Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2012, 56809-56810 [2011-23505]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56809-56810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23505]


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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.

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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 https://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
https://www.regulations.gov Web site for easy reference. Paper comments 
that duplicate the electronic submission are not necessary as all 
comments submitted to https://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 https://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.

[[Page 56810]]

    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:

 
------------------------------------------------------------------------
                                                           Proposed year
                                                               2012
                    List I chemicals                       assessment of
                                                           annual needs
                                                               (kg)
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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
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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