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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 20PUBLIC INFORMATION
 

Subpart A--Official Testimony and Information
   § 20.1 - Testimony by Food and Drug Administration employees.
   § 20.2 - Production of records by Food and Drug Administration employees.
   § 20.3 - Certification and authentication of Food and Drug Administration records.

Subpart B--General Policy
   § 20.20 - Policy on disclosure of Food and Drug Administration records.
   § 20.21 - Uniform access to records.
   § 20.22 - Partial disclosure of records.
   § 20.23 - Request for existing records.
   § 20.24 - Preparation of new records.
   § 20.25 - Retroactive application of regulations.
   § 20.26 - Indexes of certain records.
   § 20.27 - Submission of records marked as confidential.
   § 20.28 - Food and Drug Administration determinations of confidentiality.
   § 20.29 - Prohibition on withdrawal of records from Food and Drug Administration files.
   § 20.30 - Food and Drug Administration Division of Freedom of Information.
   § 20.31 - Retention schedule of requests for Food and Drug Administration records.
   § 20.32 - Disclosure of Food and Drug Administration employee names.
   § 20.33 - Form or format of response.
   § 20.34 - Search for records.

Subpart C--Procedures and Fees
   § 20.40 - Filing a request for records.
   § 20.41 - Time limitations.
   § 20.42 - Aggregation of certain requests.
   § 20.43 - Multitrack processing.
   § 20.44 - Expedited processing.
   § 20.45 - Fees to be charged.
   § 20.46 - Waiver or reduction of fees.
   § 20.47 - Situations in which confidentiality is uncertain.
   § 20.48 - Judicial review of proposed disclosure.
   § 20.49 - Denial of a request for records.
   § 20.50 - Nonspecific and overly burdensome requests.
   § 20.51 - Referral to primary source of records.
   § 20.52 - Availability of records at National Technical Information Service.
   § 20.53 - Use of private contractor for copying.
   § 20.54 - Request for review without copying.
   § 20.55 - Indexing trade secrets and confidential commercial or financial information.

Subpart D--Exemptions
   § 20.60 - Applicability of exemptions.
   § 20.61 - Trade secrets and commercial or financial information which is privileged or confidential.
   § 20.62 - Inter- or intra-agency memoranda or letters.
   § 20.63 - Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
   § 20.64 - Records or information compiled for law enforcement purposes.
   § 20.65 - National defense and foreign policy.
   § 20.66 - Internal personnel rules and practices.
   § 20.67 - Records exempted by other statutes.

Subpart E--Limitations on Exemptions
   § 20.80 - Applicability of limitations on exemptions.
   § 20.81 - Data and information previously disclosed to the public.
   § 20.82 - Discretionary disclosure by the Commissioner.
   § 20.83 - Disclosure required by court order.
   § 20.84 - Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.
   § 20.85 - Disclosure to other Federal government departments and agencies.
   § 20.86 - Disclosure in administrative or court proceedings.
   § 20.87 - Disclosure to Congress.
   § 20.88 - Communications with State and local government officials.
   § 20.89 - Communications with foreign government officials.
   § 20.90 - Disclosure to contractors.
   § 20.91 - Use of data or information for administrative or court enforcement action.

Subpart F--Availability of Specific Categories of Records
   § 20.100 - Applicability; cross-reference to other regulations.
   § 20.101 - Administrative enforcement records.
   § 20.102 - Court enforcement records.
   § 20.103 - Correspondence.
   § 20.104 - Summaries of oral discussions.
   § 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.
   § 20.106 - Studies and reports prepared by or with funds provided by the Food and Drug Administration.
   § 20.107 - Food and Drug Administration manuals.
   § 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and organizations.
   § 20.109 - Data and information obtained by contract.
   § 20.110 - Data and information about Food and Drug Administration employees.
   § 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.
   § 20.112 - Voluntary drug experience reports submitted by physicians and hospitals.
   § 20.113 - Voluntary product defect reports.
   § 20.114 - Data and information submitted pursuant to cooperative quality assurance agreements.
   § 20.115 - Product codes for manufacturing or sales dates.
   § 20.116 - Drug and device listing information.
   § 20.117 - New drug information.
   § 20.118 - Advisory committee records.
   § 20.119 - Lists of names and addresses.
   § 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
Source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.

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