[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: 21CFR1308.25]

[Page 92-93]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.25  Exclusion of a veterinary anabolic steroid implant product; application.

    (a) Any person seeking to have any anabolic steroid product, which 
is expressly intended for administration through implants to cattle or 
other nonhuman species and which has been approved by the Secretary of 
Health and Human Services for such administration, identified as being 
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act 
(21 U.S.C. 802(41)(B)(i)), may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (b) An application for any exclusion under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) A complete description of dosage and quantitative composition of 
the dosage form;.
    (5) The conditions of use including whether or not Federal law 
restricts this product to use by or on the order of a licensed 
veterinarian;
    (6) A description of the delivery system in which the dosage form 
will be distributed with sufficient detail to identify the product (e.g. 
20 cartridge brown plastic belt);
    (7) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;.
    (8) The name and address of the manufacturer of the dosage form if 
different from that of the applicant; and
    (9) Evidence that the product has been approved by the Secretary of 
Health and Human Services for administration through implant to cattle 
or other nonhuman species.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the

[[Page 93]]

Administrator shall notify the applicant of his acceptance or 
nonacceptance of the application, and if not accepted, the reason 
therefore. The Administrator need not accept an application for filing 
if any of the requirements prescribed in paragraph (b) of this section 
is lacking or is not set forth as to be readily understood. The 
applicant may amend the application to meet the requirements of 
paragraph (b) of this section. If the application is accepted for 
filing, the Administrator shall issue and have published in the Federal 
Register his order on the application, which shall include a reference 
to the legal authority under which the order is issued and the findings 
of fact and conclusions of law upon which the order is based. This order 
shall specify the date on which it will take effect. The Administrator 
shall permit any interested person to file written comments on or 
objections to the order within 60 days of the date of publication in the 
Federal Register. If any such comments or objections raise significant 
issues regarding any finding of fact or conclusion of law upon which the 
order is based, the Administrator shall immediately suspend the 
effectiveness of the order until he may reconsider the application in 
light of the comments and objections filed. Thereafter, the 
Administrator shall reinstate, revoke, or amend his original order as he 
determines appropriate.
    (d) The Administrator may at any time revoke or modify any 
designation of excluded status granted pursuant to this section by 
following the procedures set forth in paragraph (c) of this section for 
handling an application for an exclusion which has been accepted for 
filing.

[56 FR 42936, Aug. 30, 1991]