[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.1]

[Page 49-51]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 312.1  Scope.




                      Subpart A_General Provisions

Sec.
312.1 Scope.
312.2 Applicability.

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312.3 Definitions and interpretations.
312.6 Labeling of an investigational new drug.
312.7 Promotion and charging for investigational drugs.
312.10 Waivers.

          Subpart B_Investigational New Drug Application (IND)

312.20 Requirement for an IND.
312.21 Phases of an investigation.
312.22 General principles of the IND submission.
312.23 IND content and format.
312.30 Protocol amendments.
312.31 Information amendments.
312.32 IND safety reports.
312.33 Annual reports.
312.34 Treatment use of an investigational new drug.
312.35 Submissions for treatment use.
312.36 Emergency use of an investigational new drug (IND).
312.38 Withdrawal of an IND.

                    Subpart C_Administrative Actions

312.40 General requirements for use of an investigational new drug in a 
          clinical investigation.
312.41 Comment and advice on an IND.
312.42 Clinical holds and requests for modification.
312.44 Termination.
312.45 Inactive status.
312.47 Meetings.
312.48 Dispute resolution.

        Subpart D_Responsibilities of Sponsors and Investigators

312.50 General responsibilities of sponsors.
312.52 Transfer of obligations to a contract research organization.
312.53 Selecting investigators and monitors.
312.54 Emergency research under Sec. 50.24 of this chapter.
312.55 Informing investigators.
312.56 Review of ongoing investigations.
312.57 Recordkeeping and record retention.
312.58 Inspection of sponsor's records and reports.
312.59 Disposition of unused supply of investigational drug.
312.60 General responsibilities of investigators.
312.61 Control of the investigational drug.
312.62 Investigator recordkeeping and record retention.
312.64 Investigator reports.
312.66 Assurance of IRB review.
312.68 Inspection of investigator's records and reports.
312.69 Handling of controlled substances.
312.70 Disqualification of a clinical investigator.

    Subpart E_Drugs Intended to Treat Life-threatening and Severely-
                         debilitating Illnesses

312.80 Purpose.
312.81 Scope.
312.82 Early consultation.
312.83 Treatment protocols.
312.84 Risk-benefit analysis in review of marketing applications for 
          drugs to treat life-threatening and severely-debilitating 
          illnesses.
312.85 Phase 4 studies.
312.86 Focused FDA regulatory research.
312.87 Active monitoring of conduct and evaluation of clinical trials.
312.88 Safeguards for patient safety.

                         Subpart F_Miscellaneous

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 Drugs for investigational use in laboratory research animals or 
          in vitro tests.

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371; 42 U.S.C. 
262.

    Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 312 can be found at 69 
FR 13717, Mar. 24, 2004.



    (a) This part contains procedures and requirements governing the use 
of investigational new drugs, including procedures and requirements for 
the submission to, and review by, the Food and Drug Administration of 
investigational new drug applications (IND's). An investigational new 
drug for which an IND is in effect in accordance with this part is 
exempt from the premarketing approval requirements that are otherwise 
applicable and may be

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shipped lawfully for the purpose of conducting clinical investigations 
of that drug.
    (b) References in this part to regulations in the Code of Federal 
Regulations are to chapter I of title 21, unless otherwise noted.