[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.32]

[Page 26]
 
                         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. 1301.32  Action on applications for research in Schedule I substances.

    (a) In the case of an application for registration to conduct 
research with controlled substances listed in Schedule I, the 
Administrator shall process the application and protocol and forward a 
copy of each to the Secretary of Health and Human Services (Secretary) 
within 7 days after receipt. The Secretary shall determine the 
qualifications and competency of the applicant, as well as the merits of 
the protocol (and shall notify the Administrator of his/her 
determination) within 21 days after receipt of the application and 
complete protocol, except that in the case of a clinical investigation, 
the Secretary shall have 30 days to make such determination and notify 
the Administrator. The Secretary, in determining the merits of the 
protocol, shall consult with the Administrator as to effective 
procedures to safeguard adequately against diversion of such controlled 
substances from legitimate medical or scientific use.
    (b) An applicant whose protocol is defective shall be notified by 
the Secretary within 21 days after receipt of such protocol from the 
Administrator (or in the case of a clinical investigation within 30 
days), and he/she shall be requested to correct the existing defects 
before consideration shall be given to his/her submission.
    (c) If the Secretary determines the applicant qualified and 
competent and the research protocol meritorious, he/she shall notify the 
Administrator in writing of such determination. The Administrator shall 
issue a certificate of registration within 10 days after receipt of this 
notice, unless he/she determines that the certificate of registration 
should be denied on a ground specified in section 304(a) of the Act (21 
U.S.C. 824(a)). In the case of a supplemental protocol, a replacement 
certificate of registration shall be issued by the Administrator.
    (d) If the Secretary determines that the protocol is not meritorious 
and/or the applicant is not qualified or competent, he/she shall notify 
the Administrator in writing setting forth the reasons for such 
determination. If the Administrator determines that grounds exist for 
the denial of the application, he/she shall within 10 days issue an 
order to show cause pursuant to Sec. 1301.37 and, if requested by the 
applicant, hold a hearing on the application pursuant to Sec. 1301.41. 
If the grounds for denial of the application include a determination by 
the Secretary, the Secretary or his duly authorized agent shall furnish 
testimony and documents pertaining to his determination at such hearing.
    (e) Supplemental protocols will be processed in the same manner as 
original research protocols. If the processing of an application or 
research protocol is delayed beyond the time limits imposed by this 
section, the applicant shall be so notified in writing.

[62 FR 13953, Mar. 24, 1997]