Title 21

PART 20

Part 20 - Public Information

PART 20 - PUBLIC INFORMATION Authority:5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1. Source:42 FR 15616, Mar. 22, 1977, unless otherwise noted.

21:1.0.1.1.16.1SUBPART A
Subpart A - Official Testimony and Information
21:1.0.1.1.16.1.63.1SECTION 20.1
   20.1 Testimony by Food and Drug Administration employees.
21:1.0.1.1.16.1.63.2SECTION 20.2
   20.2 Production of records by Food and Drug Administration employees.
21:1.0.1.1.16.1.63.3SECTION 20.3
   20.3 Certification and authentication of Food and Drug Administration records.
21:1.0.1.1.16.2SUBPART B
Subpart B - General Policy
21:1.0.1.1.16.2.63.1SECTION 20.20
   20.20 Policy on disclosure of Food and Drug Administration records.
21:1.0.1.1.16.2.63.2SECTION 20.21
   20.21 Uniform access to records.
21:1.0.1.1.16.2.63.3SECTION 20.22
   20.22 Partial disclosure of records.
21:1.0.1.1.16.2.63.4SECTION 20.23
   20.23 Request for existing records.
21:1.0.1.1.16.2.63.5SECTION 20.24
   20.24 Preparation of new records.
21:1.0.1.1.16.2.63.6SECTION 20.25
   20.25 Retroactive application of regulations.
21:1.0.1.1.16.2.63.7SECTION 20.26
   20.26 Indexes of certain records.
21:1.0.1.1.16.2.63.8SECTION 20.27
   20.27 Submission of records marked as confidential.
21:1.0.1.1.16.2.63.9SECTION 20.28
   20.28 Food and Drug Administration determinations of confidentiality.
21:1.0.1.1.16.2.63.10SECTION 20.29
   20.29 Prohibition on withdrawal of records from Food and Drug Administration files.
21:1.0.1.1.16.2.63.11SECTION 20.30
   20.30 Food and Drug Administration Division of Freedom of Information.
21:1.0.1.1.16.2.63.12SECTION 20.31
   20.31 Retention schedule of requests for Food and Drug Administration records.
21:1.0.1.1.16.2.63.13SECTION 20.32
   20.32 Disclosure of Food and Drug Administration employee names.
21:1.0.1.1.16.2.63.14SECTION 20.33
   20.33 Form or format of response.
21:1.0.1.1.16.2.63.15SECTION 20.34
   20.34 Search for records.
21:1.0.1.1.16.3SUBPART C
Subpart C - Procedures and Fees
21:1.0.1.1.16.3.63.1SECTION 20.40
   20.40 Filing a request for records.
21:1.0.1.1.16.3.63.2SECTION 20.41
   20.41 Time limitations.
21:1.0.1.1.16.3.63.3SECTION 20.42
   20.42 Aggregation of certain requests.
21:1.0.1.1.16.3.63.4SECTION 20.43
   20.43 Multitrack processing.
21:1.0.1.1.16.3.63.5SECTION 20.44
   20.44 Expedited processing.
21:1.0.1.1.16.3.63.6SECTION 20.45
   20.45 Fees to be charged.
21:1.0.1.1.16.3.63.7SECTION 20.46
   20.46 Waiver or reduction of fees.
21:1.0.1.1.16.3.63.8SECTION 20.47
   20.47 Situations in which confidentiality is uncertain.
21:1.0.1.1.16.3.63.9SECTION 20.48
   20.48 Judicial review of proposed disclosure.
21:1.0.1.1.16.3.63.10SECTION 20.49
   20.49 Denial of a request for records.
21:1.0.1.1.16.3.63.11SECTION 20.50
   20.50 Nonspecific and overly burdensome requests.
21:1.0.1.1.16.3.63.12SECTION 20.51
   20.51 Referral to primary source of records.
21:1.0.1.1.16.3.63.13SECTION 20.52
   20.52 Availability of records at National Technical Information Service.
21:1.0.1.1.16.3.63.14SECTION 20.53
   20.53 Use of private contractor for copying.
21:1.0.1.1.16.3.63.15SECTION 20.54
   20.54 Request for review without copying.
21:1.0.1.1.16.3.63.16SECTION 20.55
   20.55 Indexing trade secrets and confidential commercial or financial information.
21:1.0.1.1.16.4SUBPART D
Subpart D - Exemptions
21:1.0.1.1.16.4.63.1SECTION 20.60
   20.60 Applicability of exemptions.
21:1.0.1.1.16.4.63.2SECTION 20.61
   20.61 Trade secrets and commercial or financial information which is privileged or confidential.
21:1.0.1.1.16.4.63.3SECTION 20.62
   20.62 Inter- or intra-agency memoranda or letters.
21:1.0.1.1.16.4.63.4SECTION 20.63
   20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.
21:1.0.1.1.16.4.63.5SECTION 20.64
   20.64 Records or information compiled for law enforcement purposes.
21:1.0.1.1.16.4.63.6SECTION 20.65
   20.65 National defense and foreign policy.
21:1.0.1.1.16.4.63.7SECTION 20.66
   20.66 Internal personnel rules and practices.
21:1.0.1.1.16.4.63.8SECTION 20.67
   20.67 Records exempted by other statutes.
21:1.0.1.1.16.5SUBPART E
Subpart E - Limitations on Exemptions
21:1.0.1.1.16.5.63.1SECTION 20.80
   20.80 Applicability of limitations on exemptions.
21:1.0.1.1.16.5.63.2SECTION 20.81
   20.81 Data and information previously disclosed to the public.
21:1.0.1.1.16.5.63.3SECTION 20.82
   20.82 Discretionary disclosure by the Commissioner.
21:1.0.1.1.16.5.63.4SECTION 20.83
   20.83 Disclosure required by court order.
21:1.0.1.1.16.5.63.5SECTION 20.84
   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.
21:1.0.1.1.16.5.63.6SECTION 20.85
   20.85 Disclosure to other Federal government departments and agencies.
21:1.0.1.1.16.5.63.7SECTION 20.86
   20.86 Disclosure in administrative or court proceedings.
21:1.0.1.1.16.5.63.8SECTION 20.87
   20.87 Disclosure to Congress.
21:1.0.1.1.16.5.63.9SECTION 20.88
   20.88 Communications with State and local government officials.
21:1.0.1.1.16.5.63.10SECTION 20.89
   20.89 Communications with foreign government officials.
21:1.0.1.1.16.5.63.11SECTION 20.90
   20.90 Disclosure to contractors.
21:1.0.1.1.16.5.63.12SECTION 20.91
   20.91 Use of data or information for administrative or court enforcement action.
21:1.0.1.1.16.6SUBPART F
Subpart F - Availability of Specific Categories of Records
21:1.0.1.1.16.6.63.1SECTION 20.100
   20.100 Applicability; cross-reference to other regulations.
21:1.0.1.1.16.6.63.2SECTION 20.101
   20.101 Administrative enforcement records.
21:1.0.1.1.16.6.63.3SECTION 20.102
   20.102 Court enforcement records.
21:1.0.1.1.16.6.63.4SECTION 20.103
   20.103 Correspondence.
21:1.0.1.1.16.6.63.5SECTION 20.104
   20.104 Summaries of oral discussions.
21:1.0.1.1.16.6.63.6SECTION 20.105
   20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.
21:1.0.1.1.16.6.63.7SECTION 20.106
   20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.
21:1.0.1.1.16.6.63.8SECTION 20.107
   20.107 Food and Drug Administration manuals.
21:1.0.1.1.16.6.63.9SECTION 20.108
   20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations.
21:1.0.1.1.16.6.63.10SECTION 20.109
   20.109 Data and information obtained by contract.
21:1.0.1.1.16.6.63.11SECTION 20.110
   20.110 Data and information about Food and Drug Administration employees.
21:1.0.1.1.16.6.63.12SECTION 20.111
   20.111 Data and information submitted voluntarily to the Food and Drug Administration.
21:1.0.1.1.16.6.63.13SECTION 20.112
   20.112 Voluntary drug experience reports submitted by physicians and hospitals.
21:1.0.1.1.16.6.63.14SECTION 20.113
   20.113 Voluntary product defect reports.
21:1.0.1.1.16.6.63.15SECTION 20.114
   20.114 Data and information submitted pursuant to cooperative quality assurance agreements.
21:1.0.1.1.16.6.63.16SECTION 20.115
   20.115 Product codes for manufacturing or sales dates.
21:1.0.1.1.16.6.63.17SECTION 20.116
   20.116 Drug and device registration and listing information.
21:1.0.1.1.16.6.63.18SECTION 20.117
   20.117 New drug information.
21:1.0.1.1.16.6.63.19SECTION 20.118
   20.118 Advisory committee records.
21:1.0.1.1.16.6.63.20SECTION 20.119
   20.119 Lists of names and addresses.
21:1.0.1.1.16.6.63.21SECTION 20.120
   20.120 Records available in Food and Drug Administration Public Reading Rooms.