40186 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

1308.24(a). All other requirements of the 

CSA and the CFR apply, including, but 

not limited to, registration as an 

importer as required by 21 U.S.C. 957. 

Chemical Preparations Containing 

Newly Controlled Substances 

The statutory authority for exempt 

chemical preparations is based on the 

control status of substances contained 

within a preparation, the intended 

administration of a preparation, and the 

packaged form of a preparation. DEA 

conducts a case-by-case analysis of each 

application for exemption to determine 

whether exemption of a preparation 

from certain provisions of the CSA is 

appropriate pursuant to the specified 

statutory and regulatory requirements. 

Most exempt chemical preparations 

have remained effective until the holder 

of a specific exempt chemical 

preparation specifically requested that 

the exemption be terminated. The CSA 

allows for modifications to the 

controlled substances schedules to add, 

remove, or change the schedule of 

substances thus resulting in periodic 

modifications to the control status of 

various substances. 21 U.S.C. 811(a). 

Since the CSA was enacted in 1970, 

DEA has on several occasions added to, 

removed from, or modified the 

schedules of controlled substances in 

accordance with the CSA. Such changes 

may result in the non-compliance of 

exempt chemical preparations with 

current statutes or regulations if 

chemical preparations that have already 

obtained exempt status contain newly 

controlled substances. For example, 

although an exempt chemical 

preparation may continue to be 

packaged in the same manner as when 

it was approved, non-controlled 

substances in the preparation may 

become controlled, thus prompting the 

need for a new application for 

exemption of the chemical preparation 

to ensure continued compliance. Other 

preparations that previously contained 

no controlled substances may contain 

newly controlled substances and thus 

would require an application for 

exemption. 

DEA reviews applications for 

chemical preparation exemptions based 

on the statutes and regulations that are 

in place at the time of the application, 

including the control status of 

substances included in the preparation. 

DEA must remain vigilant to ensure that 

exempt chemical preparations remain 

consistent with the standards set forth 

in the CSA and its implementing 

regulations. As such, DEA reminds the 

public that any chemical preparation, 

regardless of whether it was previously 

exempt, that contains a newly 

controlled substance will require a new 

application for exemption pursuant to 

21 U.S.C. 811(g)(3)(B) and 21 CFR 

1308.23–1308.24. 

Review of Exemptions Pursuant to 21 

U.S.C. 811(g)(3) 

Based on inquiries received from 

industry, DEA is conducting a 

comprehensive review of the exempt 

chemical preparation regulations. DEA’s 

regulations at 21 CFR 1308.24(a) state 

that approved chemical preparations are 

exempt from certain provisions of both 

Subchapter I and Subchapter II of the 

CSA: ‘‘The chemical preparations and 

mixtures approved pursuant to 1308.23 

are exempt from application of sections 

302, 303, 305, 306, 307, 308, 309, 1002, 

1003 and 1004 of the Act (21 U.S.C. 

822–823, 825–829, 952–954) and 

1301.74 of this chapter, to the extent 

described in paragraphs (b) to (h) of this 

section.’’ Pursuant to its regulations, 

DEA has provided exemptions from the 

application of section 302, 303, 305, 

306, 307, 308, 309, 1002, 1003, and 1004 

of the Act (21 U.S.C. 822–823, 825–829, 

952–954) and 21 CFR 1301.74 since the 

implementation of the regulations in the 

early 1970s. Until DEA’s analysis of the 

exemption regulations is complete, DEA 

will continue to review and provide 

exemptions to chemical preparations 

consistent with the implementing 

regulations, when warranted. DEA will 

publish a future notice regarding the 

outcome of DEA’s review of its 

regulations with respect to the 

exemption of chemical preparations. 

Opportunity for Comment 

Pursuant to 21 CFR 1308.23, any 

interested person may submit written 

comments on or objections to any 

chemical preparation in this order that 

has been approved or denied as exempt. 

If any comments or objections raise 

significant issues regarding any finding 

of fact or conclusion of law upon which 

this order is based, the Deputy Assistant 

Administrator will immediately 

suspend the effectiveness of any 

applicable part of this order until he 

may reconsider the application in light 

of the comments and objections filed. 

Approved Exempt Chemical 

Preparations Are Posted on DEA’s Web 

Site 

A list of all current exemptions, 

including those listed in this order, is 

available on DEA’s Web site at http:// 

www.DEAdiversion.usdoj.gov/ 

schedules/exempt/exempt_chemlist.pdf. 

The dates of applications of all current 

exemptions are posted for easy 

reference. 

Dated: June 17, 2013. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2013–16010 Filed 7–2–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–378] 

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 2014 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: This notice proposes initial 

year 2014 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 August 2, 

2013. 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–378’’ 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 http:// 

www.regulations.gov for easy reference. 

Paper comments that duplicate the 

electronic submission are not necessary 

as all comments submitted to 

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, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40187 

Springfield, VA 22152, Telephone: (202) 

307–7165. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

All comments received are considered 

part of the public record and made 

available for public inspection online at 

http://www.regulations.gov and in 

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. 

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 2014 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 

2014 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 2014 

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 2014 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 2014 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 (gammahydroxybutyric 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 quotas 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 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 DEA. 

DEA does not anticipate utilizing the 

reserve in the absence of these 

circumstances. 

The Deputy Administrator, therefore, 

proposes that the year 2014 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: 

Basic class—schedule I Proposed 

2014 quotas 

(1-Pentyl-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone (UR–144) ..... 15 g 

[1-(5-fluoro-pentyl)-1H-indol3-yl](2,2,3,3- 

tetramethylcyclopropyl)methanone (XLR11) ........ 15 g 

1-(1- 

Phenylcyclohexyl)pyrrolidine ........................ 10 g 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ....... 45 g 

1-(5-Fluoropentyl)-3-(2- 

iodobenzoyl)indole 

(AM694) ............................ 45 g 

1-[1-(2- 

Thienyl)cyclohexyl]piperidine ....... 5 g 


emcdonald on DSK67QTVN1PROD with NOTICES
40188 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

Basic class—schedule I Proposed 

2014 quotas 

1-[2-(4-Morpholinyl)ethyl]-3- 

(1-naphthoyl)indole (JWH– 

200) ................................... 45 g 

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

(JWH–073) ........................ 45 g 

1-Cyclohexylethyl-3-(2- 

methoxyphenylacetyl)indole (SR–18 and RCS– 

8) ....................................... 45 g 

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

(JWH–019) ........................ 45 g 

1-Methyl-4-phenyl-4- 

propionoxypiperidine ......... 2 g 

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

AM678) .............................. 45 g 

1-Pentyl-3-(2- 

chlorophenylacetyl)indole 

(JWH–203) ........................ 45 g 

1-Pentyl-3-(2- 

methoxyphenylacetyl)indole (JWH–250) ........... 45 g 

1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) .... 45 g 

1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) .... 45 g 

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

4) ....................................... 45 g 

1-Pentyl-3-[1-(4- 

methoxynaphthoyl)]indole 

(JWH–081) ........................ 45 g 

2-(2,5-Dimethoxy-4-(n)- 

propylphenyl)ethanamine 

(2C–P) ............................... 30 g 

2-(2,5-Dimethoxy-4- 

ethylphenyl)ethanamine 

(2C–E) ............................... 30 g 

2-(2,5-Dimethoxy-4- 

methylphenyl)ethanamine 

(2C–D) ............................... 30 g 

2-(2,5-Dimethoxy-4-nitrophenyl)ethanamine (2C–N) 30 g 

2-(2,5- 

Dimethoxyphenyl)ethanamine (2C–H) ......... 30 g 

2-(4-Chloro-2,5- 

dimethoxyphenyl)ethanamine (2C–C) ......... 30 g 

2-(4-Iodo-2,5- 

dimethoxyphenyl)ethanamine (2C–I) .......... 30 g 

2,5-Dimethoxy-4- 

ethylamphetamine (DOET) 25 g 

2,5-Dimethoxy-4-npropylthiophenethylamine 25 g 

2,5-Dimethoxyamphetamine 25 g 

2-[4-(Ethylthio)-2,5- 

dimethoxyphenyl]ethanamine (2C–T–2) ..... 30 g 

2-[4-(Isopropylthio)-2,5- 

dimethoxyphenyl]ethanamine (2C–T–4) ..... 30 g 

3,4,5- 

Trimethoxyamphetamine ... 25 g 

3,4- 

Methylenedioxyamphetamine (MDA) .......................... 55 g 

3,4- 

Methylenedioxymethamphetamine (MDMA) ............... 50 g 

3,4-Methylenedioxy-Nethylamphetamine (MDEA) 40 g 

Basic class—schedule I Proposed 

2014 quotas 

3,4-Methylenedioxy-Nmethylcathinone 

(methylone) ....................... 50 g 

3,4- 

Methylenedioxypyrovalerone (MDPV) ........................ 35 g 

3-Methylfentanyl ................... 2 g 

3-Methylthiofentanyl .............. 2 g 

4-Bromo-2,5- 

dimethoxyamphetamine 

(DOB) ................................ 25 g 

4-Bromo-2,5- 

dimethoxyphenethylamine 

(2–CB) ............................... 25 g 

4-Methoxyamphetamine ....... 100 g 

4-Methyl-2,5- 

dimethoxyamphetamine 

(DOM) ............................... 25 g 

4-Methylaminorex ................. 25 g 

4-Methyl-N-methylcathinone 

(mephedrone) .................... 45 g 

5-(1,1-Dimethylheptyl)-2- 

[(1R,3S)-3- 

hydroxycyclohexyl]-phenol 68 g 

5-(1,1-Dimethyloctyl)-2- 

[(1R,3S)-3- 

hydroxycyclohexyl]-phenol 

(cannabicyclohexanol or 

CP–47, 497 C8-homolog) 53 g 

5-Methoxy-3,4- 

methylenedioxyamphetamine ..................................... 25 g 

5-Methoxy-N,Ndiisopropyltryptamine ........ 25 g 

5-Methoxy-N,Ndimethyltryptamine ............ 25 g 

Acetyl-alpha-methylfentanyl .. 2 g 

Acetyldihydrocodeine ............ 2 g 

Acetylmethadol ..................... 2 g 

Allylprodine ........................... 2 g 

Alphacetylmethadol .............. 2 g 

Alpha-ethyltryptamine ........... 25 g 

Alphameprodine .................... 2 g 

Alphamethadol ...................... 2 g 

Alpha-methylfentanyl ............ 2 g 

Alpha-methylthiofentanyl ...... 2 g 

Alpha-methyltryptamine 

(AMT) ................................ 25 g 

Aminorex ............................... 25 g 

Benzylmorphine .................... 2 g 

Betacetylmethadol ................ 2 g 

Beta-hydroxy-3- 

methylfentanyl ................... 2 g 

Beta-hydroxyfentanyl ............ 2 g 

Betameprodine ..................... 2 g 

Betaprodine .......................... 2 g 

Bufotenine ............................. 3 g 

Cathinone ............................. 26 g 

Codeine Methylbromide ........ 5 g 

Codeine-N-oxide ................... 200 g 

Desomorphine ...................... 5 g 

Diethyltryptamine .................. 25 g 

Difenoxin ............................... 50 g 

Dihydromorphine .................. 3,300,000 g 

Dimethyltryptamine ............... 25 g 

Dipipanone ............................ 5g 

Fenethylline .......................... 5 g 

Gamma-hydroxybutyric acid 70,250,000 g 

Heroin ................................... 25 g 

Hydromorphinol .................... 2 g 

Hydroxypethidine .................. 2 g 

Ibogaine ................................ 5 g 

Basic class—schedule I Proposed 

2014 quotas 

Lysergic acid diethylamide 

(LSD) ................................. 30 g 

Marihuana ............................. 21,000 g 

Mescaline .............................. 25 g 

Methaqualone ....................... 10 g 

Methcathinone ...................... 25 g 

Methyldihydromorphine ........ 2 g 

Morphine Methylbromide ...... 5 g 

Morphine Methylsulfonate .... 5 g 

Morphine-N-oxide ................. 175 g 

N-(1-adamantyl)-1-pentyl-1Hindazole-3-carboxamide 

(AKB48) ............................. 15 g 

N-Benzylpiperazine ............... 25 g 

N,N-Dimethylamphetamine ... 25 g 

N-Ethyl-1- 

phenylcyclohexylamine ..... 5 g 

N-Ethylamphetamine ............ 24 g 

N-Hydroxy-3,4- 

methylenedioxyamphetamine ..................................... 24 g 

Noracymethadol .................... 2 g 

Norlevorphanol ..................... 52 g 

Normethadone ...................... 2 g 

Normorphine ......................... 18 g 

Para-fluorofentanyl ............... 2 g 

Parahexyl .............................. 5 g 

Phenomorphan ..................... 2 g 

Pholcodine ............................ 2 g 

Properidine ........................... 2 g 

Psilocybin .............................. 30 g 

Psilocyn ................................ 30 g 

Tetrahydrocannabinols ......... 491,000 g 

Thiofentanyl .......................... 2 g 

Tilidine .................................. 10 g 

Trimeperidine ........................ 2 g 

Basic class—schedule II Proposed 

2014 quotas 

1-Phenylcyclohexylamine ..... 3 g 

1- 

Piperdinocyclohexanecarbonitrile (PCC) .................... 3 g 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ................ 2,687,500 g 

Alfentanil ............................... 17,625 g 

Alphaprodine ......................... 3 g 

Amobarbital ........................... 9 g 

Amphetamine (for conversion) .................................. 18,375,000 g 

Amphetamine (for sale) ........ 49,000,000 g 

Carfentanil ............................ 6 g 

Cocaine ................................. 240,000 g 

Codeine (for conversion) ...... 68,750,000 g 

Codeine (for sale) ................. 46,125,000 g 

Dextropropoxyphene ............ 19 g 

Dihydrocodeine ..................... 100,750 g 

Diphenoxylate ....................... 750,000 g 

Ecgonine ............................... 127,500 g 

Ethylmorphine ....................... 3 g 

Fentanyl ................................ 2,108,750 g 

Glutethimide .......................... 3 g 

Hydrocodone (for sale) ......... 99,625,000 g 

Hydromorphone .................... 5,968,750 g 

Isomethadone ....................... 5 g 

Levo-alphacetylmethadol 

(LAAM) .............................. 4 g 

Levomethorphan ................... 6 g 

Levorphanol .......................... 2,000 g 

Lisdexamfetamine ................. 23,750,000 g 

Meperidine ............................ 6,250,000 g 

Meperidine Intermediate-A ... 6 g 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40189 

Basic class—schedule II Proposed 

2014 quotas 

Meperidine Intermediate-B ... 11 g 

Meperidine Intermediate-C ... 6 g 

Metazocine ........................... 6 g 

Methadone (for sale) ............ 31,875,000 g 

Methadone Intermediate ....... 38,875,000 g 

Methamphetamine ................ 3,911,375 g 

[1,250,000 grams of levo-desoxyephedrine 

for use in a non-controlled, non-prescription product; 2,600,000 grams for methamphetamine mostly for conversion to a 

schedule III product; and 61,375 grams for 

methamphetamine (for sale)]. 

Methylphenidate ................... 96,750,000 g 

Morphine (for conversion) .... 91,250,000 g 

Morphine (for sale) ............... 62,500,000 g 

Nabilone ................................ 30,375 g 

Noroxymorphone (for conversion) .................................. 12,250,000 g 

Noroxymorphone (for sale) ... 1,262,500 g 

Opium (powder) .................... 112,500 g 

Opium (tincture) .................... 625,000 g 

Oripavine .............................. 22,750,000 g 

Oxycodone (for conversion) 9,250,000 g 

Oxycodone (for sale) ............ 149,375,000 g 

Oxymorphone (for conversion) .................................. 17,250,000 g 

Oxymorphone (for sale) ........ 7,750,000 g 

Pentobarbital ......................... 35,000,000 g 

Phenazocine ......................... 6 g 

Phencyclidine ........................ 6 g 

Phenmetrazine ...................... 3 g 

Phenylacetone ...................... 29,980,050 g 

Racemethorphan .................. 3 g 

Remifentanil .......................... 3,750 g 

Secobarbital .......................... 215,003 g 

Sufentanil .............................. 6,255 g 

Tapentadol ............................ 17,500,000 g 

Thebaine ............................... 145,000,000 g 

Basic class—list I chemicals Proposed 

2014 quotas 

Ephedrine (for conversion) ... 15,100,000 g 

Ephedrine (for sale) .............. 2,900,000 g 

Phenylpropanolamine (for 

conversion) ........................ 25,700,000 g 

Phenylpropanolamine (for 

sale) .................................. 5,300,000 g 

Pseudoephedrine (for conversion) ............................. 5,000 g 

Pseudoephedrine (for sale) .. 156,000,000 g 

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 2014 

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 2014 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: June 27, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–16052 Filed 7–2–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Office of Juvenile Justice and 

Delinquency Prevention 

[OMB Number 1121–0219] 

Agency Information Collection 

Activities; Proposed Collection; 

Comments Requested: Juvenile 

Residential Facility Census (Extension, 

Without Change, of a Currently 

Approved Collection) 

ACTION: 60 Day Notice. 

The Department of Justice (DOJ), 

Office of Justice Programs, Office of 

Juvenile Justice and Delinquency 

Prevention, will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The proposed 

information collection is published to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 

‘‘sixty days’’ until September 3, 2013. 

This process is conducted in accordance 

with 5 CFR 1320.10. 

If you have comments especially on 

the estimated public burden or 

associated response time, suggestions, 

or need a copy of the proposed 

information collection instrument with 

instructions or additional information, 

please contact Brecht Donoghue, (202) 

305–1270, Office of Juvenile Justice and 

Delinquency Prevention, Office of 

Justice Programs, U.S. Department of 

Justice, 810 Seventh Street NW., 

Washington, DC 20531. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address one or more 

of the following four points: 

—Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

—Evaluate the accuracy of the agencies 

estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

—Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

—Minimize the burden of the collection 

of information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms 

of information technology, e.g., 

permitting electronic submission of 

responses. 

Overview of This Information 

Collection Back to Top 

(1) Type of information collection: 

Extension, without change, of a 

currently approved collection. 

(2) The title of the form/collection: 

Juvenile Residential Facility Census. 

(3) The agency form number, if any, 

and the applicable component of the 

Department sponsoring the collection: 

The form number is CJ–15, Office of 

Juvenile Justice and Delinquency 

Prevention, United States Department of 

Justice. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Federal Government, 

State, Local or Tribal. Other: Not-forprofit institutions; Business or other forprofit. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond/reply: It is estimated that 2,545 

respondents will complete a 2-hour 

questionnaire. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: Approximately 5,090 hours. 

If additional information is required, 

contact: Jerri Murray, Department 

Clearance Officer, U.S. Department of 

Justice, Justice Management Division, 

Policy and Planning Staff, Two 

Constitution Square, 145 N Street NE., 

Suite 3W–1407B, Washington, DC 

20530. 


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