[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)]
[Rules and Regulations]
[Pages 32453-32457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14880]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-460]


Schedules of Controlled Substances: Temporary Placement of Acryl 
Fentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Temporary scheduling order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this temporary scheduling order to schedule the synthetic 
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl 
fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts 
and salts of isomers, esters, and ethers, into Schedule I. This action 
is based on a finding by the Administrator that the placement of acryl 
fentanyl into Schedule I of the Controlled Substances Act is necessary 
to avoid an imminent hazard to the public safety. As a result of this 
order, the regulatory controls and administrative, civil, and criminal 
sanctions applicable to Schedule I controlled substances will be 
imposed on persons who handle (manufacture, distribute, reverse 
distribute, import, export, engage in research, conduct instructional 
activities or chemical analysis, or possess), or propose to handle, 
acryl fentanyl.

DATES: This temporary scheduling order is effective July 14, 2017, 
until July 15, 2019, unless it is extended for an additional year or a 
permanent scheduling proceeding is completed. The DEA will publish a 
document in the Federal Register announcing an extension or permanence.

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

SUPPLEMENTARY INFORMATION: 

Legal Authority

    Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, 
provides the Attorney General with the authority to temporarily place a 
substance into Schedule I of the CSA for two years without regard to 
the requirements of 21 U.S.C. 811(b) if he finds that such action is 
necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 
811(h)(1). In addition, if proceedings to control a substance are

[[Page 32454]]

initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend 
the temporary scheduling \1\ for up to one year. 21 U.S.C. 811(h)(2).
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this document adheres to 
the statutory language of 21 U.S.C. 811(h), which refers to a 
``temporary scheduling order.'' No substantive change is intended.
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    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of his intention to temporarily place a substance 
into Schedule I of the CSA.\2\ The Administrator transmitted the notice 
of intent to place acryl fentanyl into Schedule I on a temporary basis 
to the Assistant Secretary by letter dated April 17, 2017. The 
Assistant Secretary responded to this notice by letter dated May 2, 
2017, and advised that based on review by the Food and Drug 
Administration (FDA), there are currently no investigational new drug 
applications or approved new drug applications for acryl fentanyl. The 
Assistant Secretary also stated that the HHS has no objection to the 
temporary placement of acryl fentanyl into Schedule I of the CSA. The 
DEA has taken into consideration the Assistant Secretary's comments as 
required by 21 U.S.C. 811(h)(4). Acryl fentanyl is not currently listed 
in any schedule under the CSA, and no exemptions or approvals are in 
effect for acryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. 
The DEA has found that the control of acryl fentanyl in Schedule I on a 
temporary basis is necessary to avoid an imminent hazard to the public 
safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent 
to issue a temporary order to schedule acryl fentanyl was published in 
the Federal Register on June 2, 2017. 82 FR 25564.
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    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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    To find that placing a substance temporarily into Schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's 
history and current pattern of abuse; the scope, duration and 
significance of abuse; and what, if any, risk there is to the public 
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes 
actual abuse, diversion from legitimate channels, and clandestine 
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed into Schedule I. 21 U.S.C. 811(h)(1). 
Substances in Schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).
    Available data and information for acryl fentanyl, summarized 
below, indicate that this synthetic opioid has a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. The DEA's three-factor analysis, and the Assistant 
Secretary's May 2, 2017, letter, are available in their entirety under 
the tab ``Supporting Documents'' of the public docket of this action at 
www.regulations.gov under FDMS Docket ID: DEA-2017-0005 (Docket Number 
DEA-460).

Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-like substances continues to be 
a significant concern. These substances are distributed to users, often 
with unpredictable outcomes. Acryl fentanyl has recently been 
encountered by law enforcement and public health officials and the 
adverse health effects and outcomes are demonstrated by fatal overdose 
cases. The documented negative effects of acryl fentanyl are consistent 
with those of other opioids.
    On October 1, 2014, the DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) to replace the 
System to Retrieve Information from Drug Evidence (STRIDE) as its 
laboratory drug evidence data system of record. DEA laboratory data 
submitted after September 30, 2014, are reposited in STARLiMS. Data 
from STRIDE and STARLiMS were queried on May 5, 2017. STARLiMS 
registered 36 reports containing acryl fentanyl, from Alabama, 
Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, 
Missouri, North Carolina, South Carolina, Tennessee, Texas, and West 
Virginia. According to STARLiMS, the first laboratory submission of 
acryl fentanyl occurred in July 2016 in Texas.
    The National Forensic Laboratory Information System (NFLIS) is a 
national drug forensic laboratory reporting system that systematically 
collects results from drug chemistry analyses conducted by other 
federal, state and local forensic laboratories across the country. 
NFLIS registered 74 reports containing acryl fentanyl from state or 
local forensic laboratories in Arkansas, California, Connecticut, Iowa, 
Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin 
(query date: May 5, 2017).\3\ The first report of acryl fentanyl was 
reported in Wisconsin in May 2016. The DEA is not aware of any 
laboratory identifications of acryl fentanyl prior to 2016.
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    \3\ Data are still being collected for February 2017-April 2017 
due to the normal lag period for labs reporting to NFLIS.
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    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including acryl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of acryl fentanyl have been encountered in 
powder form, in solution, and packaged similar to that of heroin. Acryl 
fentanyl has been encountered as a single substance as well as in 
combination with other substances of abuse, including heroin, fentanyl, 
4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has 
been connected to fatal overdoses, in which insufflation and 
intravenous routes of administration were documented.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate acryl fentanyl is being 
abused for its opioid properties. This abuse of acryl fentanyl has 
resulted in morbidity and mortality (see DEA 3-Factor Analysis for full 
discussion). The DEA has received reports for at least 83 confirmed 
fatalities associated with acryl fentanyl. Information on these deaths, 
occurring as early as September 2016, was collected by the DEA from 
post-mortem toxicology and medical examiner reports. These deaths were 
reported from, and occurred in, Illinois (27), Maryland (22), New 
Jersey (1),

[[Page 32455]]

Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a total of 110 
drug reports in which acryl fentanyl was identified in drug exhibits 
submitted to forensic laboratories in 2016 and 2017 from law 
enforcement encounters in Alabama, Arkansas, California, Connecticut, 
Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Missouri, 
North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, 
West Virginia, and Wisconsin. It is likely that the prevalence of acryl 
fentanyl in opioid analgesic-related emergency room admissions and 
deaths is underreported as standard immunoassays may not differentiate 
this substance from fentanyl.
    The population likely to abuse acryl fentanyl overlaps with the 
population abusing prescription opioid analgesics, heroin, fentanyl, 
and other fentanyl-related substances. This is evidenced by the routes 
of drug administration and drug use history documented in acryl 
fentanyl fatal overdose cases and encounters of the substance by law 
enforcement officials. Because abusers of acryl fentanyl are likely to 
obtain this substance through unregulated sources, the identity, 
purity, and quantity are uncertain and inconsistent, thus posing 
significant adverse health risks to the end user. Individuals who 
initiate (i.e., use a drug for the first time) acryl fentanyl abuse are 
likely to be at risk of developing substance use disorder, overdose, 
and death similar to that of other opioid analgesics (e.g., fentanyl, 
morphine, etc.).

Factor 6. What, if Any, Risk There Is to the Public Health

    Acryl fentanyl exhibits pharmacological profiles similar to that of 
fentanyl and other [micro]-opioid receptor agonists. The toxic effects 
of acryl fentanyl in humans are demonstrated by overdose fatalities 
involving this substance. Abusers of acryl fentanyl may not know the 
origin, identity, or purity of this substance, thus posing significant 
adverse health risks when compared to abuse of pharmaceutical 
preparations of opioid analgesics, such as morphine and oxycodone.
    Based on information reviewed by the DEA, the misuse and abuse of 
acryl fentanyl leads to the same qualitative public health risks as 
heroin, fentanyl and other opioid analgesic substances. As with any 
non-medically approved opioid, the health and safety risks for users 
are high. The public health risks attendant to the abuse of heroin and 
opioid analgesics are well established and have resulted in large 
numbers of drug treatment admissions, emergency department visits, and 
fatal overdoses.
    Acryl fentanyl has been associated with numerous fatalities. At 
least 83 confirmed overdose deaths involving acryl fentanyl abuse have 
been reported from Illinois, Maryland, New Jersey, Ohio, and 
Pennsylvania in 2016 and 2017. As the data demonstrates, the potential 
for fatal and non-fatal overdoses exists for acryl fentanyl; thus, 
acryl fentanyl poses an imminent hazard to the public safety.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard 
to Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the data and 
information summarized above, the continued uncontrolled manufacture, 
distribution, reverse distribution, importation, exportation, conduct 
of research and chemical analysis, possession, and abuse of acryl 
fentanyl pose an imminent hazard to the public safety. The DEA is not 
aware of any currently accepted medical uses for this substance in 
treatment in the United States. A substance meeting the statutory 
requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be 
placed into Schedule I. Substances in Schedule I are those that have a 
high potential for abuse, no currently accepted medical use in 
treatment in the United States, and a lack of accepted safety for use 
under medical supervision. Available data and information for acryl 
fentanyl indicate that this substance has a high potential for abuse, 
no currently accepted medical use in treatment in the United States, 
and a lack of accepted safety for use under medical supervision. As 
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the 
Administrator, through a letter dated April 17, 2017, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance into Schedule I. A notice of intent was subsequently 
published in the Federal Register on June 2, 2017. 82 FR 25564.

Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Administrator considered available data and 
information, herein sets forth the grounds for his determination that 
it is necessary to temporarily schedule acryl fentanyl into Schedule I 
of the CSA, and finds that placement of this synthetic opioid into 
Schedule I of the CSA is necessary to avoid an imminent hazard to the 
public safety.
    Because the Administrator hereby finds it necessary to temporarily 
place this synthetic opioid into Schedule I to avoid an imminent hazard 
to the public safety, this temporary order scheduling acryl fentanyl 
will be effective on the date of publication in the Federal Register, 
and will be in effect for a period of two years, with a possible 
extension of one additional year, pending completion of the regular 
(permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Permanent scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling 
process of formal rulemaking affords interested parties with 
appropriate process and the government with any additional relevant 
information needed to make a determination. Final decisions that 
conclude the permanent scheduling process of formal rulemaking are 
subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders 
are not subject to judicial review. 21 U.S.C. 811(h)(6).

Requirements for Handling

    Upon the effective date of this temporary order, acryl fentanyl 
will become subject to the regulatory controls and administrative, 
civil, and criminal sanctions applicable to the manufacture, 
distribution, reverse distribution, importation, exportation, 
engagement in research, and conduct of instructional activities or 
chemical analysis with, and possession of Schedule I controlled 
substances including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses), or 
who desires to handle, acryl fentanyl must be registered with the DEA 
to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 
and in accordance with 21 CFR parts 1301 and 1312, as of July 14, 2017. 
Any person who currently handles acryl fentanyl, and is not registered 
with the DEA, must submit an application for registration and may not 
continue to handle acryl fentanyl as of July 14, 2017, unless the DEA 
has approved that application for registration pursuant to 21 U.S.C. 
822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. 
Retail sales

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of Schedule I controlled substances to the general public are not 
allowed under the CSA. Possession of any quantity of this substance in 
a manner not authorized by the CSA on or after July 14, 2017 is 
unlawful and those in possession of any quantity of this substance may 
be subject to prosecution pursuant to the CSA.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a Schedule I registration to handle acryl fentanyl, must 
surrender all quantities of currently held acryl fentanyl.
    3. Security. Acryl fentanyl is subject to Schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July 
14, 2017.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of acryl fentanyl must be in compliance with 21 
U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current 
DEA registrants shall have 30 calendar days from July 14, 2017, to 
comply with all labeling and packaging requirements.
    5. Inventory. Every DEA registrant who possesses any quantity of 
acryl fentanyl on the effective date of this order must take an 
inventory of all stocks of this substance on hand, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11. Current DEA registrants shall have 30 calendar days from the 
effective date of this order to be in compliance with all inventory 
requirements. After the initial inventory, every DEA registrant must 
take an inventory of all controlled substances (including acryl 
fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to acryl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR parts 1304, 1312, 1317, and Sec.  1307.11. Current DEA 
registrants shall have 30 calendar days from the effective date of this 
order to be in compliance with all recordkeeping requirements.
    7. Reports. All DEA registrants who manufacture or distribute acryl 
fentanyl must submit reports pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312 as of July 14, 2017.
    8. Order Forms. All DEA registrants who distribute acryl fentanyl 
must comply with order form requirements pursuant to 21 U.S.C. 828 and 
in accordance with 21 CFR part 1305 as of July 14, 2017.
    9. Importation and Exportation. All importation and exportation of 
acryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, 
and in accordance with 21 CFR part 1312 as of July 14, 2017.
    10. Quota. Only DEA registered manufacturers may manufacture acryl 
fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 
and in accordance with 21 CFR part 1303 as of July 14, 2017.
    11. Liability. Any activity involving acryl fentanyl not authorized 
by, or in violation of the CSA, occurring as of July 14, 2017, is 
unlawful, and may subject the person to administrative, civil, and/or 
criminal sanctions.

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 
temporary scheduling action where such action is necessary to avoid an 
imminent hazard to the public safety. As provided in this subsection, 
the Attorney General may, by order, schedule a substance in Schedule I 
on a temporary basis. Such an order may not be issued before the 
expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary. 21 U.S.C. 811(h)(1).
    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued, the DEA believes that the notice 
and comment requirements of the Administrative Procedure Act (APA) at 5 
U.S.C. 553, do not apply to this temporary scheduling action. In the 
alternative, even assuming that this action might be subject to 5 
U.S.C. 553, the Administrator finds that there is good cause to forgo 
the notice and comment requirements of 5 U.S.C. 553, as any further 
delays in the process for issuance of temporary scheduling orders would 
be impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety.
    Further, the DEA believes that this temporary scheduling action is 
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act. The 
requirements for the preparation of an initial regulatory flexibility 
analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA 
is not required by the APA or any other law to publish a general notice 
of proposed rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism) it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. However, if this were a rule, pursuant to the Congressional 
Review Act, ``any rule for which an agency for good cause finds that 
notice and public procedure thereon are impracticable, unnecessary, or 
contrary to the public interest, shall take effect at such time as the 
federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It 
is in the public interest to schedule this substance immediately to 
avoid an imminent hazard to the public safety. This temporary 
scheduling action is taken pursuant to 21 U.S.C. 811(h), which is 
specifically designed to enable the DEA to act in an expeditious manner 
to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) 
exempts the temporary scheduling order from standard notice and comment 
rulemaking procedures to ensure that the process moves swiftly. For the 
same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to 
move quickly to place this substance into Schedule I because it poses 
an imminent hazard to the public safety, it would be contrary to the 
public interest to delay implementation of the temporary scheduling 
order. Therefore, this order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this temporary order to 
both Houses of Congress and to the Comptroller General, although such 
filing is not required under the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 
because, as noted above, this action is an order, not a rule.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control,

[[Page 32457]]

Reporting and recordkeeping requirements.

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

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

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

0
2. Amend Sec.  1308.11 by adding paragraph (h)(17) to read as follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *

(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide,            (9811)
 its isomers, esters, ethers, salts and salts of
 isomers, esters and ethers (Other names: acryl
 fentanyl, acryloylfentanyl)............................
 

* * * * *

    Dated: July 10, 2017.
Chuck Rosenberg
Acting Administrator.
[FR Doc. 2017-14880 Filed 7-13-17; 8:45 am]
 BILLING CODE 4410-09-P