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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 360bbb6 Risk communication us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 360bbb6 21 U.S.C. § 360bbb6 current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s360bbb6 data/legal/raw/us/code/title-21/usc21.xml b548d505ab335be6cf836fa6cfe90bdc812332aa1dcd2c24d756b41fa4bb9bbb 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 7bbbfe4fb2bf21db61d8021582ae4513e3090b90ecbebb36fd9c0034c75b1ace 2026-07-04 official
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21 U.S.C. § 360bbb6 - Risk communication

Text

(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.

(June 25, 1938, ch. 675, § 567, as added Pub. L. 11085, title IX, § 917, Sept. 27, 2007, 121 Stat. 960; amended Pub. L. 117286, § 4(a)(157), Dec. 27, 2022, 136 Stat. 4323.)

Notes

Editorial Notes

Amendments2022—Subsec. (a)(4). Pub. L. 117286 substituted “Section 1013 of title 5” for “Section 14 of the Federal Advisory Committee Act”.