[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Pages 46519-46523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19052]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-365]
Proposed Aggregate Production Quotas for Schedule I and II
Controlled Substances and Proposed Assessment of Annual Needs for the
List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine
for 2013
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: This notice proposes initial year 2013 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA) and assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before September 4, 2012. Commenters should be
aware that the electronic Federal Docket Management System will not
accept comments after midnight Eastern Time on the last day of the
comment period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-365'' on all electronic and written correspondence.
DEA encourages that all comments be submitted electronically through
http://www.regulations.gov using the electronic comment form provided
on that site. An electronic copy of this document is also available at
the http://www.regulations.gov Web site for easy reference. Paper
comments that duplicate the electronic submission are not necessary as
all comments submitted to http://www.regulations.gov will be posted for
public review and are part of the official docket record. Written
comments submitted via regular or express mail should be sent to the
Drug Enforcement Administration, Attention: DEA Federal Register
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:
[[Page 46520]]
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter.
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 posted online or made available
in the public docket 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 posted online or made available
in the public docket, 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. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the For Further Information Contact paragraph.
Background
Section 306 of the 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 ephedrine,
pseudoephedrine, and phenylpropanolamine. This responsibility has been
delegated to the Administrator of the DEA by 28 CFR 0.100. The
Administrator, in turn, has redelegated this function to the Deputy
Administrator, pursuant to 28 CFR 0.104.
The proposed year 2013 aggregate production quotas represent those
quantities of schedule I and II controlled substances, and the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be
manufactured in the United States in 2013 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 include imports of
ephedrine, pseudoephedrine, and phenylpropanolamine but do not include
imports of controlled substances for use in industrial processes.
In determining the proposed 2013 aggregate production quotas and
assessment of annual needs, DEA has taken into account the criteria
that DEA is required to consider in accordance with 21 U.S.C. 826(a),
21 CFR 1303.11 (aggregate production quotas for controlled substances),
and 21 CFR 1315.11 (assessment of annual needs for ephedrine,
pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate
production quotas and assessment of annual needs for 2013 by
considering (1) total net disposal of the class or chemical by all
manufacturers and chemical importers during the current and two
preceding years; (2) trends in the national rate of net disposal of the
class or chemical; (3) total actual (or estimated) inventories of the
class or chemical and of all substances manufactured from the class or
chemical, and trends in inventory accumulation; (4) projected demand
for such class or chemical as indicated by procurement and chemical
import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and
1315.34; and (5) other factors affecting the medical, scientific,
research, and industrial needs in the United States, lawful export
requirements, and reserve stocks, as the Deputy Administrator finds
relevant. Other factors 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 2013 assessment of annual needs, DEA used the calculation
methodology previously described in the 2010 and 2011 assessment of
annual needs (74 FR 60294 and 75 FR 79407, respectively).
DEA also specifically considered that inventory allowances granted
to individual manufacturers 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. See 21 CFR 1303.24. 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, DEA proposes to include
in all schedule II aggregate production quotas, and certain schedule I
aggregate production quotas (gamma-hydroxybutyric acid and
tetrahydrocannabinols), 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 established aggregate production quota will reflect these
included amounts. This action will not affect the ability of
manufacturers to maintain inventory allowances as specified by
regulation. DEA expects that maintaining this reserve in certain
established aggregate production quotas will mitigate adverse public
affects if an unforeseen event resulted in substantial disruption to
the amount of controlled substances available to provide for legitimate
public need, as determined by DEA. DEA does not anticipate utilizing
the reserve in the absence of these circumstances.
The Deputy Administrator, therefore, proposes that the year 2013
aggregate production quotas and assessment of annual needs for the
following schedule I and II controlled substances and for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, be established as
follows:
[[Page 46521]]
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Proposed 2013 quotas g
------------------------------------------------------------------------
Basic Class--Schedule I
------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole 45
(AM2201).................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole 45
(AM694)..................................
1-[1-(2-Thienyl)cyclohexyl]piperidine..... 5
1-[2-(4-Morpholinyl)ethyl]-3-(1- 45
naphthoyl)indole (JWH-200)...............
1-Butyl-3-(1-naphthoyl)indole (JWH-073)... 45
1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole (SR-18 and RCS-
8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)... 45
1-Methyl-4-phenyl-4-propionoxypiperidine.. 2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 45
and AM678)...............................
1-Pentyl-3-(2-chlorophenylacetyl)indole 45
(JWH-203)................................
1-Pentyl-3-(2-methoxyphenylacetyl)indole 45
(JWH-250)................................
1-Pentyl-3-(4-chloro-1-naphthoyl)indole 45
(JWH-398)................................
1-Pentyl-3-(4-methyl-1-naphthoyl)indole 45
(JWH-122)................................
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole 45
(JWH-081)................................
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR- 45
19, RCS-4)...............................
2-(2,5-Dimethoxy-4-(n)- 15
propylphenyl)ethanamine (2C-P)...........
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine 15
(2C-E)...................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine 15
(2C-D)...................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine 15
(2C-N)...................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).. 15
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine 15
(2C-C)...................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine 15
(2C-I)...................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)... 12
2,5-Dimethoxy-4-n-propylthiophenethylamine 12
2,5-Dimethoxyamphetamine.................. 12
2-[4-(Ethylthio)-2,5- 15
dimethoxyphenyl]ethanamine (2C-T-2)......
2-[4-(Isopropylthio)-2,5- 15
dimethoxyphenyl]ethanamine (2C-T-4)......
3-Methylfentanyl.......................... 2
3-Methylthiofentanyl...................... 2
3,4-Methylenedioxyamphetamine (MDA)....... 30
3,4-Methylenedioxy-N-methylcathinone 15
(methylone)..............................
3,4-Methylenedioxy-N-ethylamphetamine 24
(MDEA)...................................
3,4-Methylenedioxymethamphetamine (MDMA).. 35
3,4-Methylenedioxypyrovalerone (MDPV)..... 15
3,4,5-Trimethoxyamphetamine............... 12
4-Bromo-2,5-dimethoxyamphetamine (DOB).... 12
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 12
4-Methoxyamphetamine...................... 88
4-Methylaminorex.......................... 12
4-Methyl-2,5-dimethoxyamphetamine (DOM)... 12
4-Methyl-N-methylcathinone (mephedrone)... 15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68
hydroxycyclohexyl]-phenol................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 53
hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-47, 497 C8-
homolog).................................
5-Methoxy-3,4-methylenedioxyamphetamine... 12
5-Methoxy-N,N-diisopropyltryptamine....... 12
5-Methoxy-N,N-dimethyltryptamine.......... 10
Acetyl-alpha-methylfentanyl............... 2
Acetyldihydrocodeine...................... 2
Acetylmethadol............................ 2
Allylprodine.............................. 2
Alphacetylmethadol........................ 2
Alpha-ethyltryptamine..................... 12
Alphameprodine............................ 2
Alphamethadol............................. 2
Alpha-methylfentanyl...................... 2
Alpha-methylthiofentanyl.................. 2
Alpha-methyltryptamine (AMT).............. 12
Aminorex.................................. 12
Benzylmorphine............................ 2
Betacetylmethadol......................... 2
Beta-hydroxy-3-methylfentanyl............. 2
Beta-hydroxyfentanyl...................... 2
Betameprodine............................. 2
Betamethadol.............................. 2
Betaprodine............................... 2
Bufotenine................................ 3
Cathinone................................. 12
Codeine-N-oxide........................... 602
Desomorphine.............................. 5
[[Page 46522]]
Diethyltryptamine......................... 12
Difenoxin................................. 50
Dihydromorphine........................... 3,300,000
Dimethyltryptamine........................ 18
Gamma-hydroxybutyric acid................. 46,250,000
Heroin.................................... 25
Hydromorphinol............................ 54
Hydroxypethidine.......................... 2
Ibogaine.................................. 5
Lysergic acid diethylamide (LSD).......... 30
Marihuana................................. 21,000
Mescaline................................. 13
Methaqualone.............................. 10
Methcathinone............................. 14
Methyldihydromorphine..................... 2
Morphine-N-oxide.......................... 655
N-Benzylpiperazine........................ 12
N,N-Dimethylamphetamine................... 12
N-Ethylamphetamine........................ 12
N-Hydroxy-3,4-methylenedioxyamphetamine... 12
Noracymethadol............................ 2
Norlevorphanol............................ 52
Normethadone.............................. 2
Normorphine............................... 18
Para-fluorofentanyl....................... 2
Phenomorphan.............................. 2
Pholcodine................................ 2
Properidine............................... 2
Psilocybin................................ 2
Psilocyn.................................. 4
Tetrahydrocannabinols..................... 491,000
Thiofentanyl.............................. 2
Tilidine.................................. 10
Trimeperidine............................. 2
------------------------------------------------------------------------
Basic Class--Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................... 3
1-Piperdinocyclohexanecarbonitrile........ 21
4-Anilino-N-phenethyl-4-piperidine (ANPP). 2,250,000
Alfentanil................................ 38,250
Alphaprodine.............................. 3
Amobarbital............................... 9
Amphetamine (for conversion).............. 18,375,000
Amphetamine (for sale).................... 38,000,000
Carfentanil............................... 6
Cocaine................................... 240,000
Codeine (for conversion).................. 81,250,000
Codeine (for sale)........................ 49,506,250
Dextropropoxyphene........................ 19
Dihydrocodeine............................ 250,000
Diphenoxylate............................. 750,000
Ecgonine.................................. 127,500
Ethylmorphine............................. 3
Fentanyl.................................. 2,108,750
Glutethimide.............................. 3
Hydrocodone (for sale).................... 78,750,000
Hydromorphone............................. 4,535,000
Isomethadone.............................. 5
Levo-alphacetylmethadol (LAAM)............ 4
Levomethorphan............................ 6
Levorphanol............................... 4,500
Lisdexamfetamine.......................... 19,250,000
Meperidine................................ 6,875,000
Meperidine Intermediate-A................. 6
Meperidine Intermediate-B................. 11
Meperidine Intermediate-C................. 6
Metazocine................................ 6
Methadone (for sale)...................... 25,000,000
Methadone Intermediate.................... 32,500,000
Methamphetamine........................... 3,912,500
------------------------------------------------------------------------
[[Page 46523]]
[962,500 grams of levo-desoxyephedrine for
use in a non-controlled, non-prescription
product; 2,888,750 grams for
methamphetamine mostly for conversion to
a schedule III product; and 61,250 grams
for methamphetamine (for sale)]..........
------------------------------------------------------------------------
Methylphenidate........................... 72,250,000
Morphine (for conversion)................. 103,750,000
Morphine (for sale)....................... 51,250,000
Nabilone.................................. 25,628
Noroxymorphone (for conversion)........... 9,000,000
Noroxymorphone (for sale)................. 508,750
Opium (powder)............................ 91,250
Opium (tincture).......................... 1,287,500
Oripavine................................. 22,750,000
Oxycodone (for conversion)................ 10,250,000
Oxycodone (for sale)...................... 123,375,000
Oxymorphone (for conversion).............. 16,000,000
Oxymorphone (for sale).................... 6,875,000
Pentobarbital............................. 42,500,000
Phenazocine............................... 6
Phencyclidine............................. 30
Phenmetrazine............................. 3
Phenylacetone............................. 20,000,000
Racemethorphan............................ 3
Remifentanil.............................. 2,500
Secobarbital.............................. 215,003
Sufentanil................................ 6,250
Tapentadol................................ 13,500,000
Thebaine.................................. 145,000,000
------------------------------------------------------------------------
Basic Class--List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)................ 12,000,000
Ephedrine (for sale)...................... 3,200,000
Phenylpropanolamine (for conversion)...... 25,700,000
Phenylpropanolamine (for sale)............ 4,400,000
Pseudoephedrine (for sale)................ 185,000,000
------------------------------------------------------------------------
The Deputy 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 be established at zero. Pursuant to 21
CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant
factors, the Deputy Administrator may adjust the 2013 aggregate
production quotas and assessment of annual needs as needed.
Comments
Pursuant to 21 CFR 1303.11 and 21 CFR 1315.11, any interested
person may submit written comments on or objections to these proposed
determinations. Based on comments received in response to this Notice,
the Deputy Administrator may hold a public hearing on one or more
issues raised. In the event the Deputy Administrator decides in his
sole discretion to hold such a hearing, the Deputy Administrator will
publish a notice of any such hearing in the Federal Register. After
consideration of any comments and after a hearing, if one is held, the
Deputy Administrator will publish in the Federal Register a final order
establishing the 2013 aggregate production quota for each basic class
of controlled substance and assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Dated: July 31, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-19052 Filed 8-2-12; 8:45 am]
BILLING CODE 4410-09-P