To ensure the safety of human and pet food.

TEXT OF AMENDMENTS

SA 1008. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

Strike section 252 and insert the following:

SEC. __. MARIJUANA SMOKED BY PATIENTS.

(a) Evaluation and Report.--
(1) Evaluation.--The Secretary of Health and Human Services
shall conduct an evaluation of the manufacture, distribution,
and use of marijuana in States that have enacted laws
legalizing, decriminalizing, or otherwise allowing the use of
marijuana for purported medical use to determine--
(A) whether such activity is taking place in violation of
any provision of Federal law for which the Department of
Health of Human Services is responsible; and
(B) whether such marijuana activities are taking place in
violation of any provision of the Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) that is designed to ensure the
safety and effectiveness of drugs used by the American
public.
(2) Report.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to Congress a report concerning the
findings of the evaluation conducted under paragraph (1).
(b) Determination of Effectiveness.--Not later than 30 days
after the date of enactment of this Act, the Commissioner of
Food and Drugs shall, based on available scientific data,
make a determination, and disclose such determination to the
general public, concerning--
(1) whether or not smoked marijuana is a safe or effective
treatment for any medical condition; and
(2) the adverse impact to human health, both physician and
mental, as a result of smoking marijuana.
______

SA 1009. Mr. HATCH submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the end of title II, insert the following:

Subtitle __Antibiotic Safety and Innovation

SEC. 2__. DEVELOPMENT OF ANTIMICROBIALS.

(a) Incentives for Development of New Antibiotics and New
Antibiotic Uses.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), as amended by this Act, is
further amended by adding at the end the following:
``(r)(1) Notwithstanding any provision of the Food and Drug
Administration Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is the subject of
an approved application described in paragraph (2) may elect
to receive, with respect to the drug--
``(A)(i) the 3-year exclusivity period referred to under
clauses (iii) and (iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection (j)(5)(F); and
``(ii) the 5-year exclusivity period referred to under
subsection (c)(3)(E)(ii) and under subsection (j)(5)(F)(ii);
or
``(B) a patent term extension under section 156 of title
35, United States Code.
``(2) An application described under this paragraph is an
application for marketing submitted under this section after
the date of enactment of this subsection in which--
``(A) the drug that is the subject of the application
contains an antibiotic drug; and
``(B) such antibiotic drug was the subject of an
application received by the Secretary under section 507 of
this Act (as in effect before November 21, 1997).
``(3) Paragraph (1) shall not be construed to entitle a
drug that is the subject of an approved application described
in paragraph (2) for any market exclusivities or patent
extensions other than those exclusivities or extensions
described in paragraph (1).''.
(b) Bioequivalence to Listed Antibiotic Drug.--Section
505(j)(8) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(8)) is amended by adding at the end the
following:
``(D) Notwithstanding any other provision of this
subsection, an oral antibiotic drug that is not intended to
be absorbed into the bloodstream shall be considered to be
bioequivalent to a listed antibiotic drug only if--
``(i) clinical trials do not show a significant difference
between the antibiotic drug and the listed antibiotic drug in
safety and effectiveness; or
``(ii) the Secretary has--

``(I) established alternative, scientifically valid methods
that are reasonably expected to detect a significant
difference between the antibiotic drug and the listed
antibiotic drug in safety and effectiveness;
``(II) developed the alternative, scientifically valid
methods described in subclause (I) through notice and comment
rulemaking in accordance with section 553 of title 5, United
States Code; and
``(III) determined that, based on the alternative,
scientifically valid methods described in subclauses (I) and
(II), there is no significant difference between the
antibiotic drug and the listed antibiotic drug in safety and
effectiveness.''.

(c) Public Meeting.--The Commissioner of Food and Drugs
shall convene a public meeting and, if appropriate, issue
guidance regarding which serious and life-threatening
infectious diseases, such as diseases due to gram-negative
bacteria and other diseases due to antibiotic-resistant
bacteria, potentially qualify for available grants and
contracts under subsection (a) of section 5 of the Orphan
Drug Act (21 U.S.C. 360ee(a)) or other incentives for
development.
(d) Grants and Contracts for the Development of Orphan
Drugs.--Subsection (c) of section 5 of the Orphan Drug Act
(21 U.S.C. 360ee(c)) is amended to read as follows:
``(c) For grants and contracts under subsection (a), there
are authorized to be appropriated such sums as already have
been appropriated for fiscal year 2007, and $35,000,000 for
each subsequent fiscal year.''.

SEC. 2__. ESTABLISHMENT OF ANTIMICROBIAL BREAKPOINTS.

(a) Definition.--In this section, the term ``antimicrobial
breakpoint'' means specific values which characterize
bacteria as clinically susceptible, intermediate, or
resistant to the drug (or drugs) tested, such as Minimum
Inhibitory Concentrations (MICs) or zones of inhibitions.
(b) Establishment of Breakpoints.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
direct the Commissioner of Food and Drugs to establish and
periodically update antimicrobial breakpoints.
(2) Review and update.--Antimicrobial breakpoints shall be
reviewed and updated as necessary pursuant to recommendations
from the Antimicrobial Resistance Task Force and in
consultation with the Centers for Disease Control and
Prevention, or more frequently upon the discretion of the
Commissioner of Food and Drugs, but in no case less than once
every 5 years.
(c) Public Availability.--The Secretary shall direct the
Commissioner of Food and Drugs to make antimicrobial
breakpoints publicly available within 30 days of the date of
establishment and any update under this section.
(d) Advisory Organizations.--The Commissioner of Food and
Drugs may contract with an organization or organizations to
aid in the establishment of antimicrobial breakpoints under
this section in a manner not inconsistent with the Federal
Advisory Committee Act (5 U.S.C. App.). The Commissioner of
Food and Drugs shall make the final determination regarding
establishments of antimicrobial breakpoints under this
section.

SEC. 2__. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING
ENANTIOMERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S. C. 355), as amended by this subtitle, is amended by
adding at the end the following:

[[Page S5512]]

``(s) Drugs Containing Enantiomers.--For purposes of
subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an
application is submitted under subsection (b) for a non-
racemic drug containing as an active ingredient a single
enantiomer that is contained in a racemic drug approved in
another application under subsection (b), the single
enantiomer shall not be considered the same active ingredient
contained in the approved racemic drug, if--
``(1)(A) the single enantiomer has not been previously
approved as an active ingredient except in the approved
racemic drug; and
``(B) the application submitted under subsection (b) for
the drug containing the single enantiomer includes full
reports of investigations described in subsection (b)(1)(A)
which do not rely on any investigations that are part of the
application submitted under subsection (b) for approval of
the approved racemic drug; and
``(2)(A) the application submitted under subsection (b) for
the drug containing the single enantiomer is not submitted
for approval of a use--
``(i) in a therapeutic area in which the approved racemic
drug has been approved; or
``(ii) for which any other enantiomer of the racemic drug
has been approved; or
``(B) in the case of an antibiotic drug, such drug is
demonstrated through well-controlled clinical trials to be
safe and effective for a use for which the racemic drug has
not been approved and for which no other enantiomer of the
racemic drug has been previously approved.''.
______

SA 1010. Mr. COCHRAN (for himself, Mr. Carper, Mr. Nelson of
Nebraska, Mr. Hatch, Mr. Bennett, Mr. Enzi, Mr. Burr, and Mr. Menendez)
submitted an amendment intended to be proposed to amendment SA 990
submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr. Grassley, Mr.
McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders,
Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082, to amend the
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; as
follows:

At the end of the amendment, add the following:

SEC. __. PROTECTION OF HEALTH AND SAFETY.

This title, and the amendments made by this title, shall
become effective only if the Secretary of Health and Human
Services certifies to Congress that the implementation of
this title (and amendments) will--
(1) pose no additional risk to the public's health and
safety; and
(2) result in a significant reduction in the cost of
covered products to the American consumer.
______

SA 1011. Ms. STABENOW (for herself, Mr. Thune, Mr. Lott, Mr. Brown,
and Mr. Kohl) submitted an amendment intended to be proposed by her to
the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize and amend the prescription drug user fee provisions, and
for other purposes; as follows:

At the appropriate place, insert the following:

SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY
ACTION.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by this Act, is amended by adding at
the end the following:
``(r) Citizen Petitions and Petitions for Stay of Agency
Action.--
``(1) In general.--
``(A) No delay of consideration or approval.--
``(i) In general.--With respect to a pending application
submitted under subsection (b)(2) or (j), if a petition is
submitted to the Secretary that seeks to have the Secretary
take, or refrain from taking, any form of action relating to
the approval of the application, including a delay in the
effective date of the application, clauses (ii) and (iii)
shall apply.
``(ii) No delay of consideration.--The receipt of a
petition is not just cause to delay consideration of an
application submitted under subsection (b)(2) or (j) and
consideration of a petition described in clause (i) shall be
separate and apart from the review of an application
submitted under either such subsection.
``(iii) No delay of approval without determination.--The
Secretary shall not delay approval of an application
submitted under subsection (b)(2) or (j) while a petition
described in clause (i) is reviewed and considered unless the
Secretary determines, not later than 30 days after the
submission of the petition, that a delay is necessary to
protect the public health.
``(B) Determination of delay.--With respect to a
determination by the Secretary under subparagraph (A)(iii)
that a delay is necessary to protect the public health the
following shall apply:
``(i) Not later than 5 days after making such
determination, the Secretary shall publish on the Internet
website of the Food and Drug Administration a detailed
statement providing the reasons underlying the determination.
The detailed statement shall include a summary of the
petition and comments and supplements, the specific
substantive issues that the petition raises which need to be
considered prior to approving a pending application submitted
under subsection (b)(2) or (j), and any clarifications and
additional data that is needed by the Secretary to promptly
review the petition.
``(ii) Not later than 10 days after making such
determination, the Secretary shall provide notice to the
sponsor of the pending application submitted under subsection
(b)(2) or (j) and provide an opportunity for a meeting with
appropriate staff as determined by the Commissioner to
discuss the determination.
``(2) Timing of final agency action on petitions.--
``(A) In general.--Notwithstanding a determination made by
the Secretary under paragraph (1)(A)(iii), the Secretary
shall take final agency action with respect to a petition not
later than 180 days of submission of that petition unless the
Secretary determines, prior to the date that is 180 days
after the date of submission of the petition, that a delay is
necessary to protect the public health.
``(B) Determination of delay.--With respect to a
determination by the Secretary under subparagraph (A) that a
delay is necessary to protect the public health the following
shall apply:
``(i) Not later than 5 days after making the determination
under subparagraph (A), the Secretary shall publish on the
Internet website of the Food and Drug Administration a
detailed statement providing the reasons underlying the
determination. The detailed statement should include the
state of the review of the petition, the specific outstanding
issues that still need to be resolved, a proposed timeframe
to resolve the issues, and any additional information that
has been requested by the Secretary of the petitioner or
needed by the Secretary in order to resolve the petition and
not further delay an application filed under subsection
(b)(2) or (j).
``(ii) Not later than 10 days after making the
determination under subparagraph (A), the Secretary shall
provide notice to the sponsor of the pending application
submitted under subsection (b)(2) or (j) and provide an
opportunity for a meeting with appropriate staff as
determined by the Commissioner to discuss the determination.
``(3) Verifications.--
``(A) Petitions for review.--The Secretary shall not accept
a petition for review unless it is signed and contains the
following verification: `I certify that, to my best knowledge
and belief: (a) this petition includes all information and
views upon which the petition relies; and (b) this petition
includes representative data and/or information known to the
petitioner which are unfavorable to the petition. I further
certify that the information upon which I have based the
action requested herein first became known to the party on
whose behalf this petition is filed on or about __________. I
received or expect to receive payments, including cash and
other forms of consideration, from the following persons or
organizations to file this petition: ________. I verify under
penalty of perjury that the foregoing is true and correct.',
with the date of the filing of such petition and the
signature of the petitioner inserted in the first and second
blank space, respectively.
``(B) Supplemental information.--The Secretary shall not
accept for review any supplemental information or comments on
a petition unless the party submitting such information or
comments does so in written form and that the subject
document is signed and contains the following verification:
`I certify that, to my best knowledge and belief: (a) I have
not intentionally delayed submission of this document or its
contents. I further certify that the information upon which I
have based the action requested herein first became known to
me on or about __________. I received or expect to receive
payments, including cash and other forms of consideration,
from the following persons or organizations to submit this
information or its contents: _____. I verify under penalty of
perjury that the foregoing is true and correct.', with the
date of the submission of such document and the signature of
the petitioner inserted in the first and second blank space,
respectively.
``(4) Annual report on delays in approvals per petition.--
The Secretary shall annually submit to the Congress a report
that specifies--
``(A) the number of applications under subsection (b)(2)
and (j) that were approved during the preceding 1-year
period;
``(B) the number of petitions that were submitted during
such period;
``(C) the number of applications whose effective dates were
delayed by petitions during such period and the number of
days by which the applications were so delayed; and
``(D) the number of petitions that were filed under this
subsection that were deemed by the Secretary under paragraph
(1)(A)(iii) to require delaying an application under
subsection (b)(2) or (j) and the number of days by which the
applications were so delayed.
``(5) Exception.--This subsection does not apply to a
petition that is made by the sponsor of the application under
subsection (b)(2) or (j) and that seeks only to have the
Secretary take or refrain from taking any form of action with
respect to that application.
``(6) Report by inspector general.--The Office of Inspector
General of the Department of Health and Human Services shall
issue a report not later than 2 years after the

[[Page S5513]]

date of enactment of this subsection evaluating evidence of
the compliance of the Food and Drug Administration with the
requirement that the consideration by the Secretary of
petitions that do not raise public health concerns remain
separate and apart from the review and approval of an
application submitted under subsection (b)(2) or (j).
``(7) Definition.--For purposes of this subsection, the
term `petition' includes any request to the Secretary,
without regard to whether the request is characterized as a
petition.''.
______

SA 1012. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. AUTHORIZATION OF APPROPRIATIONS FOR THE OFFICE OF
GENERIC DRUGS.

Notwithstanding section 736(b) of the Federal Food, Drug,
and Cosmetic Act (as amended by section 103(b) of this Act),
the Secretary of Health and Human Services shall allocate
$20,000,000 of the user fees generated by section 736(a) of
the Federal Food, Drug, and Cosmetic Act (as amended by
section 103(a) of this Act), for each fiscal year beginning
with fiscal year 2009 and ending with fiscal year 2012, to
the Office of Generic Drugs of the Food and Drug
Administration, for the sole purpose of reviewing and
approving abbreviated new drug applications.
______

SA 1013. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. OFFICE OF GENERIC DRUGS.

(a) Findings.--Congress makes the following findings:
(1) More than $100,000,000,000 in blockbuster brand
pharmaceutical products will lose patent protection between
April 2007 and 2010. As a result, more applications for
generic versions of these products will be filed with the
Office of Generic Drugs of the Food and Drug Administration.
(2) The staff of the Office of Generic Drugs is backlogged.
Approximately 800 generic drug applications are pending
review as of April 2007.
(3) The workload of the Office of Generic Drugs has
increased by 36 percent since 2004, yet the Office has the
same budget and the same number of staff.
(4) The workload of the Office of Generic Drugs also has
increased due to the filing of citizen petitions by brand
companies designed to delay generic drug approvals.
(5) A modest investment in the Office of Generic Drugs,
such as $15,000,000, would help to make more affordable
medicines available in a timely manner to consumers and
public and private health care purchasers, who would save
billions of dollars.
(6) Those savings also would enable the Federal Government
to reach more Americans through important health care
initiatives, such as Medicare, Medicaid, and programs to
improve children's health care, assist the chronically ill,
and fight HIV/AIDS.
(b) Authorization of Appropriations.--Notwithstanding
section 736(b) of the Federal Food, Drug, and Cosmetic Act
(as amended by section 103(b) of this Act), the Secretary of
Health and Human Services shall allocate $20,000,000 of the
user fees generated by section 736(a) of the Federal Food,
Drug, and Cosmetic Act (as amended by section 103(a) of this
Act), for each fiscal year beginning with fiscal year 2009
and ending with fiscal year 2012, to the Office of Generic
Drugs of the Food and Drug Administration, for the sole
purpose of reviewing and approving abbreviated new drug
applications.
______

SA 1014. Mr. VITTER submitted an amendment intended to be proposed to
amendment SA 990 submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr.
Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor,
Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082,
to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and
amend the prescription drug user fee provisions, and for other
purposes; which was ordered to lie on the table; as follows:

At the appropriate place in the amendment, insert the
following:

SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION
DRUGS.

(a) Required Technologies.--The Secretary of Health and
Human Services shall require that the packaging of any
prescription drug incorporate--
(1) radio frequency identification (RFID) tagging
technology, or similar trace and track technologies that have
an equivalent function;
(2) tamper-indicating technologies; and
(3) blister security packaging when possible.
(b) Use of Technologies.--
(1) Authorized uses.--The Secretary shall require that
technologies described in subsection (a)(1) be used
exclusively to authenticate the pedigree of prescription
drugs, including by--
(A) implementing inventory control;
(B) tracking and tracing prescription drugs;
(C) verifying shipment or receipt of prescription drugs;
(D) authenticating finished prescription drugs; and
(E) electronically authenticating the pedigree of
prescription drugs.
(2) Privacy protection.--The Secretary shall prohibit
technologies required by subsection (a)(1) from containing or
transmitting any information that may be used to identify a
health care practitioner or the prescription drug consumer.
(3) Prohibition against advertising.--The Secretary shall
prohibit technologies required by subsection (a)(1) from
containing or transmitting any advertisement or information
about prescription drug indications or off-label prescription
drug uses.
(c) Recommended Technologies.--The Secretary shall
encourage the manufacturers and distributors of prescription
drugs to incorporate into the packaging of such drugs, in
addition to the technologies required under subsection (a),
overt optically variable counterfeit-resistant technologies
that--
(1) are visible to the naked eye, providing for visual
identification of prescription drug authenticity without the
need for readers, microscopes, lighting devices, or scanners;
(2) are similar to technologies used by the Bureau of
Engraving and Printing to secure United States currency;
(3) are manufactured and distributed in a highly secure,
tightly controlled environment; and
(4) incorporate additional layers of non-visible covert
security features up to and including forensic capability.
(d) Standards for Packaging.--
(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of prescription drugs,
the Secretary shall require manufacturers of prescription
drugs to incorporate the technologies described in paragraphs
(1), (2), and (3) of subsection (a), and shall encourage
manufacturers and distributors of prescription drugs to
incorporate the technologies described in subsection (c),
into multiple elements of the physical packaging of the
drugs, including--
(A) blister packs, shrink wrap, package labels, package
seals, bottles, and boxes; and
(B) at the item level.
(2) Labeling of shipping container.--Shipments of
prescription drugs shall include a label on the shipping
container that incorporates the technologies described in
subsection (a)(1), so that members of the supply chain
inspecting the packages will be able to determine the
authenticity of the shipment. Chain of custody procedures
shall apply to such labels and shall include procedures
applicable to contractual agreements for the use and
distribution of the labels, methods to audit the use of the
labels, and database access for the relevant governmental
agencies for audit or verification of the use and
distribution of the labels.
(e) Penalty.--A prescription drug is deemed to be
misbranded for purposes of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or
labeling of the drug is in violation of a requirement or
prohibition applicable to the drug under subsection (a), (b),
or (d).
(f) Transitional Provisions; Effective Dates.--
(1) National specified list of susceptible prescription
drugs.--
(A) Initial publication.--Not later than 180 days after the
date of the enactment of this Act, the Secretary shall
publish in the Federal Register a list, to be known as the
National Specified List of Susceptible Prescription Drugs,
consisting of not less than 30 of the prescription drugs that
are most frequently subject to counterfeiting in the United
States (as determined by the Secretary).
(B) Revision.--Not less than annually through the end of
calendar year 2010, the Secretary shall review and, as
appropriate, revise the National Specified List of
Susceptible Prescription Drugs. The Secretary may not revise
the List to include fewer than 30 prescription drugs.
(2) Effective dates.--The Secretary shall implement the
requirements and prohibitions of subsections (a), (b), and
(d)--
(A) with respect to prescription drugs on the National
Specified List of Susceptible Prescription Drugs, beginning
not later than the earlier of--
(i) 1 year after the initial publication of such List; or
(ii) December 31, 2008; and
(B) with respect to all prescription drugs, beginning not
later than December 31, 2011.
(3) Authorized uses during transitional period.--In lieu of
the requirements specified in subsection (b)(1), for the
period beginning on the effective date applicable under
paragraph (2)(A) and ending on the commencement of the
effective date applicable under paragraph (2)(B), the
Secretary shall require that technologies described in
subsection (a)(1) be used exclusively to verify the
authenticity of prescription drugs.
(g) Definitions.--In this Act:

[[Page S5514]]

(1) The term ``pedigree''--
(A) means the history of each prior sale, purchase, or
trade of the prescription drug involved to a distributor or
retailer of the drug (including the date of the transaction
and the names and addresses of all parties to the
transaction); and
(B) excludes information about the sale, purchase, or trade
of the drug to the drug consumer.
(2) The term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)).
(3) The term ``Secretary'' means the Secretary of Health
and Human Services.

______

SA 1015. Mr. HAGEL (for himself and Mrs. Clinton) submitted an
amendment intended to be proposed by him to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. LUNG CANCER COMPUTED TOMOGRAPHY ASSESSMENT AND
INTERIM QUALITY STANDARDS.

Not later than 180 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit
to Congress a report that contains--
(1) an assessment of the number, quality, charges, and
capabilities of sites offering computed tomography scanning
for the diagnosis of lung cancer;
(2) interim quality standards for computed tomography
scanning for the diagnosis of lung cancer which incorporate
the protocol established by the International Early Lung
Cancer Action Program and contained in the document dated
October 20, 2006 entitled ``International Early Lung Cancer
Action Program: Enrollment and Screening Protocol''; and
(3) recommendations, including legislative recommendations
if appropriate, for the establishment of lung cancer
diagnostic centers, as practicable, to collect and analyze
the data as recommended under the protocol described in
paragraph (2) in order to continue and accelerate research
into the early detection, diagnosis, and treatment of lung
cancer.
______

SA 1016. Mr. SPECTER submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place in the bill, insert the following:

SEC. __. NATIONAL CENTERS FOR PHARMACEUTICAL INNOVATION.

Chapter VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 371 et seq.) is amended by adding at the end the
following:

``Subchapter __--Establishment of the National Centers for
Pharmaceutical Innovation

``SEC. __1. ESTABLISHMENT OF THE CENTERS.

``(a) In General.--The Commissioner of Food and Drugs, in
consultation with the Secretary, shall establish through
competitive selection not more than 5 university-based
National Centers for Pharmaceutical Innovation (referred to
in this subchapter as the `Centers').
``(b) Purpose of Centers.--The purpose of the Centers is to
advance the Food and Drug Administration's Critical Path
Initiative, as well as subsequent efforts, to modernize
medical pharmaceutical product development by--
``(1) designing methodologies to dramatically increase the
speed at which new drugs enter the market while significantly
reducing the cost of such process;
``(2) developing new technological tools to speed the
creation of safer, more effective drugs targeted at
individuals;
``(3) assisting the Food and Drug Administration with drug
therapy-monitoring programs to look for adverse consequences
utilizing medicines;
``(4) expanding the quality and number of professionals
trained in translational medicine, translational
therapeutics, and the manufacture of pharmaceutical and
biotechnology products; and
``(5) introducing new technologies to improve the
manufacture of pharmaceutical and biotechnology products.

``SEC. __2. CRITERIA FOR SELECTION.

``The Commissioner of Food and Drugs, in consultation with
the Secretary, shall select the Centers from among qualified
university or university consortium applicants on the basis
of key factors in pharmaceutical product development, safety,
and manufacturing technology, including--
``(1) whether the applicant has established graduate
training programs that integrate the elements of
translational therapeutics, including basic and clinical
pharmacology, pharmaceutical science, including
pharmacokinetic modeling, analytical technologies, genomics
and proteomics, pharmacoepidemiology, informatics, and
statistics;
``(2) demonstration of extensive experience in the
development and evaluation of medicines through drug approval
to the post-marketing process;
``(3) scientific programs in translational therapeutics and
pharmaceutical science designed to hasten the personalization
of medicine;
``(4) proficiencies in pharmaceutical and biotechnology
science and engineering, including therapy development and
manufacturing; and
``(5) other factors that the Commissioner of Food and Drugs
determines appropriate.

``SEC. __3. AUTHORIZATION OF APPROPRIATIONS.

``There are authorized to be appropriated to carry out this
subchapter such sums as may be necessary for each of the
fiscal years 2008 through 2013.''.
______

SA 1017. Mr. GREGG (for himself and Mr. Coleman) submitted an
amendment intended to be proposed to amendment SA 990 submitted by Mr.
Dorgan (for himself, Ms. Snowe,, Mr. Grassley, Mr. McCain, Ms.
Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr.
Whitehouse, and Mrs. McCaskill) to the bill S. 1082, to amend the
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

Strike sections 7 and 8 of the amendment and insert the
following:

SEC. 7. INTERNET PHARMACIES.

(a) Internet Pharmacies.--Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 510 the following:

``SEC. 511. INTERNET PHARMACIES.

``(a) Definitions.--In this section:
``(1) Advertising service provider.--The term `advertising
service provider' means an advertising company that contracts
with a provider of an interactive computer service (as
defined in section 230(f) of the Communications Act of 1934
(47 U.S.C. 230(f)) to provide advertising on the Internet.
``(2) Designated payment system.--
``(A) In general.--The term `designated payment system'
means a system used by a person described in subparagraph (B)
to effect a credit transaction, electronic fund transfer, or
money transmitting service that the Board determines, by
regulation or order, is regularly used in connection with, or
to facilitate restricted transactions.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic
fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national,
regional, or local network constructed primarily to effect a
credit transaction, electronic fund transfer, or money
transmitting service.
``(3) Federal functional regulator.--The term `Federal
functional regulator' has the meaning given the term in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
``(4) Internet pharmacy.--The term `Internet pharmacy'
means a person that offers to dispense or dispenses in the
United States a prescription drug through an Internet website
in interstate commerce, regardless of whether the physical
location of the principal place of business of the Internet
pharmacy is in the United States or in another country.
``(5) Prescription drug.--The term `prescription drug'
means a drug described in section 503(b) that is approved by
the Secretary under section 505.
``(6) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of
a individual who places an unlawful Internet pharmacy request
to any person engaged in the operation of an unlicensed
Internet pharmacy, of--
``(A) credit, or the proceeds of credit, extended to or on
behalf of the individual for the purpose of the unlawful
Internet request (including credit extended through the use
of a credit card);
``(B) an electronic fund transfer or funds transmitted by
or through a money transmitting business, or the proceeds of
an electronic fund transfer or money transmitting service,
from or on behalf of the individual for the purpose of the
unlawful Internet request;
``(C) a check, draft, or similar instrument which is drawn
by or on behalf of the individual for the purpose of the
unlawful Internet request and is drawn on or payable at or
through any financial institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Board by regulation) that
involves a financial institution as a payor or financial
intermediary on behalf of or for the benefit of the
individual for the purpose of the unlawful Internet request.
``(7) Treating provider.--The term `treating provider'
means a health care provider licensed in the United States
who is authorized to prescribe medications and who--
``(A)(i) performs a documented patient evaluation
(including a patient history and physical examination) of an
individual, portions of which may be conducted by other
health professionals;

[[Page S5515]]

``(ii) discusses with the individual the treatment options
of the individual and the risks and benefits of treatment;
and
``(iii) maintains contemporaneous medical records
concerning the individual; or
``(B) provides care to an individual as part of an on-call
or cross-coverage arrangement with a health care provider
described in subparagraph (A).
``(8) Unlawful internet pharmacy request.--The term
`unlawful Internet pharmacy request' means the request, or
transmittal of a request, made to an unlicensed Internet
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, telephone, or electronic mail, or by a
means that involves the use, in whole or in part, of the
Internet.
``(9) Unlicensed internet pharmacy.--The term `unlicensed
Internet pharmacy' means an Internet pharmacy that is not
licensed under this section.
``(10) Other definitions.--
``(A) Board.--The term `Board' means the Board of Governors
of the Federal Reserve System.
``(B) Credit; creditor; credit card.--The terms `credit',
`creditor', and `credit card' have the meanings given the
terms in section 103 of the Truth in Lending Act (15 U.S.C.
1602).
``(C) Electronic fund transfer.--The term `electronic fund
transfer'--
``(i) has the meaning given the term in section 903 of the
Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) includes any fund transfer covered under article 4A
of the Uniform Commercial Code, as in effect in any State.
``(D) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in section 903 of the
Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(E) Money transmitting business; money transmitting
service.--The terms `money transmitting business' and `money
transmitting service' have the meanings given the terms in
section 5330(d) of title 31, United States Code.
``(b) In General.--An Internet pharmacy may only dispense
or offer to dispense a prescription drug to a person in the
United States in accordance with this section.
``(c) Licensing of Internet Pharmacies.--
``(1) In general.--An Internet pharmacy shall be licensed
by the Secretary in accordance with this section prior to
offering to dispense or dispensing a prescription drug to an
individual.
``(2) Conditions for licensing.--
``(A) Application requirements.--An Internet pharmacy shall
submit to the Secretary an application that includes--
``(i)(I) in the case of an Internet pharmacy located in the
United States, verification that, in each State in which the
Internet pharmacy engages in dispensing or offering to
dispense prescription drugs, the Internet pharmacy, and all
employees and agents of the Internet pharmacy, is in
compliance with applicable Federal and State laws regarding--

``(aa) the practice of pharmacy, including licensing laws
and inspection requirements; and
``(bb) the manufacturing and distribution of controlled
substances, including with respect to mailing or shipping
controlled substances to consumers; or

``(II) in the case of an Internet pharmacy whose principal
place of business is located outside the United States,
verification that--

``(aa) all employees and agents of the Internet pharmacy
are in compliance with applicable Federal and State laws
regarding the practice of pharmacy, including licensing laws
and inspection requirements;
``(bb) the Internet pharmacy is in compliance with
applicable Federal and State laws regarding the practice of
pharmacy, including licensing laws and inspection
requirements;
``(cc) the Internet pharmacy expressly and affirmatively
agrees to provide and maintain an agent for service of
process in the United States;
``(dd) the Internet pharmacy expressly and affirmatively
agrees to be subject to the jurisdiction of the United States
and any of its States or territories where it engages in
commerce; and
``(ee) the Internet pharmacy agrees to affix to each
shipping container of drugs to be shipped in the United
States such markings as the Secretary determines to be
necessary to identify that the shipment is from a licensed
Internet pharmacy, which may include anticounterfeiting or
track-and-trace technologies;

``(ii) verification that the person that owns the Internet
pharmacy has not had a license for an Internet pharmacy
terminated by the Secretary, and that no other Internet
pharmacy owned by the person has had a license under this
subsection that has been terminated by the Secretary;
``(iii) verification from the person that owns the Internet
pharmacy that the person will permit inspection of the
facilities and business practices of the Internet pharmacy by
the Secretary to the extent necessary to determine whether
the Internet pharmacy is in compliance with this subsection;
``(iv) in the case of an agreement between a patient and an
Internet pharmacy that releases the Internet pharmacy, and
any employee or agent of the Internet pharmacy, from
liability for damages arising out of the negligence of the
Internet pharmacy, an assurance that such a limitation of
liability shall be null and void;
``(v) verification that the Internet pharmacy expressly and
affirmatively agrees to provide the Secretary with the
identity of any providers of interactive computer services
that provide host services or advertising services for the
Internet pharmacy; and
``(vi) assurance that the Internet pharmacy will comply
with the requirements under subparagraphs (B) and (C).
``(B) Identification requirements.--An Internet pharmacy
shall post in a clear and visible manner, on each page of the
website of the Internet pharmacy or by a link to a separate
page, the following information:
``(i) The street address, city, ZIP Code or comparable mail
code, State (or comparable entity), country, and telephone
number of--

``(I) each place of business of the Internet pharmacy; and
``(II) the name of the supervising pharmacist of the
Internet pharmacy and each individual who serves as a
pharmacist for purposes of the Internet pharmacy website.

``(ii) The names of all States in which the Internet
pharmacy and the pharmacists employed by the Internet
pharmacy are licensed or otherwise authorized to dispense
prescription drugs.
``(iii) If the Internet pharmacy makes referrals to, or
solicits on behalf of, a health care practitioner or group of
practitioners in the United States for prescription
services--

``(I) the name, street address, city, ZIP Code or
comparable mail code, State, and telephone number of the
practitioner or group; and
``(II) the name of each State in which each practitioner is
licensed or otherwise authorized to prescribe drugs.

``(iv) A statement that the Internet pharmacy will dispense
prescription drugs only after receipt of a valid prescription
from a treating provider.
``(v) A distinctive tamper resistant seal to identify that
the Internet pharmacy is licensed.
``(C) Professional services requirements.--An Internet
pharmacy shall carry out the following:
``(i) Maintain patient medication profiles and other
related data in a readily accessible format organized to
facilitate consultation with treating providers, caregivers,
and patients.
``(ii) Conduct prospective drug use reviews before
dispensing medications or medical devices.
``(iii) Ensure patient confidentiality and the protection
of patient identity and patient-specific information, in
accordance with the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996.
``(iv) Offer interactive and meaningful consultation by a
licensed pharmacist to the caregiver or patient before and
after the time at which the Internet pharmacy dispenses the
drug.
``(v)(I) Establish a mechanism for patients to report
errors and suspected adverse drug reactions.
``(II) Document in the reporting mechanism the response of
the Internet pharmacy to those reports.
``(III) Submit those reports within 3 days of receipt and
the response of the Internet pharmacy to the Food and Drug
Administration in a manner determined appropriate by the
Secretary.
``(vi) Develop a system to inform caregivers and patients
about drug recalls.
``(vii) Educate caregivers and patients about the
appropriate means of disposing of expired, damaged, or
unusable medications.
``(viii) Assure that the sale of a prescription drug is in
accordance with a valid prescription from the treating
provider of the individual.
``(ix)(I) Verify the validity of the prescription of an
individual by using 1 of the following methods:

``(aa) If the prescription for any drug other than a
controlled substance (as defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802)) is received from
an individual or the treating provider of the individual by
mail (including a private carrier), or from the treating
provider of the individual by electronic mail, the validity
of the prescription shall be confirmed in accordance with all
applicable Federal and State laws.
``(bb) If the prescription is for a controlled substance
(as defined in section 102 of the Controlled Substances Act),
the validity of the prescription shall be confirmed with the
treating provider as described in subclause (II).

``(II) When seeking verification of a prescription of an
individual under subclause (I)(bb), an Internet pharmacy
shall provide to the treating provider the following
information:

``(aa) The full name and address of the individual.
``(bb) Identification of the prescription drug.
``(cc) The quantity of the prescription drug to be
dispensed.
``(dd) The date on which the individual presented the
prescription to the Internet pharmacy.
``(ee) The date and time of the verification request.
``(ff) The name of a contact person at the Internet
pharmacy, including a voice telephone number, electronic mail
address, and facsimile telephone number.

[[Page S5516]]

``(III) A prescription is verified under subclause (I)(bb)
only if 1 of the following occurs:

``(aa) The treating provider confirms, by direct
communication with the Internet pharmacy, that the
prescription is accurate.
``(bb) The treating provider informs the Internet pharmacy
that the prescription is inaccurate and provides the accurate
prescription.

``(IV) An Internet pharmacy shall not fill a prescription
if--

``(aa) a treating provider informs the Internet pharmacy
within 72 hours after receipt of a communication under
subclause (I)(bb) that the prescription is inaccurate or
expired; or
``(bb) the treating provider does not respond within that
time.

``(x) Maintain, for such period of time as the Secretary
shall prescribe by regulation, a record of all direct
communications with a treating provider regarding the
dispensing of a prescription drug, including verification of
the prescription.
``(3) Licensure procedure.--
``(A) Action by secretary.--On receipt of a complete
licensing application from an Internet pharmacy under
paragraph (2), the Secretary shall--
``(i) assign an identification number to the Internet
pharmacy;
``(ii) notify the applicant of the receipt of the licensing
application; and
``(iii) if the Internet pharmacy is in compliance with the
conditions under paragraph (2), issue a license not later
than 60 days after receipt of a licensing application from
the Internet pharmacy.
``(B) Electronic filing.--
``(i) In general.--For the purpose of reducing paperwork
and reporting burdens, the Secretary shall require the use of
electronic methods of submitting to the Secretary a licensing
application required under this section and provide for
electronic methods of receiving the applications.
``(ii) Authentication.--In providing for the electronic
submission of such licensing applications under this section,
the Secretary shall ensure that adequate authentication
protocols are used to allow identification of the Internet
pharmacy and validation of the data as appropriate.
``(4) Database.--
``(A) In general.--The Secretary shall compile, maintain,
and periodically update a database of the Internet pharmacies
licensed under this section.
``(B) Availability.--The Secretary shall make the database
described under subparagraph (A) and information submitted by
the licensee under paragraph (2)(B) available to the public
on an Internet website and through a toll-free telephone
number.
``(5) Fees.--
``(A) In general.--
``(i) Licensing application fee.--The Secretary shall
establish a licensing application fee to be paid by all
applicants.
``(ii) Renewal fee.--The Secretary shall establish a yearly
renewal fee to be paid by all Internet pharmacies licensed
under this section.
``(B) Collection.--
``(i) Collection of licensing application fee.--A licensing
application fee payable for the fiscal year in which the
Internet pharmacy submits a licensing application, as
established under subparagraph (C), shall be payable upon the
submission to the Secretary of such licensing application.
``(ii) Collection of renewal fees.--After the licensing
application fee is paid for the first fiscal year of
licensure, the yearly renewal fee, as established under
subparagraph (C), shall be payable on or before October 1 of
each subsequent fiscal year.
``(iii) One fee per internet pharmacy.--The licensing
application fee and yearly renewal fee shall be paid only
once for each Internet pharmacy for a fiscal year in which
the fee is payable.
``(C) Fee amount.--The amount of the licensing application
fee and the yearly renewal fee for an Internet pharmacy shall
be determined each year by the Secretary based on the
anticipated costs to the Secretary of enforcing the
requirements of this section in the subsequent fiscal year.
``(D) Annual fee determination.--
``(i) In general.--Not later than 60 days before the
beginning of each fiscal year beginning after September 30,
2007, the Secretary shall determine the amount of the
licensing application fee and the yearly renewal fee for that
fiscal year.
``(ii) Publication of fee amount.--Not later than 60 days
before each fiscal year, the Secretary shall publish the
amount of the licensing application fee and the yearly
renewal fee under this section for that fiscal year and
provide for a period of 30 days for the public to provide
written comments on the fees.
``(E) Use of fees.--The fees collected under this section
shall be used, without further appropriation, to carry out
this section.
``(F) Failure to pay fee.--
``(i) Due date.--A fee payable under this section shall be
paid by the date that is 30 days after the date on which the
fee is due.
``(ii) Failure to pay.--If an Internet pharmacy subject to
a fee under this section fails to pay the fee by the date
specified under clause (i), the Secretary shall not permit
the Internet pharmacy to engage in the dispensing of drugs as
described under this section until all such fees owed by the
Internet pharmacy are paid.
``(G) Reports.--Beginning with fiscal year 2008, not later
than 60 days after the end of each fiscal year during which
licensing application fees are collected under this section,
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 that describes--
``(i) implementation of the licensing fee authority during
the fiscal year; and
``(ii) the use by the Secretary of the licensing fees
collected during the fiscal year for which the report is
made.
``(6) Suspension.--
``(A) In general.--If the Secretary determines that an
Internet pharmacy is engaged in a pattern of violations of
any of the requirements of this Act, the Secretary may
immediately order the suspension of the license of the
Internet pharmacy.
``(B) Appeal of suspension order.--An Internet pharmacy
subject to a suspension order under subparagraph (A) may
appeal the suspension order to the Secretary. Not later than
30 days after an appeal is filed, the Secretary, after
providing opportunity for an informal hearing, shall affirm
or terminate the order.
``(C) Failure to act.--If, during the 30-day period
specified in subparagraph (B), the Secretary fails to provide
an opportunity for a hearing or to affirm or terminate the
order, the order shall be deemed to be terminated.
``(D) No judicial review.--An order under this paragraph
shall not be subject to judicial review.
``(7) Termination of license.--The Secretary may terminate
a license issued under this subsection, after notice to the
Internet pharmacy and an opportunity for a hearing, and if
the Secretary determines that the Internet pharmacy--
``(A) has demonstrated a pattern of noncompliance with this
section;
``(B) has made an untrue statement of material fact in its
licensing application; or
``(C) is in violation of any applicable Federal or State
law relating to the dispensing of a prescription drug.
``(8) Renewal evaluation.--
``(A) In general.--Before renewing a license of an Internet
pharmacy under this subsection, the Secretary shall conduct
an evaluation to determine whether the Internet pharmacy is
in compliance with this section.
``(B) Evaluation of internet pharmacies.--At the discretion
of the Secretary and as applicable, an evaluation under
subparagraph (A) may include testing of the Internet pharmacy
website or other systems through which the Internet pharmacy
communicates with consumers, and a physical inspection of the
records and premises of the pharmacy.
``(9) Contract for operation of program.--
``(A) In general.--The Secretary may award a contract under
this subsection for the operation of the licensing program.
``(B) Term.--The duration of a contract under subparagraph
(A) shall not exceed 5 years and may be renewable.
``(C) Performance review.--The Secretary shall annually
review performance under a contract under subparagraph (A).
``(d) Providers of Interactive Computer Services or
Advertising Services.--No provider of interactive computer
services (as defined in section 230(f) of the Communications
Act of 1934 (47 U.S.C. 230(f)) or an advertising service
provider shall be liable under this section on account of
another person's selling or dispensing of a prescription
drug, so long as the provider of the interactive computer
service or the advertising service provider does not own or
exercise corporate control over such person.
``(e) Policies and Procedures Required To Prevent Payments
for Unlawful Internet Pharmacy Requests.--
``(1) Regulations.--Not later than 180 days after
designating a system under subsection (a)(2), the Board shall
promulgate regulations that require--
``(A) an operator of a credit card system that is a
designated payment system, an operator of an international,
national, or local network used to effect a credit
transaction, electronic fund transfer, or money transmitting
service that is a designated payment system, and an operator
of any other designated payment system specified by the Board
that is centrally managed and is primarily engaged in the
transmission and settlement of credit transactions,
electronic transfers, or money transmitting services where at
least 1 party to the transaction or transfer is an
individual; and

``(B) in the case of a designated payment system, other
than a designated payment system described in subparagraph
(A), a person described in subsection (a)(2)(B);

to establish policies and procedures that are reasonably
designed to prevent the introduction of restricted
transactions into a designated payment system or the
completion of restricted transactions using a designated
payment system.
``(2) Requirements for policies and procedures.--In
promulgating regulations under paragraph (1), the Board
shall--
``(A) identify types of policies and procedures, including
nonexclusive examples, that shall be considered to be
reasonably designed to identify and reasonably designed to
prevent the introduction of a restricted transaction in a
designated payment or the completion of restricted
transactions using a designated payment system; and

[[Page S5517]]

``(B) to the extent practicable, permit any designated
payment system, or person described in subsection (a)(2)(B),
as applicable, to choose among alternative means of
preventing the introduction or completion of restricted
transactions.
``(3) No liability for blocking or refusing to honor
restricted transaction.--
``(A) In general.--A designated payment system, or a person
described in subsection (a)(2)(B), that is subject to a
regulation or an order issued under this subsection, and any
participant in such payment system, that--
``(i) prevents or otherwise refuses to honor restricted
transactions, in an effort to implement the policies and
procedures required under this subsection or to otherwise
comply with this section, shall not be liable to any party
for such action; and
``(ii) prevents or otherwise refuses to honor a
nonrestricted transaction in an effort to implement the
policies and procedures under this subsection or to otherwise
comply with this section, shall not be liable to any party
for such action.
``(B) Compliance with this subsection.--A person described
in subsection (a)(2)(B) meets the requirements of this
subsection, if any, if the person relies on and complies with
the policies and procedures of a designated payment system of
which the person is a member or in which the person is a
participant, and such policies and procedures of the
designated payment system comply with the requirements of the
regulations under paragraph (1)(B).
``(4) Enforcement.--
``(A) In general.--This subsection shall be enforced by the
Federal functional regulators and the Federal Trade
Commission under applicable law in the manner provided in
section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C.
6805(a)).
``(B) Factors to be considered.--In considering any
enforcement action under this subsection against a payment
system or person described in subsection (a)(2)(B), the
Federal functional regulators and the Federal Trade
Commission shall consider the following factors:
``(i) The extent to which the payment system or person
knowingly permits restricted transactions.
``(ii) The history of the payment system or person in
connection with permitting restricted transactions.
``(iii) The extent to which the payment system or person
has established and is maintaining policies and procedures in
compliance with regulations prescribed under this subsection.
``(iv) The feasibility that any specific remedy prescribed
can be implemented by the payment system or person without
substantial deviation from normal business practice.
``(v) The costs and burdens the specific remedy will have
on the payment system or person.
``(f) Reports Regarding Internet-Related Violations of
Federal and State Laws on Dispensing of Drugs.--The Secretary
shall, pursuant to the submission of an application meeting
criteria prescribed by the Secretary, make an award of a
grant or contract to an entity with experience in developing
and maintaining systems for the purpose of--
``(1) identifying Internet pharmacy websites that are not
licensed or that appear to be operating in violation of
Federal or State laws concerning the dispensing of drugs;
``(2) reporting such Internet pharmacy websites to State
medical licensing boards and State pharmacy licensing boards,
and to the Attorney General and the Secretary, for further
investigation; and
``(3) submitting, for each fiscal year for which the award
under this subsection is made, a report to the Secretary
describing investigations undertaken with respect to
violations described in paragraph (1).
``(g) Transactions Permitted.--A designated payment system
or person subject to a regulation or an order issued under
subsection (e) may engage in transactions with licensed and
unlicensed Internet pharmacies in connection with
investigating violations or potential violations of any rule
or requirement adopted by the payment system or person in
connection with complying with subsection (e). A person
subject to a regulation or an order issued under subsection
(e) and the agents and employees of that person shall not be
found to be in violation of, or liable under, any Federal,
State, or other law for engaging in any such transaction.
``(h) Relation to State Laws.--No requirement, prohibition,
or liability may be imposed on a designated payment system or
person subject to a regulation or an order issued under
subsection (e) under the laws of any State with respect to
any payment transaction by an individual because the payment
transaction involves a payment to an Internet pharmacy.
``(i) Timing of Requirements.--A designated payment system
or a person subject to a regulation under subsection (e)
shall adopt policies and procedures reasonably designed to
comply with any regulations required under subsection (e) not
later than 180 days after the date on which such final
regulations are issued.''.
(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
``(hh)(1) The sale, under section 511, of a drug that is
not a prescription drug, the sale of such a prescription drug
without a valid prescription from a treating provider, or the
ownership or operation of an Internet pharmacy, in violation
of section 511.
``(2) The representation by advertisement, sales
presentation, direct communication (including telephone,
facsimile, or electronic mail), or otherwise by an Internet
pharmacy, that a prescription drug may be obtained from the
Internet pharmacy without a prescription, in violation of
section 511.
``(3) The advertisement related to a prescription drug
through any media including sales presentation, direct
communication (including telephone, facsimile, or electronic
mail), by an unlicensed Internet pharmacy.
``(4) The provision of an untrue statement of material fact
in the licensing application of an Internet pharmacy.
``(5) For purposes of this subsection, any term used in
this subsection that is also used in section 511 shall have
the meaning given that term in section 511.''.
(c) Links to Unlicensed Internet Pharmacies.--Section 302
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332)
is amended by adding at the end the following:
``(c)(1) In the case of a violation of section 511 relating
to an unlicensed Internet pharmacy (as defined in such
section 511), the district courts of the United States and
the United States courts of the territories shall have
jurisdiction to order a provider of an interactive computer
service to remove, or disable access to, links to a website
violating that section that resides on a computer server that
the provider controls or operates.
``(2) Relief under paragraph (1)--
``(A) shall be available only after provision to the
provider of notice and an opportunity to appear;
``(B) shall not impose any obligation on the provider to
monitor its service or to affirmatively seek facts indicating
activity violating section 511;
``(C) shall specify the provider to which the relief
applies; and
``(D) shall specifically identify the location of the
website to be removed or to which access is to be
disabled.''.
(d) Regulations.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate interim final regulations to carry
out the amendments made by this section.
(2) Effective date.--The requirement of licensure under
section 511 of the Federal Food, Drug, and Cosmetic Act (as
added by this section) shall take effect on the date
determined by the Secretary of Health and Human Services but
in no event later than 90 days after the effective date of
the interim final regulations under paragraph (1).
(e) Penalties.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end
the following:
``(g) Notwithstanding subsection (a), any person who
knowingly violates paragraph (1), (2), (3), or (4) of section
301(hh) shall be imprisoned for not more than 10 years or
fined in accordance with title 18, United States Code, or
both.''.
______

SA 1018. Mr. DeMINT (for himself, Mr. Inhofe, Mr. Brownback, Mr.
Martinez, Mr. Vitter, and Mr. Coburn) submitted an amendment intended
to be proposed by him to the bill S. 1082, to amend the Federal Food,
Drug, and Cosmetic Act to reauthorize and amend the prescription drug
user fee provisions, and for other purposes; as follows:

In section 214(b)(3)(B) of the bill, insert ``, except with
respect to the drug Mifeprex (mifepristone), such assessment
shall be submitted 6 months after the applicant is so
notified'' before the period at the end.
______

SA 1019. Mr. CASEY (for himself and Mr. Specter) submitted an
amendment intended to be proposed by him to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. ORPHAN DISEASE TREATMENT IN CHILDREN.

(a) Finding.--The Senate finds that parents of children
suffering from rare genetic diseases known as orphan diseases
face multiple obstacles in obtaining safe and effective
treatment for their children due mainly to the fact that many
Food and Drug Administration-approved drugs used in the
treatment of orphan diseases in children may not be approved
for pediatric indications.
(b) Sense of the Senate.--It is the sense of the Senate
that the Food and Drug Administration should enter into a
contract with the Institute of Medicine for the conduct of a
study concerning measures that may be taken to improve the
likelihood that Food and Drug Administration-approved drugs
that are safe and effective in treating children with orphan
diseases are made available and affordable for pediatric
indications.
______

SA 1020. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act

[[Page S5518]]

to reauthorize and amend the prescription drug user fee provisions, and
for other purposes; which was ordered to lie on the table; as follows:

Strike clause (i) of section 402(j)(3)(A) of the Public
Health Service Act, as added by this bill, and insert the
following:
``(i) In general.--

``(I) Requirement.--Not later than 90 days after the date
of enactment of the Food and Drug Administration
Revitalization Act, for all clinical trials (except as
provided in subclause (II)), whether federally or privately
funded, conducted to test the safety or efficacy (including
comparative efficacy), of any drug or device (including those
drugs or devices approved or cleared by the Secretary), the
Secretary shall ensure that the registry data bank includes
links to results information for such clinical trial--

``(aa) not earlier than 30 days after the date of the
approval of the drug involved or clearance or approval of the
device involved; or
``(bb) not later than 30 days after such information
becomes publicly available, as applicable.

``(II) Exception.--The requirement of subclause (I) shall
not apply to phase I clinical investigations conducted to
test solely the safety of an unapproved drug or unlicensed
biological product, or pilot or feasibility studies conducted
to confirm the design and operating specifications of an
unapproved or not yet cleared medical device.
``(III) Voluntary submission.--A responsible party for a
clinical trial that is not an applicable drug clinical trial
or an applicable device clinical trial may submit to the
Secretary results information for a clinical trial described
in subclause (II).
``(IV) Expanded registry data bank.--Notwithstanding any
other provision of law, the clinical trials described in
subclause (I) shall be clinical trials of which the results
information with respect to such trials is appropriate for
adding to the expanded registry data bank, as described in
subparagraph (C).

At the end section 402(j)(4) of the Public Health Service
Act, as added by this bill, insert the following:
``(F) Trials conducted outside of the united states.--
``(i) In general.--With respect to clinical trials
described in clause (ii), the responsible party shall submit
to the Secretary the information required under this
subsection. The Secretary shall ensure that such information
and the results of such clinical trials are made available to
the public in a timely manner and as soon as practicable
after receiving such information. Failure to comply with this
paragraph shall be deemed to be a failure to submit
information as required under this subsection, and the
appropriate remedies and sanctions under this section shall
apply.
``(ii) Clinical trial described.--A clinical trial is
described in this clause if--

``(I) such trial is conducted outside of the United States;
and
``(II) the data from such trial is--

``(aa) submitted to the Secretary as part of an
application, including a supplemental application, for a drug
or device under section 505, 510, 515, or 520 of the Federal
Food, Drug, and Cosmetic Act or for the biological product
under section 351 of this Act; or
``(bb) used in advertising or labeling to make a claim
about the drug or device involved.
``(iii) Expanded registry data bank.--Notwithstanding any
other provision of law, the clinical trials described in
clause (ii) shall be clinical trials of which the results
information with respect to such trials is appropriate for
adding to the expanded registry data bank, as described in
paragraph (3)(C).
______

SA 1021. Mrs. CLINTON submitted an amendment intended to be proposed
by her to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of the bill, add the following:

SEC. __. NO SUNSET FOR SECTION 505B.

Notwithstanding any provision of this Act, an amendment
made by this Act, or any other provision of law, section 505B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c)
and the authority provided for under such section shall not
sunset but shall remain in effect.
______

SA 1022. Mr. DURBIN (for himself, Mr. Enzi, Mr. Kennedy, Mr. Allard,
Mr. Kohl, Ms. Cantwell, Mr. Schumer, Mr. Biden, Mr. Nelson of Florida,
and Mr. Casey) proposed an amendment to the bill S. 1082, to amend the
Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; as
follows:

At the end of the bill, insert the following:

TITLE __--FOOD SAFETY

SEC. _01. FINDINGS.

(a) Findings.--Congress finds that--
(1) the safety and integrity of the United States food
supply is vital to the public health, to public confidence in
the food supply, and to the success of the food sector of the
Nation's economy;
(2) illnesses and deaths of individuals and companion
animals caused by contaminated food--
(A) have contributed to a loss of public confidence in food
safety; and
(B) have caused significant economic losses to
manufacturers and producers not responsible for contaminated
food items;
(3) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and the
ability to detect all forms of contamination; and
(B) an increasing volume of imported food from a wide
variety of countries; and
(C) a shortage of adequate resources for monitoring and
inspection;
(4) the United States is increasing the amount of food that
it imports such that --
(A) from 2003 to the present, the value of food imports has
increased from $45,600,000,000 to $64,000,000,000; and
(B) imported food accounts for 13 percent of the average
Americans diet including 31 percent of fruits, juices, and
nuts, 9.5 percent of red meat and 78.6 percent of fish and
shellfish; and
(5) the number of full time equivalent Food and Drug
Administration employees conducting inspections has decreased
from 2003 to 2007.

SEC. _02. ENSURING THE SAFETY OF PET FOOD.

(a) Processing and Ingredient Standards.--Not later than 18
months after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this title as
the ``Secretary''), in consultation with the Association of
American Feed Control Officials, and other relevant
stakeholder groups, including veterinary medical
associations, animal health organizations, and pet food
manufacturers, shall by regulation establish--
(1) processing and ingredient standards with respect to pet
food, animal waste, and ingredient definitions; and
(2) updated standards for the labeling of pet food that
includes nutritional information and ingredient information.
(b) Early Warning Surveillance Systems and Notification
During Pet Food Recalls.--Not later than 180 days after the
date of enactment of this Act, the Secretary shall by
regulation establish an early warning and surveillance system
to identify adulteration of the pet food supply and outbreaks
of illness associated with pet food. In establishing such
system, the Secretary shall--
(1) use surveillance and monitoring mechanisms similar to,
or in coordination with, those mechanisms used by the Centers
for Disease Control and Prevention to monitor human health,
such as the Foodborne Diseases Active Surveillance Network
(FoodNet) and PulseNet;
(2) consult with relevant professional associations and
private sector veterinary hospitals; and
(3) work with the Health Alert Network and other
notification networks to inform veterinarians and relevant
stakeholders during any recall of pet food.

SEC. _03. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS
DURING A RECALL.

The Secretary shall, during an ongoing recall of human or
pet food--
(1) work with companies, relevant professional
associations, and other organizations to collect and
aggregate information pertaining to the recall;
(2) use existing networks of communication including
electronic forms of information dissemination to enhance the
quality and speed of communication with the public; and
(3) post information regarding recalled products on the
Internet website of the Food and Drug Administration in a
consolidated, searchable form that is easily accessed and
understood by the public.

SEC. _04. STATE AND FEDERAL COOPERATION.

(a) In General.--The Secretary shall work with the States
in undertaking activities and programs that assist in
improving the safety of fresh and processed produced so that
State food safety programs involving the safety of fresh and
processed produce and activities conducted by the Secretaries
function in a coordinated and cost-effective manner. With the
assistance provided under subsection (b), the Secretary shall
encourage States to--
(1) establish, continue, or strengthen State food safety
programs, especially with respect to the regulation of retail
commercial food establishments; and
(2) establish procedures and requirements for ensuring that
processed produce under the jurisdiction of the State food
safety programs is not unsafe for human consumption.
(b) Assistance.--The Secretary may provide to a State, for
planning, developing, and implementing such a food safety
program--
(1) advisory assistance;
(2) technical assistance, training, and laboratory
assistance (including necessary materials and equipment); and
(3) financial and other assistance.
(c) Service Agreements.--The Secretary may, under an
agreement entered into with a Federal, State, or local
agency, use, on a reimbursable basis or otherwise, the
personnel, services, and facilities of the agency to carry
out the responsibilities of the agency under this section. An
agreement entered into with a State agency under this
subsection may provide for training of State employees.

SEC. _05. ADULTERATED FOOD REGISTRY.

(a) Findings.--Congress makes the following findings:

[[Page S5519]]

(1) In 1994, Congress passed the Dietary Supplement Health
and Education Act (P.L. 103-417) to provide the Food and Drug
Administration with the legal framework to ensure that
dietary supplements are safe and properly labeled foods.
(2) In 2006, Congress passed the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (P.L. 109-462)
to establish a mandatory reporting system of serious adverse
events for non-prescription drugs and dietary supplements
sold and consumed in the United States.
(3) The adverse event reporting system created under the
Dietary Supplement and Nonprescription Drug Consumer
Protection Act will serve as the early warning system for any
potential public health issues associated with the use of
these food products.
(4) A reliable mechanism to track patterns of adulteration
in food would support efforts by the Food and Drug
Administration to effectively target limited inspection
resources to protect the public health.
(b) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:

``SEC. 417. ADULTERATED FOOD REGISTRY.

``(a) Definitions.--In this section:
``(1) Importer.--The term `importer', with respect to an
article of food, means the person who submitted the notice
with respect to such article of food under section 801(m).
``(2) Responsible party.--The term `responsible party',
with respect to an article of food, means any registered food
facility under section 415(a), including those responsible
for the manufacturing, processing, packaging or holding of
such food for consumption in the United States.
``(3) Reportable adulterated food.--The term `reportable
adulterated food' for purposes of this section means a food
that is adulterated or--
``(A) presents a situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death as defined in section 7.3(m)(1) of title, Code of
Federal Regulations (or any successor regulations); or
``(B) meets the threshold established in section 304(h).
``(b) Establishment.--
``(1) In general.--Not later than 180 days after the date
of enactment of this section, the Secretary shall establish
within the Food and Drug Administration an Adulterated Food
Registry to which instances of reportable adulterated food
may be submitted by the Food and Drug Administration after
receipt of reports of adulteration, via an electronic portal,
from--
``(A) Federal, State, and local public health officials;
``(B) an importer;
``(C) a responsible party; or
``(D) a consumer or other individual.
``(2) Review by secretary.--The Secretary shall review and
determine the validity of the information submitted under
paragraph (1) for the purposes of identifying adulterated
food, submitting entries to the Adulterated Food Registry,
acting under subsection (c), and exercising other existing
food safety authorities under the Act to protect the public
health.
``(c) Issuance of an Alert by the Secretary.--
``(1) In general.--The Secretary shall issue an alert with
respect to an adulterated food if the Adulterated Food
Registry shows that the food--
``(A) has been associated with repeated and separate
outbreaks of illness or has been repeatedly determined to be
adulterated; or
``(B) is a reportable adulterated food.
``(2) Scope of alert.--An alert under paragraph (1) may
apply to a particular food or to food from a particular
producer, manufacturer, shipper, growing area, or country, to
the extent that elements in subparagraph (A) or (B) of
paragraph (1) are associated with the particular food,
producer, manufacturer, shipper, growing area, or country.
``(d) Submission by a Consumer or Other Individual.--A
consumer or other individual may submit a report to the Food
and Drug Administration using the electronic portal data
elements described in subsection (e). Such reports shall be
evaluated by the Secretary as specified in subsection (b)(2).
``(e) Notification and Reporting of Adulteration.--
``(1) Determination by responsible party or importer.--If a
responsible party or importer determines that an article of
food it produced, processed, manufactured, distributed, or
otherwise handled is a reportable adulterated food, the
responsible party shall provide the notifications described
under paragraph (2).
``(2) Notification of adulteration.--
``(A) In general.--Not later than 5 days after a
responsible party or importer receives a notification, the
responsible party or importer, as applicable, shall review
whether the food referenced in the report described in
paragraph (1) is a reportable adulterated food.
``(B) Notification.--If a determination is made by such
responsible party or importer that the food is a reportable
adulterated food, such responsible party or importer shall,
no later than 5 days after such determination is made, notify
other responsible parties directly linked in the supply chain
to which and from which the article of reportable adulterated
food was transferred.
``(3) Submission of reports to the food and drug
administration by a responsible party or importer.--The
responsible party or importer, as applicable, shall submit a
report to the Food and Drug Administration through the
electronic portal using the data elements described in
subsection (f) not later than 2 days after a responsible
party or importer--
``(A) makes a notification under paragraph (2)(B); or
``(B) determines that an article of food it produced,
processed, manufactured, distributed, imported, or otherwise
handled is a reportable adulterated food, except that if such
adulteration was initiated with such responsible party or
importer, was detected prior to any transfer of such article
of food, and was destroyed, no report is necessary.
``(f) Data Elements in the Registry.--A report submitted to
the Food and Drug Administration electronic portal under
subsection (e) shall include the following data elements:
``(1) Contact information for the individual or entity
submitting the report.
``(2) The date on which an article of food was determined
to be adulterated or suspected of being adulterated.
``(3) A description of the article of food including the
quantity or amount.
``(4) The extent and nature of the adulteration.
``(5) The disposition of the article.
``(6) Product information typically found on packaging
including product codes, use by dates, and names of
manufactures or distributors.
``(7) Information about the place of purchase or process by
which the consumer or other individual acquired the article
of adulterated food.
``(8) In the case of a responsible party or an importer,
the elements required for the registration of food facilities
under section 415(a).
``(9) The contact information for parties directly linked
in the supply chain and notified under subsection (e)(2).
``(10) In the case of an importer, the elements required
for the prior notice of imported food shipments under section
801(m).
``(g) Maintenance and Inspection of Records.--The
responsible person or importer shall maintain records related
to each report received, notification made, and report
submitted to the Food and Drug Administration under this
section and permit inspection of such records as provided for
in section 414. Such records shall also be made available
during an inspection under section 704.
``(h) Request for Information.--Section 552 of title 5,
United States Code, shall apply to any request for
information regarding a record in the Adulterated Food
Registry.
``(i) Homeland Security Notification.--If, after receiving
a report under subsection (e), the Secretary suspects such
food may have been deliberately adulterated, the Secretary
shall immediately notify the Secretary of Homeland Security.
The Secretary shall make the data in the Adulterated Imported
Food Registry available to the Secretary of Homeland
Security.''.
(c) Definition.--Section 201(ff) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking
``section 201(g)'' and inserting ``sections 201(g) and 417''.
(d) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by this
Act, is further amended by adding at the end the following:
``(kk) The failure to provide a report as required under
section 417(e)(3).
``(ll) The falsification a report as required under section
417(e)(3).''.
(e) Suspected Food Adulteration Regulations.--The Secretary
shall, within 180 days of enactment of this Act, promulgate
regulations that establish standards and thresholds by which
importers and responsible parties shall be required and
consumers may be able to, under section 417 of the Federal
Food, Drug, and Cosmetic Act (as added by this section)--
(1) report instances of suspected reportable adulteration
of food to the Food and Drug Administration for possible
inclusion in the Adulterated Food Registry after evaluation
of such report; and
(2) notify, in keeping with subsection (e)(2) of such
section 417, other responsible parties directly linked in the
supply chain, including establishments as defined in section
415(b) of such Act.
(f) Effective Date.--The requirements of section 417(e) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), shall become effective 180 days after the
date of enactment of this Act.

SEC. _06. SENSE OF THE SENATE.

It is the sense of the Senate that--
(1) it is vital for Congress to provide the Food and Drug
Administration with additional resources, authorities, and
direction with respect to ensuring the safety of the food
supply of the United States;
(2) additional inspectors are required to improve the Food
and Drug Administration's ability to safeguard the food
supply of the United States;
(3) because of the increasing volume of international trade
in food products the Secretary of Health and Human Services
should make it a priority to enter into agreements with the
trading partners of the United States with respect to food
safety; and
(4) the Senate should work to develop a comprehensive
response to the issue of food safety.

[[Page S5520]]

SEC. _07. ANNUAL REPORT TO CONGRESS.

The Secretary shall, on an annual basis, submit to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives a report that includes, with
respect to the preceding 1-year period--
(1) the number and amount of food products regulated by the
Food and Drug Administration imported into the United States,
aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration
inspectors of imported food products referenced in paragraph
(1) and the number of Food and Drug Administration
inspections performed on such products; and
(3) aggregated data on the findings of such inspections,
including data related to violations of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and
enforcement actions used to follow-up on such findings and
violations.

SEC. _08. RULE OF CONSTRUCTION.

Nothing in this title (or an amendment made by this title)
shall be construed to affect--
(1) the regulation of dietary supplements under the Dietary
Supplement Health and Education Act; or
(2) the adverse event reporting system for dietary
supplements created under the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.

SEC. _09. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated to carry out this
title (and the amendments made by this title) such sums as
may be necessary.

______

SA 1023. Mr. DURBIN submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. STUDY ON FOOD INSPECTION AND SAFETY USER FEES.

(a) In General.--The Secretary of Health and Human Services
shall conduct a study to determine the feasibility of
instituting a user fee program for food inspections and food
safety that incorporates lessons learned from the user fee
program for prescription drugs under chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.)
and that is designed to increase the resources and
capabilities of the Food and Drug Administration to safeguard
the food supply of the United States.
(b) Report to Congress.--Not later than 180 days after the
date of enactment of this Act, the Secretary of Health and
Human Services shall submit to Congress a report that--
(1) describes the findings of the study conducted under
subsection (a); and
(2) includes--
(A) any recommendations for legislation related to such
findings; and
(B) provides details, with respect to such recommended
legislation, regarding--
(i) the expected revenues for the Food and Drug
Administration;
(ii) the expected costs to the private sector, categorized
by industry; and
(iii) any other relevant information.
______

SA 1024. Mr. SALAZAR submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

SEC. __. PROHIBITION OF REORGANIZATION PLAN PENDING REVIEW.

(a) In General.--The Commissioner of Food and Drugs may not
implement a reorganization plan that reduces or consolidates
the number of laboratory facilities currently in operation
within the Office of Regulatory Affairs of the Food and Drug
Administration pending a comprehensive review of the
reorganization plan by the Comptroller General of the United
States to determine--
(1) the impact of the reorganization on the mission of the
Food and Drug Administration to ensure that foods, cosmetics,
and medical products are safe, effective, and properly
promoted and labeled;
(2) the projected cost savings; and
(3) the projected operational efficiencies.
(b) Report.--Not later than 1 year after the date of
enactment of this section, the Comptroller General of the
United States shall issue a report on the impact of the
reorganization plan described in subsection (a).
______

SA 1025. Mr. SCHUMER (for himself, Mrs. Clinton, Mr. Enzi, Mr. Hatch,
and Mr. Kennedy) proposed an amendment to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; as
follows:

At the end of the bill, add the following:

SEC. __. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON
BIOLOGICS.

(a) Findings.--The Senate finds the following:
(1) The Food and Drug Administration has stated that it
requires legislative authority to review follow-on biologics.
(2) Business, consumer, and government purchasers require
competition and choice to ensure more affordable prescription
drug options.
(3) Well-constructed policies that balance the needs of
innovation and affordability have broad bipartisan support.
(b) Sense of the Senate.--It is the sense of the Senate
that--
(1) legislation should be enacted to--
(A) provide the Food and Drug Administration with the
authority and flexibility to approve biopharmaceuticals
subject to an abbreviated approval pathway;
(B) ensure that patient safety remains paramount in the
system;
(C) establish a regulatory pathway that is efficient,
effective, and scientifically-grounded and that also includes
measures to ensure timely resolution of patent disputes; and
(D) provide appropriate incentives to facilitate the
research and development of innovative biopharmaceuticals.
______

SA 1026. Mr. FEINGOLD submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

SEC. __. PUBLICATION OF ANNUAL REPORTS.

(a) In General.--The Commissioner on Food and Drugs shall
annually submit to Congress and publish on the Internet
website of the Food and Drug Administration, a report
concerning the results of the Administration's pesticide
residue monitoring program, that includes--
(1) information and analysis similar to that contained in
the report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'' as released in June of
2005;
(2) based on an analysis of previous samples, an
identification of products or countries (for imports) that
require special attention and additional study (including
details on the plans for such additional studies), including
in the initial report (and subsequent reports as determined
necessary) the results and analysis of the Ginseng Dietary
Supplements Special Survey as described on page 13 of the
report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'';
(3) information on the relative number of interstate and
imported shipments of each tested commodity that were
sampled, including recommendations on whether sampling is
statistically significant, provides confidence intervals or
other related statistical information, and whether the number
of samples should be increased and the details of any plans
to provide for such increase; and
(4) a description of whether certain commodities are being
improperly imported as another commodity, including a
description of additional steps that are being planned to
prevent such smuggling.
(b) Initial Reports.--Annual reports under subsection (a)
for fiscal years 2004 through 2006 may be combined into a
single report, by not later than June 1, 2008, for purposes
of publication under subsection (a). Thereafter such reports
shall be completed by June 1 of each year for the data
collected for the year that was 2-years prior to the year in
which the report is published.
(c) Memorandum of Understanding.--The Commissioner of Food
and Drugs, the Administrator of the Food Safety and
Inspection Service, and the head of the Agricultural
Marketing Service shall enter into a memorandum of
understanding to permit inclusion of data in the reports
under subsection (a) relating to testing carried out by the
Food Safety and Inspection Service and the Agricultural
Marketing Service on meat, poultry, eggs, and certain raw
agricultural products, respectively.
______

SA 1027. Mr. DURBIN submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

TITLE __--FOOD SAFETY

SEC. __. FOOD SAFETY FOR HUMANS AND PETS.

Chapter IV of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 341 et seq.) is amended by adding at the end the
following:

``SEC. 417. NOTIFICATION AND RECALL.

``(a) Notice to Secretary of Violation.--
``(1) In general.--A person that has reason to believe that
any food introduced into or in interstate commerce, or held
for sale (whether or not the first sale) after shipment in
interstate commerce, may be in violation of this Act shall
immediately notify the Secretary of the identity and location
of the food.
``(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Secretary may require by regulation.

[[Page S5521]]

``(b) Recall and Consumer Notification; Voluntary
Actions.--If the Secretary determines that food is in
violation of this Act when introduced into or while in
interstate commerce or while held for sale (whether or not
the first sale) after shipment in interstate commerce and
that there is a reasonable probability that the food, if
consumed, would present a threat to public health, as
determined by the Secretary, the Secretary shall give the
appropriate persons (including the manufacturers, importers,
distributors, or retailers of the food) an opportunity to--
``(1) cease distribution of the food;
``(2) notify all persons--
``(A) processing, distributing, or otherwise handling the
food to immediately cease such activities with respect to the
food; or
``(B) to which the food has been distributed, transported,
or sold, to immediately cease distribution of the food;
``(3) recall the food;
``(4) in conjunction with the Secretary, provide notice of
the finding of the Secretary--
``(A) to consumers to whom the food was, or may have been,
distributed; and
``(B) to State and local public health officials; or
``(5) take any combination of the measures described in
this paragraph, as determined by the Secretary to be
appropriate in the circumstances.
``(c) Civil and Criminal Penalties.--
``(1) Civil sanctions.--
``(A) Civil penalty.--Any person that commits an act that
violates the notification and recall standards under
subsection (b) (including a regulation promulgated or order
issued under this Act) may be assessed a civil penalty by the
Secretary of not more than $10,000 for each such act.
``(B) Separate offense.--Each act described in subparagraph
(A) and each day during which that act continues shall be
considered a separate offense.
``(2) Other requirements.--
``(A) Written order.--The civil penalty described in
paragraph (1) shall be assessed by the Secretary by a written
order, which shall specify the amount of the penalty and the
basis for the penalty under subparagraph (B) considered by
the Secretary.
``(B) Amount of penalty.--Subject to paragraph (1)(A), the
amount of the civil penalty shall be determined by the
Secretary, after considering--
``(i) the gravity of the violation;
``(ii) the degree of culpability of the person;
``(iii) the size and type of the business of the person;
and
``(iv) any history of prior offenses by the person under
this Act.
``(C) Review of order.--The order may be reviewed only in
accordance with subsection (d).
``(3) Exception.--No person shall be subject to the
penalties of this subsection--
``(A) for having received, proffered, or delivered in
interstate commerce any food, if the receipt, proffer, or
delivery was made in good faith, unless that person refuses
to furnish (on request of an officer or employee designated
by the Secretary)--
``(i) the name, address and contact information of the
person from whom that person purchased or received the food;
``(ii) copies of all documents relating to the person from
whom that person purchased or received the food; and
``(iii) copies of all documents pertaining to the delivery
of the food to that person; or
``(B) if that person establishes a guaranty signed by, and
containing the name and address of, the person from whom that
person received in good faith the food, stating that the food
is not adulterated or misbranded within the meaning of this
Act.
``(d) Judicial Review.--
``(1) In general.--An order assessing a civil penalty under
subsection (c) shall be a final order unless the person--
``(A) not later than 30 days after the effective date of
the order, files a petition for judicial review of the order
in the United States court of appeals for the circuit in
which that person resides or has its principal place of
business or the United States Court of Appeals for the
District of Columbia; and
``(B) simultaneously serves a copy of the petition by
certified mail to the Secretary.
``(2) Filing of record.--Not later than 45 days after the
service of a copy of the petition under paragraph (1)(B), the
Secretary shall file in the court a certified copy of the
administrative record upon which the order was issued.
``(3) Standard of review.--The findings of the Secretary
relating to the order shall be set aside only if found to be
unsupported by substantial evidence on the record as a whole.
``(e) Collection Actions for Failure to Pay.--
``(1) In general.--If any person fails to pay a civil
penalty assessed under subsection (c) after the order
assessing the penalty has become a final order, or after the
court of appeals described in subsection (d) has entered
final judgment in favor of the Secretary, the Secretary shall
refer the matter to the Attorney General, who shall institute
in a United States district court of competent jurisdiction a
civil action to recover the amount assessed.
``(2) Limitation on review.--In a civil action under
paragraph (1), the validity and appropriateness of the order
of the Secretary assessing the civil penalty shall not be
subject to judicial review.
``(f) Penalties Paid Into Account.--The Secretary--
``(1) shall deposit penalties collected under this section
in an account in the Treasury; and
``(2) may use the funds in the account, without further
appropriation or fiscal year limitation--
``(A) to carry out enforcement activities under food safety
law; or
``(B) to provide assistance to States to inspect retail
commercial food establishments, such as an establishment that
holds, stores, or transports food or food ingredients, or
other food or firms under the jurisdiction of State food
safety programs.
``(g) Discretion of the Secretary to Prosecute.--Nothing in
this section or section 418 requires the Secretary to report
for prosecution, or for the commencement of an action, the
violation of this Act in a case in which the Secretary finds
that the public interest will be adequately served by the
assessment of a civil penalty under this section.
``(h) Remedies Not Exclusive.--The remedies provided in
this section may be in addition to, and not exclusive of,
other remedies that may be available.

``SEC. 418. MANDATORY RECALL ACTION.

``(a) Mandatory Actions.--If a person referred to in
section 417(b) refuses to or does not adequately carry out
the actions described in that section within the time period
and in the manner prescribed by the Secretary, the Secretary
shall--
``(1) have authority to control and possess the food,
including ordering the shipment of the food from a food
establishment, such as an establishment that holds, stores,
or transports food or food ingredients, to the Secretary--
``(A) at the expense of such food establishment; or
``(B) in an emergency (as determined by the Secretary), at
the expense of the Secretary; and
``(2) by order, require, as the Secretary determines to be
necessary, the person to immediately--
``(A) cease distribution of the food; and
``(B) notify all persons--
``(i) processing, distributing, or otherwise handling the
food to immediately cease such activities with respect to the
food; or
``(ii) if the food has been distributed, transported, or
sold, to immediately cease distribution of the food.
``(b) Notification to Consumers by Secretary.--The
Secretary shall, as the Secretary determines to be necessary,
provide notice of the finding of the Secretary under
paragraph (1)--
``(1) to consumers to whom the food was, or may have been,
distributed; and
``(2) to State and local public health officials.
``(c) Nondistribution by Notified Persons.--A person that
processes, distributes, or otherwise handles the food, or to
which the food has been distributed, transported, or sold,
and that is notified under section 417(b)(2) or subsection
(a)(2)(B) of this section shall immediately cease
distribution of the food.
``(d) Availability of Records to Secretary.--Each person
referred to in section 417 that processed, distributed, or
otherwise handled food shall make available to the Secretary
information necessary to carry out this subsection, as
determined by the Secretary, regarding--
``(1) persons that processed, distributed, or otherwise
handled the food; and
``(2) persons to which the food has been transported, sold,
distributed, or otherwise handled.
``(e) Informal Hearings on Orders.--
``(1) In general.--The Secretary shall provide any person
subject to an order under subsection (a) with an opportunity
for an informal hearing, to be held as soon as practicable
but not later than 2 business days after the issuance of the
order.
``(2) Scope of the hearing.--In a hearing under paragraph
(1), the Secretary shall consider the actions required by the
order and any reasons why the food that is the subject of the
order should not be recalled.
``(f) Post-Hearing Recall Orders.--
``(1) Amendment of order.--If, after providing an
opportunity for an informal hearing under subsection (e), the
Secretary determines that there is a reasonable probability
that the food that is the subject of an order under
subsection (a), if consumed, would present a threat to the
public health, the Secretary, as the Secretary determines to
be necessary, may--
``(A) amend the order to require recall of the food or
other appropriate action;
``(B) specify a timetable in which the recall shall occur;
``(C) require periodic reports to the Secretary describing
the progress of the recall; and
``(D) provide notice of the recall to consumers to whom the
food was, or may have been, distributed.
``(2) Vacation of orders.--If, after providing an
opportunity for an informal hearing under subsection (e), the
Secretary determines that adequate grounds do not exist to
continue the actions required by the order, the Secretary
shall vacate the order.
``(g) Remedies Not Exclusive.--The remedies provided in
this section shall be in addition to, and not exclusive of,
other remedies that may be available.''.
______

SA 1028. Mr. ROCKEFELLER (for himself, Mr. Schumer, Mr. Leahy, Mr.

[[Page S5522]]

Kohl, and Ms. Stabenow) submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of the bill, add the following:

SEC.__. PROHIBITION OF AUTHORIZED GENERICS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by this Act, is further amended by
adding at the end the following:
``(s) Prohibition of Authorized Generic Drugs.--
``(1) In general.--Notwithstanding any other provision of
this Act, no holder of a new drug application approved under
subsection (c) shall manufacture, market, sell, or distribute
an authorized generic drug, direct or indirectly, or
authorize any other person to manufacture, market, sell, or
distribute an authorized generic drug.
``(2) Authorized generic drug.--For purposes of this
subsection, the term `authorized generic drug'--
``(A) means any version of a listed drug (as such term is
used in subsection (j)) that the holder of the new drug
application approved under subsection (c) for that listed
drug seeks to commence marketing, selling, or distributing,
directly or indirectly, after receipt of a notice sent
pursuant to subsection (j)(2)(B) with respect to that listed
drug; and
``(B) does not include any drug to be marketed, sold, or
distributed--
``(i) by an entity eligible for exclusivity with respect to
such drug under subsection (j)(5)(B)(iv); or
``(ii) after expiration or forfeiture of any exclusivity
with respect to such drug under such subsection
(j)(5)(B)(iv).''.
______

SA 1029. Mr. SANDERS submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

Beginning on page 138 strike line 5 and all that follows
through line 10 on page 142 and insert the following:
``(x) specify a process for annual Board review of the
operations of the Foundation;
``(xi) establish specific duties of the Executive Director;
and
``(xii) establish specific policies to safeguard the
Federal Government's patent rights in inventions made with
Federal assistance through the Foundation;
``(B) prioritize and provide overall direction to the
activities of the Foundation;
``(C) evaluate the performance of the Executive Director;
and
``(D) carry out any other necessary activities regarding
the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of the Board
appointed under paragraph (1)(C) shall be 4 years, except
that the terms of offices for the initial appointed members
of the Board shall expire on a staggered basis as determined
by the ex officio members.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the remaining members
to execute the duties of the Board; and
``(ii) shall be filled by appointment by the appointed
members described in paragraph (1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does not
serve the full term applicable under subparagraph (A), the
individual appointed under subparagraph (B) to fill the
resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of the
member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(e) Incorporation.--The ex officio members of the Board
shall serve as incorporators and shall take whatever actions
necessary to incorporate the Foundation.
``(f) Nonprofit Status.--The Foundation shall be considered
to be a corporation under section 501(c) of the Internal
Revenue Code of 1986, shall be subject to the provisions of
such section, and shall be considered a nonprofit
organization for purpose of section 201(i) of title 35,
United States Code.
``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific
duties and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.
``(h) Administrative Powers.--In carrying out this
subchapter, the Board, acting through the Executive Director,
may--
``(1) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and
define their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation is
acquired, held, and transferred;
``(B) general operations of the Foundation are to be
conducted; and
``(C) the privileges granted to the Board by law are
exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information,
services, and facilities of such department or agencies in
carrying out this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the
Foundation under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation,
except that Federal rights in patented inventions made with
Federal assistance shall be preserved;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees, except that Federal rights
in patented inventions made with Federal assistance shall be
preserved;
______

SA 1030. Mr. SANDERS submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

On page 171, between lines 18 and 19, insert the following:
``(C) Additional certification.--At the time of the
submission of an application under section 505 of the Federal
Food, Drug, and Cosmetic Act, section 515 of such Act,
section 520(m) of such Act or section 351 of the Public
Health Service Act, or submission of a report under section
510(k) of such Act, such application or submission shall be
accompanied by a certification that all applicable
requirements of sections 201 through 212 of title 35, United
States Code, and any other provision of Federal law relating
to Federal rights in patented inventions made with Federal
Government assistance, have been met, including, where
applicable, the requirement under section 201(f) of such
title that the benefits of such inventions be made available
to the public on reasonable terms, including price.''.
______

SA 1031. Mr. SANDERS submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

On page 171, line 16, insert before the period the
following: ``, and that any patent filed or that will be
filed contains a statement specifying that the invention was
made with Federal Government support and that the Federal
Government has certain rights in it, if such a statement is
otherwise required by law''.
______

SA 1032. Mr. SANDERS submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

On page 156, between lines 2 and 3, insert the following:

``(VII) The rights of the Federal Government in the drug or
device that is the subject of the clinical trial.''.

______

SA 1033. Mr. SANDERS submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

On page 145, between lines 11 and 12, insert the following:
``(n) Protecting Federal Rights in Patented Inventions
Developed With Federal Government Assistance.--Any invention
developed by the Foundation or with the funds of the
Foundation shall be considered a subject invention for
purposes of section 201(e) of title 35, United States
Code.''.

____________________