21 U.S.C. § 379d-2 — Policy on the review and clearance of scientific articles published by FDA employees

(a) Definition In this section, the term “ article ” means a paper, poster, abstract, book, book chapter, or other published writing. (b) Policies The Secretary , through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles . (c) Timing of submission for review If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration , for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation. (d) Timing for review and clearance The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review. (e) Non-timely review If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b). (f) Effect Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law. (June 25, 1938, ch. 675, § 713, as added Pub. L. 110–85, title XI, § 1101 , Sept. 27, 2007 , 121 Stat. 971 .) CFR Title Parts 21 5 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 20 , 25

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