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 2018

Federal RegisterAug 7, 2017

Ask Donna

What actually matters in this document.

Text

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471N]

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 2018

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

The Drug Enforcement Administration (DEA) proposes to establish the 2018 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 September 6, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the

Federal Register

. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the

Federal Register

a final order establishing the 2018 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-471N” on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to

http://www.regulations.gov

and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on

Regulations.gov

. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment

in lieu

of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

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 2018 Aggregate Production Quotas and Assessment of Annual Needs

The proposed year 2018 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 2018 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 2018 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 2018 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 2018 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).

The Acting Administrator, therefore, proposes to establish the 2018 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

2018

quotas

(g)

Schedule I

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-Benzylpiperazine

1-Methyl-4-phenyl-4-propionoxypiperidine

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-Fluoroisobutyryl fentanyl

4-FMC; Flephedrone

4-MEC; 4-Methyl-N-ethylcathinone

4-Methoxyamphetamine

150

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

4-Methylaminorex

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)

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1

-indazole-3-carboxamido)-3-methylbutanoate)

5F-APINACA; 5F-AKB48 (

-(adamantan-1-yl)-1-(5-fluoropentyl)-1

-indazole-3-carboxamide)

5-Fluoro-PB-22; 5F-PB-22

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1

indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone

5-Methoxy-3,4-methylenedioxyamphetamine

5-Methoxy-N,N-diisopropyltryptamine

5-Methoxy-N,N-dimethyltryptamine

AB-CHMINACA

AB-FUBINACA

AB-PINACA

ADB-FUBINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1

-indazole-3-carboxamide)

Acetyl Fentanyl

100

Acetyl-

alpha

-methylfentanyl

Acetyldihydrocodeine

Acetylmethadol

ADB-PINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1

-indazole-3-carboxamide)

AH-7921

Allylprodine

Alphacetylmethadol

alpha-

Ethyltryptamine

Alphameprodine

Alphamethadol

alpha

-Methylfentanyl

alpha

-Methylthiofentanyl

alpha

-Methyltryptamine (AMT)

alpha

-Pyrrolidinobutiophenone (α-PBP)

alpha

-Pyrrolidinopentiophenone (α-PVP)

Aminorex

APINCA, AKB48 (

-(1-adamantyl)-1-pentyl-1

-indazole-3-carboxamide)

Benzylmorphine

Betacetylmethadol

beta

-Hydroxy-3-methylfentanyl

beta

-Hydroxyfentanyl

beta

-Hydroxythiofentanyl

Betameprodine

Betamethadol

Betaprodine

Bufotenine

Butylone

Butyryl fentanyl

Cathinone

Codeine methylbromide

Codeine-N-oxide

192

Desomorphine

Diethyltryptamine

Difenoxin

8,225

Dihydromorphine

1,000,160

Dimethyltryptamine

Dipipanone

Etorphine

Fenethylline

Furanyl fentanyl

gamma

-Hydroxybutyric acid

37,130,000

Heroin

Hydromorphinol

Hydroxypethidine

Ibogaine

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

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

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

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

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

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

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

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

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

Lysergic acid diethylamide (LSD)

MAB-CHMINACA; ADB-CHMINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1

-indazole-3-carboxamide)

MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1

-indole-3-carboxamido)-3,3-dimethylbutanoate)

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1

-indazole-3-carboxamido)-3,3-dimethylbutanoate)

Marihuana

443,680

Mecloqualone

Mescaline

Methaqualone

Methcathinone

Methyldesorphine

Methyldihydromorphine

Morphine methylbromide

Morphine methylsulfonate

Morphine-N-oxide

150

N,N

-Dimethylamphetamine

Naphyrone

-Ethyl-1-phenylcyclohexylamine

-Ethylamphetamine

-Hydroxy-3,4-methylenedioxyamphetamine

Noracymethadol

Norlevorphanol

Normethadone

Normorphine

Para-fluorofentanyl

Parahexyl

PB-22; QUPIC

Pentedrone

Pentylone

Phenomorphan

Pholcodine

Psilocybin

Psilocyn

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

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

Tetrahydrocannabinols

384,460

Thiofentanyl

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

Tilidine

Trimeperidine

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone

U-47700

Schedule II

1-Phenylcyclohexylamine

1-Piperidinocyclohexanecarbonitrile

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

1,342,320

Alfentanil

2,538

Alphaprodine

Amobarbital

18,894

Amphetamine (for conversion)

11,280,000

Amphetamine (for sale)

39,856,000

Carfentanil

Cocaine

92,120

Codeine (for conversion)

15,040,000

Codeine (for sale)

40,015,800

Dextropropoxyphene

Dihydrocodeine

264,140

Dihydroetorphine

Diphenoxylate (for conversion)

14,100

Diphenoxylate (for sale)

770,800

Ecgonine

88,134

Ethylmorphine

Etorphine hydrochloride

Fentanyl

1,342,320

Glutethimide

Hydrocodone (for conversion)

114,680

Hydrocodone (for sale)

50,348,280

Hydromorphone

4,547,720

Isomethadone

Levo-alphacetylmethadol (LAAM)

Levomethorphan

Levorphanol

12,126

Lisdexamfetamine

17,869,000

Meperidine

2,717,540

Meperidine Intermediate—A

Meperidine Intermediate—B

Meperidine Intermediate—C

Metazocine

Methadone (for sale)

22,278,000

Methadone Intermediate

24,064,000

Methamphetamine

1,446,754

[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

60,724,000

Morphine (for conversion)

4,089,000

Morphine (for sale)

33,958,440

Nabilone

17,860

Noroxymorphone (for conversion)

14,044,540

Noroxymorphone (for sale)

376,000

Opium (powder)

84,600

Opium (tincture)

564,000

Oripavine

24,534,000

Oxycodone (for conversion)

2,453,400

Oxycodone (for sale)

95,692,000

Oxymorphone (for conversion)

20,962,000

Oxymorphone (for sale)

3,395,280

Pentobarbital

25,850,000

Phenazocine

Phencyclidine

Phenmetrazine

Phenylacetone

Racemethorphan

Racemorphan

Remifentanil

2,820

Secobarbital

161,682

Sufentanil

1,880

Tapentadol

18,388,280

Thebaine

94,000,000

List I Chemicals

Ephedrine (for conversion)

47,000

Ephedrine (for sale)

4,136,000

Phenylpropanolamine (for conversion)

14,100,000

Phenylpropanolamine (for sale)

7,990,000

Pseudoephedrine (for conversion)

Pseudoephedrine (for sale)

169,200,000

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 2018 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 2018 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 27, 2017.

Chuck Rosenberg,

Acting Administrator.

[FR Doc. 2017-16439 Filed 8-4-17; 8:45 am]

BILLING CODE 4410-09-P

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.