[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Rules and Regulations]
[Pages 37300-37301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15529]



[[Page 37300]]

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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.

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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.

0
For the reasons set out above, 21 CFR part 1308 is amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

    Authority:  21 U.S.C. 811, 812, 871(b) unless otherwise noted.


0
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]
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