21 CFR §21.53
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
When an individual has filed a statement of disagreement under § 21.52(b)(2), the Food and Drug Administration shall:
- (a)Mark any portion of the record that is disputed to assure that the record will clearly show that portion is disputed whenever the record is disclosed.
- (b)In any subsequent disclosure under § 21.70 or § 21.71(a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under § 21.50.
- (c)If an accounting was made under § 21.71(d) and (e) of a disclosure of the record under § 21.71(a), provide to all previous recipients of the record a copy of the statement of disagreement and the agency statement, if any.