21 C.F.R. PART 20--PUBLIC INFORMATION
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 20--PUBLIC INFORMATION
Subpart A--OFFICIAL TESTIMONY AND INFORMATION
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| Testimony by Food and Drug Administration employees.
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| Production of records by Food and Drug Administration employees.
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| Certification and authentication of Food and Drug Administration records.
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Subpart B--GENERAL POLICY
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| Policy on disclosure of Food and Drug Administration records.
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| Uniform access to records.
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| Partial disclosure of records.
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| Request for existing records.
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| Preparation of new records.
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| Retroactive application of regulations.
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| Indexes of certain records.
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| Submission of records marked as confidential.
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| Food and Drug Administration determinations of confidentiality.
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| Prohibition on withdrawal of records from Food and Drug Administration files.
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| Food and Drug Administration Freedom of Information Staff.
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| Retention schedule of requests for Food and Drug Administration records.
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| Disclosure of Food and Drug Administration employee names.
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| Form or format of response.
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Subpart C--PROCEDURES AND FEES
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| Filing a request for records.
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| Aggregation of certain requests.
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| Waiver or reduction of fees.
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| Situations in which confidentiality is uncertain.
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| Judicial review of proposed disclosure.
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| Denial of a request for records.
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| Nonspecific and overly burdensome requests.
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| Referral to primary source of records.
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| Availability of records at National Technical Information Service.
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| Use of private contractor for copying.
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| Request for review without copying.
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| Indexing trade secrets and confidential commercial or financial information.
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Subpart D--EXEMPTIONS
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| Applicability of exemptions.
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| Trade secrets and commercial or financial information which is privileged or confidential.
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| Inter- or intra-agency memoranda or letters.
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| Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
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| Records or information compiled for law enforcement purposes.
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| National defense and foreign policy.
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| Internal personnel rules and practices.
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| Records exempted by other statutes.
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Subpart E--LIMITATIONS ON EXEMPTIONS
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| Applicability of limitations on exemptions.
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| Data and information previously disclosed to the public.
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| Discretionary disclosure by the Commissioner.
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| Disclosure required by court order.
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| Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.
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| Disclosure to other Federal government departments and agencies.
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| Disclosure in administrative or court proceedings.
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| Communications with State and local government officials.
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| Communications with foreign government officials.
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| Disclosure to contractors.
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| Use of data or information for administrative or court enforcement action.
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Subpart F--AVAILABILITY OF SPECIFIC CATEGORIES OF RECORDS
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| Applicability; cross-reference to other regulations.
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| Administrative enforcement records.
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| Court enforcement records.
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| Summaries of oral discussions.
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| Testing and research conducted by or with funds provided by the Food and Drug Administration.
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| Studies and reports prepared by or with funds provided by the Food and Drug Administration.
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| Food and Drug Administration manuals.
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| Agreements between the Food and Drug Administration and other departments, agencies, and organizations.
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| Data and information obtained by contract.
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| Data and information about Food and Drug Administration employees.
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| Data and information submitted voluntarily to the Food and Drug Administration.
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| Voluntary drug experience reports submitted by physicians and hospitals.
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| Voluntary product defect reports.
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| Data and information submitted pursuant to cooperative quality assurance agreements.
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| Product codes for manufacturing or sales dates.
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| Drug and device listing information.
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| Advisory committee records.
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| Lists of names and addresses.
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| Records available in Food and Drug Administration Public Reading Rooms.
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