I 117th CONGRESS 1st Session H. R. 5857 IN THE HOUSE OF REPRESENTATIVES November 4, 2021 Mr. Bera (for himself and Mr. Young ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to enhance the national strategy for combating and eliminating tuberculosis, and for other purposes.

1. Short title This Act may be cited as the Comprehensive TB Elimination Act of 2021 . 2. National strategy for combating and eliminating tuberculosis (a) In general Section 317E of the Public Health Service Act ( 42 U.S.C. 247b–6 ) is amended— (1) in subsection (a)— (A) by striking The Secretary and inserting the following: (1) Grants The Secretary ; and (B) by adding at the end the following: (2) Priority In making grants under this subsection, the Secretary may give priority to State health departments proposing to focus on the prevention, control, and elimination of tuberculosis in high-risk populations, including foreign-born, homeless, incarcerated, HIV-tuberculosis co-infected, and medically underserved populations. ; (2) in subsection (b)— (A) in paragraph (3)— (i) in subparagraph (C), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and adjusting the margins accordingly; and (ii) by redesignating subparagraphs (A) through (F) as clauses (i) through (vi), respectively, and adjusting the margins accordingly; (B) by redesignating paragraphs (1) through (8) as subparagraphs (A) through (H), respectively, and adjusting the margins accordingly; (C) in the matter preceding subparagraph (A), as so redesignated, by striking With respect to and inserting the following: (1) In general With respect to ; (D) by striking subparagraph (B), as so redesignated, and inserting the following: (B) Research, investigations, experiments, demonstrations, and studies in the health sciences that are related to— (i) the development of new tools, including vaccines and antimicrobial drugs, to prevent and treat tuberculosis; (ii) novel therapeutics for special populations, including pediatric populations, immunosuppressed individuals, and pregnant women; (iii) the development or testing of medical diagnostics to detect tuberculosis; (iv) research to address the epidemiology, mechanisms, and pathogenesis of tuberculosis; (v) public health interventions to address the prevention, treatment, and control of tuberculosis, such as directly observed therapy and non-pharmaceutical intervention; (vi) methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis; and (vii) other relevant research areas. ; (E) in subparagraph (C), as so redesignated— (i) by redesignating clause (vi), as so redesignated, as clause (vii); (ii) in clause (v), as so redesignated, by striking ; and and inserting ; ; and (iii) by inserting after clause (v), as so redesignated, the following: (vi) the intensification of efforts to prevent, detect, and treat latent tuberculosis; and ; (F) in subparagraph (D), as so redesignated, by inserting before the period the following: , including public awareness campaigns and development of educational, risk, and media communications, using materials in languages appropriate to target audiences. ; (G) in subparagraph (F), as so redesignated, by striking paragraphs (1) through (4) and inserting subparagraphs (A) through (D) ; and (H) by adding at the end the following: (2) Selection In carrying out the activities described in paragraph (1), the Secretary— (A) is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice; and (B) may seek input from the Biomedical Advanced Research and Development Authority in identifying novel candidates to utilize in the efforts under this subsection to prevent, diagnose, and control tuberculosis. ; (3) by redesignating subsections (c) through (h) as subsections (d) through (i), respectively; (4) 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, territories, Indian Tribes, Tribal organization, urban Indian health organizations, health service providers to Indian Tribes, Native Hawaiian health organizations, community health centers, and Federally qualified health centers for coordinating the programs and services of such entities to ensure timely and appropriate prevention, risk-based screening, diagnosis, and treatment of latent and active 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. ; (5) in subsections (d), (e), and (f), as so redesignated, by striking (a) or (b) each place it appears and inserting (a), (b), or (c) ; (6) in subsection (g)(4), as so redesignated, by adding at the end the following: (C) Report to Congress The Secretary is encouraged to make the reports under subparagraph (A), or other publications relevant to domestic tuberculosis surveillance, publicly available on the internet website of the Centers for Disease Control and Prevention and to disseminate such information to stakeholders. ; (7) in subsection (h), as so redesignated— (A) in paragraph (1)— (i) by striking research into new tools under subsection (b)(2) and inserting the research, investigations, experiments, demonstrations, and studies in health science under subsection (b)(1)(B) ; and (ii) by inserting ensuring access to the products developed as a result of such research, investigations, experiments, demonstrations, and studies and after advice regarding ; and (B) in paragraph (3)— (i) by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and (ii) by inserting after subparagraph (C) the following: (D) members of the Biomedical Advanced Research and Development Authority; ; and (8) in subsection (i)(1)(A), as so redesignated, by striking $200,000,000 and all that follows through the period and inserting $142,200,000 for fiscal year 2022, $195,700,000 for fiscal year 2023, $225,000,000 for fiscal year 2024, $236,250,000 for fiscal year 2025, $248,062,500 for fiscal year 2026, and $260,465,625 for fiscal year 2027. . (b) NIH tuberculosis activities Section 424C(b) of the Public Health Service Act (42 U.S.C. 285b–7c(b)) is amended by striking paragraph (1) and inserting the following: (1) enhancing basic, clinical, and operational research on tuberculosis, including with respect to— (A) drug-resistant tuberculosis; (B) infection with tuberculosis and latency and progression of tuberculosis; and (C) pediatric tuberculosis; . 3. GAO studies (a) Tuberculosis prevention and elimination study Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall issue a report on the coordination of efforts in the United States to— (1) prevent, control, and eliminate tuberculosis; and (2) implement the activities under section 317E of the Public Health Service Act ( 42 U.S.C. 247b–6 ), as amended by this Act, and the National Action Plan for Combating Multidrug-Resistant Tuberculosis, issued in December 2015. (b) Study on tuberculosis activities Not later than 6 months after the date of enactment of this Act, the Comptroller General of the United States shall issue to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the coordination of activities between the Food and Drug Administration and the Centers for Disease Control and Prevention with respect to— (1) shortages of critical tuberculosis drugs in the United States; (2) efforts to increase the availability of pediatric tuberculosis drug formulations in the United States; (3) mitigating the cost of tuberculosis drugs for States, including efforts to ensure States have timely access to treatments for individuals with tuberculosis; and (4) consideration for the introduction in the United States of pediatric tuberculosis drug formulations that are available in foreign countries.