[Federal Register: September 20, 2007 (Volume 72, Number 182)]
[Notices]
[Page 53911-53912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se07-87]
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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 dea.diversion.policy@usdoj.gov. 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:
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Proposed year
2008 assessment
List I chemicals 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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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