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Title 21 - Food and Drugs

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 20 - PUBLIC 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.
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 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 Freedom of Information Staff.
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.
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.
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.
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.
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 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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