[Federal Register Volume 62, Number 235 (Monday, December 8, 1997)]
[Proposed Rules]
[Pages 64526-64527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31951]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 173P]
Schedules of Controlled Substances: Proposed Placement of
Sibutramine Into Schedule IV
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This proposed rule is issued by the Acting Deputy
Administrator of the DEA to place the substance, sibutramine, including
its salts and optical isomers into Schedule IV of the Controlled
Substances Act (CSA). This proposed action is based on a recommendation
from the Assistant Secretary for Health of the Department of Health and
Human Services (DHHS) that sibutramine be added to Schedule IV and on
an evaluation of the relevant data by the DEA. If finalized, this
action will impose the regulatory controls and criminal sanctions of
Schedule IV on those who handle sibutramine and products containing
sibutramine.
DATES: Comments, objections, and requests for a hearing must be
received on or before January 7, 1998.
ADDRESSES: Comments, objections and requests for a hearing should be
submitted in quintuplicate to the Acting Deputy Administrator, Drug
Enforcement Administration, Washington, D.C. 20537, Attn.: DEA Federal
Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, D.C. 20537, (202) 307-7183.
[[Page 64527]]
SUPPLEMENTARY INFORMATION: Sibutramine is an amphetamine analogue
pharmacologically similar to other anorectic agents that produce
central nervous system stimulation and amphetamine-like effects in
humans and animals. Sibutramine hydrochloride will be marketed under
the trade name of MERIDA as an oral anorectic for the long term
management of obesity.
The Acting Deputy Administrator of the DEA received a letter dated
November 12, 1997 from the Acting Assistant Secretary for Health, on
behalf of the Secretary of the DHHS, recommending that the substance,
sibutramine, and salts and isomers thereof, be placed into Schedule IV
of the CSA (21 U.S.C. 801 et seq.). Enclosed with the letter from the
Assistant Secretary was a document prepared by the Food and Drug
Administration (FDA) entitled ``Basis for the Recommendation for
Control of Sibutramine and its Salts in Schedule IV of the Controlled
Substances Act (CSA).'' The document contained a review of the factors
which the CSA requires the Secretary to consider [21 U.S.C. 811(b)] and
the summarized recommendations regarding the placement of sibutramine
into Schedule IV of the CSA.
The factors considered by the Assistant Secretary for Health with
respect to the drug sibutramine were:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or
other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance
already controlled under the CSA.
Relying on the scientific and medical evaluation and the
recommendation of the Assistant Secretary of Health, the FDA New Drug
Application (NDA) approval on November 22, 1997, and a DEA review, the
Acting Deputy Administrator of the DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Sibutramine has a low potential for abuse relative to the drugs
or other substances in Schedule III.
(2) Sibutramine has a currently accepted medical use in treatment
in the United States.
(3) Abuse of sibutramine may lead to limited physical dependence
and psychological dependence relative to the drugs or other substances
in Schedule III.
Interested persons are invited to submit their comments, objections
or requests for a hearing, in writing, with regard to this proposal.
Requests for a hearing should state, with particularity, the issues
concerning which the person desires to be heard. All correspondence
regarding this matter should be submitted to the Acting Deputy
Administrator, Drug Enforcement Administration, Washington, D.C. 20537.
Attention: DEA Federal Register Representative/CCR. In the event that
comments, objections or requests for a hearing raise one or more issues
which the Acting Deputy Administrator finds warrants a hearing, the
Acting Deputy Administrator shall order a public hearing by notice in
the Federal Register, summarizing the issues to be heard and setting
the time for the hearing.
In accordance with the provisions of the CSA (21 U.S.C. 811(a)),
this action is a formal rulemaking on the record after opportunity for
a hearing. Such proceedings are conducted pursuant to the provisions of
5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office
of Management and Budget pursuant to Executive Order (E.O.) 12866,
Section 3(d)(1).
The Acting Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), has reviewed this proposed rule and
by approving it certifies that it will not have a significant economic
impact on a substantial number of small-business entities. Sibutramine
is a new drug in the United States; recent approval of the product and
its labeling by the FDA will allow it to be marked once it is placed
into Schedule IV of the CSA. This proposed rule, if finalized, will
allow these entities to have access to a new pharmaceutical product.
This rule will not result in the expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of the United States-based companies to
compete with foreign-based companies in domestic and export markets.
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with E.O. 12612, it is
determined that this rule, if finalized, does not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, drug traffic control,
narcotics, prescription drugs.
Under the authority vested in the Attorney General by section
201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the
Administrator of the DEA by the Department of Justice regulations (28
CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Acting Deputy Administrator hereby proposes that 21 CFR
part 1308 be amended as follows:
PART 1308--[AMENDED]
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
Sec. 1308.14 [Amended]
2. Section 1308.14 is proposed to be amended by redesignating the
existing paragraph (e)(10) as (e)(11) and adding a new paragraph
(e)(10) to read as follows:
Sec. 1308.14 Schedule IV
* * * * *
(10) Sibutramine...................................................1675
* * * * *
Dated: December 2, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-31951 Filed 12-5-97; 8:45 am]
BILLING CODE 4410-09-M
