Federal Register / Vol. 77, No. 138 / Wednesday, July 18, 2012 / Notices 42333 

Modification may also be obtained by 

mail from the Consent Decree Library, 

P.O. Box 7611, U.S. Department of 

Justice, Washington, DC 20044–7611 or 

by faxing or emailing a request to 

‘‘Consent Decree Copy’’ 

(EESCDCopy.ENRD@usdoj.gov), fax no. 

(202) 514–0097, phone confirmation 

number (202) 514–5271. In requesting a 

copy from the Consent Decree Library, 

please enclose a check in the amount of 

$2.75 (25 cents per page reproduction 

cost) payable to the U.S. Treasury or, if 

by email or fax, forward a check in that 

amount to the Consent Decree Library at 

the stated address. 

Ronald Gluck, 

Assistant Chief, Environmental Enforcement 

Section, Environment and Natural Resources 

Division. 

[FR Doc. 2012–17417 Filed 7–17–12; 8:45 am] 

BILLING CODE 4410–15–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–353] 

Proposed Adjustment of the 

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 to adjust 

the 2012 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 17, 

2012. 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–353’’ 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 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: John 

W. Partridge, Chief, Liaison and Policy 

Section, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, Telephone: (202) 

307–4654. 

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. 

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 

On December 12, 2011, DEA 

established the assessment of annual 

needs for 2012 for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, pursuant to 21 

U.S.C. 826(a) and 21 CFR 1315.11 (76 

FR 77252). That Notice indicated that 

DEA would adjust the assessment of 

annual needs at a later date, if 

necessary, as provided in 21 CFR 

1315.13. 

DEA now proposes to adjust the 

established assessment of annual needs 

for 2012 for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. In proposing the 

adjustment, DEA has taken into account 

the criteria that DEA is required to 

consider in accordance with 21 CFR 

1315.13. DEA proposes the adjustment 

of the assessment of annual needs for 

2012 by considering: (1) Changes in 

demand, changes in the national rate of 

net disposal, and changes in the rate of 

net disposal by the registrants holding 

individual manufacturing or import 

quotas for the chemical; (2) whether any 

increased demand or changes in the 

national and/or individual rates of net 

disposal are temporary, short term, or 

long term; (3) whether any increased 

demand can be met through existing 

inventories, increased individual 

manufacturing quotas, or increased 

importation without increasing the 

assessment of annual needs; (4) whether 

any decreased demand will result in 

excessive inventory accumulation by all 

persons registered to handle the 

particular chemical; 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. 

Analysis 

In determining whether to propose 

adjustments to the 2012 assessment of 

annual needs, DEA considered the total 

net disposals (i.e., sales) of the list I 


tkelley on DSK3SPTVN1PROD with NOTICES
42334 Federal Register / Vol. 77, No. 138 / Wednesday, July 18, 2012 / Notices 

chemicals for the current and preceding 

two years, actual and estimated 

inventories, projected demand (2012), 

industrial use, and export requirements 

from updated data provided by DEA 

registered manufacturers and importers 

in procurement quota applications (DEA 

250), manufacturing quota applications 

(DEA 189), import quota applications 

(DEA 488), declarations for import and 

export, and other information. Data 

considered included data submitted to 

DEA after the initial assessment of 

annual needs had been established. DEA 

notes that the inventory, acquisition 

(purchases), and disposition (sales) data 

proved by DEA registered manufacturers 

and importers reflects the most current 

information available. In developing the 

proposed 2012 revision, 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). 

As of June 6, 2012, DEA registered 

manufacturers of dosage form products 

containing pseudoephedrine requested 

quota for 322,385 kg of 

pseudoephedrine. DEA registered 

manufacturers of pseudoephedrine 

reported sales totaling approximately 

189,030 kg in 2010 and 268,669 kg in 

2011; this represents a 30 percent 

increase in sales reported by these firms 

from 2010 to 2011. Additionally, DEA 

considered information on trends in the 

national rate of net disposals from sales 

data provided by IMS Health. The initial 

assessment of annual needs was based 

on data received by DEA as of October 

17, 2011. Based on the updated 

information provided to DEA as of June 

6, 2012, DEA is proposing to increase 

the 2011 assessment of annual needs for 

pseudoephedrine from 258,000 kg to 

278,000 kg. 

As of June 6, 2012, DEA registered 

manufacturers of dosage form products 

containing ephedrine requested quota 

for 4,221 kg of ephedrine (for sale) in 

2012. DEA registered manufacturers of 

ephedrine reported sales totaling 

approximately 1,598 kg in 2010 and 

3,158 kg in 2011; this represents a 49 

percent increase in sales reported by 

these firms from 2010 to 2011. 

Additionally, DEA considered 

information on trends in the national 

rate of net disposals from sales data 

provided by IMS Health. The initial 

assessment of annual needs was based 

on data received by DEA as of October 

17, 2011. Based on the updated 

information provided to DEA as of June 

6, 2012, DEA is proposing to increase 

the 2012 assessment of annual needs for 

ephedrine (for sale) from 4,000 kg to 

4,300 kg. 

As of June 6, 2012, DEA registered 

manufacturers of phenylpropanolamine 

(for sale) requested quota for 7,763 kg of 

phenylpropanolamine (for sale). DEA 

registered manufacturers of 

phenylpropanolamine reported sales 

totaling approximately 4,790 kg in 2010 

and 5,289 kg in 2011; this represents a 

nine percent increase in sales reported 

by these firms from 2010 to 2011. DEA 

notes that phenylpropanolamine is sold 

primarily as a veterinary product and is 

not approved for human consumption. 

IMS Health’s NSP Data does not capture 

sales of phenylpropanolamine to 

veterinary channels and is, therefore, 

not considered. The initial assessment 

of annual needs was based on data 

received by DEA as of October 17, 2011. 

DEA is proposing to increase the 2012 

assessment of annual needs for 

phenylpropanolamine (for sale) from 

5,200 kg to 5,800 kg. 

As of June 6, 2012, the data provided 

to DEA for review of 

phenylpropanolamine (for conversion) 

and ephedrine (for conversion) 

demonstrated no significant changes in 

demand or net disposals. DEA has thus 

determined that the assessment of 

annual needs for these chemicals— 

phenylpropanolamine (for conversion) 

and ephedrine (for conversion)—shall 

remain unchanged. 

The Administrator, therefore, 

proposes the following adjustment of 

the 2012 assessment of annual needs for 

the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine as follows: 

List I chemicals 

2012 assessment of annual 

needs 

(kg) 

Proposed adjustment to the 

2012 assessment of annual 

needs (kg) 

Ephedrine (for sale) ................................................................................................................................................. 4,000 4,300 

Phenylpropanolamine (for sale) ............................................................................................................................... 5,200 5,800 

Pseudoephedrine ..................................................................................................................................................... 258,000 278,000 

Phenylpropanolamine (for conversion) .................................................................................................................... 26,200 No Change 

Ephedrine (for conversion) ...................................................................................................................................... 12,000 No Change 

In finalizing the adjustment of the 

2012 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: July 13, 2012. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2012–17522 Filed 7–17–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Office of Justice Programs 

[OJP (OJJDP) Docket No. 1596] 

Meeting of the Attorney General’s 

National Task Force on Children 

Exposed to Violence (Correction) 

AGENCY: Office of Justice Programs, 

Justice. 

ACTION: Notice; correction. 

SUMMARY: The Office of Justice Programs 

(OJP) published a notice in the Federal 

Register on July 2, 2012, announcing a 

meeting of the Attorney General’s 

National Task Force on Children 

Exposed to Violence (the ‘‘task force’’). 

As that notice stated, the final agenda 


tkelley on DSK3SPTVN1PROD with NOTICES