Rules - 2010
FR Doc 2010-15529[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Rules and Regulations]
[Page 37300-37301]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn10-9]
[[Page 37300]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-313F]
RIN 1117-AB26
Correction of Code of Federal Regulations: Removal of Temporary Listing of Benzylfentanyl and Thenylfentanyl as Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final Rule.
SUMMARY: This rulemaking corrects Title 21 Code of Federal Regulations
(CFR) by deleting regulations which list the substances benzylfentanyl
and thenylfentanyl as being temporarily subject to schedule I controls
under the emergency scheduling provisions of the Controlled Substances
Act (CSA). The temporary scheduling of benzylfentanyl and
thenylfentanyl expired on November 29, 1986. DEA determined that these
compounds were both essentially inactive, with no evidence of abuse
potential. As such, these compounds are no longer schedule I controlled
substances and all references to these compounds are being deleted from
DEA regulations.
DATES: This rulemaking becomes effective June 29, 2010.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152 at (202) 307-7183.
SUPPLEMENTARY INFORMATION: The CSA was amended by the Comprehensive
Crime Control Act of 1984 (Pub. L.98-473) which became effective on
October 12, 1984. This Act included a provision (21 U.S.C. 811(h))
which allows the DEA Administrator to place a substance, on a temporary
basis, into schedule I when necessary to avoid an imminent hazard to
the public safety. This emergency scheduling authority permits
scheduling a substance that is not currently controlled, is being
abused, and is a risk to the public health while the formal rulemaking
procedures (21 U.S.C. 811) described in the CSA are being conducted. A
temporary scheduling order may be issued for one year with a possible
extension of up to six months if formal scheduling procedures have been
initiated. The proposal and order are published in the Federal Register
as are the proposals and orders for formal scheduling. The emergency
scheduling authority was given to DEA in an effort to streamline the
scheduling process in response to the growing problem of controlled
substance analogues (``designer drugs'').
On October 29, 1985, DEA published a Final Rule (50 FR 43698) which
temporarily placed Acetyl-alpha-methylfentanyl, Alpha-
methylthiofentanyl, Beta-hydroxyfentanyl, Beta-hydroxy-3-
methylfentanyl, 3-Methylthiofentanyl, Thiofentanyl, Benzylfentanyl and
Thenylfentanyl into schedule I of the CSA. This control action became
effective on November 29, 1985.
These substances were emergency scheduled based on their appearance
in the illicit market, their similarity in chemical structure to that
of controlled substances, and the likelihood that they would produce
pharmacological effects similar to those of prototypic schedule I or II
substances. Often there is no biological data available prior to the
emergency control of illicitly produced and abused substances.
Therefore, information derived from structure-activity relationship
considerations plays an important role in emergency scheduling. To keep
an emergency scheduled substance in schedule I, DEA must initiate
traditional scheduling procedures (21 U.S.C. 811) for that substance
during the one year period in which it is emergency controlled and
complete the action before the expiration of 18 months. The time
limitations of emergency scheduling underscore the need for timely
abuse liability data and the need to determine the most efficient tests
to provide the data necessary to make permanent scheduling decisions.
During the one-year temporary scheduling period, DEA must acquire
sufficient data to make a determination as to whether the emergency
scheduled substance should remain under the CSA. Often the substances
have never been studied nor are they available for study. DEA, as soon
as possible after identifying a newly abused substance, provides for
the synthesis of this substance for analytical reference standards and
biological testing. Only then can the appropriate pharmacological and
abuse liability tests be conducted.
In an effort to assess the addiction liability of these compounds,
DEA contracted studies of each of the temporarily scheduled fentanyl
compounds at the University of Michigan Medical School in Ann Arbor and
at the Medical College of Virginia in Richmond. The studies indicated
that while most of the fentanyl compounds had abuse liability profiles
that warranted control, two of these temporarily scheduled compounds
(benzylfentanyl and thenylfentanyl) did not have an addiction-forming
or addiction-sustaining liability similar to morphine.
Based on the results of these studies, on November 28, 1986, the
DEA extended the temporary scheduling of six of these substances in
schedule I. However, benzylfentanyl and thenylfentanyl were
specifically omitted from this extension (and any future permanent
control) because the pharmacological and biological testing of the
substances, which included assessment of morphine-like activity,
addiction liability, and analgesic effect, indicated that the compounds
were both essentially inactive, with no evidence of abuse potential.
Both of these substances were temporarily controlled because they
were initially found in street samples with other fentanyl analogues
and were most likely unreacted intermediates in the synthesis of the
target fentanyl analogues. The DEA, having concluded that these two
drugs lacked morphine-like addictive properties, allowed the temporary
regulation of benzylfentanyl and thenylfentanyl to expire on November
29, 1986. Therefore, these two substances were no longer regulated as
controlled substances upon that date. In contrast, however, DEA chose
to extend temporary control of the other four fentanyl compounds in a
Final Rule published November 26, 1986 (51 FR 42834) and permanently
controlled them in a Final Rule published May 29, 1987 (52 FR 20070).
Action of This Rulemaking
After the temporary listing of benzylfentanyl and thenylfentanyl
expired in November of 1986, these compounds were no longer controlled
under the CSA. However, DEA never deleted 21 CFR 1308.11(g)(1) and
(g)(2) that reference the listing of these compounds temporarily in
schedule I. This rulemaking hereby corrects the CFR to delete 21 CFR
1308.11(g)(1) and (g)(2) which previously stated:
(1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide 9818
(benzylfentanyl), its optical isomers, salts and salts of
isomers.......................................................
(2) N-[1-(2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide 9834
(thenylfentanyl), its optical isomers, salts and salts of
isomers.......................................................
[[Page 37301]]
This action therefore corrects part 1308 to remove any reference to
control of benzylfentanyl and thenylfentanyl in schedule I.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including notice of proposed rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest. The temporary placement of
benzylfentanyl and thenylfentanyl in Schedule I expired on November 29,
1986. The substances were never scheduled and should have been removed
from Title 21 of the Code of Federal Regulations, part 1308. This Final
Rule corrects this by removing benzylfentanyl and thenylfentanyl from
the listing of controlled substances in schedule I. As this Final Rule
makes a technical correction by removing benzylfentanyl and
thenylfentanyl from the Code of Federal Regulations, DEA finds it
unnecessary and impracticable to permit public notice and comment.
Therefore, DEA is publishing this document as a final rule. Further, as
the removal of these substances prevents confusion about the scheduling
of these substances, DEA finds there is good cause to make this final
rule effective immediately upon publication.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), and by approving it certifies that this regulation
will not have a significant economic impact upon a substantial number
of small entities. This action removes the substances benzylfentanyl
and thenylfentanyl from the schedules of controlled substances. These
substances were temporarily scheduled in 1985 under the emergency
scheduling provisions (21 U.S.C. 811, 21 CFR 1308.11(g)) and that
temporary scheduling expired on November 29, 1986; however, the
substances were never removed from the listing.
Executive Order 12866
The Deputy Administrator certifies that this rulemaking has been
drafted in accordance with the principles in Executive Order 12866
Sec. 1(b). It has been determined that this is not ``a significant
regulatory action.'' Therefore, this action has not been reviewed by
the Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions are deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in cost
or prices; or significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based companies to compete with foreign-based companies in
domestic and export markets.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
2. Section 1308.11 is amended by revising paragraph (g) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) Temporary listing of substances subject to emergency
scheduling. Any material, compound, mixture or preparation which
contains any quantity of the following substances:
(1) [Reserved.]
(2) [Reserved.]
Dated: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15529 Filed 6-28-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
