TITLE 21--FOOD AND DRUGS 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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