Manufacturer of Controlled Substances; Notice of Application, 73361 [E7-25114]

Download as PDF Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than February 25, 2008. Dated: December 17, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–25114 Filed 12–26–07; 8:45 am] Dated: December 17, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–25048 Filed 12–26–07; 8:45 am] Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 15, 2007, Organix Inc., 240 Salem Street, Woburn, Massachusetts 01801, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule I and II: Drug Schedule mstockstill on PROD1PC66 with NOTICES Tetrahydrocannabinols (7370) ..... Cocaine (9041) ............................. I II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for research purposes. Any other such applicant and any person who is presently registered with DEA to manufacture such substances may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than February 25, 2008. VerDate Aug<31>2005 19:40 Dec 26, 2007 Jkt 214001 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–306E] Drug Enforcement Administration (DEA), Justice. ACTION: Notice of Assessment of Annual Needs for 2008. AGENCY: SUMMARY: This notice establishes 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. EFFECTIVE DATE: December 27, 2007. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug & Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307–7183. SUPPLEMENTARY INFORMATION: Background and Legal Authority Section 713 of the Combat Methamphetamine Epidemic Act of 2005 (CMEA) (Title VII of Pub. L. 109– 177) amended section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requiring that the Attorney General establish quotas to provide for the annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. Section 715 of the CMEA amended 21 U.S.C. 952 by adding ephedrine, pseudoephedrine and phenylpropanolamine to the existing language concerning importation of controlled substances. 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. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 73361 The responsibility for establishing the assessment has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104. On September 20, 2007, a notice entitled, ‘‘Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008: Proposed’’ was published in the Federal Register (72 FR 53911). This notice proposed the initial 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 October 11, 2007. Comments Received DEA did not receive any comments or objections from the more than 1,050 DEA-registered manufacturers and importers directly impacted by this notice. However, DEA did receive one comment from a law firm representing a DEA-registered distributor of nonprescription (over-the-counter (OTC)) products containing ephedrine, pseudoephedrine, or phenylpropanolamine. When sold at retail, these products are referred to as scheduled listed chemical products.1 This same commenter commented to DEA’s proposed 2007 Assessment of Annual Needs which was published in the Federal Register on October 19, 2006 (71 FR 61801). The comment submitted to this notice is virtually identical to that previously considered by DEA in that the comment included the same reports. However, DEA notes that the current comment includes one new report and one new letter. The new report was prepared by an economist who was retained by the DEA-registered distributor being represented by the law firm. The letter was prepared by the statistician whose report was submitted as part of this commenter’s comments to the 2007 proposed assessment. The commenter’s comments related to DEA’s proposed assessments for ephedrine (for sale) and pseudoephedrine (for sale). These assessments are discussed below within 1 Title 21 U.S.C. 802(45) defines a scheduled listed chemical product as ‘‘a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine; and * * * may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug.’’ E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Page 73361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25114]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on November 15, 2007, Organix 
Inc., 240 Salem Street, Woburn, Massachusetts 01801, made application 
by renewal to the Drug Enforcement Administration (DEA) to be 
registered as a bulk manufacturer of the basic classes of controlled 
substances listed in schedule I and II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Cocaine (9041).............................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers for research purposes.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such substances may file comments or objections 
to the issuance of the proposed registration pursuant to 21 CFR 
1301.33(a).
    Any such written comments or objections being sent via regular mail 
should be addressed, in quintuplicate, to the Drug Enforcement 
Administration, Office of Diversion Control, Federal Register 
Representative (ODL), Washington, DC 20537, or any being sent via 
express mail should be sent to Drug Enforcement Administration, Office 
of Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than February 25, 2008.

    Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E7-25114 Filed 12-26-07; 8:45 am]
BILLING CODE 4410-09-P