[Federal Register: October 27, 2008 (Volume 73, Number 208)]
[Notices]
[Page 63732-63733]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc08-84]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-306F]
Final Revised Assessment of Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Final Assessment of Annual Needs for 2008.
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SUMMARY: This notice establishes the Final Revised 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.
DATES: Effective Date: October 27, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration
(DEA), 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 amended21 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 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 in
2008 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.
On June 23, 2008, a notice entitled, ``Proposed Revised Assessment
of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine,
and Phenylpropanolamine for 2008'' was published in the Federal
Register (73 FR 35410). This notice proposed the revised 2008
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 July 23, 2008.
DEA did not receive any comments or objections to the proposed
revised Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2008. 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
[[Page 63733]]
CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Deputy Administrator hereby orders that the Revised 2008
Assessment of Annual Needs for ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in kilograms of anhydrous acid or base,
be established as follows:
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Final 2008
assessment
List I chemical of annual
needs (kg)
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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
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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: October 7, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-25452 Filed 10-24-08; 8:45 am]
BILLING CODE 4410-09-P