[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47829-47834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17371]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420P]


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 2016

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust 
the 2016 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 August 22, 2016. 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

[[Page 47830]]

Federal Register a final order establishing the 2016 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-420P'' 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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 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. 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 2016 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 6, 2015 (80 FR 60400). 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 2016 Aggregate Production Quotas and 
Assessment of Annual Needs

    The DEA proposes to adjust the established 2016 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 2016 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 2016 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 2015 year-end inventories, 2015 disposition data 
submitted by quota applicants,

[[Page 47831]]

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 2016 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 described in the previously published notice establishing the 
2016 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 resulted 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 that the year 2016 
aggregate production quotas for the two temporarily scheduled 
substances be established, and to adjust the 2016 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:

------------------------------------------------------------------------
                                Established  2016    Proposed  revised
                                      quotas            2016  quotas
          Basic class          -----------------------------------------
                                       (g)                  (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
beta-Hydroxythiofentanyl......                N/A  30.
Butyryl fentanyl..............                N/A  30.
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-                15  no change.
 3-yl](naphthalen-1-
 yl)methanone (THJ-2201).
1-(1-                                          10  no change.
 Phenylcyclohexyl)pyrrolidine.
1-(5-Fluoropentyl)-3-(1-                       45  no change.
 naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2-                       45  no change.
 iodobenzoyl)indole (AM694).
1-[1-(2-                                       15  no change.
 Thienyl)cyclohexyl]piperidine.
1-[2-(4-Morpholinyl)ethyl]-3-                  45  no change.
 (1-naphthoyl)indole (JWH-200).
1-Benzylpiperazine............                 25  no change.
1-Butyl-3-(1-naphthoyl)indole                  45  no change.
 (JWH-073).
1-Cyclohexylethyl-3-(2-                        45  no change.
 methoxyphenylacetyl)indole
 (SR-18 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole                  45  no change.
 (JWH-019).
1-Methyl-4-phenyl-4-                            2  no change.
 propionoxypiperidine.
1-Pentyl-3-(1-naphthoyl)indole                 45  no change.
 (JWH-018 and AM678).
1-Pentyl-3-(2-                                 45  no change.
 chlorophenylacetyl)indole
 (JWH-203).
1-Pentyl-3-(2-                                 45  no change.
 methoxyphenylacetyl)indole
 (JWH-250).
1-Pentyl-3-(4-chloro-1-                        45  no change.
 naphthoyl)indole (JWH-398).
1-Pentyl-3-(4-methyl-1-                        45  no change.
 naphthoyl)indole (JWH-122).
1-Pentyl-3-[(4-methoxy)-                       45  no change.
 benzoyl]indole (SR-19, RCS-4).
1-Pentyl-3-[1-(4-                              45  no change.
 methoxynaphthoyl)]indole (JWH-
 081).
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)-                15  no change.
 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.

[[Page 47832]]

 
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-                          50  no change.
 methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone                 35  no change.
 (MDPV).
3-FMC; 3-Fluoro-N-                             25  no change.
 methylcathinone.
3-Methylfentanyl..............                  2  no change.
3-Methylthiofentanyl..........                  2  no change.
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-Methoxyamphetamine..........                150  no change.
4-Methyl-2,5-                                  25  no change.
 dimethoxyamphetamine (DOM).
4-Methylaminorex..............                 25  no change.
4-MEC; 4-Methyl-N-                             25  no change.
 ethylcathinone.
4-Methyl-N-methylcathinone                     45  no change.
 (mephedrone).
4-Methyl-[alpha]-                              25  no change.
 pyrrolidinopropiophenone (4-
 MePPP).
5-(1,1-Dimethylheptyl)-2-                      68  50.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol.
5-(1,1-Dimethyloctyl)-2-                       53  40.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol (cannabicyclohexanol
 or CP-47,497 C8-homolog).
5-Fluoro-UR144, XLR11.........                 25  no change.
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-PINACA.....................                 15  no change.
Acetyl-alpha-methylfentanyl...                  2  no change.
Acetyldihydrocodeine..........                  2  no change.
Acetylmethadol................                  2  no change.
AH-7921.......................                N/A  30.
Allylprodine..................                  2  no change.
alpha-Ethyltryptamine.........                 25  no change.
alpha-Methylfentanyl..........                  2  no change.
alpha-Methylthiofentanyl......                  2  no change.
alpha-Methyltryptamine (AMT)..                 25  no change.
alpha-Pyrrolidinobutiophenone                  25  no change.
 ([alpha]-PBP).
alpha-Pyrrolidinopentiophenone                 25  no change.
 ([alpha]-PVP).
Alphacetylmethadol............                  2  no change.
Alphameprodine................                  2  no change.
Alphamethadol.................                  2  no change.
Aminorex......................                 25  no change.
APINCA, AKB48.................                 25  no change.
Benzylmorphine................                  2  no change.
beta-Hydroxy-3-methylfentanyl.                  2  no change.
beta-Hydroxyfentanyl..........                  2  no change.
Betacetylmethadol.............                  2  no change.
Betameprodine.................                  2  no change.
Betamethadol..................                  4  no change.
Betaprodine...................                  2  no change.
Bufotenine....................                  3  no change.
Butylone......................                 25  no change.
Cathinone.....................                 70  30.
Codeine methylbromide.........                  5  no change.
Codeine-N-oxide...............                305  no change.
Desomorphine..................                 25  no change.
Diethyltryptamine.............                 25  no change.
Difenoxin.....................             11,000  no change.
Dihydromorphine...............          3,000,000  2,000,000.
Dimethyltryptamine............                 35  no change.
Dipipanone....................                  5  no change.
Fenethylline..................                  5  no change.
gamma-Hydroxybutyric acid.....         70,250,000  no change.
Heroin........................                 50  no change.
Hydromorphinol................                  2  no change.
Hydroxypethidine..............                  2  no change.
Ibogaine......................                  5  no change.
Lysergic acid diethylamide                     40  no change.
 (LSD).
Marihuana.....................            658,000  no change.

[[Page 47833]]

 
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,N-Dimethylamphetamine.......                 25  no change.
N-(1-Amino-3,3-dimethyl-1-                     50  no change.
 oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide (ADB-
 PINACA).
N-(1-Amino-3-methyl-1-oxobutan-                50  no change.
 2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide (AB-
 FUBINACA).
N-(1-Amino-3-methyl-1-oxobutan-                15  no change.
 2-yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide (AB-
 CHMINACA).
N-(1-phenethylpiperidin-4-yl)-                100  no change.
 N-phenylacetamide (acetyl
 fentanyl).
N-Ethyl-1-                                      5  no change.
 phenylcyclohexylamine.
N-Ethylamphetamine............                 24  no change.
N-Hydroxy-3,4-                                 24  no change.
 methylenedioxyamphetamine.
Naphyrone.....................                 25  no change.
Noracymethadol................                  2  no change.
Norlevorphanol................                 52  no change.
Normethadone..................                  2  no change.
Normorphine...................                 40  no change.
Para-fluorofentanyl...........                  5  no change.
Parahexyl.....................                  5  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.
Quinolin-8-yl 1-(5-                            50  25.
 fluoropentyl)-1H-indole-3-
 carboxylate (5-fluoro-PB-22;
 5F-PB-22).
Quinolin-8-yl 1-pentyl-1H-                     50  25.
 indole-3-carboxylate (PB-22;
 QUPIC).
Tetrahydrocannabinols.........            511,250  no change.
Thiofentanyl..................                  2  no change.
Tilidine......................                 25  no change.
Trimeperidine.................                  2  no change.
UR-144........................                 25  no change.
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.......                  5  no change.
1-                                              5  no change.
 Piperidinocyclohexanecarbonit
 rile.
4-Anilino-N-phenethyl-4-                2,950,000  2,250,000.
 piperidine (ANPP).
Alfentanil....................             17,750  no change.
Alphaprodine..................                  3  no change.
Amobarbital...................             25,125  no change.
Amphetamine (for conversion)..         15,000,000  no change.
Amphetamine (for sale)........         39,705,000  45,000,000.
Carfentanil...................                 19  no change.
Cocaine.......................            200,000  no change.
Codeine (for conversion)......         50,000,000  no change.
Codeine (for sale)............         63,900,000  no change.
Dextropropoxyphene............                 19  no change.
Dihydrocodeine................            226,375  no change.
Dihydroetorphine..............                  3  no change.
Diphenoxylate (for conversion)             31,250  18,750.
Diphenoxylate (for sale)......          1,337,500  no change.
Ecgonine......................            125,000  no change.
Ethylmorphine.................                  3  5.
Etorphine hydrochloride.......                  3  no change.
Fentanyl......................          2,300,000  no change.
Glutethimide..................                  3  no change.
Hydrocodone (for conversion)..            235,000  177,500.
Hydrocodone (for sale)........         88,500,000  86,000,000.
Hydromorphone.................          8,250,000  7,000,000.
Isomethadone..................                  5  no change.
Levo-alphacetylmethadol (LAAM)                  4  no change.
Levomethorphan................                 30  33.
Levorphanol...................              7,125  no change.
Lisdexamfetamine..............         29,750,000  23,750,000.
Meperidine....................          5,450,000  4,632,500.
Meperidine Intermediate-A.....                  6  no change.

[[Page 47834]]

 
Meperidine Intermediate-B.....                 11  no change.
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...............         96,750,000  84,375,000.
Morphine (for conversion).....         91,250,000  no change.
Morphine (for sale)...........         62,500,000  no change.
Nabilone......................             18,750  no change.
Noroxymorphone (for                    17,500,000  no change.
 conversion).
Noroxymorphone (for sale).....          1,475,000  625,000.
Opium (powder)................            112,500  no change.
Opium (tincture)..............            687,500  375,000.
Oripavine.....................         30,000,000  no change.
Oxycodone (for conversion)....          6,250,000  5,000,000.
Oxycodone (for sale)..........        139,150,000  no change.
Oxymorphone (for conversion)..         29,000,000  25,000,000.
Oxymorphone (for sale)........          7,750,000  6,250,000.
Pentobarbital.................         38,125,000  no change.
Phenazocine...................                  6  no change.
Phencyclidine.................                 50  no change.
Phenmetrazine.................                  3  no change.
Phenylacetone.................                 50  no change.
Racemethorphan................                  3  5.
Racemorphan...................                  3  no change.
Remifentanil..................              3,750  no change.
Secobarbital..................            215,003  no change.
Sufentanil....................              6,255  no change.
Tapentadol....................         25,500,000  no change.
Thebaine......................        125,000,000  no change.
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)....            100,000  50,000.
Ephedrine (for sale)..........          4,000,000  no change.
Phenylpropanolamine (for               22,400,000  15,000,000.
 conversion).
Phenylpropanolamine (for sale)          8,500,000  no change.
Pseudoephedrine (for                        7,000  40.
 conversion).
Pseudoephedrine (for sale)....        224,500,000  200,000,000.
------------------------------------------------------------------------

    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 2016 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 2016 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 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17371 Filed 7-21-16; 8:45 am]
 BILLING CODE 4410-09-P