IN THE SENATE OF THE UNITED STATES
August 3, 2021
Mr. Brown (for himself, Mr. Blumenthal, Ms. Klobuchar, Mr. Van Hollen, and Mr. Markey) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To amend the Public Health Service Act to enhance the national strategy for combating and eliminating tuberculosis, and for other purposes.
This Act may be cited as the
Comprehensive TB Elimination Act of 2021.
National strategy for combating and eliminating tuberculosis
Section 317E of the Public Health Service Act (42 U.S.C. 247b–6) is amended—
in subsection (a)—
The Secretary and inserting the following:
by adding at the end the following:
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 coinfected, and medically underserved populations.
in subsection (b)—
in paragraph (3)—
in subparagraph (C), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and adjusting the margins accordingly; and
by redesignating subparagraphs (A) through (F) as clauses (i) through (vi), respectively, and adjusting the margins accordingly;
by redesignating paragraphs (1) through (8) as subparagraphs (A) through (H), respectively, and adjusting the margins accordingly;
in the matter preceding subparagraph (A), as so redesignated, by striking
With respect to and inserting the following:
With respect to
by striking subparagraph (B), as so redesignated, and inserting the following:
Research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—
the development of new tools, including vaccines and antimicrobial drugs, to prevent and treat tuberculosis;
novel therapeutics for special populations, including pediatric populations, immunosuppressed individuals, and pregnant women;
the development or testing of medical diagnostics to detect tuberculosis;
research to address the epidemiology, mechanisms, and pathogenesis of tuberculosis;
public health interventions to address the prevention, treatment, and control of tuberculosis, such as directly observed therapy and non-pharmaceutical intervention;
methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis; and
other relevant research areas.
in subparagraph (C), as so redesignated—
by redesignating clause (vi), as so redesignated, as clause (vii);
in clause (v), as so redesignated, by striking
; and and inserting
by inserting after clause (v), as so redesignated, the following:
the intensification of efforts to prevent, detect, and treat latent tuberculosis; and
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;
in subparagraph (F), as so redesignated, by striking
paragraphs (1) through (4) and inserting
subparagraphs (A) through (D); and
by adding at the end the following:
In carrying out the activities described in paragraph (1), the Secretary—
is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice; and
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.
by redesignating subsections (c) through (h) as subsections (d) through (i), respectively;
by inserting after subsection (b) the following—
Grants for coordination of programs and services for prevention, diagnosis, and treatment
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 organizations, 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.
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.
in subsections (d), (e), and (f), as so redesignated, by striking
(a) or (b) each place it appears and inserting
(a), (b), or (c);
in subsection (g)(4), as so redesignated, by adding at the end the following:
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.
in subsection (h), as so redesignated—
in paragraph (1)—
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
ensuring access to the products developed as a result of such research, investigations, experiments, demonstrations, and studies and after
advice regarding; and
in paragraph (3)—
by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and
by inserting after subparagraph (C) the following:
members of the Biomedical Advanced Research and Development Authority;
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..
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:
enhancing basic, clinical, and operational research on tuberculosis, including with respect to—
infection with tuberculosis and latency and progression of tuberculosis; and
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—
prevent, control, and eliminate tuberculosis; and
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.
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 Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the coordination of activities between the Food and Drug Administration and the Centers for Disease Control and Prevention with respect to—
shortages of critical tuberculosis drugs in the United States;
efforts to increase the availability of pediatric tuberculosis drug formulations in the United States;
mitigating the cost of tuberculosis drugs for States, including efforts to ensure States have timely access to treatments for individuals with tuberculosis; and
consideration for the introduction in the United States of pediatric tuberculosis drug formulations that are available in foreign countries.