21 U.S.C. § 379d-1 Conflicts of Interest

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 379d-1

(a) Definitions

For purposes of this section:

(1) Advisory committee

The term "advisory committee" means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(2) Financial interest

The term "financial interest" means a financial interest under section 208(a) of title 18.

(b) Recruitment for advisory committees

(1) In general

The Secretary shall-

(A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;

(B) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities;

(C) at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including-

(i) product developers, patient groups, and disease advocacy organizations; and

(ii) relevant-

(I) professional societies;

(II) medical societies;

(III) academic organizations; and

(IV) governmental organizations; and

(D) in carrying out subparagraphs (A) and (B), take into account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees.

(2) Recruitment activities

The recruitment activities under paragraph (1) may include-

(A) advertising the process for becoming an advisory committee member at medical and scientific society conferences;

(B) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and

(C) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person whom the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.

(3) Expertise

In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.

(c) Disclosure of determinations and certifications

Notwithstanding section 13109(a)(2) of title 5, the following shall apply: