[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR2a.5]



[Page 29]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 2a_PROTECTION OF IDENTITY_RESEARCH SUBJECTS--Table of Contents

 

Sec.  2a.5  Contents of application; research projects in which drugs will 

be administered.



    (a) In addition to the information required by Sec.  2a.4 and any 

other pertinent information which the Secretary may require, each 

application for an authorization of confidentiality for a research 

project which involves the administering of a drug shall contain:

    (1) Identification of the drugs to be administered in the research 

project and a description of the methods for such administration, which 

shall include a statement of the dosages to be administered to the 

research subjects;

    (2) Evidence that individuals who administer drugs are authorized to 

do so under applicable Federal and State law; and

    (3) In the case of a controlled drug, a copy of the Drug Enforcement 

Administration Certificate of Registration (BND Form 223) under which 

the research project will be conducted.

    (b) An application for an authorization of confidentiality with 

respect to a research project which involves the administering of a 

controlled drug may include a request for exemption of persons engaged 

in the research from State or Federal prosecution for possession, 

distribution, and dispensing of controlled drugs as authorized under 

section 502(d) of the Controlled Substances Act (21 U.S.C. 872(d)) and 

21 CFR 1316.22. If the request is in such form, and is supported by such 

information, as is required by 21 CFR 1316.22, the Secretary will 

forward it, together with his or her recommendation that such request be 

approved or disapproved, for the consideration of the Administrator of 

the Drug Enforcement Administration.