Section 20.1
|
Production of records by Food and Drug Administration employees |
Section 20.2
|
Certification and authentication of Food and Drug Administration records |
Section 20.3
|
Policy on disclosure of Food and Drug Administration records |
Section 20.20
|
Uniform access to records |
Section 20.21
|
Partial disclosure of records |
Section 20.22
|
Request for existing records |
Section 20.23
|
Preparation of new records |
Section 20.24
|
Retroactive application of regulations |
Section 20.25
|
Indexes of certain records |
Section 20.26
|
Submission of records marked as confidential |
Section 20.27
|
Food and Drug Administration determinations of confidentiality |
Section 20.28
|
Prohibition on withdrawal of records from Food and Drug Administration files |
Section 20.29
|
Food and Drug Administration Division of Freedom of Information |
Section 20.30
|
Retention schedule of requests for Food and Drug Administration records |
Section 20.31
|
Disclosure of Food and Drug Administration employee names |
Section 20.32
|
Form or format of response |
Section 20.33
|
Search for records |
Section 20.34
|
Filing a request for records |
Section 20.40
|
Time limitations |
Section 20.41
|
Aggregation of certain requests |
Section 20.42
|
Multitrack processing |
Section 20.43
|
Expedited processing |
Section 20.44
|
Fees to be charged |
Section 20.45
|
Waiver or reduction of fees |
Section 20.46
|
Situations in which confidentiality is uncertain |
Section 20.47
|
Judicial review of proposed disclosure |
Section 20.48
|
Denial of a request for records |
Section 20.49
|
Nonspecific and overly burdensome requests |
Section 20.50
|
Referral to primary source of records |
Section 20.51
|
Availability of records at National Technical Information Service |
Section 20.52
|
Use of private contractor for copying |
Section 20.53
|
Request for review without copying |
Section 20.54
|
Indexing trade secrets and confidential commercial or financial information |
Section 20.55
|
Applicability of exemptions |
Section 20.60
|
Trade secrets and commercial or financial information which is privileged or confidential |
Section 20.61
|
Inter- or intra-agency memoranda or letters |
Section 20.62
|
Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy |
Section 20.63
|
Records or information compiled for law enforcement purposes |
Section 20.64
|
National defense and foreign policy |
Section 20.65
|
Internal personnel rules and practices |
Section 20.66
|
Records exempted by other statutes |
Section 20.67
|
Applicability of limitations on exemptions |
Section 20.80
|
Data and information previously disclosed to the public |
Section 20.81
|
Discretionary disclosure by the Commissioner |
Section 20.82
|
Disclosure required by court order |
Section 20.83
|
Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U |
Section 20.84
|
Disclosure to other Federal government departments and agencies |
Section 20.85
|
Disclosure in administrative or court proceedings |
Section 20.86
|
Disclosure to Congress |
Section 20.87
|
Communications with State and local government officials |
Section 20.88
|
Communications with foreign government officials |
Section 20.89
|
Disclosure to contractors |
Section 20.90
|
Use of data or information for administrative or court enforcement action |
Section 20.91
|
Applicability; cross-reference to other regulations |
Section 20.100
|
Administrative enforcement records |
Section 20.101
|
Court enforcement records |
Section 20.102
|
Correspondence |
Section 20.103
|
Summaries of oral discussions |
Section 20.104
|
Testing and research conducted by or with funds provided by the Food and Drug Administration |
Section 20.105
|
Studies and reports prepared by or with funds provided by the Food and Drug Administration |
Section 20.106
|
Food and Drug Administration manuals |
Section 20.107
|
Agreements between the Food and Drug Administration and other departments, agencies, and organizations |
Section 20.108
|
Data and information obtained by contract |
Section 20.109
|
Data and information about Food and Drug Administration employees |
Section 20.110
|
Data and information submitted voluntarily to the Food and Drug Administration |
Section 20.111
|
Voluntary drug experience reports submitted by physicians and hospitals |
Section 20.112
|
Voluntary product defect reports |
Section 20.113
|
Data and information submitted pursuant to cooperative quality assurance agreements |
Section 20.114
|
Product codes for manufacturing or sales dates |
Section 20.115
|
Drug and device listing information |
Section 20.116
|
New drug information |
Section 20.117
|
Advisory committee records |
Section 20.118
|
Lists of names and addresses |
Section 20.119
|
Records available in Food and Drug Administration Public Reading Rooms |
Section 20.120
|
Scope |