[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Notices]
[Pages 53911-53912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18528]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-306P]


Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2008: Proposed

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed annual assessment of needs for 2008.

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SUMMARY: This notice proposes the initial year 2008 assessment of 
annual needs for certain List I chemicals in accordance with the Combat 
Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006. 
The Act required DEA to establish production quotas and import quotas 
for ephedrine, pseudoephedrine, and phenylpropanolamine. This was done 
to prevent the illicit use of these three chemicals in the clandestine 
manufacture of methamphetamine. The enactment of the CMEA places 
additional regulatory controls upon the manufacture, distribution, 
importation, and exportation of the three List I chemicals.

DATES: Written comments or objections must be postmarked, and 
electronic comments must be sent, on or before October 11, 2007.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-306'' on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. Comments may be directly sent to DEA electronically by 
sending an electronic message to [email protected]. DEA 
will accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file format other than those specifically listed here.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine 
Epidemic Act of 2005 (Title VII of Pub. L. 109-177) (CMEA) amended 
section 306 of the Controlled Substances Act (CSA) (21 U.S.C. section 
826) by adding ephedrine, pseudoephedrine, and phenylpropanolamine to 
existing language to read as follows: ``The Attorney General shall 
determine the total quantity and establish production quotas for each 
basic class of controlled substance in schedules I and II and for 
ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured 
each calendar year to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks.'' Further, section 715 of CMEA amended 21 U.S.C. 952 
``Importation of controlled substances'' by adding the same List I 
chemicals to the existing language in paragraph (a), and by adding a 
new paragraph (d) to read as follows:

     (a) Controlled substances in schedule I or II and narcotic 
drugs in schedule III, IV, or V; exceptions
    It shall be unlawful to import into the customs territory of the 
United States from any place outside thereof (but within the United 
States), or to import into the United States from any place outside 
thereof, any controlled substance in schedule I or II of subchapter 
I of this chapter, or any narcotic drug in schedule III, IV, or V of 
subchapter I of this chapter, or ephedrine, pseudoephedrine, and 
phenylpropanolamine, except that--
    (1) Such amounts of crude opium, poppy straw, concentrate of 
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and 
phenylpropanolamine, as the Attorney General finds to be necessary 
to provide for medical, scientific, or other legitimate purposes, 
and
* * * * *
    (d)(1) With respect to a registrant under Section 958 who is 
authorized under Subsection (a)(1) to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, at any time during the year 
the registrant may apply for an increase in the amount of such 
chemical that the registrant is authorized to import, and the 
Attorney General may approve the application if the Attorney General 
determines that the approval is necessary to provide for medical, 
scientific, or other legitimate purposes regarding the chemical.

    Editor's Note: This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 952(a) and (d)(1).

    The responsibility for establishing the assessment of annual needs 
has been delegated to the Administrator of the DEA by 28 CFR section 
0.100. The Administrator, in turn, has redelegated this function to the 
Deputy Administrator, pursuant to 28 CFR section 0.104.
    The proposed year 2008 assessment of annual needs represents those 
quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which 
may be manufactured domestically and/or imported into the United States 
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.
    Pursuant to 21 CFR part 1315, the Deputy Administrator of the DEA 
will, in early 2008, adjust the assessment of annual needs and 
individual importing and manufacturing quotas allocated for the year 
based upon 2007 year-end inventory and actual 2007 disposition data 
supplied by quota recipients for ephedrine, pseudoephedrine, and 
phenylpropanolamine.
    The Deputy Administrator hereby proposes that the year 2008 
assessment

[[Page 53912]]

of annual needs for the following List I chemicals, expressed in 
kilograms of anhydrous base or acid, be established as follows:

------------------------------------------------------------------------
                                                         Proposed year
                                                        2008 assessment
                   List I chemicals                     of annual needs
                                                              [kg]
------------------------------------------------------------------------
Ephedrine (for sale).................................             11,500
Ephedrine (for conversion)...........................            128,760
Pseudoephedrine (for sale)...........................            511,100
Phenylpropanolamine (for sale).......................              5,545
Phenylpropanolamine (for conversion).................             85,470
------------------------------------------------------------------------

    Ephedrine (for conversion) refers to the industrial use of 
ephedrine, i.e., that which will be converted to pseudoephedrine. 
Phenylpropanolamine (for conversion) refers to the industrial use of 
phenylpropanolamine, i.e., that which will be converted to drug 
products administered to patients with Acquired Immune Deficiency 
Syndrome and Attention Deficit Disorder. The ``for sale'' assessments 
refer to the amount of ephedrine, pseudoephedrine, and 
phenylpropanolamine intended for ultimate use in products containing 
these List I chemicals.
    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the ADDRESSES section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned chemicals without filing comments or objections regarding the 
others. If a person believes that one or more of these issues warrant a 
hearing, the individual should so state and summarize the reasons for 
this belief.
    In the event that comments or objections to this proposal raise one 
or more issues which the Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal Register, summarizing the issues to be heard and setting the 
time for the hearing.
    The Office of Management and Budget has determined that notices of 
quotas are not subject to centralized review under Executive Order 
12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601-612. The 
establishment of the assessment of annual needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine is 
mandated by law.
    The assessments are necessary to provide for the estimated medical, 
scientific, research and industrial needs of the United States, for 
export requirements, and the establishment and maintenance of reserve 
stocks. Accordingly, the Deputy Administrator has determined that this 
action does not require a regulatory flexibility analysis.
    This action meets the applicable standards set forth in sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.
    This action is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This action will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices; or significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets.

    Dated: September 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E7-18528 Filed 9-19-07; 8:45 am]
BILLING CODE 4410-09-P