21 C.F.R. § 21.74 Providing notice that a record is disputed.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 21—PROTECTION OF PRIVACY
Subpart G—Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject Individual
§ 21.74 Providing notice that a record is disputed.

