[Federal Register Volume 59, Number 243 (Tuesday, December 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31162]
[[Page Unknown]]
[Federal Register: December 20, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA--126P]
21 CFR Part 1308
Schedules of Controlled Substances; Proposed Placement of 4-
Bromo-2,5-dimethoxyphenethylamine Into Schedule I
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This notice of proposed rulemaking is issued by the Deputy
Administrator of the Drug Enforcement Administration (DEA) to place 4-
bromo-2,5-dimethoxyphenethylamine (4-bromo-2,5-DMPEA) into Schedule I
of the Controlled Substances Act (CSA). This proposed action by the DEA
Deputy Administrator is based on data gathered and reviewed by the DEA.
If finalized, this proposed action would impose the regulatory control
mechanisms and criminal sanctions of Schedule I on the manufacture,
distribution, and possession of 4-bromo-2,5-DMPEA.
DATES: Comments must be submitted on or before January 19, 1995.
ADDRESSES: Comments and objections should be submitted to the Deputy
Administrator, Drug Enforcement Administration, Washington, D.C. 20537,
Attention: DEA Federal Register Representative.
FOR FURTHER INFORMATION CONTACT:
Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug
Enforcement Administration, Washington, D.C. 20537, Telephone: (202)
307-7183.
SUPPLEMENTARY INFORMATION: On January 6, 1994, the Acting Administrator
of the DEA published a final rule in the Federal Register (59 FR 671)
amending Sec. 1308.11(g) of Title 21 of the Code of Federal Regulations
to temporarily place 4-bromo-2,5-DMPEA into Schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h).
This final rule, which became effective on the date of publication, was
based on findings by the Acting Administrator that the temporary
scheduling of 4-bromo-2,5-DMPEA was necessary to avoid an imminent
hazard to the public safety. Section 201(h)(2) of the CSA (21 U.S.C.
811(h)(2)) requires that the temporary scheduling of a substance
expires at the end of one year from the effective date of the order.
However, if proceedings to schedule a substance pursuant to 21 U.S.C.
811(a)(1) have been initiated and are pending, the temporary scheduling
of a substance may be extended for up to six months. Under this
provision, the temporary scheduling of 4-bromo-2,5-DMPEA which would
expire on January 6, 1995, may be extended to July 6, 1995. This
extension is being ordered by the DEA Deputy Administrator in a
separate action.
The DEA has gathered and reviewed the available information
regarding the trafficking, actual abuse and the relative potential for
abuse for 4-bromo-2,5-DMPEA. The Deputy Administrator has submitted
this data to the Assistant Secretary for Health, Department of Health
and Human Services. In accordance with 21 U.S.C. 811(b), the Deputy
Administrator also requested a scientific and medical evaluation and a
scheduling recommendation for 4-bromo-2,5-DMPEA from the Assistant
Secretary for Health.
The Food and Drug Administration (FDA) has notified the DEA that
there are no exemptions or approvals in effect under Section 505 of the
Federal Food, Drug, and Cosmetic Act for 4-bromo-2,5-DMPEA. A search of
the scientific and medical literature revealed no indications of
current medical use of 4-bromo-2,5-DMPEA in the United States.
4-bromo-2,5-DMPEA is structurally similar to the Schedule I
phenylisopropylamine hallucinogens, 4-bromo-2,5-dimethoxyphenethylamine
(DOB). Like DOM and DOB, 4-bromo-2,5-DMPEA displays high affinity for
central serotonin receptors and is capable of substituting for DOM or
DOB in drug discrimination studies conducted in rats. These data
suggest that 4-bromo-2,5-DMPEA is a psychoactive substance capable of
producing effects similar, though not identical, to DOM and DOB. Data
from human studies indicate that 4-bromo-2,5-DMPEA is orally active at
0.1-0.2 mg/kg producing an intoxication with considerable euphoria and
sensory enhancement which lasts for 6 to 8 hours. Higher doses have
been reported to produce intense and frightening hallucinations.
The DEA first encountered 4-bromo-2,5-DMPEA in 1979. Since that
time, several exhibits of 4-bromo-2,5-DMPEA have been analyzed by
Federal and state forensic laboratories in Arizona, California,
Colorado, Georgia, Illinois, Iowa, Kentucky, Oregon, Pennsylvania and
Texas. Clandestine laboratories producing 4-bromo-2,5-DMPEA were seized
in California in 1986 and 1994 and in Arizona in 1992. It has been
represented as 3,4-methylenedioxy-methamphetamine (MDMA) and has been
sold in sugar cubes as LSD. Recently, 4-bromo-2,5-DMPEA has been
promoted as an aphrodisiac and distributed under the product name of
Nexus. DEA has seized several thousand dosage units of this product.
The Deputy Administrator, based on the information gathered and
reviewed by his staff and after consideration of the factors in 21
U.S.C. 811(c), believes that sufficient data exist to propose and to
support that 4-bromo-2,5-DMPEA be placed into Schedule I of the CSA
pursuant to 21 U.S.C. 811(a). The specific findings required pursuant
to 21 U.S.C. 811 and 812 for a substance to be placed into Schedule I
are as follows:
(1) The drug or other substance has a high potential for abuse.
(2) The drug or other substance has no currently accepted medical
use in treatment in the United States.
(3) There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
Before issuing a final rule in this matter, the DEA Deputy
Administrator will take into consideration the scientific and medical
evaluation and scheduling recommendation of the Secretary of the
Department of Health and Human Services in accordance with 21 U.S.C.
811(b). The Deputy Administrator will also consider relevant comments
from other concerned parties.
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 Deputy
Administrator, Drug Enforcement Administration, Washington, D.C. 20537,
Attention: DEA Federal Register Representative. In the event that
comments, objections, or requests for a hearing raise one or more
issues which the Deputy Administrator finds warrants a hearing, the
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.
The Deputy Administrator of the DEA hereby certifies that proposed
placement of 4-bromo-2,5-DMPEA into Schedule I of the CSA will have no
significant impact upon entities whose interests must be considered
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action
involves the control of a substance with no currently accepted medical
use in the United States.
This proposed rulemaking is not a significant regulatory action for
the purposes of Executive Order (E.O.) 12866 of September 30, 1993.
Drug scheduling matters are not subject to review by the Office of
Management and Budget (OMB) pursuant to provisions of E.O. 12866,
Section 3(d)(1).
This action has been analyzed in accordance with the principles and
criteria in E.O. 12612, and it has been determined that this proposed
rulemaking 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 Deputy Administrator hereby proposes that 21 CFR Part
1308 be amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871b, unless otherwise noted.
2. Section 1308.11 is amended by redesignating the existing
paragraphs (d)(3) through (d)(30) as (d)(4) through (d)(31) and adding
a new paragraph (d)(3) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(3) 4-Bromo-2,5-dimethoxyphenethylamine--7392
Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-
aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
3. Section 1308.11 is further amended by removing paragraph (g)(3).
Dated: December 13, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-31162 Filed 12-19-94; 8:45 am]
BILLING CODE 4410-09-M
