Notice: Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2009: Proposed

Federal Register: September 19, 2008 (Volume 73, Number 183)
                  Page 54431-54432

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed annual assessment of needs for 2009.

SUMMARY: This notice proposes the initial year 2009 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. 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 must be postmarked, and electronic comments 
must be sent, on or before October 20, 2008.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-314P'' 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, 8701 Morrissette Drive, Springfield, 
Virginia 22152, Attention: DEA Federal Register Representative/ODL. 
Written comments sent via express mail should be sent to DEA 
Headquarters: DEA Federal Register Representative/ODL, 8701 Morrissette 
Drive, Springfield, Virginia 22152. Comments may be directly sent to 
DEA electronically by sending an electronic message to 
dea.diversion.policy@usdoj.gov. However, persons wishing to request a 
hearing should note that such requests must be written and manually 
signed; requests for a hearing will not be accepted via electronic 
means. 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, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrisette Drive, Springfield, Virginia 22152, 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. 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, 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

[[Page 54432]]

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 proposed year 2009 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 substance for: the estimated 
medical, scientific, research, and industrial needs of the United 
States; lawful export requirements; and the establishment and 
maintenance of reserve stocks.
    To develop the 2009 assessment of annual needs for the United 
States, DEA considered applications for 2009 import, manufacturing, and 
procurement quotas received from DEA registered manufacturers and 
importers. DEA further considered information contained in import and 
export declarations (DEA-486) along with information relating to trends 
in the national rate of disposals, actual and estimated inventories, 
and projected demand for the List I chemicals ephedrine, 
pseudoephedrine and phenylpropanolamine in accordance with 21 CFR 
1315.11.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes the following 2009 assessment of annual needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2009, 
expressed in kilograms of anhydrous base:

------------------------------------------------------------------------
                                                 Proposed Year 2009
             List I chemicals                assessment of annual needs
------------------------------------------------------------------------
Ephedrine (for sale)......................  2,500 kg
Ephedrine (for conversion)................  110,000 kg
Pseudoephedrine (for sale)................  415,000 kg
Phenylpropanolamine (for sale)............  7,500 kg
Phenylpropanolamine (for conversion)......  50,000 kg
------------------------------------------------------------------------

    Ephedrine (for conversion) refers to the industrial use of 
ephedrine, i.e., that which will be converted to another basic drug 
class such as methamphetamine or pseudoephedrine. Phenylpropanolamine 
(for conversion) refers to the industrial use of phenylpropanolamine, 
i.e., that which will be converted to another basic drug class such as 
amphetamine used for the manufacture of drug products for the treatment 
of attention-deficit hyperactivity disorders. 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 substances 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. Persons wishing to request a hearing should 
note that such requests must be written and manually signed; requests 
for a hearing will not be accepted via electronic means. 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 as per 21 CFR 1315.13(e).

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this action will not 
have a significant economic 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 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 
lawful 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.

Executive Order 12866

    The Office of Management and Budget has determined that notices of 
assessment of annual needs are not subject to centralized review under 
Executive Order 12866.

Executive Order 13132

    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.

Executive Order 12988

    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

Unfunded Mandates Reform Act of 1995

    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 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.

Congressional Review Act

    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. 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 10, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-21960 Filed 9-18-08; 8:45 am]

BILLING CODE 4410-09-P