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Federal Register / Vol. 72, No.

247 / Thursday, December 27, 2007 / Notices 73361

Any such written comments or Dated: December 17, 2007. The responsibility for establishing the
objections being sent via regular mail Joseph T. Rannazzisi, assessment has been delegated to the
should be addressed, in quintuplicate, Deputy Assistant Administrator, Office of Administrator of the DEA by 28 CFR
to the Drug Enforcement Diversion Control, Drug Enforcement 0.100. The Administrator, in turn, has
Administration, Office of Diversion Administration. redelegated this function to the Deputy
Control, Federal Register Representative [FR Doc. E7–25114 Filed 12–26–07; 8:45 am] Administrator, pursuant to 28 CFR
(ODL), Washington, DC 20537, or any BILLING CODE 4410–09–P 0.104.
being sent via express mail should be On September 20, 2007, a notice
sent to Drug Enforcement entitled, ‘‘Assessment of Annual Needs
Administration, Office of Diversion DEPARTMENT OF JUSTICE for the List I Chemicals Ephedrine,
Control, Federal Register Representative Pseudoephedrine, and
(ODL), 8701 Morrissette Drive, Drug Enforcement Administration Phenylpropanolamine for 2008:
Springfield, Virginia 22152; and must be [Docket No. DEA–306E] Proposed’’ was published in the Federal
filed no later than February 25, 2008. Register (72 FR 53911). This notice
Dated: December 17, 2007. Established Assessment of Annual proposed the initial 2008 Assessment of
Needs for the List I Chemicals Annual Needs for ephedrine (for sale),
Joseph T. Rannazzisi,
Ephedrine, Pseudoephedrine, and ephedrine (for conversion),
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Phenylpropanolamine for 2008 pseudoephedrine (for sale),
Administration. phenylpropanolamine (for sale) and
AGENCY: Drug Enforcement phenylpropanolamine (for conversion).
[FR Doc. E7–25048 Filed 12–26–07; 8:45 am] Administration (DEA), Justice. All interested persons were invited to
BILLING CODE 4410–09–P
ACTION: Notice of Assessment of Annual comment on or object to the proposed
Needs for 2008. assessments on or before October 11,
DEPARTMENT OF JUSTICE 2007.
SUMMARY: This notice establishes the
initial year 2008 Assessment of Annual Comments Received
Drug Enforcement Administration
Needs for certain List I chemicals in DEA did not receive any comments or
Manufacturer of Controlled accordance with the Combat objections from the more than 1,050
Substances; Notice of Application Methamphetamine Epidemic Act of DEA-registered manufacturers and
2005 (CMEA), enacted on March 9, importers directly impacted by this
Pursuant to § 1301.33(a) of Title 21 of 2006. notice. However, DEA did receive one
the Code of Federal Regulations (CFR), comment from a law firm representing
this is notice that on November 15, EFFECTIVE DATE: December 27, 2007.
a DEA-registered distributor of
2007, Organix Inc., 240 Salem Street, FOR FURTHER INFORMATION CONTACT:
nonprescription (over-the-counter
Woburn, Massachusetts 01801, made Christine A. Sannerud, PhD, Chief, Drug (OTC)) products containing ephedrine,
application by renewal to the Drug & Chemical Evaluation Section, Drug pseudoephedrine, or
Enforcement Administration (DEA) to Enforcement Administration, phenylpropanolamine. When sold at
be registered as a bulk manufacturer of Washington, DC 20537, Telephone: retail, these products are referred to as
the basic classes of controlled (202) 307–7183. scheduled listed chemical products.1
substances listed in schedule I and II: SUPPLEMENTARY INFORMATION: This same commenter commented to
Drug Schedule Background and Legal Authority DEA’s proposed 2007 Assessment of
Annual Needs which was published in
Tetrahydrocannabinols (7370) ..... I
Section 713 of the Combat the Federal Register on October 19,
Cocaine (9041) ............................. II Methamphetamine Epidemic Act of 2006 (71 FR 61801). The comment
2005 (CMEA) (Title VII of Pub. L. 109– submitted to this notice is virtually
The company plans to manufacture 177) amended section 306 of the identical to that previously considered
the listed controlled substances in bulk Controlled Substances Act (CSA) (21 by DEA in that the comment included
for sale to its customers for research U.S.C. 826) requiring that the Attorney the same reports. However, DEA notes
purposes. General establish quotas to provide for that the current comment includes one
Any other such applicant and any the annual needs for ephedrine, new report and one new letter. The new
person who is presently registered with pseudoephedrine, and report was prepared by an economist
DEA to manufacture such substances phenylpropanolamine. Section 715 of who was retained by the DEA-registered
may file comments or objections to the the CMEA amended 21 U.S.C. 952 by distributor being represented by the law
issuance of the proposed registration adding ephedrine, pseudoephedrine and firm. The letter was prepared by the
pursuant to 21 CFR 1301.33(a). phenylpropanolamine to the existing statistician whose report was submitted
Any such written comments or language concerning importation of as part of this commenter’s comments to
objections being sent via regular mail controlled substances. the 2007 proposed assessment.
should be addressed, in quintuplicate, The 2008 Assessment of Annual The commenter’s comments related to
to the Drug Enforcement Needs represents those quantities of DEA’s proposed assessments for
Administration, Office of Diversion ephedrine, pseudoephedrine, and ephedrine (for sale) and
Control, Federal Register Representative phenylpropanolamine which may be pseudoephedrine (for sale). These
(ODL), Washington, DC 20537, or any manufactured domestically and/or assessments are discussed below within
being sent via express mail should be imported into the United States in 2008
mstockstill on PROD1PC66 with NOTICES

sent to Drug Enforcement to provide adequate supplies of each 1 Title 21 U.S.C. 802(45) defines a scheduled

Administration, Office of Diversion chemical for: The estimated medical, listed chemical product as ‘‘a product that contains
Control, Federal Register Representative scientific, research, and industrial needs ephedrine, pseudoephedrine, or
phenylpropanolamine; and * * * may be marketed
(ODL), 8701 Morrissette Drive, of the United States; lawful export or distributed lawfully in the United States under
Springfield, Virginia 22152; and must be requirements; and the establishment the Federal Food, Drug, and Cosmetic Act as a
filed no later than February 25, 2008. and maintenance of reserve stocks. nonprescription drug.’’

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