[Federal Register Volume 62, Number 104 (Friday, May 30, 1997)]
[Rules and Regulations]
[Pages 29289-29290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14112]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 161I]
Schedules of Controlled Substances: Excluded Veterinary Anabolic
Steroid Implant Products
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Interim rule and request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) is designating eight
veterinary anabolic steroid implant products as being excluded from the
Controlled Substances Act. This action is part of the ongoing
implementation of the Anabolic Steroids Control Act.
DATES: Effective Date: May 30, 1997. Comments must be submitted on or
before July 29, 1997.
ADDRESSES: Comments and objections should be submitted to the Acting
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537. Attention: DEA
Federal Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section. Telephone:
(202) 307-7183.
SUPPLEMENTARY INFORMATION: The Anabolic Steroids Control Act of 1990
(ASCA) (title XIX of Pub. L. 101-647) placed anabolic steroids into
Schedule III of the Controlled Substances Act (CSA) (21 U.S.C. 801 et
seq.). Section 1902(b)(41)(B)(i) of the ASCA provides for the exclusion
of any anabolic steroid which the Secretary of Health and Human
Services has approved for administration through implants to cattle of
other nonhuman species. The procedure for implementing this section of
the ASCA is described in section 1308.25 of Title 21 Code of Federal
Regulations. The purpose of this rule is to identify eight products
which the Acting Deputy Assistant Administrator for the Office of
Diversion Control finds meet the excluded veterinary anabolic steroid
implant product criteria.
The Acting Deputy Assistant Administrator, having reviewed the
applications which were made in conformance with 21 CFR 1308.25, finds
that the anabolic steroid products, ComponentTM E-H,
ComponentTM TE-S, ComponentTM T-H,
ComponentTM T-S, Revalor-G, Revalor-
H, Synovex H, and Synovex Plus, are expressly
intended for administration through
[[Page 29290]]
implants to cattle and have been approved by the Secretary of Health
and Human Services for such use. Therefore, pursuant to the authority
vested in the Attorney General by title XIX of Pub. L. 101-647 as
delegated to the Administrator of the DEA pursuant to 21 U.S.C. 871(a)
and 28 CFR 0.100, the Acting Deputy Assistant Administrator hereby
orders that the following anabolic steroid veterinary implant products
be added to those described in 21 CFR 1308.26(a) and excluded from
application of the CSA.
Excluded Veterinary Anabolic Steroid Implant Products
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Trade name Company NDC code Delivery system Ingredients Quantity
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Component E-H...................... VetLife, Inc., 021641-002 20 implant belt................. Testosterone propionate................ 200 mg/implant.
Norcross, GA. 8 pellets/implant............... Estradiol benzoate..................... (25 mg/pellet).
20 mg/implant.
(2.5 mg/pellet).
Component E-H...................... Elanco, Scarborough, DIN01968327 20 implant belt................. Testosterone propionate................ 200 mg/implant.
Ont. 8 pellets/implant............... Estradiol benzoate..................... (25 mg/pellet).
20 mg/implant.
(2.5 mg/pellet).
Component TE-S..................... VetLife, Inc., 021641-004 20 implant belt................. Trenbolone acetate..................... 120 mg/implant.
Norcross, GA. 6 pellets/implant............... Estradiol.............................. (20 mg/pellet).
24 mg/implant.
(4 mg/pellet).
Component T-H...................... VetLife, Inc., 021641-006 20 implant belt................. Trenbolone acetate..................... 200 mg/implant.
Norcross, GA. 10 pellets/implant (20 mg/pellet).
Component T-S...................... VetLife, Inc., 021641-005 20 implant belt................. Trenbolone acetate..................... 140 mg/implant.
Norcross, GA. 7 pellets/implant (20 mg/pellet).
Revalor-G.......................... Hoechst Roussel Vet, 12799-811 10 implant cartridge............ Trenbolone acetate..................... 40 mg/implant.
Somerville, NJ. 2 pellets/implant............... Estradiol.............................. (20 mg/pellet).
4 mg/implant.
(2 mg/pellet).
Revalor-H.......................... Hoechst Roussel Vet, 12799-810 10 implant cartridge............ Trenbolone acetate..................... 140 mg/implant.
Somerville, NJ. 7 pellets/implant............... Estradiol.............................. (20 mg/pellet).
14 mg/implant.
(2 mg/pellet).
Synovex H.......................... Fort Dodge Labs, Fort 0856-3901 10 implant cartridge............ Testosterone propionate................ 200 mg/implant.
Dodge, IA. 8 pellets/implant............... Estradiol benzoate..................... (25 mg/pellet).
20 mg/implant.
(2.5 mg/pellet).
Synovex Plus....................... Fort Dodge Labs, Fort 0856-3904 10 implant cartridge............ Trenbolone acetate..................... 200 mg/implant.
Dodge, IA. 8 pellets/implant............... Estradiol benzoate..................... (25 mg/pellet).
28 mg/implant.
(3.5 mg/pellet).
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The exemption of these products relates to their production,
distribution, and use in animals only. If any person distributes,
dispenses or otherwise diverts these products to use in humans, he/she
shall be deemed to have distributed a Schedule III controlled substance
and may be prosecuted for CSA violations.
Interested persons are invited to submit their comments in writing
with regard to this interim rule. If any comments or objections raise
significant issues regarding any finding of fact or conclusion of law
upon which this order is based, the Acting Deputy Assistant
Administrator shall immediately suspend the effectiveness of this order
until he may reconsider the application in light of the comments and
objections filed. Thereafter, the Acting Deputy Assistant Administrator
shall reinstate, revoke, or amend his original order as he determines
appropriate.
The granting of excluded status relieves persons who handle the
excluded products in the course of legitimate business from the
registration, record keeping, security, and other requirements imposed
by the CSA. Accordingly, the Acting Deputy Assistant Administrator
certifies that this action will have no negative economic impact upon
small entities whose interests must be considered under the Regulatory
Flexibility Act (5 U.S.C. 601, et seq.).
This action has been analyzed in accordance with the principles and
criteria contained in E.O. 12612, and it has been determined that this
matter does not have sufficient federalism implications to require the
preparation of a Federalism Assessment.
It has been determined that drug control matters are not subject to
review by the Office of Management and Budget (OMB) pursuant to the
provisions of E.O. 12866. Accordingly, this action is not subject to
those provisions of E.O. 12778 which are contingent upon review by OMB.
Nevertheless, the Acting Deputy Assistant Administrator has determined
that this is not a ``major rule,'' as that term is used in E.O. 12866,
and that it would otherwise meet the applicable standards of sections
2(a) and 2(b)(2) of E.O. 12778.
Dated: May 21, 1997.
Terrance W. Woodworth,
Acting Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration.
[FR Doc. 97-14112 Filed 5-29-97; 8:45 am]
BILLING CODE 4410-09-M
