21 CFR 21.53
§ 21.53 Notation and disclosure of disputed records.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 21.53, § 21.53 Notation and disclosure of disputed records, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83400
- Permanent ID
ys:prov:83400@1- SHA-256
f7de1c06c6cad4fa93e0c1a7509635cda2b27bcaec02d848eb41b3908df91add
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.