[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.35]

[Page 65-67]
 
                        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 B_Investigational New Drug Application (IND)
 
Sec.  312.35  Submissions for treatment use.

    (a) Treatment protocol submitted by IND sponsor. Any sponsor of a 
clinical

[[Page 66]]

investigation of a drug who intends to sponsor a treatment use for the 
drug shall submit to FDA a treatment protocol under Sec.  312.34 if the 
sponsor believes the criteria of Sec.  312.34 are satisfied. If a 
protocol is not submitted under Sec.  312.34, but FDA believes that the 
protocol should have been submitted under this section, FDA may deem the 
protocol to be submitted under Sec.  312.34. A treatment use under a 
treatment protocol may begin 30 days after FDA receives the protocol or 
on earlier notification by FDA that the treatment use described in the 
protocol may begin.
    (1) A treatment protocol is required to contain the following:
    (i) The intended use of the drug.
    (ii) An explanation of the rationale for use of the drug, including, 
as appropriate, either a list of what available regimens ordinarily 
should be tried before using the investigational drug or an explanation 
of why the use of the investigational drug is preferable to the use of 
available marketed treatments.
    (iii) A brief description of the criteria for patient selection.
    (iv) The method of administration of the drug and the dosages.
    (v) A description of clinical procedures, laboratory tests, or other 
measures to monitor the effects of the drug and to minimize risk.
    (2) A treatment protocol is to be supported by the following:
    (i) Informational brochure for supplying to each treating physician.
    (ii) The technical information that is relevant to safety and 
effectiveness of the drug for the intended treatment purpose. 
Information contained in the sponsor's IND may be incorporated by 
reference.
    (iii) A commitment by the sponsor to assure compliance of all 
participating investigators with the informed consent requirements of 21 
CFR part 50.
    (3) A licensed practioner who receives an investigational drug for 
treatment use under a treatment protocol is an ``investigator'' under 
the protocol and is responsible for meeting all applicable investigator 
responsibilities under this part and 21 CFR parts 50 and 56.
    (b) Treatment IND submitted by licensed practitioner. (1) If a 
licensed medical practitioner wants to obtain an investigational drug 
subject to a controlled clinical trial for a treatment use, the 
practitioner should first attempt to obtain the drug from the sponsor of 
the controlled trial under a treatment protocol. If the sponsor of the 
controlled clinical investigation of the drug will not establish a 
treatment protocol for the drug under paragraph (a) of this section, the 
licensed medical practitioner may seek to obtain the drug from the 
sponsor and submit a treatment IND to FDA requesting authorization to 
use the investigational drug for treatment use. A treatment use under a 
treatment IND may begin 30 days after FDA receives the IND or on earlier 
notification by FDA that the treatment use under the IND may begin. A 
treatment IND is required to contain the following:
    (i) A cover sheet (Form FDA 1571) meeting Sec.  312.23(g)(1).
    (ii) Information (when not provided by the sponsor) on the drug's 
chemistry, manufacturing, and controls, and prior clinical and 
nonclinical experience with the drug submitted in accordance with Sec.  
312.23. A sponsor of a clinical investigation subject to an IND who 
supplies an investigational drug to a licensed medical practitioner for 
purposes of a separate treatment clinical investigation shall be deemed 
to authorize the incorporation-by-reference of the technical information 
contained in the sponsor's IND into the medical practitioner's treatment 
IND.
    (iii) A statement of the steps taken by the practitioner to obtain 
the drug under a treatment protocol from the drug sponsor.
    (iv) A treatment protocol containing the same information listed in 
paragraph (a)(1) of this section.
    (v) A statement of the practitioner's qualifications to use the 
investigational drug for the intended treatment use.
    (vi) The practitioner's statement of familiarity with information on 
the drug's safety and effectiveness derived from previous clinical and 
nonclinical experience with the drug.
    (vii) Agreement to report to FDA safety information in accordance 
with Sec.  312.32.

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    (2) A licensed practitioner who submits a treatment IND under this 
section is the sponsor-investigator for such IND and is responsible for 
meeting all applicable sponsor and investigator responsibilities under 
this part and 21 CFR parts 50 and 56.

[52 FR 19477, May 22, 1987, as amended at 57 FR 13249, Apr. 15, 1992; 67 
FR 9585, Mar. 4, 2002]