[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:

------------------------------------------------------------------------
                                                            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