[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1316.46]

[Page 148]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table of Contents
 
                   Subpart D--Administrative Hearings
 
Sec. 1316.46  Inspection of record.

    (a) The record bearing on any proceeding, except for material 
described in subsection (b) of this section, shall be available for 
inspection and copying by any person entitled to participate in such 
proceeding, during office hours in the office of the Hearing Clerk, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) The following material shall not be available for inspection as 
part of the record:
    (1) A research protocol filed with an application for registration 
to conduct research with controlled substances listed in Schedule I, 
pursuant to Sec. 1301.32 (a)(6) of this chapter, if the applicant 
requests that the protocol be kept confidential;
    (2) An outline of a production or manufacturing process filed with 
an application for registration to manufacture a new narcotic controlled 
substance, pursuant to Sec. 1301.33 of this chapter, if the applicant 
requests that the outline be kept confidential;
    (3) Any confidential or trade secret information disclosed in 
conjunction with an application for registration, or in reports filed 
while registered, or acquired in the course of an investigation, 
entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C. 
842(a) (8)) or any other law restricting public disclosure of 
information; and
    (4) Any material contained in any investigatory report, memorandum, 
or file, or case report compiled by the Administration.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]