2018-18265. 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 2018

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

The Drug Enforcement Administration (DEA) proposes to adjust the 2018 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 September 24, 2018. 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 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-471P” 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:

Thomas D. Sonnen, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: [phone].

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 2018 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 November 8, 2017 (82 FR 51873). 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 2018 Aggregate Production Quotas and Assessment of Annual Needs

The DEA proposes to adjust the established 2018 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 2018 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 2018 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 2017 year-end inventories, 2017 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 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 2018 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).

The Acting Administrator, therefore, proposes to adjust the 2018 aggregate production quotas for certain schedule I and II controlled substances and the 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	Established 2018 quotas (g)	Proposed revised 2018 quotas (g)
Temporarily Scheduled Substances
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide	N/A	25.
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide	N/A	25.
Cyclopropyl Fentanyl	N/A	20.
Fentanyl related substances	N/A	25.
Isobutyryl Fentanyl	N/A	25.
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate	N/A	25.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide	N/A	25.
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate	N/A	25.
Ocfentanil	N/A	25.
Para-flourobutyryl fentanyl	N/A	25.
Tetrahydrofuranyl fentanyl	N/A	5.
Valeryl fentanyl	N/A	25.
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine	Zero	20.
1-(1-Phenylcyclohexyl)pyrrolidine	10	15.
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine	zero	10.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)	30	no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)	30	no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine	15	no change.
1-Benzylpiperazine	25	no change.
1-Methyl-4-phenyl-4-propionoxypiperidine	2	10.
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-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)	30	no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)	30	no change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)	30	no change.
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)	30	no change.
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)	25	no change.
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)	30	no change.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)	30	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-2)	30	no change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)	30	no change.
3,4,5-Trimethoxyamphetamine	30	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)	40	no change.
3,4-Methylenedioxypyrovalerone (MDPV)	35	no change.
3-FMC; 3-Fluoro-N-methylcathinone	25	no change.
3-Methylfentanyl	30	no change.
3-Methylthiofentanyl	30	no change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)	30	no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)	25	no change.
4-Fluoroisobutyryl fentanyl	30	no change.
4-FMC; Flephedrone	25	no change.
4-MEC; 4-Methyl-N-ethylcathinone	25	no change.
4-Methoxyamphetamine	150	no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)	25	no change.
4-Methylaminorex	25	no change.
4-Methyl-N-methylcathinone (mephedrone)	45	no change.
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)	25	no change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol	50	no change.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)	40	no change.
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)	30	no change.
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)	30	no change.
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)	30	no change.
5-Fluoro-PB-22; 5F-PB-22	20	no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H indol- 3-yl](2,2,3,3-tetramethylcyclopropyl)methanone	25	no change.
5-Methoxy-3,4-methylenedioxyamphetamine	25	no change.
5-Methoxy-N,N-diisopropyltryptamine	25	no change.
5-Methoxy-N,N-dimethyltryptamine	25	no change.
AB-CHMINACA	30	no change.
AB-FUBINACA	50	no change.
AB-PINACA	30	no change.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)	30	no change.
Acetyl Fentanyl	100	no change.
Acetyl-alpha-methylfentanyl	30	no change.
Acetyldihydrocodeine	30	no change.
Acetylmethadol	2	no change.
Acryl Fentanyl	25	no change.
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide)	50	no change.
AH-7921	30	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	30	no change.
alpha-Methylthiofentanyl	30	no change.
alpha-Methyltryptamine (AMT)	25	no change.
alpha-Pyrrolidinobutiophenone (α-PBP)	25	no change.
alpha-Pyrrolidinopentiophenone (α-PVP)	25	no change.
Aminorex	25	no change.
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)	25	no change.
Benzylmorphine	30	no change.
Betacetylmethadol	2	no change.
beta-Hydroxy-3-methylfentanyl	30	no change.
beta-Hydroxyfentanyl	30	no change.
beta-Hydroxythiofentanyl	30	no change.
Betameprodine	2	no change.
Betamethadol	4	no change.
Betaprodine	2	no change.
Bufotenine	3	no change.
Butylone	25	no change.
Butyryl fentanyl	30	no change.
Cathinone	24	no change.
Codeine methylbromide	30	no change.
Codeine-N-oxide	192	no change.
Desomorphine	25	no change.
Diapromide	Zero	20.
Diethylthiambutene	Zero	20.
Diethyltryptamine	25	no change.
Difenoxin	8,225	no change.
Dihydromorphine	1,000,160	no change.
Dimethyltryptamine	35	50.
Dipipanone	5	no change.
Etorphine	30	no change.
Fenethylline	30	no change.
Furanyl fentanyl	30	no change.
gamma-Hydroxybutyric acid	37,130,000	no change.
Heroin	45	no change.
Hydromorphinol	40	no change.
Hydroxypethidine	2	no change.
Ibogaine	30	no change.
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)	35	no change.
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)	45	no change.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)	45	no change.
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)	30	no change.
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)	30	no change.
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)	35	no change.
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)	30	no change.
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)	30	no change.
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)	30	no change.
Lysergic acid diethylamide (LSD)	40	no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide)	30	no change.
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)	30	no change.
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)	30	no change.
Marihuana	443,680	1,140,216.
Mecloqualone	30	no change.
Mescaline	25	no change.
Methaqualone	60	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	150	no change.
N,N-Dimethylamphetamine	25	no change.
Naphyrone	25	no change.
N-Ethyl-1-phenylcyclohexylamine	5	no change.
N-Ethyl-3-piperidyl benzilate	Zero	10.
N-Ethylamphetamine	24	no change.
N-Hydroxy-3,4-methylenedioxyamphetamine	24	no change.
Noracymethadol	2	no change.
Norlevorphanol	55	no change.
Normethadone	2	no change.
Normorphine	40	no change.
Para-fluorofentanyl	25	no change.
Parahexyl	5	no change.
PB-22; QUPIC	20	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.
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)	45	no change.
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)	30	no change.
Tetrahydrocannabinols	384,460	no change.
Thiofentanyl	25	no change.
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)	30	no change.
Tilidine	25	no change.
Trimeperidine	2	no change.
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone	25	no change.
U-47700	30	no change.
Schedule II
1-Phenylcyclohexylamine	4	15.
1-Piperidinocyclohexanecarbonitrile	4	25.
4-Anilino-N-phenethyl-4-piperidine (ANPP)	1,342,320	no change.
Alfentanil	6,200	no change.
Alphaprodine	2	no change.
Amobarbital	20,100	no change.
Amphetamine (for conversion)	11,280,000	12,700,000.
Amphetamine (for sale)	39,856,000	no change.
Anileridine	Zero	20.
Carfentanil	20	no change.
Cocaine	92,120	no change.
Codeine (for conversion)	15,040,000	12,900,000.
Codeine (for sale)	40,015,000	no change.
Dextropropoxyphene	35	no change.
Dihydrocodeine	264,140	no change.
Dihydroetorphine	2	no change.
Diphenoxylate (for conversion)	14,100	no change.
Diphenoxylate (for sale)	770,800	no change.
Ecgonine	88,134	no change.
Ethylmorphine	30	no change.
Etorphine hydrochloride	32	no change.
Fentanyl	1,342,320	no change.
Glutethimide	2	no change.
Hydrocodone (for conversion)	114,680	no change.
Hydrocodone (for sale)	50,348,280	44,710,000.
Hydromorphone	4,547,720	no change.
Isomethadone	30	no change.
Levo-alphacetylmethadol (LAAM)	5	no change.
Levomethorphan	30	2,200.
Levorphanol	12,126	38,000.
Lisdexamfetamine	17,869,000	19,000,000.
Meperidine	2,717,540	1,913,148.
Meperidine Intermediate-A	5	30.
Meperidine Intermediate-B	30	no change.
Meperidine Intermediate-C	5	30.
Metazocine	15	no change.
Methadone (for sale)	22,278,000	no change.
Methadone Intermediate	24,064,000	no change.
Methamphetamine	1,446,754	no change.
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]
Methylphenidate	64,600,000	no change.
Morphine (for conversion)	4,089,000	no change.
Morphine (for sale)	33,958,440	31,456,000.
Nabilone	31,000	62,000.
Noroxymorphone (for conversion)	14,044,540	16,440,000.
Noroxymorphone (for sale)	376,000	no change.
Opium (powder)	84,600	no change.
Opium (tincture)	564,000	no change.
Oripavine	24,534,000	no change.
Oxycodone (for conversion)	2,453,400	no change.
Oxycodone (for sale)	95,692,000	85,578,000.
Oxymorphone (for conversion)	20,962,000	no change.
Oxymorphone (for sale)	3,395,280	3,137,240.
Pentobarbital	25,850,000	no change.
Phenazocine	5	no change.
Phencyclidine	35	no change.
Phenmetrazine	25	no change.
Phenylacetone	40	no change.
Racemethorphan	5	no change.
Racemorphan	5	no change.
Remifentanil	2,820	3,000.
Secobarbital	161,682	172,100.
Sufentanil	1,880	no change.
Tapentadol	18,388,280	no change.
Thebaine	94,000,000	86,200,000.
List I Chemicals
Ephedrine (for conversion)	47,000	no change.
Ephedrine (for sale)	4,136,000	no change.
Phenylpropanolamine (for conversion)	14,100,000	no change.
Phenylpropanolamine (for sale)	7,990,000	no change.
Pseudoephedrine (for conversion)	40	1,000.
Pseudoephedrine (for sale)	180,000,000	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 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 any adjustment of 2018 aggregate production quotas 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: August 17, 2018.

Uttam Dhillon,

Acting Administrator.