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Title 21

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eCFR Content

Editorial codification of the general and permanent rules published in the Federal Register.

Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 312 Investigational New Drug Application 312.1 – 312.320
Subpart A General Provisions 312.1 – 312.10
Subpart B Investigational New Drug Application (IND) 312.20 – 312.38
Subpart C Administrative Actions 312.40 – 312.48
Subpart D Responsibilities of Sponsors and Investigators 312.50 – 312.70
Subpart E Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses 312.80 – 312.88
Subpart F Miscellaneous 312.110 – 312.145
§ 312.110 Import and export requirements.
§ 312.120 Foreign clinical studies not conducted under an IND.
§ 312.130 Availability for public disclosure of data and information in an IND.
§ 312.140 Address for correspondence.
§ 312.145 Guidance documents.
Subpart G Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests 312.160
§ 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
Subpart H [Reserved]
Subpart I Expanded Access to Investigational Drugs for Treatment Use 312.300 – 312.320
§ 312.300 General.
§ 312.305 Requirements for all expanded access uses.
§ 312.310 Individual patients, including for emergency use.
§ 312.315 Intermediate-size patient populations.
§ 312.320 Treatment IND or treatment protocol.