[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56807-56809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23499]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-350R]


Proposed Adjustment of the Assessment of Annual Needs for the 
List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine 
for 2011

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: This notice proposes to adjust the 2011 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 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-350R'' on all electronic and written correspondence. 
DEA encourages all comments be submitted

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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, Ph.D., Chief, 
UN Reporting and Quota Section, Drug Enforcement Administration, 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 307-
7183.

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'' paragraph.

Background

    On December 20, 2010, DEA established the assessment of annual 
needs for 2011 for the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, pursuant to 21 U.S.C. 826(a) and 21 CFR 1315.11 
(75 FR 79407). 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 assessments of annual 
needs for 2011 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 2011 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 2011 
assessment of annual needs, DEA considered the total net disposals 
(i.e. sales) of the List I chemicals for the current and preceding two 
years, actual and estimated inventories, projected demand (2011), 
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 provided by DEA registered manufacturers and 
importers reflects the most current information available. In 
developing the proposed 2011 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 April 18, 2011, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested the authority to purchase 
249,634 kg of pseudoephedrine. DEA registered manufacturers of 
pseudoephedrine reported sales totaling approximately 202,779 kg in 
2009 and 216,724 kg in 2010; this represents a seven percent increase 
in sales reported by these firms from 2009 to 2010. 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 21, 2010. 
Based on the updated information provided to DEA as of April 18, 2011, 
DEA is proposing to increase the 2011 assessment of annual needs for 
pseudoephedrine (for sale) from 280,000 kg to 299,000 kg.
    As of April 18, 2011, DEA registered manufacturers of 
phenylpropanolamine (for conversion) requested authority to purchase a 
total of 24,953 kg of phenylpropanolamine for the manufacture of 
amphetamine. DEA registered manufacturers of phenylpropanolamine 
reported sales of phenylpropanolamine totaling approximately 11,486 kg 
in 2009 and 17,086 kg in 2010; this represents a 33 percent increase in 
sales reported by these firms from 2009 to 2010. In 2011, DEA 
registered manufacturers reported

[[Page 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:

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                                          2011 Assessment of annual   Proposed adjustment to the 2011 assessment
            List I chemicals                        needs                          of annual needs
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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.
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    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]
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