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Notice of proposed revised 2008 assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
FR Doc E8-14108[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Notices] [Page 35410-35412] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn08-68]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-306R]
Proposed 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 proposed revised 2008 assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
SUMMARY: This notice proposes revised 2008 assessment of annual needs for the
List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES: Written comments must be postmarked, and electronic comments must be
sent, on or before July 23, 2008.
ADDRESSES: To ensure proper handling of comments, please reference "Docket
No. DEA-306R'' 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, 8701 Morrissette Drive,
Springfield, VA 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, 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.
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 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).
On December 27, 2007, a notice was published in the Federal Register which
established the assessment of annual needs for the List I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine (72 FR 73361). Pursuant to 21 CFR
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 2007 disposition data supplied
by quota recipients for ephedrine, pseudoephedrine, and phenylpropanolamine, and
other information available to the DEA.
The proposed revised 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 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.
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 revised 2008 assessment
of annual needs for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine for 2008, expressed in grams of anhydrous base:
List I chemicals
|
Previously established initial 2008 assessment/(kg)
|
Proposed revised 2008 assessment/(kg)
|
Ephedrine (for sale)
|
11,500
|
11,500
|
Ephedrine (for conversion)
|
128,760
|
128,760
|
Pseudoephedrine (for sale)
|
511,100
|
511,100
|
Phenylpropanolamine (for sale)
|
5,545
|
5,545
|
Phenylpropanolamine (for conversion)
|
85,470
|
85,470
|
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
[[Page 35412]]
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: June 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-14108 Filed 6-20-08; 8:45 am]
BILLING CODE 4410-09-P
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