I
109th CONGRESS
2d Session
H. R. 5836
IN THE HOUSE OF REPRESENTATIVES
July 19, 2006
Mr. Brown of Ohio (for himself and Mrs. Wilson of New Mexico) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act with respect to making progress toward the goal of eliminating tuberculosis, and for other purposes.
Short title; table of contents
Short title
This Act may be cited
as the Comprehensive Tuberculosis
Elimination Act of 2006
.
Table of contents
The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Title I—Centers for Disease Control and Prevention
Subtitle A—National program for elimination of tuberculosis
Sec. 101. National program.
Subtitle B—Interagency collaboration
Sec. 111. Advisory council for elimination of tuberculosis.
Subtitle C—New tools for tuberculosis elimination
Sec. 121. New tools.
Subtitle D—Authorizations of appropriations
Sec. 131. Authorizations of appropriations.
Title II—National Institutes of Health
Sec. 201. Activities of National Heart, Lung, and Blood Institute.
Sec. 202. Activities of National institute of Allergy and Infectious Diseases.
Sec. 203. John E. Fogarty International Center for Advanced Study in the Health Sciences.
Sec. 204. Loan repayment programs regarding research on tuberculosis.
Findings
The Congress finds as follows:
Each year approximately 9 million people
become ill with active tuberculosis (TB
) and 2 million of those
people die. This is a direct result of the disease having the ability to
develop resistance to treatments and to travel easily across borders.
In 2005, there were 14,093 cases of active TB reported in the United States. However, the decline of 3.8 percent in the national TB case rate from 2004 to 2005 was one of the smallest declines in more than a decade.
In addition to those with active TB, an estimated 10 to 15 million people in the United States have latent TB.
The increasing occurrence of multidrug resistant TB, including extensively drug-resistant TB—which is resistant to at least two main first-line drugs and additionally to three or more of the six classes of second-line drugs—raises concerns of a future epidemic of virtually untreatable TB.
New tools are needed to more effectively prevent, diagnose, and treat TB. The standard method of diagnosing TB is over 100 years old, and fails to adequately detect TB in children and those coinfected with HIV/AIDS. The newest class of anti-TB drug is 40 years old, while rates of multidrug resistant TB are rising globally.
Centers for Disease Control and Prevention
National program for elimination of tuberculosis
National program
Section 317E of the Public Health Service Act (42 U.S.C. 247b-6) is amended—
by striking the heading for the section and
inserting the following: national program for elimination of
tuberculosis
; and
by amending subsection (b) to read as follows:
Research and development; demonstration projects; education and training
With respect to the prevention, control and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:
Research, with priority given to research and development concerning—
clinical trials to evaluate the safety and effectiveness of new drugs, diagnostics, and vaccines for latent tuberculosis infection and active tuberculosis;
epidemiological studies of populations at risk of tuberculosis; and
field studies to evaluate the effectiveness of new drugs, diagnostics, and vaccines, and evaluation of efforts to eliminate the disease.
Demonstration projects for—
the development of regional capabilities to prevent, control and eliminate tuberculosis;
the intensification of efforts to prevent, detect, and treat tuberculosis among African Americans and reduce or eliminate the racial disparity in the incidence of tuberculosis in that population;
the intensification of efforts to control tuberculosis along the United States-Mexico border and among United States-Mexico binational populations;
the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States; and
collaboration with Immigration and Customs Enforcement to identify and treat immigrants with active or latent tuberculosis infection.
A public information and education program.
Education, training and clinical skills improvement activities for health professionals, including allied health personnel and emergency response employees.
Provide support for the Tuberculosis Trials Consortium, the Tuberculosis Epidemiologic Studies Consortium, and Regional Training and Medical Consultation Centers to carry out activities under paragraphs (1) through (4).
Collaboration with international organizations and foreign countries in carrying out such activities.
.
Interagency collaboration
Advisory council for elimination of tuberculosis
In general
Section 317E(f) of the Public Health Service Act (42 U.S.C. 247b-6(f)) is amended—
by redesignating paragraph (5) as paragraph (6); and
by striking paragraphs (2) through (4), and inserting the following:
Duties
The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary, the Assistant Secretary for Health, and the Director of the Centers for Disease Control and Prevention. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—
coordinating the activities of the Public Health Service and other Federal agencies that relate to the disease, including activities under subsection (b); and
efficiently utilizing the Federal resources involved.
National plan
In general
In carrying out paragraph (2), the Council shall make recommendations on the development, revision, and implementation of a national plan to eliminate tuberculosis in the United States.
Consultation
In carrying out subparagraph (A), the Council shall consult with public and private entities, including—
individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the Federal Government and who represent the disciplines relevant to tuberculosis elimination;
members of public-private partnerships established to address the elimination of tuberculosis ;
members of national and international nongovernmental organizations established to address tuberculosis elimination; and
members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis.
Certain components of plan
In carrying out subparagraph (A), the Council shall—
consider the recommendations of the Institute of Medicine regarding the elimination of tuberculosis;
consider recommendations for the involvement of the United States in continuing global and cross-border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States such as Mexico; and
review the extent to which progress has been made toward eliminating tuberculosis.
Annual report
The Council shall annually submit to Congress and the Secretary a report on the activities carried under this section, other than subsection (g). Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, including with respect to—
activities under subsection (b); and
the national plan referred to in paragraph (3).
Composition
The Council shall be composed of—
representatives from the Centers for Disease Control and Prevention, the National Institutes of Health, the United States Agency for International Development, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other Federal departments and agencies that carry out significant activities related to tuberculosis;
State and local tuberculosis control and public health and officials;
individuals who are scientists, physicians, laboritorians, and other health professionals who represent disciplines relevant to tuberculosis elimination;
members of national and international nongovernmental organizations established to address the elimination of tuberculosis; and
members from the general public who are knowledgeable with respect to the elimination of tuberculosis, including individuals who have or have had tuberculosis.
.
Rule of construction regarding current membership
With respect to the advisory council under section 317E(f) of the Public Health Service Act, the amendments made by subsection (a) may not be construed as terminating the membership on such council of any individual serving as such a member as of the day before the date of the enactment of this Act.
New tools for tuberculosis elimination
New tools
Section 317E of the Public Health Service Act (42 U.S.C. 247b–6) is amended—
by redesignating subsection (g) as subsection (h); and
by inserting after subsection (f) the following subsection:
New tools for elimination of tuberculosis
Research and development on drugs, diagnostics, and vaccines
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and coordinate research and development and related activities of such Centers to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.
Federal tuberculosis task force
Duties
The
Federal Tuberculosis Task Force (established in December 2001 as part of the
Centers for Disease Control and Prevention) (in this subsection referred to as
the Task Force
) shall provide to the Secretary and other
appropriate Federal officials advice on the implementation of paragraph (1),
include advice regarding the efficient utilization of the Federal resources
involved.
National plan for new tools development
In carrying out paragraph (1), the Task Force shall make recommendations on the development of a national plan for the development of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.
Consultation
In developing the national plan under paragraph (1), the Task Force shall consult with—
scientists, physicians, and other health professionals and who represent the specialties and disciplines relevant to the research under consideration;
members from public-private partnerships or foundations (or both) engaged in research relevant to research under consideration;
members of national and international nongovernmental organizations established to address tuberculosis elimination;
members from the general public who are knowledgeable with respect to tuberculosis, including individuals who have or have had tuberculosis; and
scientists, physicians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
Grants and contracts
The Secretary shall carry out paragraph (1) directly and through awards of grants, cooperative agreements, and contracts to public and private entities, including—
public-private partnerships;
academic institutions, including institutions of higher education;
research institutions; and
the Tuberculosis Trials Consortium and the Tuberculosis Epidemiologic Studies Consortium.
.
Authorizations of appropriations
Authorizations of appropriations
Section 317E of the Public Health Service Act, as amended by section 121(1) of this Act, is amended by amending subsection (h) to read as follows:
Authorization of appropriations
General program
In general
For the purpose of carrying out this section, other than subsection (g), there are authorized to be appropriated $528,000,000 for fiscal year 2007, and such sums as may be necessary for each of the fiscal years 2008 through 2011.
Priority in expenditure of funds
In expending amounts appropriated under subparagraph (A), the Secretary shall give priority to making grants under subsection (a) to States, which Core grants to States and local tuberculosis programs shall be distributed on the basis of a formula developed by the Secretary that takes into account the level of tuberculosis morbidity in each State, and other relevant factors in each State regarding the disease. The preceding sentence does not require the Secretary to modify the formula that was used by the Secretary for such grants for fiscal year 2006.
New tools
In general
For the purpose of carrying out subsection (g), there are authorized to be appropriated $100,000,000 for fiscal year 2007, and such sums as may be necessary for each of the fiscal years 2008 through 2011.
Limitation
The authorization of appropriations established in subparagraph (A) for a fiscal year is effective only if the amount appropriated under paragraph (1) for such year equals or exceeds the amount appropriated to carry out this section for fiscal year 2006.
.
National Institutes of Health
Activities of National Heart, Lung, and Blood Institute
Subpart 2 of part C of title IV of the Public Health Service Act (42 U.S.C. 285b et seq.) is amended by inserting after section 424B the following section:
Tuberculosis
In General
The Director of the Institute shall expand, intensify, and coordinate research and development and related activities of the Institute with respect to tuberculosis, including activities toward the goal of eliminating such disease.
Certain Activities
Activities under subsection (a) shall include—
enhancing basic and clinical research on tuberculosis; and
expanding research on the relationship between such disease and the human immunodeficiency virus.
Research Education
Tuberculosis academic awards
The Director of the Institute may provide awards to faculty of schools of medicine or osteopathic medicine to assist such faculty in developing high quality curricula in such schools designed to significantly increase the opportunities for interested individuals, including students of the school and practicing physicians and nurses, to learn the principles and practices of preventing, managing, and controlling tuberculosis.
Tuberculosis/pulmonary infection awards
The Director of the Institute may provide awards to support the career development of clinically trained professionals who are committed to research regarding pulmonary infections and tuberculosis by providing for supervised study and research.
Authorization of appropriations
Tuberculosis academic awards
For the purpose of carrying out paragraph (1), there are authorized to be appropriated $5,000,000 for fiscal year 2007, and such sums as may be necessary for each of the fiscal years 2008 through 2011.
Tuberculosis/pulmonary infection awards
For the purpose of carrying out paragraph (2), there are authorized to be appropriated $5,000,000 for fiscal year 2007, and such sums as may be necessary for each of the fiscal years 2008 through 2011.
.
Activities of National institute of Allergy and Infectious Diseases
Section 447A of the Public Health Service Act (42 U.S.C. 285f–2) is amended—
by redesignating subsection (b) as subsection (c);
by inserting after subsection (a) the following subsection:
Activities under subsection (a) shall include activities to develop a tuberculosis vaccine. Such activities shall be carried out in accordance with the blueprint for tuberculosis vaccine development described in the report prepared pursuant to the workshop convened in March 1998 by the Advisory Council for Elimination of Tuberculosis, the Director of the National Vaccine Program, and the Director of the Institute.
; and
in subsection (c) (as so redesignated), in the first sentence—
by striking
and
after 1994,
; and
by inserting
before the period the following: , $240,000,000 for fiscal year 2007,
and such sums as may be necessary for each of the fiscal years 2008 through
2011
.
John E. Fogarty International Center for Advanced Study in the Health Sciences
Section 482 of the Public Health Service Act (42 U.S.C. 287b) is amended—
by inserting
(a) In General.—
before
The general purpose
;
in subsection (a)
(as so designated), by inserting after Health Sciences
the
following: (in this subpart referred to as the
; andCenter
)
by adding at the end the following subsection:
Tuberculosis
In general
In carrying out subsection (a) with respect to tuberculosis, the Center shall expand, intensify, and coordinate international activities of the Center for research and training.
International training program
In carrying out paragraph (1), the Center shall carry out an international training program regarding tuberculosis. Such program shall be modeled after the international training program carried out by the Center with respect to the human immunodeficiency virus.
.
Loan repayment programs regarding research on tuberculosis
Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended—
by redesignating the second section 487F as section 487G; and
by inserting after section 487G (as so redesignated) the following section:
Loan repayments regarding research on tuberculosis
In carrying out sections 487C, 487E, and 487F, the Secretary shall seek to ensure that, for fiscal year 2007 and subsequent fiscal years, a portion of amounts appropriated to carry out such sections is reserved for the purpose of entering into contracts under which (in accordance with the section involved) individuals will conduct research on tuberculosis.
.