21 CFR § 21.74 - Providing notice that a record is disputed.

---
identifier: "/us/cfr/t21/s21.74"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 21.74 - Providing notice that a record is disputed."
title_number: 21
title_name: "Food and Drugs"
section_number: "21.74"
section_name: "Providing notice that a record is disputed."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "21"
part_name: "PROTECTION OF PRIVACY"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371; 5 U.S.C. 552, 552a."
regulatory_source: "42 FR 15626, Mar. 22, 1977, unless otherwise noted."
cfr_part: "21"
---


# 21.74 Providing notice that a record is disputed.

Whenever an individual has filed a statement of disagreement with the Food and Drug Administration concerning a refusal to amend a record under § 21.51(a)(2) or with another agency that provides the record to the Food and Drug Administration, the Food and Drug Administration shall in any subsequent disclosure under this subpart provide a copy of the statement of disagreement and a concise statement by the agency, if one has been prepared, of the reasons for not making the amendment(s) requested.