21 CFR Part 20
PART 20—PUBLIC INFORMATION
- PART 20—PUBLIC INFORMATION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- 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 Electronic availability and 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 registration and 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.
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