21 U.S.C. § 360bbb–6 — Risk communication

FEDERAL · 21 U.S.C. · Chapter 9

Risk communication

Current through Pub. L. 119-102

Title 21 — Food and Drugs·Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT·Subch. V·Pt. E

(a)Advisory Committee on Risk Communication

(1)In general The Secretary shall establish an advisory committee to be known as the "Advisory Committee on Risk Communication" (referred to in this section as the "Committee").

(2)Duties of Committee The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.

(3)Members The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.

(4)Permanence of Committee Section 1013 of title 5 shall not apply to the Committee established under this subsection.

(b)Partnerships for risk communi

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(a) Advisory Committee on Risk Communication
(1) In general
The Secretary shall establish an advisory committee to be known as the "Advisory Committee on Risk Communication" (referred to in this section as the "Committee").
(2) Duties of Committee
The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.
(3) Members
The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.
(4) Permanence of Committee
Section 1013 of title 5 shall not apply to the Committee established under this subsection.
(b) Partnerships for risk communication
(1) In general
The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.
(2) Partnerships
The systems developed under paragraph (1) shall—
(A) account for the diversity among physicians in terms of practice, willingness to adopt technology, and medical specialty; and
(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.

21 U.S.C. § 360bbb–6 (Risk communication) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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History

(June 25, 1938, ch. 675, §567, as added Pub. L. 110–85, title IX, §917, Sept. 27, 2007, 121 Stat. 960; amended Pub. L. 117–286, §4(a)(157), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

Editorial Notes

Amendments
2022—Subsec. (a)(4). Pub. L. 117–286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act".

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History

Editorial Notes