[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Rules and Regulations]
[Page 41188]
[FR Doc No: 2020-13983]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2020-0357]

Seafair Air Show Performance, Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notification of non-enforcement of regulation.

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SUMMARY: The Coast Guard will not enforce the safety zone for the
Seafair Air Show Performance in Lake Washington, Seattle, WA in July
and August 2020. The Captain of the Port Sector Puget Sound has
determined that since this event is cancelled, enforcement of this
regulation is not necessary.

DATES: The Coast Guard does not plan to enforce regulations in 33 CFR
165.1319 in July and August 2020.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of non-enforcement, call or email CWO2 William E.
Martinez, Sector Puget Sound Waterways Management Division, U.S. Coast
Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard normally enforces the Safety
Zone in 33 CFR 165.1319 for the Seattle Seafair Air Show Performance
held in Lake Washington, Seattle, WA. This event is typically held
annually during last week of July and the first weeks of August. This
year, the event organizers cancelled Seafair. Therefore, the Coast
Guard does not plan to enforce 33 CFR 165.1319 in July or August 2020.
    In addition to this notification of non-enforcement in the Federal
Register, if the situation changes and the Captain of the Port Sector
Puget Sound (COTP) determines that the regulated area needs to be
enforced, the COTP will issue a Broadcast Notice to Mariners and
provide actual notice of enforcement to any persons in the regulated
area.

    Dated: June 23, 2020.
L.A. Sturgis,
Captain, U.S. Coast Guard, Captain of the Port Sector Puget Sound.
[FR Doc. 2020-13983 Filed 7-8-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Proposed Rules]
[Pages 32365-32368]
[FR Doc No: 2022-11544]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0590; Project Identifier MCAI-2021-01395-T]
RIN 2120-AA64

Airworthiness Directives; MHI RJ Aviation ULC (Type Certificate
Previously Held by Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series
100 & 440) airplanes. This proposed AD was prompted by a determination
that a certain nondestructive test (NDT) procedure associated with a
certain airworthiness limitation for inspecting

surface and subsurface fatigue cracks at fuselage station (FS) 460 and
FS513 does not address all required inspections. This proposed AD would
require using a revised NDT procedure when performing an airworthiness
limitation task. This proposed AD would also prohibit the use of
earlier revisions of that NDT procedure. The FAA is proposing this AD
to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 15,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact MHI RJ
Aviation Group, Customer Response Center, 3655 Ave. des Grandes-
Tourelles, Suite 110, Boisbriand, Qu[eacute]bec J7H 0E2 Canada; North
America toll-free telephone<PHONE_NUMBER> or direct-dial telephone 450-
990-7272; fax<PHONE_NUMBER>; email [email protected]; internet https://mhirj.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0590; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Deep Gaurav, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0590; Project Identifier
MCAI-2021-01395-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Deep
Gaurav, Aerospace Engineer, Airframe and Propulsion Section, FAA, New
York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone:<PHONE_NUMBER>; email: [email protected]. Any commentary
that the FAA receives which is not specifically designated as CBI will
be placed in the public docket for this rulemaking.

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2021-47, dated December 13,
2021 (TCCA AD CF-2021-47) (referred to after this as the Mandatory
Continuing Airworthiness Information, or the MCAI), to correct an
unsafe condition for certain MHI RJ Aviation ULC Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. You may examine the MCAI on
the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0590.
    This proposed AD was prompted by a determination that the NDT
procedure specified in MHI RJ CRJ200 Nondestructive Testing Manual
(NDTM) Part 6--Eddy Current, procedure number 53-41-194, dated October
10, 2020, associated with airworthiness limitation task number 53-41-
194 does not address all required inspections. MHI RJ CRJ200 NDTM Part
6--Eddy Current, procedure number 53-41-194, dated October 10, 2020, is
a NDT procedure for the special detailed inspection (eddy current
inspection) for surface and subsurface fatigue cracks at FS460 and
FS513 referenced in airworthiness limitation task number 53-41-194.
Airworthiness limitations are the outside marker to ensure the
continued safety of an airplane but in this case, the procedure
associated with the airworthiness limitation was inadequate, leading to
missed fatigue cracking in these airplanes. The FAA is proposing this
AD to address such fatigue cracks, which could result in failure of the
pressure floor skin and consequent rapid decompression of the airplane
during flight. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    MHI RJ Aviation ULC has issued MHI RJ CRJ200 NDTM Temporary
Revision 53-109, dated March 5, 2021. This temporary revision describes
a NDT procedure to do a special detailed inspection (eddy current
inspection) for surface and subsurface cracks at FS460 and FS513. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
the unsafe condition

described previously is likely to exist or develop on other products of
the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require using a revised NDT procedure when
performing a certain airworthiness limitation task. This AD also
prohibits the use of earlier revisions of that NDT procedure when
performing that airworthiness limitation task.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 427 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
6 work-hours x $85 per hour = $510...........................              $0             $510         $217,770
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

MHI RJ Aviation ULC (Type Certificate Previously Held by Bombardier,
Inc.): Docket No. FAA-2022-0590; Project Identifier MCAI-2021-01395-
T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 15, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to MHI RJ Aviation ULC Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial numbers 7003 through 8079 inclusive, on which
Bombardier Service Bulletin 601R-53-067 and/or Bombardier Service
Bulletin 601R-53-077 has been incorporated.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a determination that a certain
nondestructive test procedure associated with a certain
airworthiness limitation for inspecting surface and subsurface
fatigue cracks at fuselage station (FS) 460 and FS513 does not
address all required inspections. The FAA is issuing this AD to
address such fatigue cracks, which could result in failure of the
pressure floor skin and consequent rapid decompression of the
airplane during flight.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance Procedure Limitation

    As of the effective date of this AD, use MHI RJ CRJ200
Nondestructive Testing Manual (NDTM) Part 6--Eddy Current, procedure
number 53-41-194, Special Detailed Inspection of the Pressure Floor
at FS460.00 and/or FS513.00 Between LBL18.00 and RBL18.00, as
specified in MHI RJ CRJ200 NDTM Temporary Revision 53-109, dated
March 5, 2021, when performing airworthiness limitation task number
53-41-194.
    Note 1 to paragraph (g): MHI RJ CRJ200 NDTM Temporary Revision
53-109, dated March 5, 2021, revises procedure number 53-41-194
specified in airworthiness limitation task number 53-41-194, which
can be found in Appendix B, Airworthiness Limitations, in Part 2,
Airworthiness Requirements, of the MHI RJ CL-600-2B19 Maintenance
Requirements Manual, CSP A-053.

(h) Maintenance Procedure Prohibition

    As of the effective date of this AD, it is prohibited to use MHI
RJ CRJ200 NDTM Part 6--Eddy Current, procedure number 53-41-194,
dated October 10, 2020, or earlier revisions when performing
airworthiness limitation task number 53-41-194.

(i) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the airplane to a location where the
airplane can be inspected, provided the flight is a non-revenue
flight.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue,

Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-794-
5531. Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or MHI RJ
Aviation ULC's TCCA Design Approval Organization (DAO). If approved
by the DAO, the approval must include the DAO-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2021-47, dated December 13, 2021, for related
information for related information. This MCAI may be found in the
AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0590.
    (2) For more information about this AD, contact Deep Gaurav,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone:<PHONE_NUMBER>; email: [email protected].
    (3) For service information identified in this AD, contact MHI
RJ Aviation Group, Customer Response Center, 3655 Ave. des Grandes-
Tourelles, Suite 110, Boisbriand, Qu[eacute]bec J7H 0E2 Canada;
North America toll-free telephone<PHONE_NUMBER> or direct-dial
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected];
internet https://mhirj.com. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on May 24, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-11544 Filed 5-27-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Page 14501]
[FR Doc No: 2014-05626]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [ Project No. 13728-001]

Goodwin Power, LLC; Notice of Intent to File License Application,
Filing of Pre-Application Document, and Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 13728-001.
    c. Date Filed: October 30, 2013.
    d. Submitted By: Goodwin Power, LLC.
    e. Name of Project: Goodwin Dam Hydroelectric Project.
    f. Location: On the Stanislaus River, in Tuolumne County,
California. No federal lands are occupied by the project works or
located within the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Magnus Johannesson, CEO, Goodwin
Power, LLC, 46 E. Penninsula Center, Palos Verde Estates, CA 90274;
(310) 699-6400<EMAIL_ADDRESS>    i. FERC Contact: Jennifer Adams at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Goodwin Power, LLC (Goodwin Power) filed its request to use the
Traditional Licensing Process on October 30, 2013. Goodwin Power
provided public notice of its request on December 18, 2013. In a letter
dated March 7, 2014, the Director of the Division of Hydropower
Licensing approved Goodwin Power's request to use the Traditional
Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, part 402; (b) NOAA Fisheries under
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act and implementing regulations at 50 CFR 600.920; and (c)
the California State Historic Preservation Officer, as required by
section 106, National Historical Preservation Act, and the implementing
regulations of the Advisory Council on Historic Preservation at 36 CFR
800.2.
    l. With this notice, we are designating Goodwin Power as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act,
section 305 of the Magnuson-Stevens Fishery Conservation and Management
Act, and section 106 of the National Historic Preservation Act.
    m. Goodwin Power filed a Pre-Application Document (PAD; including a
proposed process plan and schedule) with the Commission, pursuant to 18
CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: March 7, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-05626 Filed 3-13-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Page 11082]
[FR Doc No: 2019-05630]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Public Notice: Records Governing Off-the-Record Communications

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e) (1) (v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
             Docket No.                File date                       Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    CP17-101-000....................      3/12/19  Larson Design Group.
Exempt:
    P-13318-003.....................      3/12/19  Advisory Council on Historic Preservation.
----------------------------------------------------------------------------------------------------------------

    Dated: March 19, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-05630 Filed 3-22-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 102 (Thursday, May 26, 2022)]
[Notices]
[Page 32020]
[FR Doc No: 2022-11352]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0501; FRL-9892-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Green Power Partnership and Combined Heat
and Power Partnership (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Green Power Partnership and
Combined Heat and Power Partnership (EPA ICR Number 2173.08, OMB
Control Number 2060-0578) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through May 31, 2022. Public comments were previously requested via the
Federal Register on September 23, 2021 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before June 27, 2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2004-0501, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's
policy is that all comments received will be included in the public
docket without change including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Rebecca Taylor, Climate Protection
Partnerships Division, Office of Atmospheric Programs, MC 6202A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: In 2002, EPA's Energy Supply and Industry Branch (ESIB)
launched two partnership programs with industry and other stakeholders:
The Green Power Partnership (GPP) and the Combined Heat and Power
Partnership (CHPP). These voluntary partnership programs encourage
organizations to invest in renewable energy and combined heat and
power.
    EPA has developed this ICR to obtain authorization to collect
information from organizations participating in the GPP, CHPP, and
other ESIB programs. Organizations that join these programs voluntarily
agree to the following respective actions: (1) Designating a GPP or
CHPP liaison and filling out a Partnership Agreement; (2) for the CHPP,
information from stakeholders that download Partnership tools and for
the GPP, (3), reporting to EPA, on an annual basis, their progress
toward their green power commitment. EPA uses the data obtained from
its Partners to assess the success of these programs in achieving their
national energy and greenhouse gas (GHG) reduction goals. Partners are
organizational entities that have volunteered to participate in either
Partnership program.
    EPA needs to collect the information in the Partnership Agreements
to formally establish participation in the GPP or CHPP program and to
obtain general information about new Partners. Additional information
collected through information forms is needed to allow EPA to track
Partner progress toward meeting their GPP commitments, to enable GPP to
facilitate and encourage green power use, to assess whether actions are
worthy of recognition, and to determine progress in meeting GPP's
national energy and GHG reduction goals. EPA uses the information
submitted in additional forms to monitor the progress of current
participation and projects and identify new opportunities. EPA also
uses the data submitted by GPP and CHPP Partners to prepare reports on
GPP progress and determine the GHG reductions achieved by the program.
General information on the Partners, green power, and CHP is also
provided on the respective websites, making it available to other
Partners and the public.
    Form Numbers: EPA-430-K-05-013, 5900-583, 5900-584, 5900-585.
    Respondents/affected entities: Companies, institutional and public-
sector organizations that voluntarily participate in the EPA's Green
Power Partnership (GPP) or Combined Heat and Power Partnership (CHPP).
These include both service and goods providing industries, educational
institutions and non-governmental organizations, commercial and
industrial organizations, and local, state, or federal government
agencies.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 761 (total).
    Frequency of response: Annually, on occasion, one time.
    Total estimated burden: 1,445 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $81,314 (per year), which includes no
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 5,635 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease results from both the GPP and CHPP
having updated their program requirements to reduce program burden and
simplified collection forms into pre-populated spreadsheets or
documents. As a result of these changes, the average number of hours
per Partner has decreased from 2.87 hours to 1.89 hours. Additionally,
the total number of partners was significantly reduced in both
programs. The number of respondents has declined from 1,959 to 761. The
decrease in cost is due to O&M cost being mistakenly included in the
past ICR. This ICR does not include O&M due to them not being relevant.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-11352 Filed 5-25-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3741-3748]
[FR Doc No: 2018-01471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0181]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; World Health
Organization; Scheduling Recommendations; Carfentanil; 4-
fluoroamphetamine (4-FA) and Ten Other Substances; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments concerning
recommendations by the World Health Organization (WHO) to impose
international manufacturing and distributing restrictions, under
international treaties, on certain drug substances. The comments
received in response to this notice will be considered in preparing the
United States' position on these proposals for a meeting of the United
Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March
2018. This notice is issued under the Controlled Substances Act (CSA).

DATES: Submit either electronic or written comments by February 26,
2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery

service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0181 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; World
Health Organization; Scheduling Recommendations; Carfentanil; 4-
fluoroamphetamine (4-FA) and Ten Other Substances; Request for
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Section 201(d)(2)(B) of the CSA
(21 U.S.C. 811(d)(2)(B)) provides that when the United States is
notified under Article 2 of the Psychotropic Convention that the CND
proposes to decide whether to add a drug or other substance to one of
the schedules of the Psychotropic Convention, transfer a drug or
substance from one schedule to another, or delete it from the
schedules, the Secretary of State must transmit notice of such
information to the Secretary of Health and Human Services (Secretary of
HHS). The Secretary of HHS must then publish a summary of such
information in the Federal Register and provide opportunity for
interested persons to submit comments. The Secretary of HHS must then
evaluate the proposal and furnish a recommendation to the Secretary of
State that shall be binding on the representative of the United States
in discussions and negotiations relating to the proposal.
    As detailed in the following paragraphs, the Secretary of State has
received notification from the Secretary-General of the United Nations
(the Secretary-General) regarding six substances to be considered for
control under the Psychotropic Convention. This notification reflects
the recommendation from the 39th WHO Expert Committee for Drug
Dependence (ECDD), which met in November 2017. In the Federal Register
of August 14, 2017 (82 FR 37866), FDA announced the WHO ECDD review and
invited interested persons to submit information for WHO's
consideration.
    The full text of the notification from the Secretary-General is
provided in section II of this document. Section 201(d)(2)(B) of the
CSA requires the Secretary of HHS, after receiving a notification
proposing scheduling, to publish a notice in the Federal Register to
provide the opportunity for interested persons to submit information
and comments on the proposed scheduling action.
    The United States is also a party to the 1961 Single Convention on
Narcotic Drugs (1961 Single Convention). The Secretary of State has
received a notification from the Secretary-General regarding six
substances to be considered for control under this convention. The CSA
does not require HHS to publish a summary of such information in the
Federal Register. Nevertheless, to provide interested and affected
persons an opportunity to submit comments regarding the WHO
recommendations for narcotic drugs, the notification regarding these
substances is also included in this Federal Register notice. The
comments will be shared with other relevant Agencies to assist the
Secretary of State in formulating the position of the United States on
the control of these substances. The HHS recommendations are not
binding on the representative of the United States in discussions and
negotiations relating to

the proposal regarding control of substances under the 1961 Single
Convention.
    The short 30-day time period for the submission of comments is
needed to ensure that Health and Human Services may, in a timely
fashion, carry out the required action and be responsive to the United
Nations.

II. United Nations Notification

    The formal notification from the United Nations that identifies the
drug substances and explains the basis for the recommendations is
reproduced as follows (non-relevant text removed):

    Reference:

NAR/CL.4/2017
WHO/ECDD39; 1961C-Art.3; 1971C-Art.2
CU 2017/437/DTA/SGB

    The Secretary-General of the United Nations presents his
compliments to the Secretary of State of the United States of
America and has the honour to inform the Government that the
Director-General of the World Health Organization (WHO), pursuant to
article 3, paragraphs 1 and 3 of the Single Convention on Narcotic
Drugs of 1961 as amended by the 1972 Protocol (1961 Convention) and
article 2, paragraphs 1 and 4 of the Convention on Psychotropic
Substances of 1971 (1971 Convention) notified the Secretary-General
of the following recommendations:
    Substances recommended to be placed in Schedules I and IV of the
Single Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:

Carfentanil
    Chemical name: Methyl 1-(2-phenylethyl)- 4-[phenyl(propanoyl)
amino]piperidine- 4-carboxylate

    Substances recommended to be placed in Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:

Ocfentanil
    Chemical name: N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide
Furanyl fentanyl
    Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]furan-2-carboxamide
Acryloylfentanyl (Acryl fentanyl)
    Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]prop-
2-enamide
4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)
    Chemical name: N-(4-Fluorophenyl)-2-methyl-N-[1-(2-
phenylethyl)piperidin-4-yl]propanamide
Tetrahydrofuranylfentanyl (THF-F)
    Chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide

    Substances recommended to be placed in Schedule II of the
Convention on Psychotropic Substances (1971):

AB-CHMINACA
    Chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide
5F-ADB (5F-MDMB-PINACA)
    Chemical name: Methyl (2S)-2-{[1-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate
AB-PINACA
    Chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
pentyl-1H-indazole-3-carboxamide
UR-144
    Chemical name: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone
5F-PB-22
    Chemical name: Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-
carboxylate
4-Fluoroamphetamine (4-FA)
    Chemical name: 1-(4-Fluorophenyl)propan-2-amine

    In addition, in the letter from the Director-General of the
World Health Organization to the Secretary-General, reference is
also made to the recommendations by the thirty-ninth meeting of the
WHO Expert Committee on Drug Dependence (ECDD) for carrying out a
critical review of preparations containing almost exclusively
cannabidiol (CBD), Pregabalin, and Tramadol at a subsequent Expert
Committee meeting, as well as for Etizolam to remain under
surveillance. Furthermore, the letter also makes reference to the
recommendation by the Expert Committee with regard to cannabis and
its component substances.
    In accordance with the provisions of Article 3, paragraph 2 of
the 1961 Convention and article 2, paragraph 2 of the 1971
Convention, the Secretary-General hereby transmits the notification
as Annex I to the present note. Also in accordance with the same
provisions, the notification from WHO will be brought to the
attention of the sixty-first session of the Commission on Narcotic
Drugs (12-16 March 2018).
    In connection with the notification, WHO has also submitted the
relevant extract from the report of the thirty-ninth meeting of the
WHO Expert Committee on Drug Dependence which is hereby transmitted
as Annex II.
    In order to assist the Commission in reaching a decision, it
would be appreciated if the Government could communicate any
economic, social, legal, administrative or other factors that it
considers relevant to the possible scheduling of the afore-mentioned
substances that are recommended by WHO to be placed under
international control under the 1961 Convention (namely:
Carfentanil, Ocfentanil, Furanyl fentanyl, Acryloylfentanyl (Acryl
fentanyl), 4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF), and
Tetrahydrofuranylfentanyl (THF-F)) and the 1971 Convention (namely:
AB CHMINACA, 5F-ADB (5F-MDMB-PINACA), AB-PINACA, UR-144, 5F-PB-22
and 4-Fluoroamphetamine (4-FA)).
    Communications are to be sent at the latest by 2 February 2018
to the Executive Director of the United Nations Office on Drugs and
Crime, c/o Secretary, Commission on Narcotic Drugs, P.O. Box 500,
1400 Vienna, Austria, fax: +43-1-26060-5885, e-mail: [email protected].

28 December 2017
His Excellency
Mr. Rex Tillerson
Secretary of State of the United States of America

Annex I

Letter Addressed to the Secretary-General of the United Nations From
the Director-General of the World Health Organization

    ``The Thirty-Ninth meeting of the WHO Expert Committee on Drug
Dependence convened from 6 to 10 November 2017, at WHO headquarters
in Geneva. The objective of this meeting was to carry out an in-
depth evaluation of psychoactive substances in order to determine
whether or not WHO should recommend these substances to be placed
under international control.
    With reference to Article 2, paragraphs 1 and 4 of the
Convention on Psychotropic Substances (1971) and Article 3,
paragraphs 1 and 3 of the Single Convention on Narcotic Drugs
(1961), as amended by the 1972 Protocol, I am pleased to submit
recommendations of the World Health Organization as follows:
    To be placed in Schedules I and IV of the Single Convention on
Narcotic Drugs (1961):

--Carfentanil
    chemical name: Methyl 1-(2-phenylethyl)-4- [phenyl(propionoyl)
amino]piperidine-4-carboxylate

    To be placed in Schedule I of the Single Convention on Narcotic
Drugs (1961):

--Ocfentanil
    chemical name: N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide
--Furanyl fentanyl
    chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]furan-2-carboxamide
--Acryloylfentanyl (Acryl fentanyl)
    chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]prop-
2-enamide
--4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)
    chemical name: N-(4-Fluorophenyl)-2-methyl-N-[1-(2-
phenylethyl)piperidin-4-yl]propanamide
--Tetrahydrofuranylfentanyl (THF-F)
    chemical name: N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide

    To be placed in Schedule II of the Convention on Psychotropic
Substances (1971):

--AB-CHMINACA
    chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
(cyclohexylmethyl)-lH-indazole-3-carboxamide
--5F-ADB (5F-MDMB-PINACA)
    chemical name: Methyl (2S)-2-{[l-(5-fluoropentyl)-1H-indazole-3-
carbonyl] amino{time} -3,3-dimethylbutanoate
--AB-PINACA
    chemical name: N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-
pentyl-1H-indazole-3-carboxamide
--UR-144
    chemical name: (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone
--5F-PB-22

    chemical name: Quinolin-8-yl 1-(5-fluoropentyl)-l H-indole-3-
carboxylate
--4-Fluoroamphetamine (4-FA)
    chemical name: 1-(4-Fluorophenyl)propan-2-amine
    In addition, the Expert Committee recommended to carry out a
critical review at a subsequent Expert Committee meeting for:

--Preparations containing almost exclusively cannabidiol (CBD)
    chemical name: (1'R,2'R)-5'-Methyl-4-pentyl-2'-(prop-1-en-2-yl)-
1',2',3',4'-tetrahydro-[1,l'biphenyl]-2,6-diol
--Pregabalin
    chemical name: (3S)-3-(Aminomethyl)-5-methylhexanoic acid
--Tramadol
    chemical name: rac-(1R,2R)-2-[(Dimethylamino)methyl]-1-(3-
methoxyphenyl)cyclohexan-1-ol
    It also recommended that the following substance remain under
surveillance:

--Etizolam (INN)
    chemical name: 4-(2-Chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2:/] [1,2,4]triazolo[4,3-a][1,4]diazepine

    The recommendations and the assessments and findings on which
they are based are set out in detail in the Report of the 39th
Expert Committee on Drug Dependence, which is the Committee that
advises me on these issues. An extract of the Committee's Report is
attached in Annex 1 to this letter.
    I am very pleased with the ongoing collaboration among the
United Nations Office on Drugs and Crime (UNODC), International
Narcotics Control Board (INCB) and WHO, in particular, how this
collaboration has supported the work of the WHO Expert Committee on
Drug Dependence, and more generally, the implementation of
operational recommendations from the United Nations General Assembly
Special Session (UNGASS) 2016.
    I would like to take this opportunity to inform you that the
40th Expert Committee on Drug Dependence will take place in May 2018
and will be specifically dedicated to the pre review of cannabis and
its major components substances.''

Annex II

Extract From the Report of the 39th Expert Committee on Drug Dependence

    Substances recommended to be scheduled in Schedule I and
Schedule IV of the Single Convention on Narcotic Drugs (1961), as
amended by the 1972 Protocol:

Carfentanil

    Chemically, carfentanil is Methyl 1-(2-phenylethyl)-4-
[phenyl(propionoyl)amino]piperidine-4-carboxylate. Carfentanil has
no stereoisomers.
    Carfentanil has not been previously pre-reviewed or critically
reviewed. A notification was received from a Party to the
Conventions thus initiating a critical review.
    Carfentanil is convertible into sufentanil and alfentanil, two
very potent opioid analgesics controlled as Schedule I drugs under
the Single Convention on Narcotic Drugs of 1961. It is a [micro]-
opioid receptor agonist, and its pharmacodynamic and clinical
effects are similar to fentanyl but it is about 100 times more
potent. It binds to opioid receptors, and produces respiratory
depression, decreased consciousness, antinociception, and miosis.
The substance has been associated with hundreds of deaths and
nonfatal intoxications globally, and it has created significant
concerns in a number of countries. Due to the extremely small doses
that induce lethal effects, it poses a particularly serious threat
to public health.
    Carfentanil is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. There is sufficient evidence that it is being or is likely to
be abused so as to constitute a public health and social problem
warranting the placing of the substance under international control.
Thus, because it meets the required condition of similarity, it is
recommended that carfentanil (Methyl 1-(2-phenylethyl)-4-
[phenyl(propionoyl)amino]piperidine-4-carboxylate) be placed in
Schedule I of the Single Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of that Convention in
that the substance is liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.
    The Committee considered and recognized the impact that
international scheduling could have on veterinary access to
carfentanil in relation to its therapeutic use in large animals.
However, the Committee was particularly concerned regarding the
extreme potency of the substance and serious risk to public health.
The Committee felt that the therapeutic advantages did not offset
the severe threat to human health. As such, and with consideration
that substances in Schedule IV afford Parties the opportunity to
adopt special measures for drugs with particularly dangerous
properties, the Committee recommended that carfentanil (Methyl 1-(2-
phenylethyl)-4-[phenyl(propionoyl)amino]piperidine-4-carboxylate) be
also placed in Schedule IV of the Single Convention on Narcotic
Drugs of 1961.
    Substances recommended to be placed in Schedule I of the Single
Convention on Narcotic Drugs (1961), as amended by the 1972
Protocol:

Ocfentanil

    Chemically, ocfentanil is N-(2-Fluorophenyl)-2-methoxy-N-[1-(2-
phenylethyl)piperidin-4-yl]acetamide. It has no stereoisomers.
    Ocfentanil has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to the attention of WHO that ocfentanil is clandestinely
manufactured, poses a risk to public health and society, and has no
recognized therapeutic use by any party.
    Ocfentanil is an opioid that is structurally related to fentanyl
that is regulated under Schedule I of the Single Convention on
Narcotic Drugs of 1961, and produces opioid effects including
analgesia, euphoria, sedation, and potentially serious respiratory
depression. Ocfentanil-related deaths have been reported, and it has
come under national control in several countries in different
regions of the world.
    Ocfentanil is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. It has no recorded therapeutic use, and its use has been
associated with fatalities. There is sufficient evidence that it is
being or is likely to be abused so as to constitute a public health
and social problem warranting the placing of the substance under
international control. Thus, because it meets the required condition
of similarity, it is recommended that ocfentanil (N-(2-
Fluorophenyl)-2-methoxy-N-[1-(2-phenylethyl)piperidin-4-
yl]acetamide) be placed in Schedule I of the Single Convention on
Narcotic Drugs of 1961, as consistent with Article 3, paragraph 3
(iii) of that Convention in that the substance is liable to similar
abuse and productive of similar ill effects to drugs in Schedule I.

Furanyl fentanyl

    Chemically, furanyl fentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]furan-2-carboxamide. Furanyl fentanyl has
no stereoisomers.
    Furanyl fentanyl has not been previously pre-reviewed or
critically reviewed. A direct critical review was proposed based on
information brought to WHO's attention that furanyl fentanyl is
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognized therapeutic use by any
party.
    Furanyl fentanyl is a compound liable to similar abuse and with
similar ill effects to controlled opioids such as fentanyl that are
included in Schedule I of the Single Convention on Narcotic Drugs of
1961. It has no recorded therapeutic use and its use has been
associated with fatalities. There is sufficient evidence that it is
being or is likely to be abused so as to constitute a public health
and social problem warranting the placing of the substance under
international control. Thus, because it meets the required condition
of similarity, it is recommended that furanyl fentanyl (N-Phenyl-N-
[1-(2-phenylethyl)piperidin-4-yl]furan-2-carboxamide) be placed in
Schedule I of the Single Convention on Narcotic Drugs of 1961, as
consistent with Article 3, paragraph 3 (iii) of that Convention in
that the substance is liable to similar abuse and productive of
similar ill effects to drugs in Schedule I.

Acryloylfentanyl (Acryl fentanyl)

    Chemically, acryloylfentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]prop-2-enamide. It has no stereoisomers.
    Acryloylfentanyl has not been previously pre-reviewed or
critically reviewed. A direct critical review was proposed based on
information brought to WHO's attention that acryloylfentanyl is
clandestinely manufactured, of especially serious risk to public
health and society, and of no recognized therapeutic use by any
party.
    Acryloylfentanyl is a compound liable to similar abuse and with
similar ill effects to

controlled opioids such as fentanyl that are included in Schedule I
of the Single Convention on Narcotic Drugs of 1961. It has no
recorded therapeutic use, and its use has been associated with
fatalities. There is sufficient evidence that it is being or is
likely to be abused so as to constitute a public health and social
problem warranting the placing of the substance under international
control. Thus, because it meets the required condition of
similarity, it is recommended that acryloylfentanyl (N-Phenyl-N-[1-
(2-phenylethyl)piperidin-4-yl]prop-2-enamide) be placed in Schedule
I of the Single Convention on Narcotic Drugs of 1961, as consistent
with Article 3, paragraph 3 (iii) of that Convention in that the
substance is liable to similar abuse and productive of similar ill
effects to drugs in Schedule I.

4-Fluoroisobutyryl fentanyl (4-FIBF, pFIBF)

    Chemically, 4-fluoroisobutyryl fentanyl (4-FIBF, pFIBF) is N-(4-
Fluorophenyl)-2-methyl-N-[1-(2-phenylethyl)piperidin-4-
yl]propanamide.
    4-Fluoroisobutyryl fentanyl has not been previously pre-reviewed
or critically reviewed. A direct critical review was proposed based
on information brought to WHO's attention that it is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
    4-Fluoroisobutyryl fentanyl is a compound liable to similar
abuse and with similar ill effects to controlled opioids such as
fentanyl that are included in Schedule I of the Single Convention on
Narcotic Drugs of 1961. It has no recorded therapeutic use, and its
use has been associated with fatalities. There is sufficient
evidence that it is being or is likely to be abused so as to
constitute a public health and social problem warranting the placing
of the substance under international control. Thus, because it meets
the required condition of similarity, it is recommended that 4-
fluoroisobutyryl fentanyl (N-(4-Fluorophenyl)-2-methyl-N-[l-(2-
phenylethyl)piperidin-4-yl]propanamide) be placed in Schedule I of
the Single Convention on Narcotic Drugs of 1961, as consistent with
Article 3, paragraph 3 (iii) of that Convention in that the
substance is liable to similar abuse and productive of similar ill
effects to drugs in Schedule I.

Tetrahydrofuranylfentanyl (THF-F)

    Chemically, tetrahydrofuranylfentanyl is N-Phenyl-N-[1-(2-
phenylethyl)piperidin-4-yl]oxolane-2-carboxamide.
Tetrahydrofuranylfentanyl contains a stereogenic centre allowing for
the existence of a pair of enantiomers, (S)-
tetrahydrofuranylfentanyl and (R)-tetrahydrofuranylfentanyl. There
is no information on the actual enantiomers found on the illicit
drug market at the time of the report.
    Tetrahydrofuranylfentanyl has not been previously pre-reviewed
or critically reviewed. A direct critical review was proposed based
on information brought to WHO's attention that
tetrahydrofuranylfentanyl is clandestinely manufactured, of
especially serious risk to public health and society, and of no
recognized therapeutic use by any party.
    Tetrahydrofuranylfentanyl is a compound liable to similar abuse
and with similar ill effects to controlled opioids such as fentanyl
that are included in Schedule I of the Single Convention on Narcotic
Drugs of 1961. It has no recorded therapeutic use, and its use has
been associated with fatalities. There is sufficient evidence that
it is being or is likely to be abused so as to constitute a public
health and social problem warranting the placing of the substance
under international control. Thus, because it meets the required
condition of similarity, it is recommended that
tetrahydrofuranylfentanyl (N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-
yl]oxolane-2-carboxamide) be placed in Schedule I of the Single
Convention on Narcotic Drugs of 1961, as consistent with Article 3,
paragraph 3 (iii) of that Convention in that the substance is liable
to similar abuse and productive of similar ill effects to drugs in
Schedule I.
    Substances recommended to be scheduled in Schedule II of the
Convention on Psychotropic Substances (1971):

AB-CHMINACA

    Chemically, AB-CHMINACA is N-[(2S)-l-Amino-3-methyl-1-oxobutan-
2-yl]-1-(cyclohexylmethyl)-lHindazole-3-carboxamide. AB-CHMINACA
contains a chiral centre, so that two enantiomers exist: (R)-
ABCHMINACA and (S)-AB-CHMINACA. Based on the literature and the most
likely precursors to be used in manufacture, an (S)-configuration of
the stereocenter should be expected.
    AB-CHMINACA has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AB-CHMINACA is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
    AB-CHMINACA is a synthetic cannabinoid receptor agonist. It is
clandestinely manufactured and sold under a variety of brand names.
Its mode of action suggests also the potential for dependence and
likelihood of misuse. Effects of AB-CHMINACA are consistent with
those of synthetic cannabinoid receptor agonists and include
relaxation, euphoria, depersonalization, distorted perception of
time, impaired motor performance, hallucinations, paranoia,
confusion, fear, anxiety, tachycardia, and nausea and vomiting. Its
cannabimimetic effects are more potent than those of THC, which is
listed in Schedule II in the Convention on Psychotropic Substances
of 1971. There is evidence of an increase in number of persons using
AB-CHMINACA in many countries that have included fatal and non-fatal
cases. This substance causes substantial harm and has no therapeutic
usefulness. AB-CHMINACA has similar abuse and similar ill effects as
other synthetic cannabinoids receptor agonists already scheduled in
Schedule II of the Convention on Psychotropic Substances of 1971.
The Committee recommended that AB-CHMINACA (N-[(2S)-l-Amino-3-
methyl-1-oxobutan-2-yl]-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide) be placed in Schedule II under the Convention on
Psychotropic Substances of 1971.

5F-ADB/5F-MDMB-PINACA

    Chemically, 5F-ADB (also known as 5F-MDMB-PINACA) is Methyl
(2S)-2-{[l-(5-fluoropentyl)-1Hindazole-3-carbonyl]amino{time} -3,3-
dimethylbutanoate. 5F-ADB contains a chiral centre, so that two
enantiomers exist: (R)-5F-ADB and (S)-5F-ADB.
    5F-ADB has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 5F-ADB is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
    5F-ADB is a synthetic cannabinoid receptor agonist. It has
cannabimimetic effects that are more potent than those of THC and
MDMB-CHMICA, substances which are listed in Schedule II of the
Convention on Psychotropic Substances of 1971. Its mode of action
suggests the potential for dependence and likelihood of abuse. There
is evidence of an increase in number of persons using 5F-ADB in many
countries that have included fatal and non-fatal cases. This
substance causes substantial harm and has no therapeutic usefulness.
The Committee recommended that 5F-ADB, also known as 5F-MDMB-PINACA,
(Methyl (2S)-2-{[l-(5-fluoropentyl)-1H-indazole-3-
carbonyl]amino{time} -3,3-dimethylbutanoate) be placed in Schedule
II under the Convention on Psychotropic Substances of 1971.

AB-PINACA

    Chemically, AB-PINACA is N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-
yl]-1-pentyl-1H-indazole-3-carboxamide. AB-PINACA has stereoisomers.
    AB-PINACA has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that AB-PINACA is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
    The Committee considered that the degree of risk to public
health and society associated with the abuse of AB-PINACA is
substantial. Therapeutic usefulness has not been recorded. It
recognized that AB-PINACA has similar abuse and similar ill-effects
to other synthetic cannabinoids receptor agonists in Schedule II of
the Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that AB-PINACA is being
or is likely to be abused so as to constitute a public health and
social problem warranting the placing of the substance under
international control. The Committee recommended that ABPINACA (N-
[(2S)-l-Amino-3-methyl-1-oxobutan-2-yl]-1-pentyl-1H -indazole-3-
carboxamide) be placed in Schedule II under the Convention on
Psychotropic Substances of 1971.

UR-144

    Chemically, UR-144 is (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone. It has no stereoisomers.
    UR-144 was previously critically reviewed by the 36th ECDD in
2014. The Committee

recommended that UR-144 not be placed under international control at
that time but be kept under surveillance.
    Of particular significance to the Committee was the lack of
analytically confirmed cases of non-fatal and fatal intoxications at
the time involving solely UR-144. Subsequent data collected from the
literature and from different countries indicating that this
substance may cause substantial harm and that it has no medical use,
warranted an updated critical review.
    The Committee considered that the degree of risk to public
health and society associated with the abuse of UR-144 is
substantial. Therapeutic usefulness has not been recorded. It
recognized that UR-144 has similar abuse and similar ill-effects to
other synthetic cannabinoids receptor agonists in Schedule II of the
Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that UR-144 is being or
is likely to be abused so as to constitute a public health and
social problem warranting the placing of the substance under
international control. The Committee recommended that UR-144 ((1-
Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone) be
placed in Schedule II under the Convention on Psychotropic
Substances of 1971.

5F-PB-22

    Chemically, 5F-PB-22 is Quinolin-8-yl 1-(5-fluoropentyl)-lH-
indole-3-carboxylate. It has no stereoisomers.
    5F-PB-22 has not been previously pre-reviewed or critically
reviewed. A direct critical review was proposed based on information
brought to WHO's attention that 5F-PB-22 is clandestinely
manufactured, of especially serious risk to public health and
society, and of no recognized therapeutic use by any party.
    The Committee considered that the degree of risk to public
health and society associated with the abuse of 5F-PB-22 is
substantial. Therapeutic usefulness has not been recorded. It
recognized that 5F-PB-22 has similar abuse and similar ill-effects
to other synthetic cannabinoids receptor agonists in Schedule II of
the Convention on Psychotropic Substances of 1971. The Committee
considered that there is sufficient evidence that 5F-PB-22 is being
or is likely to be abused so as to constitute a public health and
social problem warranting the placing of the substance under
international control. The Committee recommended that 5F-PB-22
(Quinolin-8-yl 1-(5-fluoropentyl)-l H-indole-3-carboxylate) be
placed in Schedule II under the Convention on Psychotropic
Substances of 1971.

4-Fluoroamphetamine (4-FA)

    The chemical name of 4-FA is 1-(4-Fluorophenyl)propan-2-amine.
The presence of a chiral centre gives rise to the enantiomeric pair
of (S)-4-FA and (R)-4-FA, respectively. 4-FA is most likely to be
available as the racemic mixture.
    4-FA underwent a critical review in 2015. At that time, the
committee recommended that 4-FA not be placed under international
control due to insufficient evidence regarding dependence, abuse,
and risks to public health. However, it was kept under surveillance.
Preliminary information collected from various sources indicated
that this substance may cause substantial harm and that it has no
medical use, thereby warranting an updated critical review.
    4-FA is a ring-substituted derivative of amfetamine that is
listed in Schedule II of the Convention on Psychotropic Substances
of 1971. The clinical features associated with 4-FA intoxications
include agitation, tachycardia, hypertension, hyperthermia,
cardiovascular toxicity and cerebrovascular complications such as
severe headaches and cerebral hemorrhage. Some severe adverse
reactions required hospitalizations and others resulted in death.
    The Committee considered that the degree of risk to public
health and society associated with the abuse of 4-FA is substantial.
Therapeutic usefulness has not been recorded. It recognized that 4-
FA has similar abuse and similar ill-effects to substances in
Schedule II of the Convention on Psychotropic Substances of 1971.
    The Committee considered that there is sufficient evidence that
4-FA is being or is likely to be abused so as to constitute a public
health and social problem warranting the placing of the substance
under international control. The Committee recommended that 4-FA (1-
(4-Fluorophenyl)propan-2-amine) be placed in Schedule II under the
Convention on Psychotropic Substances of 1971.
    Substances recommended for critical review:

Preparations Containing Almost Exclusively Cannabidiol (CBD)

    Chemically, cannabidiol is (l'R,2'R)-5'-Methyl-4-pentyl-2'-
(prop-1-en-2-yl)-l',2',3',4'-tetrahydro-[1,1'-biphenyl]-2,6-diol.
Cannabidiol (CBD) is normally taken to refer to the naturally
occurring (-)- enantiomer.
    Cannabidiol has not been previously pre-reviewed or critically
reviewed by the Expert Committee on Drug Dependence (ECDD). The
current review was based on the recommendation from the 38th ECDD
that pre-review documentation on cannabis-related substances,
including cannabidiol, be prepared and evaluated at a subsequent
committee meeting.
    CBD is not specifically listed in the schedules of the 1961,
1971 or 1988 International Drug Control Conventions. There is no
evidence that CBD as a substance is liable to similar abuse and
similar ill-effects as substances in the 1961 or 1971 Conventions
(including cannabis and dronabinol (THC), respectively). The purpose
of the pre-review was to determine whether current information
justifies an Expert Committee critical review whereby the Committee
finds that information may justify the scheduling or a change in the
scheduling of the substance in the 1961 or 1971 Conventions. As CBD
is not currently a scheduled substance in its own right (only as a
component of cannabis extracts), current information does not
justify a change in this scheduling position and does not justify
scheduling of the substance.
    However, CBD is produced for pharmaceutical purposes as an
extract of cannabis, and cannabis extracts and tinctures are
included in the Single Convention on Narcotic Drugs of 1961. The
pre-review of Cannabis Extracts and Tinctures will be held at the
40th ECDD meeting in May 2018. Therefore it is also recommended that
extracts or preparations containing almost exclusively CBD
(cannabidiol; (l'R,2'R)-5' Methyl-4-pentyl-2'-(prop-1-en-2-yl)-
1',2',3',4'-tetrahydro-[1,l'-biphenyl]-2,6-diol) be subject to
critical review at that meeting.

Pregabalin

    Chemically, pregabalin is (3S)-3-(Aminomethyl)-5-methylhexanoic
acid. Pregabalin is the (S)-(+)-isomer of 3-isobutyl-GABA.
    Pregabalin has not been previously pre-reviewed or critically
reviewed. A pre-review at the 39th ECDD was proposed based on
information received by the WHO Secretariat regarding the misuse of
pregabalin.
    Pregabalin, a gabapentinoid, is an analogue of gamma amino
butyric acid (GABA), but does not act at GABA receptors or synapses
or bind to benzodiazepine receptors. While pregabalin has
therapeutic uses, the increasing evidence of its misuse and abuse in
many countries is becoming a growing cause for concern.
    Pregabalin has been shown to have the capacity to produce a
state of dependence. On this basis, the Committee recommended that
pregabalin ((3S)-3-(Aminomethyl)-5-methylhexanoic acid) proceed to a
future critical review. The Committee requested that the Secretariat
collect further data to support the critical review.

Tramadol

    Chemically, tramadol is rac-(1R,2R)-2-[(Dimethylamino)methyl]-1-
(3-methoxyphenyl)cyclohexan-1-ol. Tramadol has two chiral centres
and consequently, four different stereoisomers exist: (1R,2R),
(1S,2S), (1R,2S), and (1S,2R).
    Pre-reviews of Tramadol have been carried out by the ECDD in
1992, 2000, 2006, and 2014 and a critical review in 2002. The
Committee most recently at its 36th meeting in 2014, and based on
the evidence available regarding dependence, abuse and risks to
public health, recommended that a critical review of tramadol was
not warranted at that time. On the basis of information received by
the WHO Secretariat regarding the misuse of tramadol, it was
recommended that a pre-review of tramadol be carried out at the 39th
ECDD in November 2017.
    Tramadol is used as a medication for controlling moderate acute
and chronic painful conditions, and it is listed in several national
essential medicines lists. It produces opioid-like effects
predominately through the conversion of tramadol into its active
metabolite. There is growing evidence of abuse of tramadol in many
countries, accompanied by adverse reactions, and tramadol-associated
deaths. The Committee recommended that tramadol ((rac-(1R,2R)-2-
[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol) proceed
to a critical review at a subsequent meeting. The Committee
requested the Secretariat to collect additional data for the
critical review, including engagement with Member States to

obtain information on the extent of problems associated with
tramadol misuse. Also, the Committee asked for information on the
medical use of tramadol including the extent that low income
countries, countries facing conflicts and aid and relief agencies
use and possibly rely on tramadol for provision of analgesia.
    Substance recommended to remain under surveillance:

Etizolam (INN)

    Chemically, etizolam is 4-(2-Chlorophenyl)-2-ethyl-9-methyl-6H-
thieno[3,2-f][1,2,4]triazolo[4,3-a][l,4]diazepine. It does not have
stereoisomers.
    The ECDD reviewed etizolam at the 26th meeting (1989) and the
27th meeting (1990). At the 37th ECDD in 2015, the committee pre-
reviewed etizolam and recommended that a critical review of etizolam
was warranted for a future meeting. The Committee noted deficiencies
in information and suggested several potential sources that could be
helpful in the preparation of the critical review, including those
from traffic accident reports, seizure data, user forums, and
pharmacovigilance data.
    Owing to the lack of significantly more information since the
pre-review conducted by the 37th ECDD in 2015, and considering the
current insufficiency of data regarding dependence, abuse and risks
to public health, the Committee recommended that etizolam (4-(2-
Chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f] [1,2,4]triazolo[4,3-
a][l,4]diazepine) be kept under surveillance. The Committee asked
the Secretariat to request more data from Member States that may be
affected by the misuse of etizolam, and which could facilitate a
future review.

III. Discussion

    Although WHO has made specific scheduling recommendations for each
of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered
for control under the Psychotropic Convention include the following:
(1) Accept the WHO recommendations; (2) accept the recommendations to
control, but control the drug substance in a schedule other than that
recommended; or (3) reject the recommendations entirely.
    Carfentanil, also known as 4-carbomethoxyfentanyl, is an extremely
potent synthetic opioid that is similar in structure to and
approximately 100 times more potent than fentanyl as an analgesic. At
one time legitimately produced, carfentanil is no longer manufactured,
marketed, or used in the United States; it is approved by FDA for use
under restricted conditions by veterinarians as an immobilizing agent
for certain large animals. Illicitly produced carfentanil is a
particularly harmful fentanyl analogue that is also being laced into
heroin or sold by itself and trafficked in the United States. It is not
approved for human use. Drug seizure data indicate that carfentanil is
typically used in small doses to cut heroin and other illicitly abused
drugs. The significant risk to public health associated with
carfentanil use stems from its respiratory depressive effects with very
small amounts. Several fatalities have been reported as the result of
carfentanil overdoses. On October 28, 1988, the Drug Enforcement
Administration (DEA) published a Final Rule that placed carfentanil in
Schedule II of the CSA (53 FR 43684). As such, no additional controls
will be necessary to fulfill U.S. obligations if carfentanil is placed
in Schedules I and IV of the Single Convention on Narcotic Drugs
(1961).
    Ocfentanil is a synthetically produced opioid that is structurally
related to fentanyl and approximately equipotent in effect. Reported
risks associated with use of ocfentanil include development of opioid
use disorder, overdose, and fatal overdose. It has no approved medical
use in the United States. The DEA initiated the temporary placement of
this substance under Schedule I by publishing a notification of intent
in the Federal Register on December 13, 2017 (82 FR 58575). As such,
additional controls will be necessary to fulfill U.S. obligations if
ocfentanil is placed in Schedules I of the Single Convention on
Narcotic Drugs (1961).
    Furanyl fentanyl (Fu-F) is a potent clandestinely produced
synthetic opioid that is an analog of fentanyl. Evidence suggests that
the pattern of abuse of fentanyl analogues, including furanyl fentanyl,
parallels that of heroin and prescription opioid analgesics. Fu-F
produces typical opioid effects that include respiratory depression and
loss of consciousness. Seizures of Fu-F have been encountered in powder
form. Fu-F has been connected to fatal overdoses, in which intravenous
routes of administration are documented. It has no approved medical use
in the United States. On November 29, 2016, the DEA issued a final
order to temporarily schedule Fu-F and its isomers, esters, ethers,
salts and salts of isomers, esters and ethers into Schedule I pursuant
to the temporary scheduling provisions of the CSA (81 FR 85873). As
such, additional permanent controls will be necessary to fulfill U.S.
obligations if Fu-F is controlled under Schedule I of the 1961 Single
Convention.
    Acryloylfentanyl (Acryl fentanyl) belongs to the 4-
anilidopiperidine class of synthetic opioids and is similar in
structure to fentanyl. Acryloylfentanyl is a clandestinely produced
analog of fentanyl and sold illegally as a research chemical on several
websites. Acryloylfentanyl has also been associated with adverse events
typically associated with opioid use such as respiratory depression,
anxiety, constipation, tiredness, hallucinations, and withdrawal. The
use of acryloylfentanyl has also been linked to the development of
opioid use disorder, overdose, and fatal overdose.
    Acryloylfentanyl has no commercial or medical uses. On July 14,
2017, the DEA issued a temporary order to temporarily schedule
acryloylfentanyl, its isomers, esters, ethers, salts and salts of
isomers, esters and ethers into Schedule I pursuant to the temporary
scheduling provisions of the CSA (82 FR 32453). As such, additional
permanent controls will be necessary to fulfill U.S. obligations if Fu-
F is controlled under Schedule I of the 1961 Single Convention.
    4-fluoroisobutyryl fentanyl (4-FIBF) is a clandestinely produced
synthetic opioid that is an analog of fentanyl. It has m-receptor
agonist activity similar to that of fentanyl. This would result in
effects associated with opioid agonists such as analgesia, respiratory
depression, anxiety, constipation, tiredness, hallucinations,
withdrawal, development of opioid use disorder, overdose, and fatal
overdose. The use of 4-FIBF has been implicated in several cases of
overdose and fatal overdoses. 4-FIBF has not been approved for medical
use in the United States. On May 3, 2017, the DEA issued a temporary
order to temporarily schedule 4-FIBF, its isomers, esters, ethers,
salts and salts of isomers, esters and ethers into Schedule I pursuant
to the temporary scheduling provisions of the CSA (82 FR 20544). As
such, additional permanent controls will be necessary to fulfill U.S.
obligations if 4-FIBF is controlled under Schedule I of the 1961 Single
Convention.
    AB-CHMINACA is a clandestinely produced synthetic cannabinoid
agonist that is approximately 16 times more potent than delta-9-
tetrahydrocannabinol. Adverse effects produced by cannabinoid agonists
include tachycardia, agitation, hallucination, chest pain, seizure,
organ failure, anxiety, acute psychosis, and death. AB-CHMINACA has
been detected in illicit synthetic cannabinoid substances and found in
cases of overdose and hospitalizations. On October 16, 2017, the DEA
published a Final Rule to permanently control AB-CHMINACA as a Schedule
I substance under the CSA (82 FR 47971). As such, additional permanent
controls will be not necessary to fulfill U.S. obligations if AB-
CHMINACA is controlled under

Schedule I of the 1961 Single Convention.
    5F-ADB is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
and acute psychosis. 5F-ADB has been identified in overdose and/or
cases involving death attributed to their abuse. Adverse health effects
reported from incidents involving 5F-ADB and other synthetic
cannabinoids have included: nausea, persistent vomiting, agitation,
altered mental status, seizures, convulsions, loss of consciousness,
and/or cardio toxicity. On April 10, 2017, the DEA issued a temporary
scheduling order to temporarily schedule 5F-ADB, its isomers, esters,
ethers, salts and salts of isomers, esters, and ethers into Schedule I
pursuant to the temporary scheduling provisions of the CSA (82 FR
17119). As such, additional permanent controls will be necessary to
fulfill U.S. obligations if 5F-ADB is controlled under Schedule II of
the 1971 Convention on Psychotropic Substances.
    AB-PINACA is a clandestinely produced synthetic cannabinoid agonist
approximately 1.5 times as potent as delta-9-tetrahydrocannabinol.
Adverse effects produced by cannabinoid agonists include tachycardia,
agitation, hallucination, chest pain, seizure, anxiety, acute
psychosis, and death. AB-PINACA has been detected in illicit synthetic
cannabinoid substances, and reported in cases of overdose and
hospitalizations. It has not been approved for medical use in the
United States. On October 16, 2017, the DEA published a Final Rule to
permanently control AB-PINACA as a Schedule I substance under the CSA
(82 FR 47971). As such, additional permanent controls will not be
necessary to fulfill U.S. obligations if AB-PINACA is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances.
    UR-144 is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
acute psychosis, and death. UR-144 has been detected in herbal smoking
blends that are sold as herbal incense. On May 11, 2016, the DEA issued
a Final Rule to permanently schedule UR-144 into Schedule I of the CSA
(81 FR 29142). As such, additional permanent controls will not be
necessary to fulfill U.S. obligations if UR-144 is controlled under
Schedule II of the 1971 Convention on Psychotropic Substances.
    5F-PB-22 is a synthetic cannabinoid agonist with similar effects to
delta-9-tetrahydrocannabinol, one of the main psychoactive components
of cannabis. Adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
acute psychosis, and death. 5F-PB-22 is clandestinely produced. It has
been found laced on plant material and marketed as herbal products, and
is smoked for its psychoactive effects. According to the WHO, 5F-PB-22
has been associated with fatal intoxications. On September 6, 2016, the
DEA issued a Final Rule to permanently place 5F-PB-22 into Schedule I
of the CSA (81 FR 61130). As such, additional permanent controls will
not be necessary to fulfill U.S. obligations if 5F-PB-22 is controlled
under Schedule II of the 1971 Convention on Psychotropic Substances.
    4-Fluoroamphetamine (4-FA) is a psychoactive substance of the
phenethylamine and substituted amphetamine chemical classes and
produces stimulant effects. WHO reports that 4-FA is clandestinely
produced, and its use is associated with fatal and non-fatal
intoxications. 4-FA is not approved for medical use in the United
States and it is not controlled under the CSA. As such, additional
permanent controls will be necessary to fulfill U.S. obligations if 4-
FA is controlled under Schedule II of the 1971 Convention on
Psychotropic Substances.
    FDA, on behalf of the Secretary of HHS, invites interested persons
to submit comments on the notifications from the United Nations
concerning these drug substances. FDA, in cooperation with the National
Institute on Drug Abuse, will consider the comments on behalf of HHS in
evaluating the WHO scheduling recommendations. Then, under section
201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State
what position the United States should take when voting on the
recommendations for control of substances under the Psychotropic
Convention at the CND meeting in March 2018.
    Comments regarding the WHO recommendations for control of
carfentanil, ocfentanil, furanyl fentanyl (Fu-F), acryloylfentanyl
(acryl fentanyl), 4-fluoroisobutyryl fentanyl (4-FIBF), and
tetrahydrofuranylfentanyl (THF-F), under the 1961 Single Convention,
will also be forwarded to the relevant Agencies for consideration in
developing the U.S. position regarding narcotic substances at the CND
meeting.

    Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01471 Filed 1-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Rules and Regulations]
[Pages 53000-53001]
[FR Doc No: 2015-21800]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2015-0220; FRL-9932-56]
RIN 2070-AB27

Significant New Use Rule on Substituted Cyclosiloxane; Removal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is removing a significant new use rule (SNUR) promulgated
under the Toxic Substances Control Act (TSCA) for substituted
cyclosiloxane that was the subject of a premanufacture notice (PMN).
EPA published this SNUR using direct final rulemaking procedures. EPA
received a notice of intent to submit adverse comments on this rule.
Therefore, the Agency is removing this SNUR. EPA intends to publish a
proposed SNUR for this chemical substance under separate notice and
comment procedures.

DATES: This final rule is effective September 2, 2015.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2015-0220, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    A list of potentially affected entities is provided in the Federal
Register of June 5, 2015 (80 FR 32003) (FRL-9927-67). If you have
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. What SNUR is being removed?

    In the June 5, 2015 Federal Register, EPA issued a direct final
SNUR for the chemical substance that is identified in this final rule.
This direct final SNUR was issued pursuant to the procedures in 40 CFR
part 721, subpart D. EPA is removing the direct final SNUR issued for
the chemical substance identified generically as substituted
cyclosiloxane, which was the subject of PMN P-14-605.
    This direct final rule was issued pursuant to the procedures in 40
CFR part 721, subpart D. Section 721.170(d)(4)(i)(B) provides that EPA
will withdraw the relevant portion of such a direct final rule if
within 30 days of publication the Agency receives a notice of intent to
submit adverse comments on the SNUR. EPA received a notice of intent to
submit adverse comments on the SNUR, but mistakenly did not withdraw
the direct final rule as required by Sec.  721.170(d)(4)(i)(B). The

Agency is therefore removing the rule issued for the chemical substance
that was the subject of PMN P-14-605. EPA intends to publish a proposed
SNUR for this chemical substance under separate notice and comment
procedures.
    For further information regarding EPA's direct rulemaking process
for issuing SNURs, see 40 CFR part 721, subpart D, and the Federal
Register of July 27, 1989 (54 FR 31314).

III. Good Cause Finding

    EPA determined that there is good cause to first; promulgate this
final rule without opportunity for notice and comment in accordance
with section 553(b)(B) of the Administrative Procedure Act (APA), and
second; make the rule effective on the date of publication in
accordance with section 553(d) of the APA. Good cause exists because
the direct final rule was allowed to become effective in violation of
Sec.  721.170(d)(4)(i)(B).

IV. Statutory and Executive Order Reviews

    This action removes regulatory requirements that were not intended
to go into effect. As such, the Agency has determined that this removal
will not have any adverse impacts, economic or otherwise. The statutory
and Executive Order review requirements applicable to this action were
discussed in the June 5, 2015 Federal Register. Those review
requirements do not apply to this action because it is a removal and
does not contain any new or amended requirements.

V. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2). Section 808 of the CRA allows the
issuing agency to make a rule effective sooner than otherwise provided
by CRA if the agency makes a good cause finding that notice and public
procedure is impracticable, unnecessary, or contrary to the public
interest. As required by 5 U.S.C. 808(2), this determination is
supported by a brief statement in Unit III.

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: August 20, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-671q, 7542,
9601-9657, 11023, 11048.

Sec.  9.1  [Amended]

0
2. In the table in Sec.  9.1, under the undesignated center heading
``Significant New Uses of Chemical Substances,'' remove Sec.
721.10842.

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec.  721.10842  [Removed]

0
4. Remove Sec.  721.10842.

[FR Doc. 2015-21800 Filed 9-1-15; 8:45 am]
 BILLING CODE 6560-50-P