81_FR_11472 81 FR 11429 - Schedules of Controlled Substances: Extension of Temporary Placement of 10 Synthetic Cathinones in Schedule I of the Controlled Substances Act

81 FR 11429 - Schedules of Controlled Substances: Extension of Temporary Placement of 10 Synthetic Cathinones in Schedule I of the Controlled Substances Act

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 43 (March 4, 2016)

Page Range11429-11431
FR Document2016-05004

The Administrator of the Drug Enforcement Administration is issuing this final order to extend the temporary schedule I status of 10 synthetic cathinones pursuant to the temporary scheduling provisions of the Controlled Substances Act. The 10 substances are: 4-methyl-N- ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4- MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2- (methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5- yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2- (pyrrolidin-1-yl)pentan-1-one (naphyrone); and alpha- pyrrolidinobutiophenone ([alpha]-PBP) [hereinafter 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP, respectively], including their optical, positional, and geometric isomers, salts, and salts of isomers. The current final order temporarily placing 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP into schedule I is in effect through March 6, 2016. This final order will extend the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP for one year, or until the permanent scheduling action for these 10 substances is completed, whichever occurs first.

Federal Register, Volume 81 Issue 43 (Friday, March 4, 2016)
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Rules and Regulations]
[Pages 11429-11431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05004]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-386]


Schedules of Controlled Substances: Extension of Temporary 
Placement of 10 Synthetic Cathinones in Schedule I of the Controlled 
Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to extend the temporary schedule I status of 
10 synthetic cathinones pursuant to the temporary scheduling provisions 
of the Controlled Substances Act. The 10 substances are: 4-methyl-N-
ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4-
MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2-
(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-
yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone 
(4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-
(pyrrolidin-1-yl)pentan-1-one (naphyrone); and alpha-
pyrrolidinobutiophenone ([alpha]-PBP) [hereinafter 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP, respectively], including their optical, positional, 
and geometric isomers, salts, and salts of isomers. The current final 
order temporarily placing 4-MEC, 4-MePPP, [alpha]-PVP, butylone, 
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP into 
schedule I is in effect through March 6, 2016. This final order will 
extend the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP for one year, or until the permanent scheduling action for these 10 
substances is completed, whichever occurs first.

DATES: This final order is effective March 4, 2016.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for purpose of this 
action. 21 U.S.C. 801-971. The DEA published the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II.
    The CSA and its implementing regulations are designed to prevent, 
detect, and eliminate the diversion of controlled substances and listed 
chemicals into the illicit market while ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the CSA (21 U.S.C. 811) provides the Attorney 
General with the authority to temporarily place a substance into 
schedule I of the CSA for two years without regard to the requirements 
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid 
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In 
addition, if proceedings to control a substance are initiated under 21 
U.S.C. 811(a)(1), the Attorney General may extend the temporary 
scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated her scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    On March 7, 2014, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place the 10 
synthetic cathinones 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-
pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone 
([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one 
(butylone); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-
methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); and 
alpha-pyrrolidinobutiophenone ([alpha]-PBP) into schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 
FR 12938. That final order was effective on the date of publication, 
and was based on findings by the Deputy Administrator of the DEA that 
the temporary scheduling of these ten synthetic cathinones was 
necessary to avoid an imminent hazard to the public safety pursuant to 
21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) 
requires that the temporary control of these substances expires two 
years from the effective date of the scheduling order, or on March 6, 
2016. However, the CSA also provides that during the pendency of 
proceedings under 21 U.S.C. 811(a)(1) with respect

[[Page 11430]]

to the substance, the temporary scheduling of that substance could be 
extended for up to one year. Proceedings for the permanent scheduling 
of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney 
General (delegated to the Administrator of the DEA pursuant to 28 CFR 
0.100) on his or her own motion, at the request of the Secretary of 
Health and Human Services,\1\ or on the petition of any interested 
party.
---------------------------------------------------------------------------

    \1\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this final 
order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.''
---------------------------------------------------------------------------

    The Administrator of the DEA, on his own motion pursuant to 21 
U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP. The DEA has 
gathered and reviewed the available information regarding the 
pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, 
and the relative potential for abuse for these 10 synthetic cathinones. 
On December 30, 2014, the DEA submitted a request to the HHS to provide 
the DEA with a scientific and medical evaluation of available 
information and a scheduling recommendation for 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP, in accordance with 21 U.S.C. 811 (b) and (c). Upon 
evaluating the scientific and medical evidence, on March 2, 2016, the 
HHS submitted to the Administrator of the DEA its 10 scientific and 
medical evaluations for these substances. Upon receipt of the 
scientific and medical evaluation and scheduling recommendations from 
the HHS, the DEA reviewed the documents and all other relevant data, 
and conducted its own eight-factor analysis of the abuse potential of 
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP in accordance with 21 U.S.C. 811(c). 
The DEA has published a notice of proposed rulemaking for the placement 
of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 
3-FMC, naphyrone, and [alpha]-PBP into schedule I elsewhere in this 
issue of the Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Administrator of the DEA 
orders that the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP, including their optical, positional, and geometric isomers, salts, 
and salts of isomers be extended for one year, or until the permanent 
scheduling proceeding is completed, whichever occurs first.
    In accordance with this final order, the schedule I requirements 
for handling 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP, including their 
optical, positional, and geometric isomers, salts, and salts of 
isomers, will remain in effect for one year, or until the permanent 
scheduling proceeding is completed, whichever occurs first.

Regulatory Matters

    The CSA provides for an expedited temporary scheduling action where 
such action is necessary to avoid an imminent hazard to the public 
safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule 
a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) 
also provides that the temporary scheduling of a substance shall expire 
at the end of two years from the date of the issuance of the order 
scheduling such substance, except that the Attorney General may, during 
the pendency of proceedings to permanently schedule the substance, 
extend the temporary scheduling for up to one year.
    To the extent that 21 U.S.C. 811(h) directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued and extended, the DEA believes that 
the notice and comment requirements of section 553 of the 
Administrative Procedure Act (APA) (5 U.S.C. 553) do not apply to this 
extension of the temporary scheduling action. In the alternative, even 
assuming that this action might be subject to section 553 of the APA, 
the Administrator finds that there is good cause to forgo the notice 
and comment requirements of section 553, as any further delays in the 
process for extending the temporary scheduling order would be 
impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety. 
Further, the DEA believes that this final order extending the temporary 
scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, 
accordingly, is not subject to the requirements of the Regulatory 
Flexibility Act (RFA). The requirements for the preparation of an 
initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not 
applicable where, as here, the DEA is not required by section 553 of 
the APA or any other law to publish a general notice of proposed 
rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action 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 Executive Order 
13132 (Federalism), it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. It is in the public interest to maintain the temporary 
placement of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP in schedule I 
because they pose a public health risk. The temporary scheduling action 
was taken pursuant to 21 U.S.C. 811(h), which is specifically designed 
to enable the DEA to act in an expeditious manner to avoid an imminent 
hazard to the public safety. Under 21 U.S.C. 811(h), temporary 
scheduling orders are not subject to notice and comment rulemaking 
procedures. The DEA understands that the CSA frames temporary 
scheduling actions as orders rather than rules to ensure that the 
process moves swiftly, and this extension of the temporary scheduling 
order continues to serve that purpose. For the same reasons that 
underlie 21 U.S.C. 811(h), that is, the need to place these substances 
in schedule I because they pose an imminent hazard to public safety, it 
would be contrary to the public interest to delay implementation of 
this extension of the temporary scheduling order. Therefore, in 
accordance with section 808(2) of the CRA, this final order extending 
the temporary scheduling order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this final order to both 
Houses of Congress and to the Comptroller General, although such filing 
is not required under the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 
because, as noted above, this action is an order, not a rule.


[[Page 11431]]


    Dated: March 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-05004 Filed 3-3-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                     Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Rules and Regulations                                         11429

                                                PART 830—UNIQUE DEVICE                                  pyrrolidinobutiophenone (a-PBP)                       current list of all scheduled substances
                                                IDENTIFICATION                                          [hereinafter 4–MEC, 4-MePPP, a-PVP,                   is published at 21 CFR part 1308.
                                                                                                        butylone, pentedrone, pentylone, 4–                      Section 201 of the CSA (21 U.S.C.
                                                ■ 4. The authority citation for 21 CFR                  FMC, 3–FMC, naphyrone, and a-PBP,                     811) provides the Attorney General with
                                                part 830 continues to read as follows:                  respectively], including their optical,               the authority to temporarily place a
                                                  Authority: 21 U.S.C. 321, 331, 352, 353,              positional, and geometric isomers, salts,             substance into schedule I of the CSA for
                                                360, 360d, 360i, 360j, 371.                             and salts of isomers. The current final               two years without regard to the
                                                ■ 5. In § 830.110, revise paragraph (a)(1)              order temporarily placing 4–MEC, 4-                   requirements of 21 U.S.C. 811(b) if she
                                                to read as follows:                                     MePPP, a-PVP, butylone, pentedrone,                   finds that such action is necessary to
                                                                                                        pentylone, 4–FMC, 3–FMC, naphyrone,                   avoid an imminent hazard to the public
                                                § 830.110 Application for accreditation as              and a-PBP into schedule I is in effect                safety. 21 U.S.C. 811(h)(1). In addition,
                                                an issuing agency.                                      through March 6, 2016. This final order               if proceedings to control a substance are
                                                  (a) * * * (1) An applicant seeking                    will extend the temporary scheduling of               initiated under 21 U.S.C. 811(a)(1), the
                                                initial FDA accreditation as an issuing                 4–MEC, 4-MePPP, a-PVP, butylone,                      Attorney General may extend the
                                                agency shall notify FDA of its desire to                pentedrone, pentylone, 4–FMC, 3–FMC,                  temporary scheduling for up to one
                                                be accredited by sending a notification                 naphyrone, and a-PBP for one year, or                 year. 21 U.S.C. 811(h)(2).
                                                by email to: GUDIDSupport@                              until the permanent scheduling action                    Where the necessary findings are
                                                fda.hhs.gov, or by correspondence to:                   for these 10 substances is completed,                 made, a substance may be temporarily
                                                UDI Regulatory Policy Support, Center                   whichever occurs first.                               scheduled if it is not listed in any other
                                                for Devices and Radiological Health,                                                                          schedule under section 202 of the CSA
                                                                                                        DATES: This final order is effective
                                                Food and Drug Administration, 10903                                                                           (21 U.S.C. 812) or if there is no
                                                                                                        March 4, 2016.
                                                New Hampshire Ave., Bldg. 66, Rm.                                                                             exemption or approval in effect for the
                                                                                                        FOR FURTHER INFORMATION CONTACT:                      substance under section 505 of the
                                                3303, Silver Spring, MD 20993–0002.
                                                                                                        Barbara J. Boockholdt, Office of                      Federal Food, Drug, and Cosmetic Act
                                                *     *    *     *     *                                Diversion Control, Drug Enforcement                   (FDCA), 21 U.S.C. 355. 21 U.S.C.
                                                  Dated: February 29, 2016.                             Administration; Mailing Address: 8701                 811(h)(1). The Attorney General has
                                                Leslie Kux,                                             Morrissette Drive, Springfield, Virginia              delegated her scheduling authority
                                                Associate Commissioner for Policy.                      22152; Telephone: (202) 598–6812.                     under 21 U.S.C. 811 to the
                                                [FR Doc. 2016–04707 Filed 3–3–16; 8:45 am]              SUPPLEMENTARY INFORMATION:                            Administrator of the DEA. 28 CFR
                                                BILLING CODE 4164–01–P                                  Legal Authority                                       0.100.
                                                                                                           The Drug Enforcement                               Background
                                                                                                        Administration (DEA) implements and                      On March 7, 2014, the DEA published
                                                DEPARTMENT OF JUSTICE
                                                                                                        enforces titles II and III of the                     a final order in the Federal Register
                                                Drug Enforcement Administration                         Comprehensive Drug Abuse Prevention                   amending 21 CFR 1308.11(h) to
                                                                                                        and Control Act of 1970, as amended.                  temporarily place the 10 synthetic
                                                21 CFR Part 1308                                        Titles II and III are referred to as the              cathinones 4-methyl-N-ethylcathinone
                                                                                                        ‘‘Controlled Substances Act’’ and the                 (4–MEC); 4-methyl-alpha-
                                                [Docket No. DEA–386]                                    ‘‘Controlled Substances Import and                    pyrrolidinopropiophenone (4-MePPP);
                                                                                                        Export Act,’’ respectively, and are                   alpha-pyrrolidinopentiophenone (a-
                                                Schedules of Controlled Substances:                     collectively referred to as the                       PVP); 1-(1,3-benzodioxol-5-yl)-2-
                                                Extension of Temporary Placement of                     ‘‘Controlled Substances Act’’ or the                  (methylamino)butan-1-one (butylone);
                                                10 Synthetic Cathinones in Schedule I                   ‘‘CSA’’ for purpose of this action. 21                2-(methylamino)-1-phenylpentan-1-one
                                                of the Controlled Substances Act                        U.S.C. 801–971. The DEA published the                 (pentedrone); 1-(1,3-benzodioxol-5-yl)-
                                                AGENCY:  Drug Enforcement                               implementing regulations for these                    2-(methylamino)pentan-1-one
                                                Administration, Department of Justice.                  statutes in title 21 of the Code of Federal           (pentylone); 4-fluoro-N-
                                                ACTION: Final order.                                    Regulations (CFR), chapter II.                        methylcathinone (4–FMC); 3-fluoro-N-
                                                                                                           The CSA and its implementing                       methylcathinone (3–FMC); 1-
                                                SUMMARY:    The Administrator of the Drug               regulations are designed to prevent,                  (naphthalen-2-yl)-2-(pyrrolidin-1-
                                                Enforcement Administration is issuing                   detect, and eliminate the diversion of                yl)pentan-1-one (naphyrone); and alpha-
                                                this final order to extend the temporary                controlled substances and listed                      pyrrolidinobutiophenone (a-PBP) into
                                                schedule I status of 10 synthetic                       chemicals into the illicit market while               schedule I of the CSA pursuant to the
                                                cathinones pursuant to the temporary                    ensuring an adequate supply is available              temporary scheduling provisions of 21
                                                scheduling provisions of the Controlled                 for the legitimate medical, scientific,               U.S.C. 811(h). 79 FR 12938. That final
                                                Substances Act. The 10 substances are:                  research, and industrial needs of the                 order was effective on the date of
                                                4-methyl-N-ethylcathinone (4–MEC); 4-                   United States. Controlled substances                  publication, and was based on findings
                                                methyl-alpha-                                           have the potential for abuse and                      by the Deputy Administrator of the DEA
                                                pyrrolidinopropiophenone (4-MePPP);                     dependence and are controlled to                      that the temporary scheduling of these
                                                alpha-pyrrolidinopentiophenone (a-                      protect the public health and safety.                 ten synthetic cathinones was necessary
                                                PVP); 1-(1,3-benzodioxol-5-yl)-2-                          Under the CSA, every controlled                    to avoid an imminent hazard to the
                                                (methylamino)butan-1-one (butylone);                    substance is classified into one of five              public safety pursuant to 21 U.S.C.
                                                2-(methylamino)-1-phenylpentan-1-one                    schedules based upon its potential for                811(h)(1). Section 201(h)(2) of the CSA
jstallworth on DSK7TPTVN1PROD with RULES




                                                (pentedrone); 1-(1,3-benzodioxol-5-yl)-                 abuse, its currently accepted medical                 (21 U.S.C. 811(h)(2)) requires that the
                                                2-(methylamino)pentan-1-one                             use in treatment in the United States,                temporary control of these substances
                                                (pentylone); 4-fluoro-N-                                and the degree of dependence the drug                 expires two years from the effective date
                                                methylcathinone (4–FMC); 3-fluoro-N-                    or other substance may cause. 21 U.S.C.               of the scheduling order, or on March 6,
                                                methylcathinone (3–FMC); 1-                             812. The initial schedules of controlled              2016. However, the CSA also provides
                                                (naphthalen-2-yl)-2-(pyrrolidin-1-                      substances established by Congress are                that during the pendency of proceedings
                                                yl)pentan-1-one (naphyrone); and alpha-                 found at 21 U.S.C. 812(c), and the                    under 21 U.S.C. 811(a)(1) with respect


                                           VerDate Sep<11>2014   13:44 Mar 03, 2016   Jkt 238001   PO 00000   Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\04MRR1.SGM   04MRR1


                                                11430                Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Rules and Regulations

                                                to the substance, the temporary                         positional, and geometric isomers, salts,             a general notice of proposed
                                                scheduling of that substance could be                   and salts of isomers be extended for one              rulemaking.
                                                extended for up to one year.                            year, or until the permanent scheduling                  Additionally, this action is not a
                                                Proceedings for the permanent                           proceeding is completed, whichever                    significant regulatory action as defined
                                                scheduling of a substance under 21                      occurs first.                                         by Executive Order 12866 (Regulatory
                                                U.S.C. 811(a) may be initiated by the                     In accordance with this final order,
                                                                                                                                                              Planning and Review), section 3(f), and,
                                                Attorney General (delegated to the                      the schedule I requirements for
                                                                                                                                                              accordingly, this action has not been
                                                Administrator of the DEA pursuant to                    handling 4–MEC, 4-MePPP, a-PVP,
                                                                                                                                                              reviewed by the Office of Management
                                                28 CFR 0.100) on his or her own motion,                 butylone, pentedrone, pentylone, 4–
                                                                                                                                                              and Budget (OMB).
                                                at the request of the Secretary of Health               FMC, 3–FMC, naphyrone, or a-PBP,
                                                and Human Services,1 or on the petition                 including their optical, positional, and                 This action will not have substantial
                                                of any interested party.                                geometric isomers, salts, and salts of                direct effects on the States, on the
                                                   The Administrator of the DEA, on his                 isomers, will remain in effect for one                relationship between the national
                                                own motion pursuant to 21 U.S.C.                        year, or until the permanent scheduling               government and the States, or on the
                                                811(a), has initiated proceedings under                 proceeding is completed, whichever                    distribution of power and
                                                21 U.S.C. 811(a)(1) to permanently                      occurs first.                                         responsibilities among the various
                                                schedule 4–MEC, 4-MePPP, a-PVP,                                                                               levels of government. Therefore, in
                                                                                                        Regulatory Matters
                                                butylone, pentedrone, pentylone, 4–                                                                           accordance with Executive Order 13132
                                                FMC, 3–FMC, naphyrone, and a-PBP.                         The CSA provides for an expedited                   (Federalism), it is determined that this
                                                The DEA has gathered and reviewed the                   temporary scheduling action where                     action does not have sufficient
                                                available information regarding the                     such action is necessary to avoid an                  federalism implications to warrant the
                                                pharmacology, chemistry, trafficking,                   imminent hazard to the public safety. 21              preparation of a Federalism Assessment.
                                                actual abuse, pattern of abuse, and the                 U.S.C. 811(h). The Attorney General
                                                                                                        may, by order, schedule a substance in                   As noted above, this action is an
                                                relative potential for abuse for these 10                                                                     order, not a rule. Accordingly, the
                                                synthetic cathinones. On December 30,                   schedule I on a temporary basis. Id. 21
                                                                                                        U.S.C. 811(h) also provides that the                  Congressional Review Act (CRA) is
                                                2014, the DEA submitted a request to                                                                          inapplicable, as it applies only to rules.
                                                the HHS to provide the DEA with a                       temporary scheduling of a substance
                                                                                                        shall expire at the end of two years from             It is in the public interest to maintain
                                                scientific and medical evaluation of
                                                                                                        the date of the issuance of the order                 the temporary placement of 4–MEC, 4-
                                                available information and a scheduling
                                                                                                        scheduling such substance, except that                MePPP, a-PVP, butylone, pentedrone,
                                                recommendation for 4–MEC, 4-MePPP,
                                                                                                        the Attorney General may, during the                  pentylone, 4–FMC, 3–FMC, naphyrone,
                                                a-PVP, butylone, pentedrone,
                                                                                                        pendency of proceedings to                            and a-PBP in schedule I because they
                                                pentylone, 4–FMC, 3–FMC, naphyrone,
                                                                                                        permanently schedule the substance,                   pose a public health risk. The temporary
                                                and a-PBP, in accordance with 21
                                                                                                        extend the temporary scheduling for up                scheduling action was taken pursuant to
                                                U.S.C. 811 (b) and (c). Upon evaluating
                                                                                                        to one year.                                          21 U.S.C. 811(h), which is specifically
                                                the scientific and medical evidence, on
                                                                                                          To the extent that 21 U.S.C. 811(h)                 designed to enable the DEA to act in an
                                                March 2, 2016, the HHS submitted to
                                                                                                        directs that temporary scheduling                     expeditious manner to avoid an
                                                the Administrator of the DEA its 10
                                                                                                        actions be issued by order and sets forth             imminent hazard to the public safety.
                                                scientific and medical evaluations for
                                                                                                        the procedures by which such orders are               Under 21 U.S.C. 811(h), temporary
                                                these substances. Upon receipt of the
                                                                                                        to be issued and extended, the DEA                    scheduling orders are not subject to
                                                scientific and medical evaluation and
                                                                                                        believes that the notice and comment                  notice and comment rulemaking
                                                scheduling recommendations from the
                                                                                                        requirements of section 553 of the                    procedures. The DEA understands that
                                                HHS, the DEA reviewed the documents
                                                                                                        Administrative Procedure Act (APA) (5                 the CSA frames temporary scheduling
                                                and all other relevant data, and
                                                                                                        U.S.C. 553) do not apply to this                      actions as orders rather than rules to
                                                conducted its own eight-factor analysis
                                                                                                        extension of the temporary scheduling                 ensure that the process moves swiftly,
                                                of the abuse potential of 4–MEC, 4-
                                                                                                        action. In the alternative, even assuming             and this extension of the temporary
                                                MePPP, a-PVP, butylone, pentedrone,
                                                                                                        that this action might be subject to                  scheduling order continues to serve that
                                                pentylone, 4–FMC, 3–FMC, naphyrone,
                                                                                                        section 553 of the APA, the                           purpose. For the same reasons that
                                                and a-PBP in accordance with 21 U.S.C.
                                                                                                        Administrator finds that there is good                underlie 21 U.S.C. 811(h), that is, the
                                                811(c). The DEA has published a notice
                                                                                                        cause to forgo the notice and comment                 need to place these substances in
                                                of proposed rulemaking for the
                                                                                                        requirements of section 553, as any                   schedule I because they pose an
                                                placement of 4–MEC, 4-MePPP, a-PVP,
                                                                                                        further delays in the process for                     imminent hazard to public safety, it
                                                butylone, pentedrone, pentylone, 4–
                                                                                                        extending the temporary scheduling                    would be contrary to the public interest
                                                FMC, 3–FMC, naphyrone, and a-PBP
                                                                                                        order would be impracticable and                      to delay implementation of this
                                                into schedule I elsewhere in this issue
                                                                                                        contrary to the public interest in view               extension of the temporary scheduling
                                                of the Federal Register.
                                                                                                        of the manifest urgency to avoid an                   order. Therefore, in accordance with
                                                   Pursuant to 21 U.S.C. 811(h)(2), the
                                                                                                        imminent hazard to the public safety.                 section 808(2) of the CRA, this final
                                                Administrator of the DEA orders that
                                                                                                        Further, the DEA believes that this final             order extending the temporary
                                                the temporary scheduling of 4–MEC, 4-
                                                                                                        order extending the temporary                         scheduling order shall take effect
                                                MePPP, a-PVP, butylone, pentedrone,
                                                                                                        scheduling action is not a ‘‘rule’’ as                immediately upon its publication. The
                                                pentylone, 4–FMC, 3–FMC, naphyrone,
                                                                                                        defined by 5 U.S.C. 601(2), and,                      DEA has submitted a copy of this final
                                                and a-PBP, including their optical,
                                                                                                        accordingly, is not subject to the                    order to both Houses of Congress and to
jstallworth on DSK7TPTVN1PROD with RULES




                                                   1 Because the Secretary of the Department of         requirements of the Regulatory                        the Comptroller General, although such
                                                Health and Human Services has delegated to the          Flexibility Act (RFA). The requirements               filing is not required under the Small
                                                Assistant Secretary for Health of the Department of     for the preparation of an initial                     Business Regulatory Enforcement
                                                Health and Human Services the authority to make         regulatory flexibility analysis in 5 U.S.C.           Fairness Act of 1996 (Congressional
                                                domestic drug scheduling recommendations, for
                                                purposes of this final order, all subsequent
                                                                                                        603(a) are not applicable where, as here,             Review Act), 5 U.S.C. 801–808 because,
                                                references to ‘‘Secretary’’ have been replaced with     the DEA is not required by section 553                as noted above, this action is an order,
                                                ‘‘Assistant Secretary.’’                                of the APA or any other law to publish                not a rule.


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                                                                     Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Rules and Regulations                                           11431

                                                  Dated: March 2, 2016.                                    Section 6035(a)(2) provides that each              Office, Washington, DC 20402, or by
                                                Chuck Rosenberg,                                        other person required to file a return                visiting the IRS Web site at http://
                                                Acting Administrator.                                   under section 6018(b) must furnish,                   www.irs.gov.
                                                [FR Doc. 2016–05004 Filed 3–3–16; 8:45 am]              both to the Secretary and to each person
                                                                                                        who holds a legal or beneficial interest              Special Analyses
                                                BILLING CODE 4410–09–P
                                                                                                        in the property to which such return                     Certain IRS regulations, including this
                                                                                                        relates, a statement identifying the same             one, are exempt from the requirements
                                                                                                        information described in section                      of Executive Order 12866, as
                                                DEPARTMENT OF THE TREASURY                              6035(a)(1).                                           supplemented and reaffirmed by
                                                                                                           Section 6035(a)(3)(A) provides that
                                                Internal Revenue Service                                                                                      Executive Order 13563. Therefore, a
                                                                                                        each statement required to be furnished
                                                                                                                                                              regulatory impact assessment is not
                                                                                                        under section 6035 (a)(1) or (2) is to be
                                                26 CFR Part 1                                                                                                 required. In addition, section 553(b) of
                                                                                                        furnished at such time as the Secretary
                                                [TD 9757]                                               may prescribe, but in no case at a time               the Administrative Procedure Act (5
                                                                                                        later than the earlier of (i) the date                U.S.C. chapter 5) does not apply to these
                                                RIN 1545–BM98
                                                                                                        which is 30 days after the date on which              regulations because they are excepted
                                                                                                        the return under section 6018 was                     from the notice and comment
                                                Consistent Basis Reporting Between                                                                            requirements of section 553(b) and (c) of
                                                Estate and Person Acquiring Property                    required to be filed (including
                                                                                                        extensions, if any) or (ii) the date which            the Administrative Procedure Act under
                                                From Decedent                                                                                                 the interpretative rule and good cause
                                                                                                        is 30 days after the date such return is
                                                AGENCY:  Internal Revenue Service (IRS),                filed.                                                exceptions provided by section
                                                Treasury.                                                  On August 21, 2015, the Treasury                   553(b)(3)(A) and (B) of that Act. The Act
                                                                                                        Department and the IRS issued Notice                  included an immediate effective date,
                                                ACTION: Temporary regulations.
                                                                                                        2015–57, 2015–36 IRB 294. Notice                      thus making the first required
                                                SUMMARY:   This document contains                       2015–57 delays until February 29, 2016,               statements due 30 days after enactment.
                                                temporary regulations that provide                      the due date for any statements required              It is necessary to provide more time to
                                                transition rules providing that executors               by section 6035 that are due before that              provide the statements required by
                                                and other persons required to file or                   same date.                                            section 6035(a) to allow the Treasury
                                                furnish a statement under section                          On February 11, 2016, the Treasury                 Department and the IRS sufficient time
                                                6035(a)(1) or (a)(2) before March 31,                   Department and the IRS issued Notice                  to issue both substantive and procedural
                                                2016, need not do so until March 31,                    2016–19, 2016–09 IRB. That notice                     guidance on how to comply with the
                                                2016. These temporary regulations are                   provides that executors or other persons              section 6035(a) requirement and to
                                                applicable to executors and other                       required to file or furnish a statement               provide executors and other affected
                                                persons who file after July 31, 2015,                   under section 6035(a)(1) or (a)(2) before             persons the opportunity to review this
                                                returns required by section 6018(a) or                  March 31, 2016, need not do so until                  guidance before preparing the required
                                                (b).                                                    March 31, 2016.                                       statements. These regulations reiterate
                                                                                                                                                              the relief in Notice 2016–19 and,
                                                DATES:   Effective date. These regulations              Explanation of Provisions
                                                                                                                                                              because of the immediate need to
                                                are effective on March 4, 2016.                            These temporary regulations reiterate              provide relief, notice and public
                                                   Applicability dates: For date of                     that executors or other persons required              comment pursuant to 5 U.S.C. 553(b)
                                                applicability, see § 1.6035–2T(b).                      to file or furnish a statement under                  and (c) is impracticable, unnecessary,
                                                FOR FURTHER INFORMATION CONTACT:                        section 6035(a)(1) or (a)(2) before March             and contrary to the public interest. For
                                                Theresa Melchiorre (202) 317–6859 (not                  31, 2016, need not do so until March 31,              the applicability of the Regulatory
                                                a toll-free number).                                    2016. The text of these temporary                     Flexibility Act (5 U.S.C. chapter 6),
                                                Background                                              regulations also serves as the text of the            please refer to the Special Analyses
                                                                                                        proposed regulations under § 1.6035–2                 section of the preamble to the cross-
                                                  On July 31, 2015, the President of the                in the related notice of proposed                     referenced notice of proposed
                                                United States signed into law H.R. 3236,                rulemaking (REG–127923–15) in the                     rulemaking published in the Proposed
                                                the Surface Transportation and                          Proposed Rules section of this issue of               Rules section in this issue of the Federal
                                                Veterans Health Care Choice                             the Federal Register. These temporary                 Register. Pursuant to section 7805(f) of
                                                Improvement Act of 2015, Public Law                     regulations are issued within 18 months               the Internal Revenue Code (Code), these
                                                114–41, 129 Stat. 443 (Act). Section                    of the date of the enactment of the                   regulations have been submitted to the
                                                2004 of the Act added new section 6035.                 statutory provisions to which the                     Chief Counsel for Advocacy of the Small
                                                  Section 6035 imposes reporting                        temporary regulations relate and, as                  Business Administration for comment
                                                requirements with regard to the value of                authorized by section 7805(b)(2), are                 on their impact on small business.
                                                property included in a decedent’s gross                 effective/applicable to executors and
                                                estate for federal estate tax purposes.                 other persons who file a return required              Drafting Information
                                                Section 6035(a)(1) provides that the                    by section 6018(a) or (b) after July 31,
                                                executor of any estate required to file a                                                                       The principal author of these
                                                                                                        2015.
                                                return under section 6018(a) must                                                                             temporary regulations is Theresa
                                                furnish, both to the Secretary and to the               Statement of Availability of IRS                      Melchiorre, Office of the Associate Chief
                                                person acquiring any interest in                        Documents                                             Counsel (Passthroughs and Special
jstallworth on DSK7TPTVN1PROD with RULES




                                                property included in the decedent’s                       IRS Revenue Procedures, Revenue                     Industries). Other personnel from the
                                                gross estate for federal estate tax                     Rulings notices, notices and other                    Treasury Department and the IRS
                                                purposes, a statement identifying the                   guidance cited in this preamble are                   participated in their development.
                                                value of each interest in such property                 published in the Internal Revenue                     List of Subjects in 26 CFR Part 1
                                                as reported on such return and such                     Bulletin (or Cumulative Bulletin) and
                                                other information with respect to such                  are available from the Superintendent of                Income taxes, Reporting and
                                                interest as the Secretary may prescribe.                Documents, U.S. Government Printing                   recordkeeping requirements.


                                           VerDate Sep<11>2014   13:44 Mar 03, 2016   Jkt 238001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\04MRR1.SGM   04MRR1



Document Created: 2018-02-02 15:05:49
Document Modified: 2018-02-02 15:05:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis final order is effective March 4, 2016.
ContactBarbara J. Boockholdt, Office of
FR Citation81 FR 11429 

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