82 FR 26349 - Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 108 (June 7, 2017)

Page Range		26349-26351
FR Document		2017-11795

With the issuance of this final order, the Administrator of the Drug Enforcement Administration will maintain the placement of the substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its 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, acetyl fentanyl.

Federal Register, Volume 82 Issue 108 (Wednesday, June 7, 2017)

[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26349-26351]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11795]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-413]


Schedules of Controlled Substances: Placement of Acetyl Fentanyl 
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 will maintain the placement of the 
substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide), including its isomers, esters, ethers, salts, and 
salts of isomers, esters and ethers, in schedule I of the Controlled 
Substances Act. This scheduling action is pursuant to the Controlled 
Substances Act and is required in order for the United States to 
discharge its 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, acetyl fentanyl.

DATES: Effective June 7, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control

[[Page 26350]]

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 
DEA. 28 CFR 0.100.

Background

    On May 17, 2016, the Secretary-General of the United Nations 
advised the Secretary of State of the United States, that during the 
59th session of the Commission on Narcotic Drugs, acetyl fentanyl was 
added to schedule I of the Single Convention on Narcotic Drugs, 1961. 
This letter was prompted by a decision at the 59th session of the 
Commission on Narcotic Drugs in March 2016 to schedule acetyl fentanyl 
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 acetyl fentanyl 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).

Acetyl Fentanyl

    On July 17, 2015, acetyl fentanyl was temporarily placed in 
schedule I of the CSA in order to avoid an imminent hazard to the 
public safety (80 FR 42381). Acetyl fentanyl is a potent opioid 
analgesic and has no accepted medical use in the United States. Since 
2013, both law enforcement (DEA's NFLIS and STARLiMS databases) and 
public health reports demonstrate the unregulated use and distribution 
of this substance. Law enforcement reports indicate that acetyl 
fentanyl is available on the illicit market as a powder or in tablet 
form which mimic pharmaceutical opiate products. In powder form, the 
identity of the substance may go unknown to the end user as it may be 
marketed as heroin or mixed with heroin. Recent reports indicate that 
acetyl fentanyl is available over the Internet.
    Acetyl fentanyl exhibits a typical morphine-like profile in 
animals. Data from the scientific literature show that the analgesic 
potency of acetyl fentanyl is up to 15.7 times greater than that of 
morphine in mice as evaluated using an acetic acid writhing method. 
Since 2013, adverse effects due to acetyl fentanyl toxicity have been 
reported in humans. Similar to other opioids (i.e. heroin, oxycodone, 
hydrocodone, fentanyl, etc.), acetyl fentanyl induces respiratory 
depression which may lead to death in an overdose event. DEA is 
currently aware of at least 57 confirmed fatalities associated with 
acetyl fentanyl misuse and/or abuse in the United States. The extent of 
abuse and mortality associated with acetyl fentanyl is likely to be 
underestimated since it is not included in most drug screens. In 
addition, the identity of fentanyl and acetyl fentanyl cannot be 
distinguished by commonly used drug screens including enzyme-linked 
immunosorbent assay (ELISA). Further confirmatory testing (i.e. mass 
spectrometry) is required to identify acetyl fentanyl.
    The DEA is not aware of any claims or any medical or scientific 
literature suggesting that acetyl fentanyl has a currently accepted 
medical use in treatment in the United States. In addition, HHS advised 
the DEA, by letter dated April 29, 2015, that there are no approved new 
drug applications or investigational new drug applications for acetyl 
fentanyl.
    By letter, dated January 11, 2016, the DEA requested that HHS 
conduct a scientific and medical evaluation of the substance's medical 
utility and a scheduling recommendation for acetyl fentanyl. Regardless 
of this request and any potential response from HHS, 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). Therefore, consistent with the 
framework of 21 U.S.C. 811(d), DEA concludes that acetyl fentanyl has 
no currently accepted medical use in treatment in the United States and 
is most appropriately placed (as it has been since July 2015) in 
schedule I of the CSA.

Conclusion

    In order to meet the obligations of the Single Convention on 
Narcotic Drugs, 1961 and because acetyl fentanyl has no currently 
accepted medical use in treatment in the United States, the 
Administrator of the Drug Enforcement Administration has determined 
that this substance should remain in schedule I of the Controlled 
Substances Act.

Requirements for Handling

    Acetyl fentanyl has been controlled as a schedule I controlled 
substance since July 17, 2015. With publication of this final order, 
acetyl fentanyl remains 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, acetyl 
fentanyl 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. Acetyl fentanyl 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. Acetyl fentanyl is 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 acetyl fentanyl 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 
acetyl fentanyl.
    6. Inventory. Every DEA registrant who possesses any quantity of 
acetyl fentanyl must keep an inventory of all stocks of this substance 
on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR 1304.03, 1304.04, and 1304.11.

[[Page 26351]]

    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to acetyl fentanyl 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 acetyl fentanyl 
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 
acetyl fentanyl 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 acetyl fentanyl 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

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 such action be taken to comply with the United States 
obligations under the specified international agreements.

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. 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.

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.

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). However, 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, 
Narcotics, Prescription drugs.

    For the reasons set out above, the DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

    Authority:  21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. Amend Sec.  1308.11 by:
0
i. Redesignating paragraphs (b)(3) through (56) as (b)(4) through (57) 
and adding a new paragraph (b)(3); and
0
ii. Removing paragraph (h)(4), redesignating paragraphs (h)(5) through 
(15) as (h)(4) through (14), and adding reserved paragraph (h)(15).
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *
    (3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide)--9821
* * * * *

    Dated: May 30, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-11795 Filed 6-6-17; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations 26349

changes that are now in effect. cause for these amendments to become cannot be obtained in time to prevent
Specifically, section 3052 of the 21st effective on the date of publication of serious harm or death to a patient, a
Century Cures Act amended section this action. HUD may be administered without prior
520(m) of the FD&C Act to allow for approval by an IRB. In such an
List of Subjects in 21 CFR Part 814
HDE approval for devices that, among emergency situation, the physician
other things, treat or diagnose a disease Administrative practice and shall, within 5 days after the use of the
or condition that affects ‘‘not more than procedure, Confidential business device, provide written notification to
8,000’’ individuals in the United States; information, Medical devices, Medical the chairman of the IRB of such use.
this threshold had been ‘‘fewer than research, Reporting and recordkeeping Such written notification shall include
4,000’’ individuals in the United States requirements. the identification of the patient
(amending 21 U.S.C. 360j(m), passim). Therefore, under the Federal Food, involved, the date on which the device
This final rule amends part 814 (21 CFR Drug, and Cosmetic Act and under was used, and the reason for the use.
part 814) in several places to accurately authority delegated to the Commissioner * * * * *
reflect the threshold recently enacted of Food and Drugs, 21 CFR part 814 is
into law. amended as follows: § 814.126 [Amended]
In addition, section 3056 of the 21st ■ 6. Amend § 814.126(b)(1)(iii) by
Century Cures Act amended section 520 PART 814—PREMARKET APPROVAL removing the number ‘‘4,000’’ and
of the FD&C Act to remove the OF MEDICAL DEVICES adding in its place the number ‘‘8,000’’.
requirement for institutional review
committees, i.e., IRBs, for devices to be 1. The authority citation for part 814 Dated: June 1, 2017.
‘‘local’’, (amending 21 U.S.C. 360j, continues to read as follows: Anna K. Abram,
passim). This final rule amends 21 CFR Authority: 21 U.S.C. 351, 352, 353, 360, Deputy Commissioner for Policy, Planning,
814.124(a), ‘‘IRB approval’’, to remove 360c–360j, 371, 372, 373, 374, 375, 379, 379e, Legislation, and Analysis.
the term ‘‘local’’ and related language in 381. [FR Doc. 2017–11816 Filed 6–6–17; 8:45 am]
order to accurately reflect the § 814.3 [Amended]
BILLING CODE 4164–01–P
requirements recently enacted into law.
FDA finds good cause for issuing this ■ 2. Amend § 814.3(n) by removing the
amendment as a final rule without words ‘‘fewer than 4,000’’ and adding in DEPARTMENT OF JUSTICE
notice and comment because this their place the words ‘‘not more than
amendment only updates the 8,000’’. Drug Enforcement Administration
implementing regulation to restate the
§ 814.100 [Amended] 21 CFR Part 1308
statute in light of amendments recently
enacted into law (see 5 U.S.C. 553(b)(B), ■ 3. Amend § 814.100(b) introductory [Docket No. DEA–413]
relating to notice and comment text by removing the words ‘‘fewer than
procedures): ‘‘[W]hen regulations 4,000’’ and adding in their place the Schedules of Controlled Substances:
merely restate the statute they words ‘‘not more than 8,000’’. Placement of Acetyl Fentanyl Into
implement, notice-and-comment Schedule I
§ 814.102 [Amended]
procedures are unnecessary’’. Gray
Panthers Advocacy Committee v. ■ 4. Amend § 814.102 as follows: AGENCY: Drug Enforcement
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. ■ a. In paragraph (a)(5), remove the Administration, Department of Justice.
1991); see also Komjathy v. Nat. Trans. words ‘‘fewer than 4,000’’ in both ACTION: Final order.
Safety Bd., 832 F.2d 1294, 1296 (D.C. occurrences and add in their places the
words ‘‘not more than 8,000’’ for both SUMMARY: With the issuance of this final
Cir. 1987) (when a rule ‘‘does no more
occurrences; order, the Administrator of the Drug
than repeat, virtually verbatim, the
■ b. In paragraph (b)(3)(i), remove the
Enforcement Administration will
statutory grant of authority’’, notice-and-
comment procedures are not required). words ‘‘fewer than 4,000’’ and add in maintain the placement of the substance
Therefore, we are issuing these their place the words ‘‘not more than acetyl fentanyl (N-(1-
amendments as a final rule, and 8,000’’; and phenethylpiperidin-4-yl)-N-
publication of this document constitutes ■ c. In paragraph (b)(3)(ii), remove the
phenylacetamide), including its
final action on this change under the words ‘‘4,000 or more’’ and add in their isomers, esters, ethers, salts, and salts of
Administrative Procedure Act (APA) (5 place the words ‘‘more than 8,000’’. isomers, esters and ethers, in schedule
U.S.C. 553). I of the Controlled Substances Act. This
■ 5. In § 814.124, revise paragraph (a) to
In addition, FDA finds good cause for scheduling action is pursuant to the
read as follows: Controlled Substances Act and is
these amendments to become effective
on the date of publication of this action. § 814.124 Institutional Review Board required in order for the United States
The APA allows an effective date less requirements. to discharge its obligations under the
than 30 days after publication as (a) IRB approval. The HDE holder is Single Convention on Narcotic Drugs,
‘‘provided by the agency for good cause responsible for ensuring that a HUD 1961. This action continues to impose
found and published with the rule’’ (5 approved under this subpart is the regulatory controls and
U.S.C. 553(d)(3)). A delayed effective administered only in facilities having administrative, civil, and criminal
date is unnecessary in this case because oversight by an Institutional Review sanctions applicable to schedule I
the new requirements are already Board (IRB) constituted and acting controlled substances on persons who
pmangrum on DSK3GDR082PROD with RULES

effective as a matter of law. pursuant to part 56 of this chapter, handle (manufacture, distribute, import,
Furthermore, this rule does not establish including continuing review of use of export, engage in research or conduct
additional regulatory obligations or the device. In addition, a HUD may be instructional activities with, or possess),
impose additional burden on regulated administered only if such use has been or propose to handle, acetyl fentanyl.
entities. As a result, affected parties do approved by an IRB. If, however, a DATES: Effective June 7, 2017.
not need time to prepare before the rule physician in an emergency situation FOR FURTHER INFORMATION CONTACT:
takes effect. Therefore, FDA finds good determines that approval from an IRB Michael J. Lewis, Diversion Control

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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Rules and Regulations 26351

7. Records and Reports. Every DEA Executive Order 12866 (Regulatory For the reasons set out above, the DEA
registrant must maintain records and Planning and Review), section 3(f), and, amends 21 CFR part 1308 as follows:
submit reports with respect to acetyl accordingly, this action has not been
fentanyl pursuant to 21 U.S.C. 827 and reviewed by the Office of Management PART 1308—SCHEDULES OF
958, and in accordance with 21 CFR and Budget (OMB). CONTROLLED SUBSTANCES
parts 1304 and 1312. 1. The authority citation for part 1308
Executive Order 13132
8. Order Forms. All DEA registrants continues to read as follows:
who distribute acetyl fentanyl must This action does not have federalism
comply with order form requirements implications warranting the application Authority: 21 U.S.C. 811, 812, 871(b),
of Executive Order 13132. This action 956(b), unless otherwise noted.
pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305. does not have substantial direct effects ■ 2. Amend § 1308.11 by:
9. Importation and Exportation. All on the States, on the relationship ■ i. Redesignating paragraphs (b)(3)
importation and exportation of acetyl between the national government and through (56) as (b)(4) through (57) and
fentanyl must be in compliance with 21 the States, or on the distribution of adding a new paragraph (b)(3); and
U.S.C. 952, 953, 957, 958, and in power and responsibilities among the ■ ii. Removing paragraph (h)(4),
accordance with 21 CFR part 1312. various levels of government. Therefore, redesignating paragraphs (h)(5) through
10. Liability. Any activity involving in accordance with Executive Order (15) as (h)(4) through (14), and adding
acetyl fentanyl not authorized by, or in 13132 (Federalism) it is determined that reserved paragraph (h)(15).
violation of the CSA, is unlawful, and this action does not have sufficient The addition reads as follows:
may subject the person to federalism implications to warrant the § 1308.11 Schedule I.
administrative, civil, and/or criminal preparation of a Federalism Assessment.
* * * * *
sanctions. Executive Order 13175 (b) * * *
Regulatory Analyses This action does not have tribal (3) Acetyl fentanyl (N-(1-
implications warranting the application phenethylpiperidin-4-yl)-N-
Administrative Procedure Act
of Executive Order 13175. The action phenylacetamide)—9821
The CSA provides for an expedited does not have substantial direct effects * * * * *
scheduling action where control is on one or more Indian tribes, on the
required by the United States Dated: May 30, 2017.
relationship between the Federal Chuck Rosenberg,
obligations under international treaties, government and Indian tribes, or on the
conventions, or protocols. 21 U.S.C. Acting Administrator.
distribution of power and
811(d)(1). If control is required pursuant responsibilities between the Federal
[FR Doc. 2017–11795 Filed 6–6–17; 8:45 am]
to such international treaty, convention, government and Indian tribes. BILLING CODE 4410–09–P
or protocol, the Attorney General must
issue an order controlling such drug Regulatory Flexibility Act
under the schedule he deems most The Regulatory Flexibility Act (RFA) ENVIRONMENTAL PROTECTION
appropriate to carry out such (5 U.S.C. 601–612) applies to rules that AGENCY
obligations, without regard to the are subject to notice and comment
findings or procedures otherwise under section 553(b) of the APA or any 40 CFR Part 52
required for scheduling actions. Id. other law. As explained above, the CSA [EPA–R09–OAR–2015–0399; FRL–9963–25–
To the extent that 21 U.S.C. 811(d)(1) exempts this final order from notice and Region 9]
directs that if control is required by the comment. Consequently, the RFA does
United States obligations under not apply to this action. Air Plan Approval; Nevada, Lake
international treaties, conventions, or Tahoe; Second 10-Year Carbon
protocols in effect on October 27, 1970, Paperwork Reduction Act of 1995 Monoxide Limited Maintenance Plan
scheduling actions shall be issued by This action does not impose a new
order (as compared to scheduling AGENCY: Environmental Protection
collection of information requirement
pursuant to 21 U.S.C. 811(a) by rule), Agency (EPA).
under the Paperwork Reduction Act of
the DEA believes that the notice and 1995. 44 U.S.C. 3501–3521. An agency ACTION: Final rule.
comment requirements of section 553 of may not conduct or sponsor, and a SUMMARY: The Environmental Protection
the Administrative Procedure Act person is not required to respond to, a Agency (EPA) is taking final action to
(APA), 5 U.S.C. 553, do not apply to this collection of information unless it approve revisions to the State of
scheduling action. In the alternative, displays a currently valid OMB control Nevada’s (‘‘State’’) April 3, 2012 state
even if this action does constitute ‘‘rule number. implementation plan (SIP) submission
making’’ under 5 U.S.C. 551(5), this
Congressional Review Act and the State’s August 26, 2016
action is exempt from the notice and
supplement to their 2012 submittal. The
comment requirements of 5 U.S.C. 553 This action is not a major rule as
State submitted these two SIP revisions
pursuant to 21 U.S.C. 553(a)(1) as an defined by section 804 of the Small
for the Lake Tahoe, Nevada carbon
action involving a foreign affairs Business Regulatory Enforcement
monoxide (CO) area to address the
function of the United States given that Fairness Act of 1996 (Congressional
Clean Air Act (CAA) requirement to
this action is being done in accordance Review Act). However, the DEA has
submit by the eighth year of the first
with 21 U.S.C. 811(d)(1)’s requirement submitted a copy of this final order to
pmangrum on DSK3GDR082PROD with RULES

maintenance plan a second 10-year
that such action be taken to comply both Houses of Congress and to the
maintenance plan.
with the United States obligations under Comptroller General.
the specified international agreements. DATES: This final rule is effective on July
List of Subjects in 21 CFR Part 1308 7, 2017.
Executive Order 12866 Administrative practice and ADDRESSES: The EPA has established a
This action is not a significant procedure, Drug traffic control, docket for this action under Docket ID
regulatory action as defined by Narcotics, Prescription drugs. Number EPA–R09–OAR–2015–0399. All

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Document Created: 2017-06-07 02:00:36
Document Modified: 2017-06-07 02:00:36

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 June 7, 2017.
Contact		Michael J. Lewis, Diversion Control
FR Citation		82 FR 26349
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control; Narcotics and Prescription Drugs

82 FR 26349 - Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 82, Issue 108 (June 7, 2017)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration