16 CFR § 1702.16
Petitions requesting an exemption for a drug or a new drug
February 12, 2021
(a) Where the petition requests an exemption for a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1), the petitioner shall include those reports required to be filed under the Food and Drug Administration's Adverse Reaction Reporting Program.
(b) [Reserved]
[45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001]
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