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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL
 
PART 21PROTECTION OF PRIVACY
 

Subpart A - General Provisions
   § 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.
   § 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.

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