Standard: HHS - 21 CFR PART 21


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(a) This part establishes procedures to implement the Privacy Act of 1974 (5 U.S.C. 552a). It applies to records about individuals that are maintained, collected, used, or disclosed by the Food and Drug Administration and contained in Privacy Act Record Systems.

(b) This part does not:

(1) Apply to Food and Drug Administration record systems that are not Privacy Act Record Systems or make available to an individual records that may include references to him but that are not retrieved by his name or other personal identifier, whether or not contained in a Privacy Act Record System. part 20 of this chapter (the public information regulations) and other regulations referred to therein determine when records are made available in such cases.

(2) Make any records available to persons other than (i) individuals who are the subjects of the records, (ii) persons accompanying such individuals under § 21.43, (iii) persons provided records pursuant to individual consent under § 21.72, or (iv) persons acting on behalf of such individuals as legal guardians under § 21.75. Part 20 of this chapter (the public information regulations) and other regulations referred to therein determine when Food and Drug Administration records are disclosable to members of the public generally. Subpart G of this part limits the provisions of part 20 of this chapter with respect to disclosures of records about individuals from Privacy Act Record Systems to persons other than individuals who are the subjects of the records.

(3) Make available information compiled by the Food and Drug Administration in reasonable anticipation of court litigation or formal administrative proceedings. The availability of such information to any member of the public, including any subject individual or party to such litigation or proceeding shall be governed by applicable constitutional principles, rules of discovery, and part 20 of this chapter (the public information regulations).

(4) Apply to personnel records maintained by the Division of Human Resources Management, Food and Drug Administration, except as provided in § 21.32. Such records are subject to regulations of the Office of Personnel Management in 5 CFR parts 293, 294, and 297.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 21
Publish Date: 2016-04-01
Page Count: 17
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 21 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV
21 CFR PART 21 Change Type: STCH Update Date: 2014-04-01 Status: INAC

Standards That Reference This Standard

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