[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;''.
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