Federal Register, Volume 81 Issue 219 (Monday, November 14, 2016)


[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Rules and Regulations]
[Pages 79389-79393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27357]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-440]


Schedules of Controlled Substances: Temporary Placement of U-
47700 Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this final order to temporarily schedule the synthetic opioid,
3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also
known as U-47700), and its isomers, esters, ethers, salts and salts of
isomers, esters and ethers, into schedule I pursuant to the temporary
scheduling provisions of the Controlled Substances Act. This action is
based on a finding by the Administrator that the placement of U-47700
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, U-47700.

DATES: This final order is effective on November 14, 2016.

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

The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purpose of this action. The DEA publishes the
implementing regulations

[[Page 79390]]

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

Background

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.\1\ The Administrator transmitted the notice
of intent to place U-47700 into schedule I on a temporary basis to the
Assistant Secretary by letter dated April 18, 2016. The Assistant
Secretary responded to this notice by letter dated April 28, 2016, 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 U-47700. The Assistant Secretary
also stated that the HHS has no objection to the temporary placement of
U-47700 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). U-47700 is not currently listed in any schedule under
the CSA, and no exemptions or approvals are in effect for U-47700 under
section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the
control of U-47700 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 temporarily schedule U-47700
was published in the Federal Register on September 7, 2016. 81 FR
61636.
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\1\ 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 U-
47700, 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 updated three-factor analysis, and the Assistant
Secretary's April 28, 2016, 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-2016-0016
(Docket Number DEA-440).

Factor 4. History and Current Pattern of Abuse

The recreational abuse of novel opioids continues to be a
significant concern. These substances are distributed to users with
often unpredictable outcomes. The novel synthetic opioid U-47700 has
recently been encountered by law enforcement and public health
officials and the adverse health effects and outcomes are documented in
the scientific literature. Self-reporting by users describes the
effects of U-47700 to be similar to other opioids. The negative effects
documented in the scientific literature are also consistent with other
opioids. 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 participating Federal, State, and local forensic laboratories across
the country. The DEA utilizes NFLIS to monitor for drug trends. The
first laboratory submission of U-47700 was recorded in October 2015; a
total of 88 records were reported from State and local forensic
laboratories between October 2015--September 2016 according to NFLIS
(query date: October 24, 2016).
On October 1, 2014, the DEA implemented STARLiMS (a web-based,
commercial laboratory information management system) as its laboratory
drug evidence data system of record. DEA laboratory data submitted
after September 30, 2014, are reposited in STARLiMS; data from STARLiMS
were queried on November 1, 2016. STARLiMS registered 45 reports
containing U-47700 in 2016 from California, Connecticut, Florida,
Maryland, Montana, North Dakota, New Jersey, New York, Tennessee,
Texas, Virginia, West Virginia, and the District of Columbia. Through
information collected from NFLIS, law enforcement reports, and email
communications, the DEA is aware of the identification of U-47700 from
toxicology reports and submitted evidence to forensic laboratories in
several states, including Arkansas, California, Colorado, Connecticut,
Florida, Georgia, Iowa, Kentucky, Missouri, Montana, New

[[Page 79391]]

Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania, Texas, and Wisconsin. These
identifications occurred in 2015 and 2016.
Evidence suggests that the pattern of abuse of U-47700 parallels
that of heroin, prescription opioid analgesics, and other novel
opioids. Seizures of U-47700 have been encountered in powder form and
in counterfeit tablets that mimic pharmaceutical opioids. U-47700 has
also been encountered in glassine bags and envelopes and knotted
corners of plastic bags. These clandestine forms of distribution
demonstrate the abuse of this substance as a replacement for heroin or
other opioids, either knowingly or unknowingly. Further, U-47700 has
been encountered as a single substance as well as in combination with
other substances, including heroin, fentanyl, and furanyl fentanyl in
drug exhibits.
The scientific literature and information collected by DEA
demonstrate U-47700 is being abused for its opioid properties. The
distribution of U-47700 and the increased prevalence of abuse remain
deeply concerning to the DEA.

Factor 5. Scope, Duration and Significance of Abuse

The scientific literature and reports collected by the DEA
demonstrate U-47700 is being abused for its opioid properties. This
abuse of U-47700 has resulted in morbidity and mortality (see updated
DEA 3-Factor Analysis for full discussion). The DEA has received
reports for at least 46 confirmed fatalities \2\ associated with U-
47700. The information on these deaths occurring in 2015 and 2016 was
collected from email communications and toxicology and medical examiner
reports and was reported from New Hampshire (1), New York (31), North
Carolina (10), Ohio (1), Texas (2), and Wisconsin (1). The scientific
literature notes additional fatal overdoses connected to U-47700. The
population likely to abuse U-47700 appears to overlap with the
populations abusing prescription opioid analgesics, other ``designer
opioids,'' and heroin, as evidenced by drug use history documented in
U-47700 fatal overdose cases. This observation is further supported by
U-47700 being sold on the illicit market in glassine bags, some of
which are marked with stamped logos, imitating the sale of heroin.
Additionally, U-47700 has been found in counterfeit pills. Because
abusers of U-47700 are likely to obtain this substance through non-
regulated sources (i.e., on-line purchases or drug dealers), 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) U-47700 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.).
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\2\ Due to a proofreading error, the number of fatalities listed
in the U-47700 NOI, which was 15, is incorrect. The correct number,
46, has been added to this Final Order.
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STARLiMS contains 45 reports in which U-47700 was identified in
drug exhibits submitted in 2016. A query of NFLIS returned 88 records
of U-47700 being identified in exhibits submitted to State and local
forensic laboratories between October 2015--September 2016. The DEA is
not aware of any laboratory analyses of drug evidence identifying U-
47700 prior to 2015, indicating that this synthetic opioid only
recently became available as a replacement for other opioids that are
commonly abused (i.e. oxycodone, heroin, fentanyl). U-47700 is
available over the Internet and is marketed as a ``research chemical.''
The on-line sale and marketing of U-47700 are similar to other new
psychoactive substances that have rapidly appeared on the recreational
drug market and also resulted in negative consequences for the user.

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

U-47700 exhibits pharmacological profiles similar to that of
morphine and other mu-opioid receptor agonists. Cases of intoxication
are reported in the literature with morbidity and mortality associated
with U-47700 use. The toxic effects of U-47700 in humans are
demonstrated by overdoses and overdose fatalities associated with this
substance, as reported in the scientific literature. Abusers of U-47700
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. Additionally, the potent opioid U-47700 may serve as a
precursor to problematic opioid use and dependence.
Based on reports in the scientific literature and information
received by the DEA, the abuse of U-47700 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 great. 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.
U-47700 has been associated with a number of fatalities and non-
fatal overdoses as detailed in the scientific literature. The DEA has
received information connecting U-47700 to at least 46 confirmed
overdose deaths, occurring in 2015 and 2016 in New Hampshire (1), New
York (31), North Carolina (10), Ohio (1), Texas (2), and Wisconsin (1).

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, importation, exportation, and abuse of U-47700 pose an
imminent hazard to the public safety. The DEA is not aware of any
currently accepted medical uses for this substance 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 U-47700 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 18, 2016, notified the Assistant Secretary of the
DEA's intention to temporarily place this substance into schedule I.

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 U-47700 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

[[Page 79392]]

to the public safety, this final order temporarily scheduling U-47700
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 final order, U-47700 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, U-47700 must be registered with the DEA to
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958
and in accordance with 21 CFR parts 1301 and 1312, as of November 14,
2016. Any person who currently handles U-47700, and is not registered
with the DEA, must submit an application for registration and may not
continue to handle U-47700 as of November 14, 2016, 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 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 November
14, 2016 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 U-47700, must
surrender all quantities of currently held U-47700.
3. Security. U-47700 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 November 14, 2016.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of U-47700 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 November 14, 2016, to
comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of U-
47700 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 U-47700) 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 U-47700 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21
CFR parts 1304, and 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 U-
47700 must submit reports pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304, and 1312 as of November 14, 2016.
8. Order Forms. All DEA registrants who distribute U-47700 must
comply with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of November 14, 2016.
9. Importation and Exportation. All importation and exportation of
U-47700 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of November 14, 2016.
10. Quota. Only DEA registered manufacturers may manufacture U-
47700 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as of November 14, 2016.
11. Liability. Any activity involving U-47700 not authorized by, or
in violation of the CSA, occurring as of November 14, 2016, 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

[[Page 79393]]

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
because it poses a public health risk. 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 and 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 final order to both
Houses of Congress and to the Comptroller General, although such filing
is not required under the Small Business Regulatory Enforcement
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808,
because, as noted above, this action is an order, not a rule.

List of Subjects in 21 CFR Part 1308

Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.

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

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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

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


0
2. Amend Sec. 1308.11 by adding paragraph (h)(18) to read as follows:


Sec. 1308.11 Schedule I.

* * * * *
(h) * * *

(18) 3,4-Dichloro-N-[2-(dimethylamino)cyclohexyl]-N- (9547)
methylbenzamide, its isomers, esters, ethers, salts and salts
of isomers, esters and ethers (Other name: U-47700)..........


* * * * *

Dated: November 7, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-27357 Filed 11-10-16; 8:45 am]
BILLING CODE 4410-09-P