Proposed Adjustment of the Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011, 56807-56809 [2011-23499]
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Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
have been completed under Section IV,
Defendants shall deliver to the United
States an affidavit as to the fact and
manner of their compliance with
Section IV of this Final Judgment. Each
such affidavit shall include the name,
address, and telephone number of each
person who, during the preceding thirty
(30) calendar days, made an offer to
acquire, expressed an interest in
acquiring, entered into negotiations to
acquire, or was contacted or made an
inquiry about acquiring, any interest in
the Radio Assets, and shall describe in
detail each contact with any such
person during that period. Each such
affidavit shall also include a description
of the efforts Defendants have taken to
solicit buyers for the Radio Assets and
to provide required information to
prospective Acquirers, including the
limitations, if any, on such information.
Provided that the information set forth
in the affidavit is true and complete, any
objection by the United States to
information provided by Defendants,
including any limitation on information,
shall be made within fourteen (14)
calendar days of receipt of such
affidavit.
(B) Within twenty (20) calendar days
of the filing of the Complaint in this
matter, Defendants shall deliver to the
United States an affidavit that describes
in reasonable detail all actions
Defendants have taken and all steps
Defendants have implemented on an
ongoing basis to comply with Section
VII of this Final Judgment. Defendants
shall deliver to the United States an
affidavit describing any changes to the
efforts and actions outlined in
Defendants’ earlier affidavits filed
pursuant to this Section within fifteen
(15) calendar days after the change is
implemented.
(C) Defendants shall keep all records
of all efforts made to preserve the Radio
Assets until one (1) year after the
respective divestitures of WCAT,
WWKL and WRSR have been
completed.
IX. Compliance Inspection
(A) For the purposes of determining
or securing compliance with this Final
Judgment, or of determining whether
the Final Judgment should be modified
or vacated, and subject to any legally
recognized privilege, from time to time
authorized representatives of the United
States, including consultants and other
persons retained by the United States,
shall, upon written request of an
authorized representative of the
Assistant Attorney General in charge of
the Antitrust Division, and on
reasonable notice to Defendants, be
permitted:
VerDate Mar<15>2010
19:00 Sep 13, 2011
Jkt 223001
(i) Access during Defendants’ office
hours to inspect and copy, or at the
option of the United States, to require
Defendants to provide hard copy or
electronic copies of, all books, ledgers,
accounts, records, data, and documents
in the possession, custody, or control of
Defendants, relating to any matters
contained in this Final Judgment; and
(ii) To interview, either informally or
on the record, Defendants’ officers,
employees, or agents, who may have
their individual counsel present,
regarding such matters. The interviews
shall be subject to the reasonable
convenience of the interviewee and
without restraint or interference by
Defendants.
(B) Upon the written request of an
authorized representative of the
Assistant Attorney General in charge of
the Antitrust Division, Defendants shall
submit written reports or responses to
written interrogatories, under oath if
requested, relating to any of the matters
contained in this Final Judgment as may
be requested.
(C) No information or documents
obtained by the means provided in this
Section shall be divulged by the United
States to any person other than an
authorized representative of the
executive branch of the United States,
except in the course of legal proceedings
to which the United States is a party
(including grand jury proceedings), or
for the purpose of securing compliance
with this Final Judgment, or as
otherwise required by law.
(D) If at the time information or
documents are furnished by Defendants
to the United States, Defendants
represent and identify in writing the
material in any such information or
documents to which a claim of
protection may be asserted under Rule
26(c)(1)(G) of the Federal Rules of Civil
Procedure, and Defendants mark each
pertinent page of such material,
‘‘Subject to claim of protection under
Rule 26(c)(1)(G) of the Federal Rules of
Civil Procedure,’’ then the United States
shall give Defendants ten (10) calendar
days’ notice prior to divulging such
material in any legal proceeding (other
than a grand jury proceeding).
X. No Reacquisition
Defendants shall not reacquire any
part of the Radio Assets during the term
of this Final Judgment.
XI. Retention of Jurisdiction
This Court retains jurisdiction to
enable any party to this Final Judgment
to apply to this Court at any time for
further orders and directions as may be
necessary or appropriate to carry out or
construe this Final Judgment, to modify
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56807
any of its provisions, to enforce
compliance, and to punish violations of
its provisions.
XII. Expiration of Final Judgment
Unless this Court grants an extension,
this Final Judgment shall expire ten (10)
years from the date of its entry.
XIII. Public Interest Determination
The parties have complied with the
requirements of the Antitrust
Procedures and Penalties Act, 15 U.S.C.
16, including making copies available to
the public of this Final Judgment, the
Competitive Impact Statement, and any
comments thereon and the United
States’ responses to those comments.
Based upon the record before the Court,
which includes the Competitive Impact
Statement and any comments and
responses to comments filed with the
Court, entry of this Final Judgment is in
the public interest.
Court approval subject to procedures of
Antitrust Procedures and Penalties
Act, 15 U.S.C. 16.
llllllllllllllllll
l
United States District Judge.
[FR Doc. 2011–23548 Filed 9–13–11; 8:45 am]
BILLING CODE P
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
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice with request for
comments.
AGENCY:
This notice proposes to adjust
the 2011 assessment of annual needs for
the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
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
DATES:
E:\FR\FM\14SEN1.SGM
14SEN1
56808
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
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, Ph.D., Chief, UN
Reporting and Quota Section, Drug
Enforcement Administration, 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 307–7183.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
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.
VerDate Mar<15>2010
19:00 Sep 13, 2011
Jkt 223001
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
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\14SEN1.SGM
14SEN1
Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Notices
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
Ephedrine (for sale) .................................................................................
Phenylpropanolamine (for sale) ...............................................................
Pseudoephedrine (for sale) .....................................................................
Phenylpropanolamine (for conversion) ....................................................
Ephedrine (for conversion) ......................................................................
4,200 kg ....................................................
5,300 kg ....................................................
280,000 kg ................................................
21,800 kg ..................................................
18,600 kg ..................................................
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
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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19:00 Sep 13, 2011
Jkt 223001
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
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice with request for
comments.
AGENCY:
This notice proposes the
initial year 2012 assessment of annual
needs for certain List I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
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
DATES:
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
56809
Proposed adjustment to the
2011 assessment of annual
needs
No Change.
No Change.
299,000 kg.
29,500 kg.
No Change.
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.
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Pages 56807-56809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23499]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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, 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 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.
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:
----------------------------------------------------------------------------------------------------------------
2011 Assessment of annual Proposed adjustment to the 2011 assessment
List I chemicals needs 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.
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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]
BILLING CODE 4410-09-P
