[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Pages 36449-36454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16440]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-470P]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual Needs
for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2017
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust
the 2017 aggregate production quotas for several controlled substances
in schedules I and II of the Controlled Substances Act and assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before September 5, 2017. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in his sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the Federal Register a final order establishing the 2017
adjusted aggregate production quotas for schedule I and II controlled
substances, and an assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-470P'' on all correspondence, including any
attachments. The Drug Enforcement Administration encourages that all
comments be submitted electronically through the Federal eRulemaking
Portal which provides the ability to type short comments directly into
the comment field on the Web page or attach a file for lengthier
comments. Please go to http://www.regulations.gov and follow the online
instructions at that site for submitting comments. Upon completion of
your submission you will receive a Comment Tracking Number for your
comment. Please be aware that submitted comments are not
instantaneously available for public view on Regulations.gov. If you
have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment. Paper comments that duplicate electronic submissions are not
necessary and are discouraged. Should you wish to mail a paper comment
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attention: DEA
Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
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.
[[Page 36450]]
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act (FOIA) applies to all comments
received. If you want to submit personal identifying information (such
as your name, address, etc.) as part of your comment, but do not want
it to be made publicly available, you must include the phrase
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your
comment. You must also place all the personal identifying information
you do not want made publicly available in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified and located as directed
above will generally be made available in redacted form. If a comment
contains so much confidential business information or personal
identifying information that it cannot be effectively redacted, all or
part of that comment may not be made publicly available. Comments
posted to http://www.regulations.gov may include any personal
identifying information (such as name, address, and phone number)
included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this document is available at http://www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. The Attorney General has delegated this function
to the Administrator of the DEA pursuant to 28 CFR 0.100.
The DEA established the 2017 aggregate production quotas for
substances in schedules I and II and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine on October 5, 2016 (81 FR 69079). That notice
stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all
aggregate production quotas and assessments of annual need are subject
to adjustment.
Analysis for Proposed Adjusted 2017 Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the established 2017 aggregate
production quotas and assessment of annual needs for certain schedule I
and II controlled substances, and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, to be manufactured in the
United States in 2017 to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. These quotas do not include imports of controlled substances
for use in industrial processes.
In determining the proposed adjustment, the Acting Administrator
has taken into account the criteria in accordance with 21 CFR 1303.13
(adjustment of aggregate production quotas for controlled substances)
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA
determined whether to propose an adjustment of the aggregate production
quotas and assessment of annual needs for 2017 by considering: (1)
Changes in the demand for that class or chemical, changes in the
national rate of net disposal of the class or chemical, and changes in
the rate of net disposal of the class or chemical by registrants
holding individual manufacturing quotas for the class; (2) whether any
increased demand for that class or chemical, the national and/or
individual rates of net disposal of that class or chemical are
temporary, short term, or long term; (3) whether any increased demand
for that class or chemical can be met through existing inventories,
increased individual manufacturing quotas, or increased importation,
without increasing the aggregate production quota; (4) whether any
decreased demand for that class or chemical will result in excessive
inventory accumulation by all persons registered to handle that class
or chemical; and (5) other factors affecting medical, scientific,
research, and industrial needs in the United States and lawful export
requirements, as the Acting Administrator finds relevant. These quotas
do not include imports of controlled substances for use in industrial
processes.
The Acting Administrator also considered updated information
obtained from 2016 year-end inventories, 2016 disposition data
submitted by quota applicants, estimates of the medical needs of the
United States, product development, and other information made
available to the DEA after the initial aggregate production quotas and
assessment of annual needs had been established. Other factors the
Acting Administrator considered in calculating the aggregate production
quotas, but not the assessment of annual needs, include product
development requirements of both bulk and finished dosage form
manufacturers, and other pertinent information. In determining the
proposed adjusted 2017 assessment of annual needs, the DEA used the
calculation methodology previously described in the 2010 and 2011
established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and
75 FR 79407, Dec. 20, 2010, respectively).
The Acting Administrator, therefore, proposes that the year 2017
aggregate production quotas for the nine temporarily scheduled
substances be established, and to adjust the 2017 aggregate production
quotas for certain schedule I and II controlled substances and
assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, expressed in grams of
anhydrous acid or base, as follows:
[[Page 36451]]
------------------------------------------------------------------------
Established 2017 Proposed Revised
Basic class quotas (g) 2017 quotas (g)
------------------------------------------------------------------------
Temporarily Scheduled Substances
------------------------------------------------------------------------
4-Fluoroisobutyryl fentanyl... N/A 30.
5F-ADB; 5F-MDMB-PINACA (methyl N/A 30.
2-(1-(5-fluoropentyl)-1H-
indazole-3-carboxamido)-3,3-
dimethylbutanoate).
5F-AMB (methyl 2-(1-(5- N/A 30.
fluoropentyl)-1H-indazole-3-
carboxamido)-3-
methylbutanoate).
5F-APINACA; 5F-AKB48 (N- N/A 30.
(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-
carboxamide).
ADB-FUBINACA (N-(1-amino-3,3- N/A 30.
dimethyl-1-oxobutan-2-yl)-1-
(4-fluorobenzyl)-1H-indazole-
3-carboxamide).
MDMB-CHMICA; MMB-CHMINACA N/A 30.
(methyl 2-(1-
(cyclohexylmethyl)-1H-indole-
3-carboxamido)-3,3-
dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4- N/A 30.
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
Furanyl fentanyl.............. N/A 30.
U-47700....................... N/A 30.
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-(1- 10 no change.
Phenylcyclohexyl)pyrrolidine.
1-(5-Fluoropentyl)-3-(1- 30 no change.
naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2- 30 no change.
iodobenzoyl)indole (AM694).
1-[1-(2- 15 no change.
Thienyl)cyclohexyl]piperidine.
1-Benzylpiperazine............ 25 no change.
1-Methyl-4-phenyl-4- 2 no change.
propionoxypiperidine.
2-(2,5-Dimethoxy-4- 30 no change.
ethylphenyl)ethanamine (2C-E).
2-(2,5-Dimethoxy-4- 30 no change.
methylphenyl)ethanamine (2C-
D).
2-(2,5-Dimethoxy-4-nitro- 30 no change.
phenyl)ethanamine (2C-N).
2-(2,5-Dimethoxy-4-n- 30 no change.
propylphenyl)ethanamine (2C-
P).
2-(2,5- 30 no change.
Dimethoxyphenyl)ethanamine
(2C-H).
2-(4-Bromo-2,5- 25 no change.
dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-
NBOMe; 2C-B-NBOMe; 25B; Cimbi-
36).
2-(4-Chloro-2,5- 30 no change.
dimethoxyphenyl)ethanamine
(2C-C).
2-(4-Chloro-2,5- 25 no change.
dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25C-
NBOMe; 2C-C-NBOMe; 25C; Cimbi-
82).
2-(4-Iodo-2,5- 30 no change.
dimethoxyphenyl)ethanamine
(2C-I).
2-(4-Iodo-2,5-dimethoxyphenyl)- 5 30.
N-(2-methoxybenzyl)ethanamine
(25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5).
2,5-Dimethoxy-4- 25 no change.
ethylamphetamine (DOET).
2,5-Dimethoxy-4-n- 25 no change.
propylthiophenethylamine.
2,5-Dimethoxyamphetamine...... 25 no change.
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine
(2C-T-2).
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine
(2C-T-4).
3,4,5-Trimethoxyamphetamine... 25 no change.
3,4-Methylenedioxyamphetamine 55 no change.
(MDA).
3,4- 50 no change.
Methylenedioxymethamphetamine
(MDMA).
3,4-Methylenedioxy-N- 40 no change.
ethylamphetamine (MDEA).
3,4-Methylenedioxy-N- 40 no change.
methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone 35 no change.
(MDPV).
3-FMC; 3-Fluoro-N- 25 no change.
methylcathinone.
3-Methylfentanyl.............. 2 30.
3-Methylthiofentanyl.......... 2 30.
4-Bromo-2,5- 25 no change.
dimethoxyamphetamine (DOB).
4-Bromo-2,5- 25 no change.
dimethoxyphenethylamine (2-
CB).
4-FMC; Flephedrone............ 25 no change.
4-MEC; 4-Methyl-N- 25 no change.
ethylcathinone.
4-Methoxyamphetamine.......... 150 no change.
4-Methyl-2,5- 25 no change.
dimethoxyamphetamine (DOM).
4-Methylaminorex.............. 25 no change.
4-Methyl-N-methylcathinone 45 no change.
(mephedrone).
4-Methyl-[alpha]- 25 no change.
pyrrolidinopropiophenone (4-
MePPP).
5-(1,1-Dimethylheptyl)-2- 50 no change.
[(1R,3S)-3-hydroxycyclohexyl]-
phenol.
5-(1,1-Dimethyloctyl)-2- 40 no change.
[(1R,3S)-3-hydroxycyclohexyl]-
phenol (cannabicyclohexanol
or CP-47,497 C8-homolog).
5-Fluoro-PB-22; 5F-PB-22...... 20 no change.
5-Fluoro-UR144, XLR11 ([1-(5- 25 no change.
fluoro-pentyl)-1Hindol-3-
yl](2,2,3,3-
tetramethylcyclopropyl)methan
one.
5-Methoxy-3,4- 25 no change.
methylenedioxyamphetamine.
5-Methoxy-N,N- 25 no change.
diisopropyltryptamine.
5-Methoxy-N,N- 25 no change.
dimethyltryptamine.
AB-CHMINACA................... 15 30.
AB-FUBINACA................... 50 no change.
AB-PINACA..................... 15 30.
Acetyl Fentanyl............... 100 no change.
[[Page 36452]]
Acetyl-alpha-methylfentanyl... 2 30.
Acetyldihydrocodeine.......... 2 30.
Acetylmethadol................ 2 no change.
ADB-PINACA (N-(1-amino-3,3- 50 no change.
dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-
carboxamide).
AH-7921....................... 30 no change.
Allylprodine.................. 2 no change.
Alphacetylmethadol............ 2 no change.
alpha-Ethyltryptamine......... 25 no change.
Alphameprodine................ 2 no change.
Alphamethadol................. 2 no change.
alpha-Methylfentanyl.......... 2 30.
alpha-Methylthiofentanyl...... 2 30.
alpha-Methyltryptamine (AMT).. 25 no change.
alpha-Pyrrolidinobutiophenone 25 no change.
([alpha]-PBP).
alpha-Pyrrolidinopentiophenone 25 no change.
([alpha]-PVP).
Aminorex...................... 25 no change.
APINCA, AKB48 (N-(1-adamantyl)- 25 no change.
1-pentyl-1H-indazole-3-
carboxamide).
Benzylmorphine................ 2 30.
Betacetylmethadol............. 2 no change.
beta-Hydroxy-3-methylfentanyl. 2 30.
beta-Hydroxyfentanyl.......... 2 30.
beta-Hydroxythiofentanyl...... 30 no change.
Betameprodine................. 2 no change.
Betamethadol.................. 4 no change.
Betaprodine................... 2 no change.
Bufotenine.................... 3 no change.
Butylone...................... 25 no change.
Butyryl fentanyl.............. 30 no change.
Cathinone..................... 24 no change.
Codeine methylbromide......... 5 30.
Codeine-N-oxide............... 305 330
Desomorphine.................. 25 no change.
Diethyltryptamine............. 25 no change.
Difenoxin..................... 8,750 no change.
Dihydromorphine............... 1,566,000 no change.
Dimethyltryptamine............ 35 no change.
Dipipanone.................... 5 no change.
Etorphine..................... Zero 30.
Fenethylline.................. 5 30.
gamma-Hydroxybutyric acid..... 56,200,000 no change.
Heroin........................ 25 45.
Hydromorphinol................ 2 no change.
Hydroxypethidine.............. 2 no change.
Ibogaine...................... 5 30.
JWH-018 and AM678 (1-Pentyl-3- 35 no change.
(1-naphthoyl)indole).
JWH-019 (1-Hexyl-3-(1- 45 no change.
naphthoyl)indole).
JWH-073 (1-Butyl-3-(1- 45 no change.
naphthoyl)indole).
JWH-081 (1-Pentyl-3-[1-(4- 30 no change.
methoxynaphthoyl)]indole).
JWH-122 (1-Pentyl-3-(4-methyl- 30 no change.
1-naphthoyl)indole).
JWH-200 (1-[2-(4- 35 no change.
Morpholinyl)ethyl]-3-(1-
naphthoyl)indole).
JWH-203 (1-Pentyl-3-(2- 30 no change.
chlorophenylacetyl)indole).
JWH-250 (1-Pentyl-3-(2- 30 no change.
methoxyphenylacetyl)indole).
JWH-398 (1-Pentyl-3-(4-chloro- 30 no change.
1-naphthoyl)indole).
Lysergic acid diethylamide 10 40.
(LSD).
MAB-CHMINACA; ADB-CHMINACA (N- Zero 30.
(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
Marihuana..................... 472,000 no change.
Mecloqualone.................. Zero 30.
Mescaline..................... 25 no change.
Methaqualone.................. 10 60.
Methcathinone................. 25 no change.
Methyldesorphine.............. 5 no change.
Methyldihydromorphine......... 2 no change.
Morphine methylbromide........ 5 no change.
Morphine methylsulfonate...... 5 no change.
Morphine-N-oxide.............. 350 no change.
N,N-Dimethylamphetamine....... 25 no change.
Naphyrone..................... 25 no change.
N-Ethyl-1- 5 no change.
phenylcyclohexylamine.
N-Ethylamphetamine............ 24 no change.
N-Hydroxy-3,4- 24 no change.
methylenedioxyamphetamine.
[[Page 36453]]
Noracymethadol................ 2 no change.
Norlevorphanol................ 52 55.
Normethadone.................. 2 no change.
Normorphine................... 40 no change.
Para-fluorofentanyl........... 5 25.
Parahexyl..................... 5 no change.
PB-22; QUPIC.................. 20 no change.
Pentedrone.................... 25 no change.
Pentylone..................... 25 no change.
Phenomorphan.................. 2 no change.
Pholcodine.................... 5 no change.
Psilocybin.................... 30 no change.
Psilocyn...................... 50 no change.
SR-18 and RCS-8 (1- 45 no change.
Cyclohexylethyl-3-(2-
methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3- 30 no change.
[(4-methoxy)-benzoyl]indole).
Tetrahydrocannabinols......... 409,000 no change.
Thiofentanyl.................. 2 25.
THJ-2201 ([1-(5-fluoropentyl)- 15 30.
1H-indazol-3-yl](naphthalen-1-
yl)methanone).
Tilidine...................... 25 no change.
Trimeperidine................. 2 no change.
UR-144 (1-pentyl-1H-indol-3- 25 no change.
yl)(2,2,3,3-
tetramethylcyclopropyl)methan
one.
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine....... 4 no change.
1- 4 no change.
Piperidinocyclohexanecarbonit
rile.
4-Anilino-N-phenethyl-4- 1,750,000 no change.
piperidine (ANPP).
Alfentanil.................... 4,200 no change.
Alphaprodine.................. 2 no change.
Amobarbital................... 20,100 no change.
Amphetamine (for conversion).. 12,000,000 no change.
Amphetamine (for sale)........ 42,400,000 no change.
Carfentanil................... 10 20.
Cocaine....................... 103,400 no change.
Codeine (for conversion)...... 40,000,000 no change.
Codeine (for sale)............ 45,000,000 no change.
Dextropropoxyphene............ 15 35.
Dihydrocodeine................ 281,100 422,000.
Dihydroetorphine.............. 2 no change.
Diphenoxylate (for conversion) 15,000 no change.
Diphenoxylate (for sale)...... 820,000 1,110,000.
Ecgonine...................... 99,000 no change.
Ethylmorphine................. 2 30.
Etorphine hydrochloride....... 32 no change.
Fentanyl...................... 1,750,000 no change.
Glutethimide.................. 2 no change.
Hydrocodone (for conversion).. 122,000 no change.
Hydrocodone (for sale)........ 58,410,000 no change.
Hydromorphone................. 5,140,800 no change.
Isomethadone.................. 4 30.
Levo-alphacetylmethadol (LAAM) 3 5.
Levomethorphan................ 10 30.
Levorphanol................... 8,300 12,900.
Lisdexamfetamine.............. 19,000,000 no change.
Meperidine.................... 3,706,000 no change.
Meperidine Intermediate-A..... 5 no change.
Meperidine Intermediate-B..... 9 30.
Meperidine Intermediate-C..... 5 no change.
Metazocine.................... 15 no change.
Methadone (for sale).......... 23,700,000 no change.
Methadone Intermediate........ 25,600,000 no change.
Methamphetamine............... 1,539,100 no change.
------------------------------------------------------------------------
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 600,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 39,100 grams for
methamphetamine (for sale)].
------------------------------------------------------------------------
Methylphenidate............... 73,000,000 no change.
Morphine (for conversion)..... 27,300,000 no change.
Morphine (for sale)........... 41,000,000 no change.
Nabilone...................... 19,000 no change.
Noroxymorphone (for 17,700,000 no change.
conversion).
Noroxymorphone (for sale)..... 400,000 no change.
[[Page 36454]]
Opium (powder)................ 90,000 no change.
Opium (tincture).............. 907,200 600,000.
Oripavine..................... 22,000,000 22,700,000.
Oxycodone (for conversion).... 2,610,000 no change.
Oxycodone (for sale).......... 108,510,000 no change.
Oxymorphone (for conversion).. 22,300,000 no change.
Oxymorphone (for sale)........ 4,200,000 no change.
Pentobarbital................. 27,500,000 no change.
Phenazocine................... 5 no change.
Phencyclidine................. 20 35.
Phenmetrazine................. 2 25.
Phenylacetone................. 20 40.
Racemethorphan................ 2 5.
Racemorphan................... 2 5.
Remifentanil.................. 3,000 no change.
Secobarbital.................. 172,002 no change.
Sufentanil.................... 4,000 no change.
Tapentadol.................... 21,000,000 no change.
Thebaine...................... 100,000,000 no change.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).... 50,000 no change.
Ephedrine (for sale).......... 5,360,000 no change.
Phenylpropanolamine (for 15,000,000 no change.
conversion).
Phenylpropanolamine (for sale) 8,500,000 no change.
Pseudoephedrine (for 40 no change.
conversion).
Pseudoephedrine (for sale).... 200,00,000 no change.
------------------------------------------------------------------------
The Acting Administrator further proposes that aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors,
the Acting Administrator may adjust the 2017 aggregate production
quotas and assessment of annual needs as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Acting Administrator will issue and
publish in the Federal Register a final order establishing any
adjustment of 2017 aggregate production quota for each basic class of
controlled substances in schedules I and II and established assessment
of annual needs for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).
Dated: July 27, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-16440 Filed 8-3-17; 8:45 am]
BILLING CODE 4410-09-P