Comprehensive TB Elimination Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Drug Shortages Strategic Plan to include plans to ensure coordination between the Drug Shortages Task Force and the Federal Tuberculosis Task Force.
Amends the Public Health Service Act to require the Department of Health and Human Services, when awarding grants for the prevention, control, and elimination of tuberculosis, to give priority to state health departments proposing to focus on high-risk populations, including foreign-born, homeless, and uninsured populations.
Authorizes the Health Resources and Services Administration to award grants to state and local governments and federally qualified health centers to coordinate their programs and services to ensure timely and appropriate prevention, diagnosis, and treatment of tuberculosis.
Requires the Federal Tuberculosis Task Force to advise federal officials on strategies and systems to prevent and mitigate shortages of tuberculosis drugs.
Reauthorizes the national strategy for combating and eliminating tuberculosis through FY2019.
Allows the National Institutes of Health to enhance research on pediatric tuberculosis and tuberculosis infection and progression.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5835 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 5835
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act with respect to making progress toward the goal of
eliminating tuberculosis, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 10, 2014
Mr. Gene Green of Texas introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act with respect to making progress toward the goal of
eliminating tuberculosis, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Comprehensive TB Elimination Act of
2014''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Each year approximately 9,000,000 people become ill
with active tuberculosis (TB), an airborne infectious disease,
and it is estimated that 1,500,000 of those people die, making
TB the second leading global infectious disease killer.
(2) There is a global underinvestment in quality TB
control, and in the research and development of new drugs,
diagnostics and a vaccine, as well as in the relationship
between TB and HIV/AIDS.
(3) The increasing occurrence of multi-drug resistant
(``MDR'') TB, including extensively drug resistant (``XDR'') TB
which is resistant to at least two of the recommended first-
line drugs and the recommended second-line medications, is a
serious and emerging global health problem.
(4) Cases of TB are reported annually in every State within
the United States, with a total of 9,582 cases of active TB
reported in the United States in 2013.
(5) In addition to those with active TB, an estimated
8,000,000 to 10,000,000 people in the United States are
infected with the TB bacteria.
(6) Drug-resistant TB poses a particular challenge to
domestic TB control due to the high costs of treatment and
intensive health care resources required. Treatment costs for
MDR TB range from $100,000 to $300,000, which can cause a
serious strain on State public health budgets.
(7) In 2013, the United States experienced serious
shortages of first- and second-line TB drugs and biologics,
including isoniazid, the first-line TB drug, and tubersol, the
biologic used in TB skin tests.
(8) New tools are urgently needed to more effectively
prevent, diagnose, and treat TB. Within the last 40 years, only
one new TB drug has been developed and approved in the United
States, and the treatment regimen for MDR TB remains
excessively lengthy, toxic, and difficult for patients to
tolerate. The existing vaccine, which is not used in the United
States, confers no protection to adolescents and adults,
protecting only against pulmonary TB in infants and children.
(9) The expertise in identifying, treating, and preventing
TB is within the Centers for Disease Control and Prevention and
the United States public health system. The identification and
preventive treatment of the millions of people in the United
States with TB infection, representing the reservoir of future
active TB cases, is a key component of the strategy to
eliminate TB in the United States.
SEC. 3. FOOD AND DRUG ADMINISTRATION.
Clause (i) of section 506D(a)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356d(a)(1)(B)) is amended to read as follows:
``(i) plans for enhanced interagency and
intra-agency coordination, communication, and
decisionmaking, including by ensuring
coordination between the task force established
under this section and the Federal Tuberculosis
Task Force under section 317E(g) of the Public
Health Service Act in the development and
implementation of strategies and systems to
prevent and mitigate shortages of drugs used in
connection with tuberculosis;''.
SEC. 4. CENTERS FOR DISEASE CONTROL AND PREVENTION; HEALTH RESOURCES
AND SERVICES ADMINISTRATION.
(a) Prioritizing Programs for High-Risk Populations, Including
Foreign-Born, Homeless, and Uninsured Populations.--Subsection (a) of
section 317E of the Public Health Service Act (42 U.S.C. 247b-6) is
amended--
(1) by striking ``The Secretary'' and inserting the
following:
``(1) Grants.--The Secretary''; and
(2) by adding at the end the following:
``(2) Priority.--In making grants under this subsection,
the Secretary shall give priority to awarding grants to State
health departments proposing to focus on the prevention,
control, and elimination of tuberculosis in high-risk
populations, including foreign-born, homeless, and uninsured
populations.''.
(b) Grants for Coordination of Programs and Services for
Prevention, Diagnosis, and Treatment.--
(1) Grants.--Section 317E of the Public Health Service Act
(42 U.S.C. 247b-6) is amended--
(A) by redesignating subsections (c) through (h) as
subsections (d) through (i), respectively; and
(B) by inserting after subsection (b) the
following:
``(c) Grants for Coordination of Programs and Services for
Prevention, Diagnosis, and Treatment.--
``(1) Grants.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may award grants to State and local governments
and Federally qualified health centers for coordinating the
programs and services of such governments and centers to ensure
timely and appropriate prevention, diagnosis, and treatment of
tuberculosis.
``(2) Definition.--In this subsection, the term `Federally
qualified health center' has the meaning given to such term in
section 1861(aa) of the Social Security Act.''.
(2) Conforming changes.--Section 317E of the Public Health
Service Act (42 U.S.C. 247b-6) is amended--
(A) in subsections (d), (e)(1), (e)(3)(A), and
(f)(1), as redesignated, by striking ``subsection (a)
or (b)'' each place it appears and inserting
``subsection (a), (b), or (c)''; and
(B) in subsection (e)(3)(A), as redesignated, by
inserting ``(subject to subsection (a)(2))'' after
``highest priority''.
(c) Federal Tuberculosis Task Force.--Paragraph (1) of section
317E(h) of the Public Health Service Act (42 U.S.C. 247b-6(g)), as
redesignated, is amended to read as follows:
``(1) Duties.--The Federal Tuberculosis Task Force (in this
subsection referred to as the `Task Force') shall provide to
the Secretary and other appropriate Federal officials advice
on--
``(A) research into new tools under subsection
(b)(2) and ensuring access to such new tools; and
``(B) the development and implementation of
strategies and systems to prevent and mitigate
shortages of drugs used in connection with
tuberculosis.''.
(d) Reauthorization of National Strategy for Combating and
Eliminating Tuberculosis.--Section 317E(i)(1)(A) of the Public Health
Service Act (42 U.S.C. 247b-6(h)(1)(A)) is amended by striking
``$243,101,250 for fiscal year 2013'' and inserting ``$243,101,250 for
each of fiscal years 2013 through 2019''.
SEC. 5. NATIONAL INSTITUTES OF HEALTH.
Paragraph (1) of section 424C(b) of the Public Health Service Act
(42 U.S.C. 285b-7c(b)) is amended to read as follows:
``(1) enhancing basic, clinical, and operational research
on tuberculosis, including with respect to--
``(A) drug resistant tuberculosis;
``(B) infection with, and the progression of,
tuberculosis; and
``(C) pediatric tuberculosis;''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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