21 C.F.R. § 21.74

Current through October 31, 2024

Section 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.

21 C.F.R. §21.74