US Codex
Pub. L.
Notes

Title V — Increasing Communication in Medical Countermeasure Advanced Research and Development

116th Congress · Approved Jun 24, 2019 · 133 Stat. 905

TITLE V Increasing Communication in Medical Countermeasure Advanced Research and Development

SEC. 501. Medical Countermeasure Budget Plan.

Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is amended—
(1)
in the matter preceding subparagraph (A), by striking “ March 1” and inserting “ March 15”;
(2)
in subparagraph (A)—
(A)
in clause (ii), by striking “ ; and” and inserting “ ;”; and
(B)
by striking clause (iii) and inserting the following:

“(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;

“(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and

“(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;”

(3)
by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and
(4)
by inserting after subparagraph (C), the following:

“(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;”

SEC. 502. Material Threat and Medical Countermeasure Notifications.

(a)
Congressional Notification of Material Threat Determination.— Section 319F–2(c)(2)(C) (42 U.S.C. 247d–6b(c)(2)(C)) is amended by striking “ The Secretary and the Homeland Security Secretary shall promptly notify the appropriate committees of Congress” and inserting “ The Secretary and the Secretary of Homeland Security shall send to Congress, on an annual basis, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives”.
(b)
Contracting Communication.— Section 319F–2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) is amended by adding at the end the following: “ The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.”.

SEC. 503. Availability of Regulatory Management Plans.

Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(f)) is amended—
(1)
by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively;
(2)
by inserting after paragraph (2) the following:

“(3) Publication.—The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—

“(A) the process by which an applicant may submit a request for a regulatory management plan;

“(B) the timeframe by which the Secretary is required to respond to such request;

“(C) the information required for the submission of such request;

“(D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and

“(E) contact information for beginning the regulatory management plan process.”

(3)
in paragraph (6), as so redesignated, in the matter preceding subparagraph (A)—
(A)
by striking “ paragraph (4)(A)” and inserting “ paragraph (5)(A)”; and
(B)
by striking “ paragraph (4)(B)” and inserting “ paragraph (5)(B)”; and
(4)
in paragraph (7)(A), as so redesignated, by striking “ paragraph (3)(A)” and inserting “ paragraph (4)(A)”.

SEC. 504. The Biomedical Advanced Research and Development Authority and the Bioshield Special Reserve Fund.

(a)
BioShield Special Reserve Fund.— Section 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended—
(1)
by striking “ $2,800,000,000 for the period of fiscal years 2014 through 2018” and inserting “ $7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended”; and
(2)
by striking the second sentence.
(b)
The Biomedical Advanced Research and Development Authority.— Section 319L(d)(2) (42 U.S.C. 247d–7e(d)(2)) is amended by striking “ $415,000,000 for each of fiscal years 2014 through 2018” and inserting “ $611,700,000 for each of fiscal years 2019 through 2023”.

SEC. 505. Additional Strategies for Combating Antibiotic Resistance.

(a)
Advisory Council.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”) may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the “Advisory Council”.
(b)
Duties.— The Advisory Council shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving—
(1)
the effectiveness of antibiotics;
(2)
research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities;
(3)
surveillance of antibiotic-resistant bacterial infections, including publicly available and up-to-date information on resistance to antibiotics;
(4)
education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals;
(5)
methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections, including stewardship programs; and
(6)
coordination with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.
(c)
Meetings and Coordination.—
(1)
Meetings.— The Advisory Council shall meet not less than biannually and, to the extent practicable, in coordination with meetings of the Antimicrobial Resistance Task Force established in section 319E(a) of the Public Health Service Act.
(2)
Coordination.— The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the Antimicrobial Resistance Task Force established under section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)).
(d)
FACA.— The Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the activities and duties of the Advisory Council.
(e)
Extension of Advisory Council.— Not later than October 1, 2022, the Secretary shall submit 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 recommendation on whether the Advisory Council should be extended, and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, including with respect to section 319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)).