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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 20 - Public 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 - 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. |