83 FR 17486 - Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 77 (April 20, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 77 (April 20, 2018)
| Page Range | 17486-17488 | |
| FR Document | 2018-08280 |
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)] [Rules and Regulations] [Pages 17486-17488] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08280] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-478] Schedules of Controlled Substances: Placement of Butyryl Fentanyl and U-47700 Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: With the issuance of this final order, the Administrator of the Drug Enforcement Administration maintains the placement of the substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylbutanamide) and U-47700 (3,4-dichloro-N-[2- (dimethylamino)cyclohexyl]-N-methylbenzamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, butyryl fentanyl and U-47700. DATES: Effective April 20, 2018. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Legal Authority Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. 811(d)(1)) states that, if control of a substance is required ``by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by section 201 (a) (21 U.S.C. 811 (a) or section 202(b) (21 U.S.C. 812(b)) of the Act and without regard to the procedures prescribed by section 201 (a) and (b) (21 U.S.C. 811(a) and (b).'' If a substance is added to one of the schedules of the Single Convention on Narcotic Drugs (1961), then, in accordance with article 3, paragraph 7 of the Convention, as a signatory Member State, the United States is obligated to control the substance under its national drug control legislation, the CSA. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration (DEA) (Administrator). 28 CFR 0.100. Background On April 21, 2017, the Secretary-General of the United Nations advised the Secretary of State of the United States, that during the 60th session of the Commission on Narcotic Drugs, butyryl fentanyl and U-47700 were added to schedule I of the Single Convention on Narcotic Drugs, 1961. This letter was prompted by a decision at the 60th session of the Commission on Narcotic Drugs in March 2017 to schedule butyryl fentanyl and U-47700 under schedule I of the Single Convention on Narcotic Drugs. As a signatory Member State to the Single Convention on Narcotic Drugs, the United States is obligated to control butyryl fentanyl and U-47700 under its national drug control legislation, the CSA, in the schedule deemed most appropriate to carry out its international obligations. 21 U.S.C. 811(d)(1). Butyryl Fentanyl and U-47700 On May 12, 2016, and November 14, 2016, butyryl fentanyl and U- 47700, respectively, were temporarily placed in schedule I of the CSA by the Administrator in order to avoid an imminent hazard to the public safety ((81 FR 29492-butyryl fentanyl) and (81 FR 79389-U-47700)). Butyryl fentanyl and U-47700 share a pharmacological profile similar to fentanyl, morphine, and other synthetic opioids. Law enforcement and public health reports demonstrate the illicit use and distribution of these substances, which are available on the internet. Both butyryl fentanyl and U-47700 are abused for their opioid-like effects. Evidence suggests the pattern of abuse of butyryl fentanyl and U-47700 parallels that of heroin and prescription opioid analgesics. Because both butyryl fentanyl and U-47700 can be obtained through illicit sources, information on their purity and potency is often unknown, thus posing significant adverse health risks to the users. Similar to morphine and fentanyl, both butyryl fentanyl and U-47700 act as [micro]-opioid receptor agonists. Data obtained from preclinical studies (in vitro and in vivo) demonstrate that [[Page 17487]] butyryl fentanyl and U-47700 produce pharmacological effects similar to fentanyl and morphine. Specifically, in a drug discrimination study in animals, a behavioral test used to determine subjective effect and pharmacological similarity between a test substance and a known drug of abuse, butyryl fentanyl substituted fully for morphine. Further, data obtained from a drug dependency study showed that butyryl fentanyl completely suppressed signs of withdrawal in morphine-dependent monkeys. Data obtained from in vivo (in animal) studies demonstrated that U-47700, similar to fentanyl and morphine, produced analgesic effect and functioned as a [mu] opioid receptor agonist. Specifically, analgesic activity of U-47700 was attenuated by naltrexone, an opioid receptor antagonist. Since 2014, butyryl fentanyl has been associated with numerous incidences of adverse health effects in humans. The DEA is aware of at least 40 confirmed fatalities associated with the misuse and/or abuse of butyryl fentanyl in the United States. Similarly, U-47700 has been associated with numerous cases of overdoses and overdose deaths. The DEA is not aware of any claims or any medical or scientific literature suggesting that butyryl fentanyl and U-47700 have a currently accepted medical use in treatment in the United States. In addition, HHS advised the DEA, by letters dated January 13, 2016, and April 28, 2016, that there were no investigational new drug applications or approved new drug applications for butyryl fentanyl and U-47700. By letters dated December 8, 2016, and March 1, 2017, the DEA requested that HHS conduct a scientific and medical evaluation of and a scheduling recommendation for butyryl fentanyl and U-47700, respectively. The DEA is not required under 21 U.S.C. 811(d)(1) to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not required to follow the procedures prescribed by 21 U.S.C. 811(a) and (b). By letter dated November 1, 2017, the Acting Administrator advised HHS that the DEA no longer requires scientific and medical evaluations and scheduling recommendations for butyryl fentanyl and U-47700. Therefore, consistent with the framework of 21 U.S.C. 811(d), the DEA concludes that butyryl fentanyl and U-47700 have no currently accepted medical use in treatment in the United States and are most appropriately placed (as they have been since May 2016 and November 2016, respectively) in schedule I of the CSA. Further, while the DEA temporarily scheduled these substances under 21 CFR 1308.11(h), a subsection reserved for the temporary listing of substances subject to emergency scheduling, this order moves both substances to 21 CFR 1308.11(b). As explained above, since control is required under the Single Convention on Narcotic Drugs (1961), the DEA will not be initiating regular rulemaking proceedings to schedule these substances pursuant to 21 U.S.C. 811(a). Conclusion In order to meet the United States' obligations under the Single Convention on Narcotic Drugs (1961), and because butyryl fentanyl and U-47700 have no currently accepted medical use in treatment in the United States, the Administrator has determined that these substances should remain in schedule I of the CSA. Requirements for Handling Butyryl fentanyl and U-47700 have been controlled as schedule I controlled substances since May 12, 2016, and November 14, 2016, respectively. With publication of this final order, butyryl fentanyl and U-47700 remain subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, engagement in research, and conduct of instructional activities with, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research or conducts instructional activities with, or possesses), or who desires to handle, butyryl fentanyl and U-47700 must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312. 2. Disposal of stocks. Butyryl fentanyl and U-47700 must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws. 3. Security. Butyryl fentanyl and U-47700 are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of butyryl fentanyl and U-47700 must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. 5. Quota. A quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 is required in order to manufacture butyryl fentanyl and U-47700. 6. Inventory. Every DEA registrant who possesses any quantity of butyryl fentanyl and U-47700 were required to keep an inventory of all stocks of these substances on hand as of May 12, 2016, and November 14, 2016, respectively, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 7. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to butyryl fentanyl and U-47700 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 1312. 8. Order Forms. All DEA registrants who distribute butyryl fentanyl and U-47700 must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305. 9. Importation and Exportation. All importation and exportation of butyryl fentanyl and U-47700 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312. 10. Liability. Any activity involving butyryl fentanyl and U-47700 not authorized by, or in violation of, the CSA, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Executive Order 12866 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). Executive Order 13132 This action does not have federalism implications warranting the application of Executive Order 13132. This action does 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. Executive Order 13175 This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. [[Page 17488]] Administrative Procedure Act The CSA provides for an expedited scheduling action where control is required by the United States obligations under international treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is required pursuant to such international treaty, convention, or protocol, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings or procedures otherwise required for scheduling actions. Id. To the extent that 21 U.S.C. 811(d)(1) directs that if control is required by the United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, scheduling actions shall be issued by order (as compared to scheduling pursuant to 21 U.S.C. 811(a) by rule), 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 scheduling action. In the alternative, even if this action does constitute ``rule making'' under 5 U.S.C. 551(5), this action is exempt from the notice and comment requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign affairs function of the United States given that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s requirement that the United States comply with its obligations under the specified international agreements. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this final order from notice and comment. Consequently, the RFA does not apply to this action. Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501- 3521. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Congressional Review Act This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This order will not result in: ``an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.'' However, pursuant to the CRA, the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General. 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, the DEA amends 21 CFR part 1308 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), 956(b), unless otherwise noted. 0 2. In Sec. 1308.11: 0 a. Redesignate paragraphs (b)(18) through (58) as (b)(19) through (59) and add a new paragraph (b)(18); 0 b. Add paragraph (b)(60); and 0 c. Remove and reserve paragraphs (h)(2) and (4). The additions read as follows: Sec. 1308.11 Schedule I. * * * * * (b) * * * ------------------------------------------------------------------------ ------------------------------------------------------------------------ (18) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9822 phenylbutyramide)...................................... ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ ------------------------------------------------------------------------ (60) U-47700 (3,4-Dichloro-N-[2- 9547 (dimethylamino)cyclohexyl]-N-methylbenzamide).......... ------------------------------------------------------------------------ * * * * * Dated: April 11, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018-08280 Filed 4-19-18; 8:45 am] BILLING CODE 4410-09-P
![17486 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
AIRAC date State City Airport FDC No. FDC date Subject
24–May–18 ....... WI Clintonville ..................... Clintonville Muni ............ 8/3775 3/22/18 Takeoff Minimums and Obstacle
DP, Amdt 2.
24–May–18 ....... PA Philadelphia ................... Philadelphia Intl ............. 8/4432 3/22/18 RNAV (GPS) RWY 27L, Amdt
3A.
24–May–18 ....... IN Griffith ............................ Griffith-Merrillville ........... 8/4530 3/22/18 RNAV (GPS) RWY 8, Orig.
24–May–18 ....... IN Griffith ............................ Griffith-Merrillville ........... 8/4532 3/22/18 VOR RWY 8, Amdt 8A.
24–May–18 ....... IN Griffith ............................ Griffith-Merrillville ........... 8/4534 3/22/18 RNAV (GPS) RWY 26, Orig.
24–May–18 ....... RI Newport ......................... Newport State ................ 8/4781 3/29/18 VOR/DME RWY 16, Amdt 1B.
24–May–18 ....... RI Newport ......................... Newport State ................ 8/4782 3/29/18 RNAV (GPS) RWY 16, Orig-B.
24–May–18 ....... IA Denison ......................... Denison Muni ................ 8/4938 3/29/18 RNAV (GPS) RWY 12, Amdt 1.
24–May–18 ....... KS Concordia ...................... Blosser Muni .................. 8/6132 3/29/18 Takeoff Minimums and Obstacle
DP, Amdt 1.
24–May–18 ....... ID Salmon .......................... Lemhi County ................ 8/6800 3/29/18 RNAV (GPS)-D, Amdt 2.
24–May–18 ....... MI Sturgis ........................... Kirsch Muni .................... 8/6813 3/29/18 NDB RWY 18, Amdt 5D.
24–May–18 ....... NJ Teterboro ....................... Teterboro ....................... 8/8120 3/22/18 RNAV (GPS) Y RWY 19, Orig.
24–May–18 ....... CT Windsor Locks ............... Bradley Intl .................... 8/8445 3/23/18 Takeoff Minimums and Obstacle
DP, Amdt 3.
24–May–18 ....... TN Memphis ........................ Memphis Intl .................. 8/9753 3/29/18 RNAV (GPS) Z RWY 18R, Amdt
2E.
[FR Doc. 2018–08138 Filed 4–19–18; 8:45 am] Division, Drug Enforcement This letter was prompted by a decision
BILLING CODE 4910–13–P Administration; Mailing Address: 8701 at the 60th session of the Commission
Morrissette Drive, Springfield, Virginia on Narcotic Drugs in March 2017 to
22152; Telephone: (202) 598–6812. schedule butyryl fentanyl and U–47700
DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: under schedule I of the Single
Convention on Narcotic Drugs. As a
Drug Enforcement Administration Legal Authority signatory Member State to the Single
Section 201(d)(1) of the Controlled Convention on Narcotic Drugs, the
21 CFR Part 1308 Substances Act (CSA) (21 U.S.C. United States is obligated to control
[Docket No. DEA–478] 811(d)(1)) states that, if control of a butyryl fentanyl and U–47700 under its
substance is required ‘‘by United States national drug control legislation, the
Schedules of Controlled Substances: obligations under international treaties, CSA, in the schedule deemed most
Placement of Butyryl Fentanyl and conventions, or protocols in effect on appropriate to carry out its international
U–47700 Into Schedule I October 27, 1970, the Attorney General obligations. 21 U.S.C. 811(d)(1).
shall issue an order controlling such
AGENCY: Drug Enforcement Butyryl Fentanyl and U–47700
drug under the schedule he deems most
Administration, Department of Justice. appropriate to carry out such On May 12, 2016, and November 14,
ACTION: Final order. obligations, without regard to the 2016, butyryl fentanyl and U–47700,
findings required by section 201 (a) (21 respectively, were temporarily placed in
SUMMARY: With the issuance of this final
U.S.C. 811 (a) or section 202(b) (21 schedule I of the CSA by the
order, the Administrator of the Drug
U.S.C. 812(b)) of the Act and without Administrator in order to avoid an
Enforcement Administration maintains
regard to the procedures prescribed by imminent hazard to the public safety
the placement of the substances butyryl
section 201 (a) and (b) (21 U.S.C. 811(a) ((81 FR 29492-butyryl fentanyl) and (81
fentanyl (N-(1-phenethylpiperidin-4-yl)-
and (b).’’ If a substance is added to one FR 79389–U–47700)). Butyryl fentanyl
N-phenylbutanamide) and U–47700
of the schedules of the Single and U–47700 share a pharmacological
(3,4-dichloro-N-[2-
Convention on Narcotic Drugs (1961), profile similar to fentanyl, morphine,
(dimethylamino)cyclohexyl]-N-
then, in accordance with article 3, and other synthetic opioids. Law
methylbenzamide), including their
paragraph 7 of the Convention, as a enforcement and public health reports
isomers, esters, ethers, salts, and salts of
signatory Member State, the United demonstrate the illicit use and
isomers, esters and ethers, in schedule
States is obligated to control the distribution of these substances, which
I of the Controlled Substances Act. This
substance under its national drug are available on the internet. Both
scheduling action discharges the United
control legislation, the CSA. The butyryl fentanyl and U–47700 are
States obligations under the Single
Attorney General has delegated abused for their opioid-like effects.
Convention on Narcotic Drugs (1961).
scheduling authority under 21 U.S.C. Evidence suggests the pattern of abuse
This action continues to impose the
811 to the Administrator of the Drug of butyryl fentanyl and U–47700
regulatory controls and administrative,
Enforcement Administration (DEA) parallels that of heroin and prescription
civil, and criminal sanctions applicable
(Administrator). 28 CFR 0.100. opioid analgesics. Because both butyryl
to schedule I controlled substances on
fentanyl and U–47700 can be obtained
persons who handle (manufacture, Background through illicit sources, information on
distribute, import, export, engage in On April 21, 2017, the Secretary- their purity and potency is often
research or conduct instructional
sradovich on DSK3GMQ082PROD with RULES
General of the United Nations advised unknown, thus posing significant
activities with, or possess), or propose the Secretary of State of the United adverse health risks to the users.
to handle, butyryl fentanyl and U– States, that during the 60th session of Similar to morphine and fentanyl,
47700. the Commission on Narcotic Drugs, both butyryl fentanyl and U–47700 act
DATES: Effective April 20, 2018. butyryl fentanyl and U–47700 were as m-opioid receptor agonists. Data
FOR FURTHER INFORMATION CONTACT: added to schedule I of the Single obtained from preclinical studies (in
Michael J. Lewis, Diversion Control Convention on Narcotic Drugs, 1961. vitro and in vivo) demonstrate that
VerDate Sep<11>2014 15:57 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\20APR1.SGM 20APR1](https://thefederalregister.org/doc/83_FR_17563/page/1.svg)
![17488 Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Rules and Regulations
Administrative Procedure Act economy of $100,000,000 or more; a DEPARTMENT OF STATE
The CSA provides for an expedited major increase in costs or prices for
scheduling action where control is consumers, individual industries, 22 CFR Part 172
required by the United States Federal, State, or local government [Public Notice: 10248]
obligations under international treaties, agencies, or geographic regions; or
RIN 1400–AE49
conventions, or protocols. 21 U.S.C. significant adverse effects on
811(d)(1). If control is required pursuant competition, employment, investment, Service of Process; Production or
to such international treaty, convention, productivity, innovation, or on the Disclosure of Official Information in
or protocol, the Attorney General must ability of United States-based Response to Court Orders,
issue an order controlling such drug enterprises to compete with foreign- Subpoenas, Notices of Depositions,
under the schedule he deems most based enterprises in domestic and Requests for Admissions,
appropriate to carry out such export markets.’’ However, pursuant to Interrogatories, or Similar Requests or
obligations, without regard to the the CRA, the DEA has submitted a copy Demands in Connection With Federal
findings or procedures otherwise of this final order to both Houses of or State Litigation; Expert Testimony
required for scheduling actions. Id. Congress and to the Comptroller
To the extent that 21 U.S.C. 811(d)(1) AGENCY: Department of State.
General.
directs that if control is required by the ACTION: Final rule.
United States obligations under List of Subjects in 21 CFR Part 1308
international treaties, conventions, or SUMMARY: The Department of State
protocols in effect on October 27, 1970, Administrative practice and corrects erroneous citations and
scheduling actions shall be issued by procedure, Drug traffic control, typographical errors within part 172 by
order (as compared to scheduling Reporting and recordkeeping correcting or removing them.
pursuant to 21 U.S.C. 811(a) by rule), requirements. DATES: This rule is effective on May 21,
the DEA believes that the notice and 2018.
For the reasons set out above, the DEA
comment requirements of section 553 of FOR FURTHER INFORMATION CONTACT:
the Administrative Procedure Act amends 21 CFR part 1308 as follows:
Alice Kottmyer, Attorney-Adviser, 202–
(APA), 5 U.S.C. 553, do not apply to this 647–2318, kottmyeram@state.gov.
PART 1308—SCHEDULES OF
scheduling action. In the alternative, SUPPLEMENTARY INFORMATION: Section
CONTROLLED SUBSTANCES
even if this action does constitute ‘‘rule 172 of Title 22, Code of Federal
making’’ under 5 U.S.C. 551(5), this Regulations, describes procedures for
action is exempt from the notice and ■ 1. The authority citation for part 1308
continues to read as follows: the public to follow to request testimony
comment requirements of 5 U.S.C. 553 or production of documents for
pursuant to 21 U.S.C. 553(a)(1) as an Authority: 21 U.S.C. 811, 812, 871(b), litigation (so-called ‘‘Touhy requests’’).
action involving a foreign affairs 956(b), unless otherwise noted. See United States ex rel. Touhy v.
function of the United States given that Ragen, 340 U.S. 462 (1951).
this action is being done in accordance ■ 2. In § 1308.11:
In this rulemaking, the Department is
with 21 U.S.C. 811(d)(1)’s requirement ■ a. Redesignate paragraphs (b)(18) replacing the reference to Executive
that the United States comply with its through (58) as (b)(19) through (59) and Order 12356 in the first sentence of
obligations under the specified add a new paragraph (b)(18); § 172.1(e) to instead reference Executive
international agreements. ■ b. Add paragraph (b)(60); and Order 13526 (75 FR 707), the most
Regulatory Flexibility Act ■ c. Remove and reserve paragraphs recent executive order relating to
The Regulatory Flexibility Act (RFA) (h)(2) and (4). classified national security information.
(5 U.S.C. 601–612) applies to rules that Executive Order 12356 was revoked by
The additions read as follows: Executive Order 12958, which in turn
are subject to notice and comment
under section 553(b) of the APA or any § 1308.11 Schedule I. was revoked by Executive Order 13526.
other law. As explained above, the CSA The Department also corrects a
* * * * * typographical error in § 172.2(c) so that
exempts this final order from notice and
comment. Consequently, the RFA does (b) * * * the first sentence references § 172.3(c)
not apply to this action. instead of § 173.3(c). Section 173.3(c)
(18) Butyryl fentanyl (N-(1- has no connection to service of process,
Paperwork Reduction Act of 1995 phenethylpiperidin-4-yl)-N-
phenylbutyramide) ....................... 9822
whereas § 172.3(c) relates directly to
This action does not impose a new service of process.
collection of information requirement * * * * * The Department deletes the following
under the Paperwork Reduction Act of sentence in § 172.5(a): ‘‘Where
1995. 44 U.S.C. 3501–3521. An agency (60) U–47700 (3,4-Dichloro-N-[2- documents or other materials are
may not conduct or sponsor, and a (dimethylamino)cyclohexyl]-N- sought, the party should provide a
person is not required to respond to, a methylbenzamide) ....................... 9547 description using the types of
collection of information unless it identifying information suggested in 22
displays a currently valid OMB control * * * * * CFR 171.10(a) and 171.31.’’ The two
number. Dated: April 11, 2018. citations are not valid, and are likely
Robert W. Patterson,
artifacts from Part 172 as it existed in
sradovich on DSK3GMQ082PROD with RULES
Congressional Review Act the past. The Department does not
Acting Administrator.
This action is not a major rule as believe it is necessary to provide
defined by section 804 of the Small [FR Doc. 2018–08280 Filed 4–19–18; 8:45 am] alternative citations. First, there are no
Business Regulatory Enforcement BILLING CODE 4410–09–P analogs in the current regulation for the
Fairness Act of 1996 (Congressional old §§ 171.10(a) or 171.31. Second,
Review Act (CRA)). This order will not since the sentence immediately
result in: ‘‘an annual effect on the preceding the eliminated sentence calls
VerDate Sep<11>2014 15:57 Apr 19, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\20APR1.SGM 20APR1](https://thefederalregister.org/doc/83_FR_17563/page/3.svg)
Document Created: 2018-04-20 00:03:35
Document Modified: 2018-04-20 00:03:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | Effective April 20, 2018. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 83 FR 17486 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR