[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Pages 35410-35412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14108]


-----------------------------------------------------------------------

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,

[[Page 35411]]

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 [email protected]. 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:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
            List I chemicals               initial 2008    revised 2008
                                            assessment/     assessment/
                                               (kg)            (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