[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1308.25]

[Page 103-104]
 
                         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 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

[[Page 104]]

an exclusion which has been accepted for filing.

[56 FR 42936, Aug. 30, 1991]