[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Page 55503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22127]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 353]
Final Adjusted 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.
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SUMMARY: This notice establishes the Final Adjusted 2012 Assessment of
Annual Needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Effective Date: September 10, 2012.
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: The 2012 Assessment of Annual Needs
represents those quantities of ephedrine, pseudoephedrine, and
phenylpropanolamine which may be manufactured domestically and imported
into the United States in 2012 to provide adequate supplies of each
chemical for 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.
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires that the Attorney General establish an assessment of annual
needs for ephedrine, pseudoephedrine, and phenylpropanolamine. This
responsibility has been delegated to the Administrator of the DEA by 28
CFR 0.100.
On July 18, 2012, a notice entitled ``Proposed Adjustment of the
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2012'' was published in
the Federal Register (77 FR 42333). That notice proposed to adjust the
2012 Assessment of Annual Needs for ephedrine (for sale), ephedrine
(for conversion), pseudoephedrine (for sale), phenylpropanolamine (for
sale) and phenylpropanolamine (for conversion). All interested persons
were invited to comment on or object to the proposed assessments on or
before August 17, 2012.
Comments Received
DEA did not receive any comments to the proposed adjustment of the
assessment of annual needs for ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale), phenylpropanolamine (for
sale), and phenylpropanolamine (for conversion).
Conclusion
In determining the adjusted 2012 assessments, DEA used the
calculation methodology previously described in the 2010 and 2011
assessment of annual needs (74 FR 60294 and 75 FR 79407 respectively).
DEA considered 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;
whether any increased demand or changes in the national and/or
individual rates of net disposal are temporary, short term, or long
term; whether any increased demand could be met through existing
inventories, increased individual manufacturing quotas, or increased
importation without increasing the assessment of annual needs; whether
any decreased demand would result in excessive inventory accumulation
by all persons registered to handle the particular chemical; and other
factors affecting the medical, scientific, research, industrial, and
importation needs in the United States, lawful export requirements, and
reserve stocks, as found 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. The underlying data used to determine the final 2012
assessment of annual needs is the same as that used in determining the
proposed 2012 assessment of annual needs, as published on September 14,
2011, at 76 FR 56809.
In accordance with 21 U.S.C. 826(a) and 21 CFR 1315.13, the
Administrator hereby orders that the 2012 assessment of annual needs
for ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, is adjusted and established as
follows:
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Final 2012
assessment of
List I chemical annual needs
(kg)
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Ephedrine (for sale).................................... 4,300
Phenylpropanolamine (for sale).......................... 5,800
Pseudoephedrine (for sale).............................. 278,000
Phenylpropanolamine (for conversion).................... 26,200
Ephedrine (for conversion).............................. 12,000
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Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-22127 Filed 9-7-12; 8:45 am]
BILLING CODE 4410-09-P