Part 20 — Public Information
Subpart A — Official Testimony and Information
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.