21 CFR 1316.46 - Inspection of record.

§ 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. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.

(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 § 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 § 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; 75 FR 10645, Mar. 9, 2010]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
Public Laws

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1316 after this date.

  • 2017-01-30; vol. 82 # 18 - Monday, January 30, 2017
    1. 82 FR 8688 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Final rule; delay of effective date.
      Effective Dates: This Final Rule is effective January 30, 2017. The effective date of the Final Rule amending 21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321 published in the Federal Register December 30, 2016, at 81 FR 96992 is delayed to March 21, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until July 31, 2017.
      21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321