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 2015, 39156-39160 [2015-16699]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Notices]
[Pages 39156-39160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16699]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-418P]


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 2015

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration proposes to adjust the 
2015 aggregate production quotas for several controlled substances in 
schedules I and II of the Controlled Substances Act and the 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 August 7, 2015. 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.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-418P'' 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 https://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/ODL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record and will be made available for 
public inspection online at https://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 posted online or made available in the public docket, 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 the 
confidential business information to be redacted within the comment. If 
a comment has so much confidential business information that it cannot 
be effectively redacted, all or part of that comment may not be made 
available in the public docket. Comments containing personal 
identifying information or confidential business information identified 
as directed above will be made publicly available in redacted form.
    An electronic copy of this document is available at https://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 determine the total quantity and 
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. This 
responsibility has been delegated to the Administrator of the DEA. 28 
CFR 0.100(b).
    The DEA established the 2015 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 September 8, 2014 (79 FR 53216). 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 2015 Aggregate Production Quotas and 
Assessment of Annual Needs

    The DEA proposes to adjust the established 2015 aggregate 
production quotas for certain schedule I and II controlled substances 
to be manufactured in the United States in 2015 to provide for the 
estimated medical, scientific, research, and industrial needs of the 
United States, lawful export requirements, and the establishment and 
maintenance of reserve stocks. These quotas do not include imports of 
controlled substances for use in industrial processes. The DEA is not 
proposing to adjust the established 2015 assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine to be manufactured in and imported into the United 
States in 2015 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, lawful export 
requirements, and the establishment and maintenance of reserve stocks.
    In proposing the adjustment, the DEA has taken into account the 
criteria that the DEA is required to consider in accordance with 21 CFR 
1303.13 and 21 CFR 1315.13. The DEA determines whether to propose an 
adjustment of the aggregate production quotas for basic classes of 
schedule I and II controlled substances and assessment of annual needs 
for ephedrine, pseudoephedrine,

[[Page 39157]]

and phenylpropanolamine 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.
    The DEA also considered updated information obtained from 2014 
year-end inventories, 2014 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 DEA 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 2015 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).
    As previously described in the published notice establishing the 
2015 aggregate production quotas and assessment of annual needs, the 
DEA has specifically considered that inventory allowances granted to 
individual manufacturers, 21 CFR 1303.24, may not always result in the 
availability of sufficient quantities to maintain an adequate reserve 
stock pursuant to 21 U.S.C. 826(a), as intended. This would be 
concerning if a natural disaster or other unforeseen event resulted in 
substantial disruption to the amount of controlled substances available 
to provide for legitimate public need. As such, the DEA has included in 
all proposed adjusted schedule II controlled substance aggregate 
production quotas, and certain proposed adjusted schedule I controlled 
substance aggregate production quotas, an additional 25% of the 
estimated medical, scientific, and research needs as part of the amount 
necessary to ensure the establishment and maintenance of reserve 
stocks. The resulting adjusted established aggregate production quotas 
will reflect these included amounts. This action will not affect the 
ability of manufacturers to maintain inventory allowances as specified 
by regulation. The DEA expects that maintaining this reserve in certain 
established aggregate production quotas will mitigate adverse public 
effects if an unforeseen event results in substantial disruption to the 
amount of controlled substances available to provide for legitimate 
public need, as determined by the DEA. The DEA does not anticipate 
utilizing the reserve in the absence of these circumstances.
    The Acting Administrator, therefore, proposes to adjust the 2015 
aggregate production quotas for certain schedule I and II controlled 
substances expressed in grams of anhydrous acid or base, as follows:

----------------------------------------------------------------------------------------------------------------
                                                       Established  2015      Proposed  Adjusted 2015  Quotas
                                                             Quotas      ---------------------------------------
                     Basic class                      -------------------
                                                              (g)                           (g)
----------------------------------------------------------------------------------------------------------------
                                                   Schedule I
----------------------------------------------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     15  25
 tetramethylcyclopropyl)methanone (UR-144).
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          15  25
 tetramethylcyclopropyl)methanone (XLR11).
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15  no change
 yl)methanone (THJ-2201).
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one                   15  25
 (butylone).
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one                  15  25
 (pentylone).
1-(1-Phenylcyclohexyl)pyrrolidine....................                 10  no change
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....                 45  no change
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...                 45  no change
1-[1-(2-Thienyl)cyclohexyl]piperidine................                 15  no change
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-                45  no change
 200).
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..............                 45  no change
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-                45  no change
 18 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)..............                 45  no change
1-Methyl-4-phenyl-4-propionoxypiperidine.............                  2  no change
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...                 45  no change
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....                 45  no change
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...                 45  no change
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....                 45  no change
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....                 45  no change
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)                 45  no change
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..                 45  no change
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..                 30  no change
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).....                 30  no change
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....                 30  no change
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....                 30  no change
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                 30  no change
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 15  25
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe;
 25B; Cimbi-36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....                 30  no change

[[Page 39158]]

 
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                15  25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe;
 25C; Cimbi-82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......                 30  no change
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  15  no change
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe;
 25I; Cimbi-5).
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)....                 15  no change
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                 25  no change
2,5-Dimethoxy-4-n-propylthiophenethylamine...........                 25  no change
2,5-Dimethoxyamphetamine.............................                 25  no change
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-                30  no change
 2).
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30  no change
 (2C-T-4).
3,4,5-Trimethoxyamphetamine..........................                 25  no change
3,4-Methylenedioxyamphetamine (MDA)..................                 55  no change
3,4-Methylenedioxymethamphetamine (MDMA).............                 50  no change
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 40  no change
3,4-Methylenedioxy-N-methylcathinone (methylone).....                 50  no change
3,4-Methylenedioxypyrovalerone (MDPV)................                 35  no change
3-Fluoro-N-methylcathinone (3-FMC)...................                 15  25
3-Methylfentanyl.....................................                  2  no change
3-Methylthiofentanyl.................................                  2  no change
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 25  no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25  no change
4-Fluoro-N-methylcathinone (4-FMC)...................                 15  25
4-Methoxyamphetamine.................................                100  no change
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25  no change
4-Methylaminorex.....................................                 25  no change
4-Methyl-N-ethylcathinone (4-MEC)....................                 15  25
4-Methyl-N-methylcathinone (mephedrone)..............                 45  no change
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 15  25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  68  no change
 hydroxycyclohexyl]-phenol.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                53  no change
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog).
5-Methoxy-3,4-methylenedioxyamphetamine..............                 25  no change
5-Methoxy-N,N-diisopropyltryptamine..................                 25  no change
5-Methoxy-N,N-dimethyltryptamine.....................                 25  no change
Acetyl-alpha-methylfentanyl..........................                  2  no change
Acetyldihydrocodeine.................................                  2  no change
Acetylmethadol.......................................                  2  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  no change
alpha-Methylthiofentanyl.............................                  2  no change
alpha-Methyltryptamine (AMT).........................                 25  no change
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 15  25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 15  25
Aminorex.............................................                 25  no change
Benzylmorphine.......................................                  2  no change
Betacetylmethadol....................................                  2  no change
beta-Hydroxy-3-methylfentanyl........................                  2  no change
beta-Hydroxyfentanyl.................................                  2  no change
Betameprodine........................................                  2  no change
Betamethadol.........................................                  4  no change
Betaprodine..........................................                  2  no change
Bufotenine...........................................                  3  no change
Cathinone............................................                 70  no change
Codeine methylbromide................................                  5  no change
Codeine-N-oxide......................................                305  no change
Desomorphine.........................................                  5  25
Diethyltryptamine....................................                 25  no change
Difenoxin............................................             11,000  no change
Dihydromorphine......................................          3,990,000  no change
Dimethyltryptamine...................................                 35  no change
Dipipanone...........................................                  5  no change
Fenethylline.........................................                  5  no change
gamma-Hydroxybutyric acid............................         70,250,000  no change
Heroin...............................................                 25  50
Hydromorphinol.......................................                  2  no change

[[Page 39159]]

 
Hydroxypethidine.....................................                  2  no change
Ibogaine.............................................                  5  no change
Lysergic acid diethylamide (LSD).....................                 35  no change
Marihuana............................................            658,000  no change
Mescaline............................................                 25  no change
Methaqualone.........................................                 10  no change
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-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide                    15  25
 (AKB48).
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                 15  25
 indazole-3-carboxamide (ADB-PINACA).
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            15  25
 fluorobenzyl)-1H-indazole-3-carboxamide (AB-
 FUBINACA).
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-                               15  no change
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA).
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-                     15  no change
 indazole-3-carboxamide (AB-PINACA).
N,N-Dimethylamphetamine..............................                 25  no change
Naphthylpyrovalerone (naphyrone).....................                 15  25
N-Benzylpiperazine...................................                 25  no change
N-Ethyl-1-phenylcyclohexylamine......................                  5  no change
N-Ethylamphetamine...................................                 24  no change
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24  no change
Noracymethadol.......................................                  2  no change
Norlevorphanol.......................................                 52  no change
Normethadone.........................................                  2  no change
Normorphine..........................................                 18  40
Para-fluorofentanyl..................................               zero  5
Parahexyl............................................               zero  5
Phenomorphan.........................................                  2  no change
Pholcodine...........................................               zero  5
Psilocybin...........................................                 30  no change
Psilocyn.............................................                 30  no change
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         15  25
 carboxylate (5-fluoro-PB-22; 5F-PB-22).
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   15  25
 22; QUPIC).
Tetrahydrocannabinols................................            497,500  511,250
Thiofentanyl.........................................                  2  no change
Tilidine.............................................                 10  25
Trimeperidine........................................                  2  no change
----------------------------------------------------------------------------------------------------------------
                                                   Schedule II
----------------------------------------------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  5  no change
1-Piperidinocyclohexanecarbonitrile..................                  5  no change
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          2,687,500  no change
Alfentanil...........................................             17,750  no change
Alphaprodine.........................................                  3  no change
Amobarbital..........................................             25,125  no change
Amphetamine (for conversion).........................         21,875,000  no change
Amphetamine (for sale)...............................         37,500,000  no change
Carfentanil..........................................                 19  no change
Cocaine..............................................            275,000  no change
Codeine (for conversion).............................         50,000,000  no change
Codeine (for sale)...................................         49,500,000  63,900,000
Dextropropoxyphene...................................                 19  45
Dihydrocodeine.......................................            226,375  no change
Diphenoxylate (for conversion).......................             75,000  no change
Diphenoxylate (for sale).............................          1,337,500  no change
Ecgonine.............................................            174,375  no change
Ethylmorphine........................................                  3  no change
Fentanyl.............................................          2,150,000  2,300,000
Glutethimide.........................................                  3  no change
Hydrocodone (for conversion).........................            137,500  no change
Hydrocodone (for sale)...............................         99,625,000  no change
Hydromorphone........................................          7,000,000  no change
Isomethadone.........................................                  5  no change
Levo-alphacetylmethadol (LAAM).......................                  4  no change
Levomethorphan.......................................                  5  30
Levorphanol..........................................              7,125  no change

[[Page 39160]]

 
Lisdexamfetamine.....................................         29,750,000  no change
Meperidine...........................................          6,250,000  no change
Meperidine Intermediate-A............................                  6  no change
Meperidine Intermediate-B............................                 11  32
Meperidine Intermediate-C............................                  6  no change
Metazocine...........................................                 19  no change
Methadone (for sale).................................         31,875,000  no change
Methadone Intermediate...............................         34,375,000  no change
Methamphetamine......................................          2,061,375  no change
----------------------------------------------------------------------------------------------------------------
  [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams
 for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for
                                                     sale)]
----------------------------------------------------------------------------------------------------------------
Methylphenidate......................................         83,750,000  87,500,000
Morphine (for conversion)............................         91,250,000  no change
Morphine (for sale)..................................         62,500,000  no change
Nabilone.............................................             18,750  no change
Noroxymorphone (for conversion)......................         17,500,000  no change
Noroxymorphone (for sale)............................          1,475,000  no change
Opium (powder).......................................            112,500  no change
Opium (tincture).....................................            687,500  no change
Oripavine............................................         35,000,000  no change
Oxycodone (for conversion)...........................          8,350,000  no change
Oxycodone (for sale).................................        137,500,000  139,150,000
Oxymorphone (for conversion).........................         29,000,000  no change
Oxymorphone (for sale)...............................          7,750,000  no change
Pentobarbital........................................         35,000,000  no change
Phenazocine..........................................                  6  no change
Phencyclidine........................................                 19  38
Phenmetrazine........................................                  3  no change
Phenylacetone........................................          9,375,000  no change
Racemethorphan.......................................                  3  no change
Remifentanil.........................................              3,750  4,200
Secobarbital.........................................            215,003  no change
Sufentanil...........................................              6,255  no change
Tapentadol...........................................         12,500,000  no change
Thebaine.............................................        125,000,000  no change
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
Ephedrine (for conversion)...........................          1,000,000  no change
Ephedrine (for sale).................................          4,000,000  no change
Phenylpropanolamine (for conversion).................         44,800,000  no change
Phenylpropanolamine (for sale).......................          8,500,000  no change
Pseudoephedrine (for conversion).....................              7,000  no change
Pseudoephedrine (for sale)...........................        224,500,000  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 further adjust the 2015 aggregate 
production quotas and assessment of annual needs as needed.

Comments

    In accordance with 21 CFR 1303.13(c) and 1315.13(d), any interested 
person may submit written comments on or objections to these proposed 
determinations. Based on comments received in response to this notice, 
the Acting Administrator may hold a public hearing on one or more 
issues raised. 21 CFR 1303.13(c) and 1315.13(e). In the event the 
Acting Administrator decides to hold such a hearing, the Acting 
Administrator will publish a notice of the hearing in the Federal 
Register. 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 the 2015 aggregate production quota for each basic class 
of controlled substance 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 1, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-16699 Filed 7-7-15; 8:45 am]
 BILLING CODE P