[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.1]

[Page 247-248]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 21_PROTECTION OF PRIVACY--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 21.1  Scope.




                      Subpart A_General Provisions

Sec.
21.1 Scope.
21.3 Definitions.
21.10 Policy concerning records about individuals.

    Subpart B_Food and Drug Administration Privacy Act Record Systems

21.20 Procedures for notice of Food and Drug Administration Privacy Act 
          Record Systems.
21.21 Changes in systems and new systems.

        Subpart C_Requirements for Specific Categories of Records

21.30 Records of contractors.
21.31 Records stored by the National Archives and Records 
          Administration.
21.32 Personnel records.
21.33 Medical records.

   Subpart D_Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems

21.40 Procedures for submitting requests for notification and access.
21.41 Processing of requests.
21.42 Responses to requests.
21.43 Access to requested records.
21.44 Verification of identity.
21.45 Fees.

       Subpart E_Procedures for Requests for Amendment of Records

21.50 Procedures for submitting requests for amendment of records.
21.51 Responses to requests for amendment of records.
21.52 Administrative appeals of refusals to amend records.
21.53 Notation and disclosure of disputed records.
21.54 Amended or disputed records received from other agencies.

                          Subpart F_Exemptions

21.60 Policy.
21.61 Exempt systems.

[[Page 248]]

21.65 Access to records in exempt systems.

Subpart G_Disclosure of Records in Privacy Act Record Systems to Persons 
                    Other Than the Subject Individual

21.70 Disclosure and intra-agency use of records in Privacy Act Record 
          Systems; no accounting required.
21.71 Disclosure of records in Privacy Act Record Systems; accounting 
          required.
21.72 Individual consent to disclosure of records to other persons.
21.73 Accuracy, completeness, timeliness, and relevance of records 
          disclosed from Privacy Act Record Systems.
21.74 Providing notice that a record is disputed.
21.75 Rights of legal guardians.

    Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.

    Source: 42 FR 15626, Mar. 22, 1977, unless otherwise noted.



    (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 Sec. 21.43, (iii) persons provided records pursuant 
to individual consent under Sec. 21.72, or (iv) persons acting on 
behalf of such individuals as legal guardians under Sec. 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 Sec. 21.32. Such records are subject to regulations of the Office of 
Personnel Management in 5 CFR parts 293, 294, and 297.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985]