Title 21, Part 20 — Public Information

Testimony by Food and Drug Administration employees.

Production of records by Food and Drug Administration employees.

Certification and authentication of Food and Drug Administration records.

Policy on disclosure of Food and Drug Administration records.

Uniform access to records.

Partial disclosure of records.

Request for existing records.

Preparation of new records.

Retroactive application of regulations.

Electronic availability and indexes of certain records.

Submission of records marked as confidential.

Food and Drug Administration determinations of confidentiality.

Prohibition on withdrawal of records from Food and Drug Administration files.

Food and Drug Administration Division of Freedom of Information.

Retention schedule of requests for Food and Drug Administration records.

Disclosure of Food and Drug Administration employee names.

Form or format of response.

Search for records.

Filing a request for records.

Time limitations.

Aggregation of certain requests.

Multitrack processing.

Expedited processing.

Fees to be charged.

Waiver or reduction of fees.

Situations in which confidentiality is uncertain.

Judicial review of proposed disclosure.

Denial of a request for records.

Nonspecific and overly burdensome requests.

Referral to primary source of records.

Availability of records at National Technical Information Service.

Use of private contractor for copying.

Request for review without copying.

Indexing trade secrets and confidential commercial or financial information.

Applicability of exemptions.

Trade secrets and commercial or financial information which is privileged or confidential.

Inter- or intra-agency memoranda or letters.

Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.

Records or information compiled for law enforcement purposes.

National defense and foreign policy.

Internal personnel rules and practices.

Records exempted by other statutes.

Applicability of limitations on exemptions.

Data and information previously disclosed to the public.

Discretionary disclosure by the Commissioner.

Disclosure required by court order.

Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.

Disclosure to other Federal Government departments and agencies.

Disclosure in administrative or court proceedings.

Disclosure to Congress.

Communications with State and local government officials.

Communications with foreign government officials.

Disclosure to contractors.

Use of data or information for administrative or court enforcement action.

Applicability; cross-reference to other regulations.

Administrative enforcement records.

Court enforcement records.

Correspondence.

Summaries of oral discussions.

Testing and research conducted by or with funds provided by the Food and Drug Administration.

Studies and reports prepared by or with funds provided by the Food and Drug Administration.

Food and Drug Administration manuals.

Agreements between the Food and Drug Administration and other departments, agencies, and organizations.

Data and information obtained by contract.

Data and information about Food and Drug Administration employees.

Data and information submitted voluntarily to the Food and Drug Administration.

Voluntary drug experience reports submitted by physicians and hospitals.

Voluntary product defect reports.

Data and information submitted pursuant to cooperative quality assurance agreements.

Product codes for manufacturing or sales dates.

Drug and device registration and listing information.

New drug information.

Advisory committee records.

Lists of names and addresses.

Records available in Food and Drug Administration Public Reading Rooms.