[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.18]

[Page 21-22]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS 
OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1301.18  Research protocols.

    (a) A protocol to conduct research with controlled substances listed 
in Schedule I shall be in the following form and contain the following 
information where applicable:
    (1) Investigator:
    (i) Name, address, and DEA registration number; if any.
    (ii) Institutional affiliation.
    (iii) Qualifications, including a curriculum vitae and an 
appropriate bibliography (list of publications).
    (2) Research project:
    (i) Title of project.
    (ii) Statement of the purpose.
    (iii) Name of the controlled substances or substances involved and 
the amount of each needed.
    (iv) Description of the research to be conducted, including the 
number and species of research subjects, the dosage to be administered, 
the route and method of administration, and the duration of the project.
    (v) Location where the research will be conducted.
    (vi) Statement of the security provisions for storing the controlled 
substances (in accordance with Sec. 1301.75) and for dispensing the 
controlled substances in order to prevent diversion.
    (vii) If the investigator desires to manufacture or import any 
controlled substance listed in paragraph (a)(2)(iii) of this section, a 
statement of the quantity to be manufactured or imported and the sources 
of the chemicals to be used or the substance to be imported.
    (3) Authority:
    (i) Institutional approval.
    (ii) Approval of a Human Research Committee for human studies.
    (iii) Indication of an approved active Notice of Claimed 
Investigational Exemption for a New Drug (number).
    (iv) Indication of an approved funded grant (number), if any.
    (b) In the case of a clinical investigation with controlled 
substances listed in Schedule I, the applicant shall submit three copies 
of a Notice of Claimed Investigational Exemption for a New Drug (IND) 
together with a statement of the security provisions (as proscribed in 
paragraph (a)(2)(vi) of this section for a research protocol) to, and 
have such submission approved by, the Food and Drug Administration as 
required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission 
of this Notice and statement to the Food and Drug Administration shall 
be in lieu of a research protocol to the Administration as required in 
paragraph (a) of this section. The applicant, when applying for 
registration with the Administration, shall indicate that such notice 
has been submitted to the Food and Drug Administration by submitting to 
the Administration with his/her DEA Form 225 three copies of the 
following certificate:

    I hereby certify that on -------------------- (Date), pursuant to 21 
U.S.C. 355(i) and 21 CFR 130.3, I, -------------------- (Name and 
Address of IND Sponsor) submitted a Notice of Claimed Investigational 
Exemption for a New Drug (IND) to the Food and Drug Administration for:

________________________________________________________________________
(Name of Investigational Drug).

________________________________________________________________________
(Date)

________________________________________________________________________
(Signature of Applicant).

    (c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, Post Office Box 28083, Central Station, 
Washington, DC 20005, by registered mail, return receipt requested. The 
request shall contain the following

[[Page 22]]

information: DEA registration number; name of the controlled substance 
or substances and the quantity of each authorized in the approved 
protocol; and the additional quantity of each desired. Upon return of 
the receipt, the registrant shall be authorized to purchase the 
additional quantity of the controlled substance or substances specified 
in the request. The Administration shall review the letter and forward 
it to the Food and Drug Administration together with the Administration 
comments. The Food and Drug Administration shall approve or deny the 
request as an amendment to the protocol and so notify the registrant. 
Approval of the letter by the Food and Drug Administration shall 
authorize the registrant to use the additional quantity of the 
controlled substance in the research project.
    (d) In the event the registrant desires to conduct research beyond 
the variations provided in the registrant's approved protocol (excluding 
any increase in the quantity of the controlled substance requested for 
his/her research project as outlined in paragraph (c) of this section), 
he/she shall submit three copies of a supplemental protocol in 
accordance with paragraph (a) of this section describing the new 
research and omitting information in the supplemental protocol which has 
been stated in the original protocol. Supplemental protocols shall be 
processed and approved or denied in the same manner as original research 
protocols.

[62 FR 13949, Mar. 24, 1997]

                   Exceptions to Registration and Fees