirements appropriate to carry out the purposes of
the demonstration program under this section.
(2) Eligible beneficiary.--The term ``eligible
beneficiary'' means an individual who--
(A) is entitled to benefits under part A of title
XVIII of the Social Security Act or enrolled under part
B of such title; and
(B) has 2 or more risk factors associated with--
(i) chronic obstructive pulmonary disease;
(ii) diabetes; or
(iii) any other chronic condition that the
Secretary determines would be appropriate for
the purpose of providing significant potential
cost benefits to the medicare program through
the prevention of such condition.
SEC. 406. PREVENTIVE HEALTH SERVICES FOR WOMEN.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n-4a)
is amended to read as follows:
``SEC. 1509. ESTABLISHMENT OF PROGRAM FOR ADDITIONAL PREVENTIVE HEALTH
SERVICES.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may, through a
competitive review process, award grants to States that have received
grants under section 1501 for a fiscal year, to enable such State to
carry out programs--
``(1) to provide preventive health services, in addition to
the services authorized in such section 1501, for diseases such
as cardiovascular diseases, osteoporosis, and obesity;
``(2) to provide screenings, such as screening for blood
pressure, cholesterol, and osteoporosis, and other services
that the Secretary, acting through the Director of the Centers
for Disease Control and Prevention, determines to be
appropriate and feasible;
``(3) for health education, counseling, and interventions
for behavioral risk factors, such as physical inactivity and
poor nutrition, and diseases referred to in paragraph (1);
``(4) to provide appropriate referrals for medical
treatment of women receiving services pursuant to paragraph (1)
through (3), and ensuring, to the extent practicable, the
provision of appropriate follow-up services; and
``(5) to evaluate the activities conducted under paragraphs
(1) through (4) through appropriate surveillance, research, or
program monitoring activities.
``(b) Status as Participant in Program Regarding Breast and
Cervical Cancer.--The Secretary may not make a grant to a State under
subsection (a) unless the State involved agrees that services under the
grant will be provided in conjunction with entities that are screening
women for breast or cervical cancer pursuant to a grant under section
1501.
``(c) Applicability of Provisions.--The provisions of this title
shall apply to a grant under subsection (a) to the same extent and in
the same manner as such provisions apply to a grant under section 1501.
``(d) Funding.--
``(1) In general.--There is authorized to be appropriated
such sums as may be necessary to carry out this section for
fiscal year 2005 and for each subsequent fiscal year.
``(2) Limitation regarding funding with respect to breast
and cervical cancer.--No additional resources shall be
appropriated for a fiscal year under paragraph (1) unless the
amount appropriated under section 1510(a) for such fiscal year
is at least $173,920,000.''.
TITLE V--HELP (HEALTHY LIFESTYLES AND PREVENTION) AMERICA TRUST FUND
SEC. 501. HELP (HEALTHY LIFESTYLES AND PREVENTION) AMERICA TRUST FUND.
(a) Creation of Trust Fund.--There is established in the Treasury
of the United States a trust fund to be known as the `HeLP (Healthy
Lifestyles and Prevention) America Trust Fund' (referred to in this
section as the `Trust Fund'), consisting of such amounts as may be
appropriated or credited to the Trust Fund as provided in this section.
(b) Transfers to Trust Fund.--There is hereby appropriated to the
Trust Fund an amount equivalent to--
(1) the increase in revenues received in the Treasury as
the result of the amendment made by section 305 of this Act,
(2) the increase in revenues received in the Treasury as
the result of the amendments made by title II of this Act, and
(3) the receipts paid by tobacco companies under subtitle B
of title III of this Act.
(c) Distribution of Amounts in Trust Fund.--
(1) Mandatory expenditures.--On a fiscal year basis
(beginning with fiscal year 2006) and without further
appropriation the Secretary of the Treasury shall distribute
from amounts in the Trust Fund such amounts as are necessary to
provide for the Federal expenditures attributable to the
following:
(A) The amendments made to the Fruit and Vegetable
Program by section 101 of this Act.
(B) Smoking cessation drugs under title XIX of the
Social Security Act as identified by the Secretary of
Health and Human Services.
(C) Coverage of smoking cessation under the Federal
Employee Health Benefits Program under chapter 89 of
title 5, United States Code (as amended by section
403).
(D) The amendments made to the medicare program
under title XVIII of the Social Security Act by
sections 401 and 402 of this Act.
(E) The preventive health care demonstration
program carried out under section 405 of this Act.
Such amounts shall be in addition to any other amounts
appropriated for such purposes.
(2) Discretionary expenditures.--Amounts in the Trust Fund
not to exceed $2,050,000,000 shall be available, as provided in
appropriation Acts, for each fiscal year (beginning with fiscal
year 2006) only for purposes of making expenditures to carry
out the following:
(A) School nutrition environment enhancement grants
under section 18(l) of the Richard B. Russell National
School Lunch Act (as added by section 103).
(B) Mental health services in schools under
paragraphs (7) and (8) of section 5541(c) of the
Elementary and Secondary Education Act of 1965 (as
added by section 104).
(C) The Baby-Friendly Hospital Initiative carried
out under section 105 of this Act.
(D) The grant program to strengthen families and
build children's resilience carried out under section
520K of the Public Health Service Act (as added by
section 106).
(E) The reservation for early Head Start programs
under section 640(a)(6)(A) of the Head Start Act (as
amended by section 107).
(F) Community grants to prevent and reduce the
incidence of chronic disease under section 399P of the
Public Health Service Act (as added by section 213).
(G) Living well with a disability and working well
with a disability programs under sections 399Q and 399R
of the Public Health Service Act (as added by section
212).
(H) The amendments made to title 23, United States
Code, by section 213 of this Act and the nonmotorized
transportation pilot program carried out under section
213(d).
(I) The national assessment of mental health needs
program carried out under section 506C of the Public
Health Service Act (as added by section 214).
(J) The preventive medicine and public health
training grant program carried out under section 747A
of the Public Health Service Act (as added by section
215).
(K) Federal-State tobacco counter-advertising
programs under section 399S of the Public Health
Service Act (as added by section 306).
(L) Preventive health services for women, including
well-integrated screening and evaluation for women
across the Nation, under section 1509 of the Public
Health Service Act (as added by section 406).
(M) Carol M. White Physical Education Program under
subpart 10 of part D of title V of the Elementary and
Secondary Education Act of 1965.
(N) Research regarding obesity under section 601 of
this Act.
(O) Expanded Food and Nutrition Education Program
under section 3175 of title 23, United States Code.
(P) The following programs under the authority of
the Secretary of Health and Human Services through the
Centers for Disease Control and Prevention:
(i) Nutrition and physical activity grants.
(ii) Division of Adolescent and School
Health.
(iii) Verb Campaign.
(iv) Prevention research centers.
(v) 5-a-day programs.
(vi) Steps to a healthier United States.
(Q) Access to local foods and school gardens, as
authorized by section 122 of the Child Nutrition and
WIC Reauthorization Act of 2004 (Public Law 108-265).
(d) Application of Certain Rules.--For purposes of this section,
rules similar to the rules of sections 9601 and 9602 of the Internal
Revenue Code of 1986 shall apply.
TITLE VI--RESEARCH
SEC. 601. EXPANSION OF RESEARCH REGARDING OBESITY.
The Secretary of Health and Human Services shall, based on the
conclusions of the United States Preventive Services Task Force on
Obesity, conduct research on obesity prevention, treatment, and control
with regard to the following:
(1) The effectiveness of physical activity and dietary
counseling with children and adolescents in the primary care
setting to prevent, treat, and control obesity.
(2) The cost-effectiveness of intensive dietary and
physical activity counseling to prevent, treat, and control
obesity in a variety of populations.
(3) The effectiveness of dietary and physical activity
counseling among children and adolescents, low income
populations, and minority groups in the primary care setting to
prevent, treat, and control obesity.
(4) The effectiveness of the assessment of obesity by a
primary care physician and subsequent referral for obesity
counseling to a nonaffiliated obesity expert or specialist.
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