I 113th CONGRESS 2d Session H. R. 5835 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.

1. Short title This Act may be cited as the Comprehensive TB Elimination Act of 2014 . 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. 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; . 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 . 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; .