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Electronic Code of Federal Regulations

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e-CFR Data is current as of September 22, 2014

Title 21Chapter ISubchapter APart 20


TITLE 21—Food and Drugs

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

SUBCHAPTER A—GENERAL

PART 20—PUBLIC INFORMATION

rule

Subpart A—OFFICIAL TESTIMONY AND 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.
rule

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
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.
rule

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.
rule

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.
rule

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.
rule

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 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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