Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 56809 

sales of 21,008 kg for 2011; when 

compared to 2009 this represents a 45 

percent increase in sales reported by 

these firms. DEA notes that in 2011 

there were significant increased sales of 

phenylpropanolamine (for conversion) 

for the manufacture of amphetamine. 

DEA believes that current reported 2011 

sales of phenylpropanolamine (for 

conversion) supplied by DEA registered 

manufacturers best represent the 

legitimate need for 

phenylpropanolamine (for conversion). 

There were no reported exports of 

phenylpropanolamine (for conversion). 

DEA has not received any requests to 

synthesize phenylpropanolamine in 

2011. Based on the information 

provided to DEA, DEA is proposing to 

increase the 2011 assessment of annual 

needs for phenylpropanolamine (for 

conversion) from 21,800 kg to 29,500 kg. 

As of April 18, 2011, the data 

provided to DEA for review of 

ephedrine (for sale), 

phenylpropanolamine (for sale), and 

ephedrine (for conversion) 

demonstrated no significant changes in 

demand or net disposals. Thus, DEA has 

determined that the assessment of 

annual needs for these chemicals— 

ephedrine (for sale), 

phenylpropanolamine (for sale), and 

ephedrine (for conversion)—shall 

remain unchanged. 

The Administrator, therefore, 

proposes the following adjustment of 

the 2011 assessment of annual needs for 

the List I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine: 

List I chemicals 2011 Assessment of annual needs 

Proposed adjustment to the 

2011 assessment of annual 

needs 

Ephedrine (for sale) ................................................................................. 4,200 kg .................................................... No Change. 

Phenylpropanolamine (for sale) ............................................................... 5,300 kg .................................................... No Change. 

Pseudoephedrine (for sale) ..................................................................... 280,000 kg ................................................ 299,000 kg. 

Phenylpropanolamine (for conversion) .................................................... 21,800 kg .................................................. 29,500 kg. 

Ephedrine (for conversion) ...................................................................... 18,600 kg .................................................. No Change. 

In finalizing the adjustment of the 

2011 assessment of annual needs for 

ephedrine, pseudoephedrine and 

phenylpropanolamine, DEA will 

consider any additional changes in 

demand, changes in the national rate of 

net disposal, or changes in the rate of 

net disposal by the registrants holding 

individual manufacturing or import 

quotas for the chemical, in accordance 

with 21 CFR part 1315. 

Comments 

Pursuant to 21 CFR 1315.13, any 

interested person may submit written 

comments on or objections to these 

proposed determinations. 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 her 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 and 

after a hearing, if one is held, the 

Administrator will publish in the 

Federal Register a Final Order 

determining any adjustment of the 

assessment of annual needs. 

Dated: August 31, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–23499 Filed 9–13–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–353P] 

Proposed Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2012 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: This notice proposes the 

initial year 2012 assessment of annual 

needs for certain List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: Electronic comments must be 

submitted and written comments must 

be postmarked on or before October 14, 

2011. 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–353P’’ on all electronic and 

written correspondence. DEA 

encourages 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. Should 

you, however, wish to submit written 

comments via regular or express mail, 

they should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, UN 

Reporting and Quota Section, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 307–7184. 

SUPPLEMENTARY INFORMATION: 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

56810 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices 

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 

The proposed 2012 assessment of 

annual needs represents those quantities 

of ephedrine, pseudoephedrine, and 

phenylpropanolamine which may be 

manufactured domestically and/or 

imported into the United States to 

provide adequate supplies of each 

chemical to meet the estimated medical, 

scientific, research, and industrial needs 

of the United States, lawful export 

requirements, and the establishment 

and maintenance of reserve stocks of 

such chemicals. 

In proposing the 2012 assessment of 

annual needs for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, DEA has taken 

into account the criteria that DEA is 

required to consider in accordance with 

21 U.S.C. 826(a) and 21 CFR 1315.11. 

DEA proposes the assessment of annual 

needs for 2012 by considering (1) Total 

net disposal of the chemical by all 

manufacturers and importers during the 

current and two preceding years; (2) 

trends in the national rate of net 

disposals of each chemical; (3) total 

actual (or estimated) inventories of the 

chemical and of all substances 

manufactured from the chemical, and 

trends in inventory accumulation; (4) 

projected demand for each chemical as 

indicated by procurement and import 

quotas requested pursuant to 21 CFR 

1315.32; and (5) other factors affecting 

the medical, scientific, research, 

industrial, and importation needs in the 

United States, lawful export 

requirements, and reserve stocks, as the 

Administrator finds relevant. 

Other factors that DEA considered 

include trends as derived from 

information provided in applications for 

import, manufacturing, and 

procurement quotas and in import and 

export declarations. The inventory, 

acquisition (purchases), and disposition 

(sales) data as provided by DEA 

registered manufacturers and importers 

reflects the most current information 

available to DEA at the time of 

publication of this Notice. DEA notes, 

pursuant to 21 CFR 1315.13 the DEA 

may adjust the assessments of annual 

needs for ephedrine, pseudoephedrine 

or phenylpropanolamine that has been 

previously fixed pursuant to 21 CFR 

1315.11. 

Analysis 

In determining the 2012 assessments, 

DEA has used the calculation 

methodology described previously in 

the 2010 and 2011 assessment of annual 

needs (74 FR 60294 and 75 FR 79407 

respectively). Additionally, DEA 

considered the total net disposals (i.e. 

sales) of these List I chemicals for the 

current and preceding two years, actual 

and estimated inventories, projected 

demand (2012), industrial use, and 

export requirements from data provided 

by DEA registered manufacturers and 

importers in procurement quota 

applications (DEA 250), manufacturing 

quota applications (DEA 189), import 

quota applications (DEA 488), and 

declarations for import and export. DEA 

notes that the inventory, acquisition 

(purchases) and disposition (sales) data 

provided by DEA registered 

manufacturers and importers reflects the 

most current information available. 

In finalizing the 2012 assessment of 

annual needs for ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, DEA will 

consider the information contained in 

additional applications for 2012 import, 

manufacturing, and procurement quotas 

from DEA registered manufacturers and 

importers that DEA receives after the 

date of drafting this notice, June 22, 

2011, as well as the comments that DEA 

receives in response to this proposal. 

The Administrator, therefore, 

proposes the following assessment of 

annual needs for the List I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine for 2012, 

expressed in kilograms of anhydrous 

base: 

List I chemicals 

Proposed year 

2012 

assessment of 

annual needs 

(kg) 

Ephedrine (for sale) .............. 3,400 

Phenylpropanolamine (for 

sale) .................................. 5,200 

Pseudoephedrine (for sale) .. 240,000 

Phenylpropanolamine (for 

conversion) ........................ 26,200 

Ephedrine (for conversion) ... 12,000 

Comments 

Pursuant to 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 Administrator may hold a 

public hearing on one or more issues 

raised. In the event the Administrator 

decides in her 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 and 

after a hearing, if one is held, the 

Administrator will publish in the 

Federal Register a Final Order 

determining the assessment of annual 

needs for 2012 of ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

Dated: September 1, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–23505 Filed 9–13–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–343R] 

Controlled Substances: 2011 Proposed 

Aggregate Production Quotas 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: This notice proposes to adjust 

the 2011 aggregate production quotas for 

several controlled substances in 

schedules I and II of the Controlled 

Substances Act (CSA) and separately 

proposes to establish aggregate 

production quotas for five synthetic 

cannabinoids temporarily controlled in 

Schedule I. 

DATES: Electronic comments must be 

submitted and written comments must 

mstockstill on DSK4VPTVN1PROD with NOTICES