[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Pages 77252-77253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31777]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-353E]


Established 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 initial 2012 assessment of annual 
needs for the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Effective Date: December 12, 2011.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, Virginia 22152, Telephone: (202) 307-7184.

SUPPLEMENTARY INFORMATION: 

 Background

    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 to meet 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 September 14, 2011, a notice entitled ``Proposed Assessment of 
Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine for 2012'' was published in the Federal Register 
(76 FR 56809). That notice proposed 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 assessments on or before October 14, 2011.

Comments Received

    DEA received one comment regarding the proposed assessment of 
annual needs for pseudoephedrine. The commenter stated that ``the 
quotas should be increased to cover our needs. The appropriate DEA Form 
250 will be submitted shortly pertaining to the items for which we 
submitted comments.'' As of October 17, 2011, the commenter was not 
registered to manufacture the chemical pseudoephedrine and DEA had not 
received the commenter's request for 2012 quota for pseudoephedrine. 
DEA will consider the commenter's request for quota after they become 
registered to manufacture pseudoephedrine and submit a quota 
application pursuant to 21 CFR 1315.22.

Conclusion

    In determining the 2012 assessments, DEA took into account the 
criteria that DEA is required to consider in accordance with 21 U.S.C. 
826(a) and 21 CFR 1315.11. DEA has increased the assessment of annual 
need for ephedrine (for sale) and pseudoephedrine (for sale) over the 
proposed amount based on additional data that was received regarding 
the total net disposals (i.e. sales) of these List I chemicals for the 
current and preceding two years, actual and estimated inventories, 
projected demand (2012), industrial use, and export requirements. The 
relevant inventory, acquisition (purchases), and disposition (sales) 
data was provided by DEA registered manufacturers and importers in 
procurement quota applications (DEA 250), manufacturing quota 
applications (DEA 189), import quota applications (DEA 488), and 
declarations for import and export received by DEA as of October 17, 
2011. After reviewing the additional data, DEA determined that an 
increase in the proposed assessment of annual need for ephedrine (for 
sale) and pseudoephedrine (for sale) was warranted. This notice 
reflects that increase.
    In accordance with 21 U.S.C. 826 and 21 CFR 1315.11, the 
Administrator hereby determines that the 2012 assessment of annual 
needs for ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in kilograms of anhydrous acid or base, is established as 
follows:

------------------------------------------------------------------------
                                                        Established 2012
                                                          assessment of
                    List I chemical                       annual needs
                                                              (kg)
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Ephedrine (for sale)..................................             4,000
Phenylpropanolamine (for sale)........................             5,200
Pseudoephedrine (for sale)............................           258,000
Phenylpropanolamine (for conversion)..................            26,200
Ephedrine (for conversion)............................            12,000
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[[Page 77253]]

The assessment of annual needs may be adjusted at a later date pursuant 
to 21 CFR 1315.13.

    Dated: December 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-31777 Filed 12-9-11; 8:45 am]
BILLING CODE 4410-09-P