Proposed 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

Federal RegisterJul 22, 2016

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-443N]

Proposed 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.

SUMMARY:

The Drug Enforcement Administration (DEA) proposes to establish the 2017 aggregate production quotas for 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 1303.11(c) and 1315.11(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

Federal Register

a final order establishing the 2017 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-443N” 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

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.

Analysis for Proposed 2017 Aggregate Production Quotas and Assessment of Annual Needs

The proposed year 2017 aggregate production quotas and assessment of annual needs 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 2017 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 2017 aggregate production quotas and assessment of annual needs, the Acting Administrator has taken into account the criteria pursuant to 21 U.S.C. 826(a) and in accordance with 21 CFR 1303.11 (aggregate production quotas for controlled substances) and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2017 by considering: (1) Total net disposal of each 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 each class or chemical as indicated by procurement and import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting medical, scientific, research, and industrial needs of 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.

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 2017 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively).

During the calendar years 2013-2016, the DEA included an additional 25% of the estimated medical, scientific, and research needs for the United States as part of the amount necessary to ensure the establishment and maintenance of reserve stocks for all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (difenoxin, gamma-hydroxybutyric acid, and tetrahydrocannabinols). Based on interagency discussions beginning in November 2015, and after reviewing all relevant quota applications received, published FDA drug shortage lists, and subsequent reports required under 21 U.S.C. 826a for those calendar years, the Acting Administrator has determined that inclusion of the additional 25% of the estimated medical, scientific, and research needs for the United States is unnecessary. Instead, the Acting Administrator determined that 21 U.S.C. 826(c) and 21 U.S.C. 952(a)(2)(A) provide sufficient ability for the DEA to mitigate adverse public effects should a natural disaster or other unforeseen event result in substantial disruption to the amount of controlled substances available for legitimate public need. As such, DEA proposes to remove the additional 25% from the aggregate production quotas. The resulting proposed established aggregate production quotas reflect these reduced amounts.

The Acting Administrator, therefore, proposes to establish 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:

Basic class

Proposed 2017 quotas (g)

Schedule I

[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)

1-(1-Phenylcyclohexyl)pyrrolidine

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)

1-[1-(2-Thienyl)cyclohexyl]piperidine

1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)

1-Benzylpiperazine

1-Butyl-3-(1-naphthoyl)indole (JWH-073)

1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)

1-Hexyl-3-(1-naphthoyl)indole (JWH-019)

1-Methyl-4-phenyl-4-propionoxypiperidine

1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)

1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)

1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)

1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)

1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)

1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)

1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)

2,5-Dimethoxy-4-ethylamphetamine (DOET)

2,5-Dimethoxy-4-n-propylthiophenethylamine

2,5-Dimethoxyamphetamine

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)

3,4,5-Trimethoxyamphetamine

3,4-Methylenedioxyamphetamine (MDA)

3,4-Methylenedioxymethamphetamine (MDMA)

3,4-Methylenedioxy-N-ethylamphetamine (MDEA)

3,4-Methylenedioxy-N-methylcathinone (methylone)

3,4-Methylenedioxypyrovalerone (MDPV)

3-FMC; 3-Fluoro-N-methylcathinone

3-Methylfentanyl

3-Methylthiofentanyl

4-Bromo-2,5-dimethoxyamphetamine (DOB)

4-Bromo-2,5-dimethoxyphenethylamine (2-CB)

4-FMC; Flephedrone

4-Methoxyamphetamine

150

4-Methyl-2,5-dimethoxyamphetamine (DOM)

4-Methylaminorex

4-MEC; 4-Methyl-N-ethylcathinone

4-Methyl-N-methylcathinone (mephedrone)

4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)

5-Fluoro-UR144, XLR11

5-Methoxy-3,4-methylenedioxyamphetamine

5-Methoxy-N,N-diisopropyltryptamine

5-Methoxy-N,N-dimethyltryptamine

AB-PINACA

Acetyl-alpha-methylfentanyl

Acetyldihydrocodeine

Acetylmethadol

AH-7921

Allylprodine

alpha-Ethyltryptamine

alpha-Methylfentanyl

alpha-Methylthiofentanyl

alpha-Methyltryptamine (AMT)

alpha-Pyrrolidinobutiophenone (α-PBP)

alpha-Pyrrolidinopentiophenone (α-PVP)

Alphacetylmethadol

Alphameprodine

Alphamethadol

Aminorex

APINCA, AKB48

Benzylmorphine

beta-Hydroxy-3-methylfentanyl

beta-Hydroxyfentanyl

beta-Hydroxythiofentanyl

Betacetylmethadol

Betameprodine

Betamethadol

Betaprodine

Bufotenine

Butylone

Butyryl fentanyl

Cathinone

Codeine methylbromide

Codeine-N-oxide

305

Desomorphine

Diethyltryptamine

Difenoxin

8,750

Dihydromorphine

1,566,000

Dimethyltryptamine

Dipipanone

Fenethylline

gamma-Hydroxybutyric acid

56,200,000

Heroin

Hydromorphinol

Hydroxypethidine

Ibogaine

Lysergic acid diethylamide (LSD)

Marihuana

472,000

Mescaline

Methaqualone

Methcathinone

Methyldesorphine

Methyldihydromorphine

Morphine methylbromide

Morphine methylsulfonate

Morphine-N-oxide

350

N,N-Dimethylamphetamine

N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)

N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)

N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)

N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl)

100

N-Ethyl-1-phenylcyclohexylamine

N-Ethylamphetamine

N-Hydroxy-3,4-methylenedioxyamphetamine

Naphyrone

Noracymethadol

Norlevorphanol

Normethadone

Normorphine

Para-fluorofentanyl

Parahexyl

Pentedrone

Pentylone

Phenomorphan

Pholcodine

Psilocybin

Psilocyn

Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)

Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)

Tetrahydrocannabinols

409,000

Thiofentanyl

Tilidine

Trimeperidine

UR-144

Schedule II

1-Phenylcyclohexylamine

1-Piperidinocyclohexanecarbonitrile

4-Anilino-N-phenethyl-4-piperidine (ANPP)

1,000,000

Alfentanil

4,200

Alphaprodine

Amobarbital

20,100

Amphetamine (for conversion)

9,000,000

Amphetamine (for sale)

37,500,000

Carfentanil

Cocaine

94,000

Codeine (for conversion)

40,000,000

Codeine (for sale)

45,000,000

Dextropropoxyphene

Dihydrocodeine

81,100

Dihydroetorphine

Diphenoxylate (for conversion)

15,000

Diphenoxylate (for sale)

820,000

Ecgonine

90,000

Ethylmorphine

Etorphine hydrochloride

Fentanyl

1,750,000

Glutethimide

Hydrocodone (for conversion)

122,000

Hydrocodone (for sale)

58,410,000

Hydromorphone

4,300,000

Isomethadone

Levo-alphacetylmethadol (LAAM)

Levomethorphan

Levorphanol

4,900

Lisdexamfetamine

19,000,000

Meperidine

3,706,000

Meperidine Intermediate-A

Meperidine Intermediate-B

Meperidine Intermediate-C

Metazocine

Methadone (for sale)

23,700,000

Methadone Intermediate

25,600,000

Methamphetamine

1,539,100

[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

Morphine (for conversion)

27,300,000

Morphine (for sale)

41,000,000

Nabilone

15,000

Noroxymorphone (for conversion)

17,700,000

Noroxymorphone (for sale)

400,000

Opium (powder)

90,000

Opium (tincture)

300,000

Oripavine

20,000,000

Oxycodone (for conversion)

2,610,000

Oxycodone (for sale)

108,510,000

Oxymorphone (for conversion)

22,300,000

Oxymorphone (for sale)

4,200,000

Pentobarbital

27,500,000

Phenazocine

Phencyclidine

Phenmetrazine

Phenylacetone

Racemethorphan

Racemorphan

Remifentanil

3,000

Secobarbital

172,002

Sufentanil

4,000

Tapentadol

21,000,000

Thebaine

100,000,000

List I Chemicals

Ephedrine (for conversion)

50,000

Ephedrine (for sale)

4,100,000

Phenylpropanolamine (for conversion)

15,000,000

Phenylpropanolamine (for sale)

8,500,000

Pseudoephedrine (for sale)

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 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 the

2017 aggregate production quota for controlled substances in schedules I and II and establishing an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.11(c) and 1315.11(f).

Dated: July 14, 2016.

Chuck Rosenberg,

Acting Administrator.

[FR Doc. 2016-17370 Filed 7-21-16; 8:45 am]

BILLING CODE 4410-09-P

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