Title 21 Code of Federal Regulations
PART 1301 — REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
§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:
(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.
(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).
(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, by registered mail, return receipt requested. See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current mailing address. The request shall contain the following 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, as amended at 75 FR 10676, Mar. 9, 2010]
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).