[Code of Federal Regulations] |
[Title 21, Volume 1] |
[Revised as of April 1, 2020] |
[CITE: 21CFR21.74] |
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CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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PART 21 -- PROTECTION OF PRIVACY
Subpart G - Disclosure of Records in Privacy Act Record Systems to Persons Other Than the Subject Individual
Sec. 21.74 Providing notice that a record is disputed.
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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.
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