[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
[[Page 56808]]
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
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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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