The Federal Register

Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine

Thu, Dec 27 2007 11:00:00 GMT

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.

Manufacturer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated September 21, 2007, and published in the Federal Register on September 27, 2007, (72 FR 5492954930), Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, 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 schedules I and II:
Drug Schedule Tetrahydrocannabinols (7370)............... I
Dihydromorphine (9145)..................... I
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Sufentanil (9740).......................... II
Fentanyl (9801)............................ II

Remifentanil (9739)........................ II

The company plans to manufacture the listed controlled substances in bulk for distribution to its customers.

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Manufacturer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated August 16, 2007, and published in the Federal Register on August 27, 2007, (72 FR 49020), Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Building 18, Chattanooga, Tennessee 37409, 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 schedules I and II:
Drug Schedule 4Methoxyamphetamine (7411)................ I
Dihydromorphine (9145)..................... I
Difenoxin (9168)........................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193).......................

Importer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated August 28, 2007 and published in the Federal Register on September 10, 2007, (72 FR 51664), CIMA Labs, Inc., 7325 Aspen Lane, Brooklyn Park, Minnesota 55428 made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II.

The company plans to import the basic class of controlled substance for clinical trials and research.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of CIMA Labs, Inc. to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated CIMA Labs, Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included insp

Manufacturer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated August 16, 2007, and published in the Federal Register on August 27, 2007, (72 FR 49021), Cody Laboratories, 601 Yellowstone Avenue, Cody, Wyoming 82414, 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 Dihydromorphine (9145)..................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Amobarbital (2125)......................... II
Pentobarbital (2270)....................... II
Secobarbital (2315)........................ II
Phenylacetone (8501)....................... II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (91

Importer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated September 24, 2007 and published in the Federal Register on October 2, 2007, (72 FR 56102), ISP Freetown Fine Chemicals, 238 South Main Street, Assonet, Massachusetts 02702, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II.

The company plans to import the Phenylacetone to manufacture Amphetamine.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of ISP Freetown Fine Chemicals to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated ISP Freetown Fine Chemicals to ensure that the company's registration is consistent with the public interest. The investigatio

Manufacturer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated September 12, 2007, and published in the Federal Register on September 19, 2007 (72 FR 53606), Research Triangle Institute, Kenneth H. Davis Jr., Hermann Building, P.O. Box 12194, East Institute Drive, Research Triangle, North Carolina 27709, 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 schedules I and II:
Drug Schedule Marihuana (7360)............................... I

Cocaine (9041)................................. II

The Institute will manufacture small quantities of cocaine and marihuana derivatives for use by their customers in analytical kits, reagents, and reference standards as directed by NIDA.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Research Triangle Institute to manufactu

Manufacturer of Controlled Substances; Notice of Registration

Thu, Dec 27 2007 11:00:00 GMT

By Notice dated September 21, 2007, and published in the Federal Register on September 27, 2007, (72 FR 54931), Varian, Inc., Lake Forest, 25200 Commercentre Drive, Lake Forest, California 926308810, 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 II:
Drug Schedule Phencyclidine (7471)....................... II
1Piperidinocyclohexanecarbonitrile (8603). II

Benzoylecgonine (9180)..................... II

The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Varian, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Varia

Controlled Substances: Established Initial Aggregate Production Quotas for 2008

Thu, Dec 27 2007 11:00:00 GMT

This notice establishes initial 2008 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).

Importer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.

Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on November 22, 2007, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II.

The company plans to import Phenylacetone for use as a precursor in the manufacture of amphetamines only.

Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufac

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR),
[[Page 73358]]
this is notice that on November 22, 2007, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, 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 II:
Drug Schedule Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Phenylacetone (8501)....................... II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Dextropropoxyphene, bulk (nondosage forms) II
(9273).
Morphine (9300)............................ II
Thebaine (9333)............................ II
Sufentanil (9740)...

Importer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a registration under 21 U.S.C. 952(a)(2) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.

Therefore, in accordance with Title 21 Code of Federal Regulations (CFR), 1301.34(a), this is notice that on October 19, 2007, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004 1412, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of a substance controlled under the basic class of Cocaine (9041), a schedule II controlled substance.

The company plans to import small quantities of ioflupane, in the form of three separate analogues of Cocaine, to validate production and QC systems; for a reference standard; and for produci

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 20, 2007, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 600041412, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of a substance controlled under the basic class of Cocaine (9041), a schedule II controlled substance.

The company plans to manufacture a radioactive product used in diagnostic imaging in the diagnosis of Parkinson's Disease and for manufacture in bulk for investigational new drug (IND) submission and clinical trials.

Any other such applicant and any person who is presently registered with DEA to manufacture such a substance 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 o

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 31, 2007, Innovacon, Inc., 4106 Sorrento Valley Boulevard, San Diego, California 92121, made application 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
3,4Methylenedioxymethamphetamine (MDMA) I
(7405).
Heroin (9200).............................. I
Cocaine (9041)............................. II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II

Thebaine (9333)............................ II

The company plans to utilize small quantities of controlled substances to produce dru

Importer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on November 7, 2007, Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 080661742, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the basic classes of controlled substances listed in schedule II:
Drug Schedule Phenylacetone (8501)....................... II
Raw Opium (9600)........................... II

Concentrate of Poppy Staw (9670)........... II

The company plans to import the listed controlled substances as raw materials for use in the manufacture of bulk controlled substances for distribution to its customers.

No comments, objections, or requests for any hearings will be accepted on any application for registration or reregistration to import crude opium, poppy straw, concentrate of poppy straw, or coca leaves.

Any bulk manufacturer who is prese

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 7, 2007, Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 080661742, 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
Dihydromorphine (9145)..................... I
Difenoxin (9168)........................... I
Propiram (9649)............................ I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Methylphenidate (1724)..................... II
Nabilone (7379)............................ II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II

Manufacturer Of Controlled Substances; Notice Of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 6, 2007, Noramco Inc., Division of Ortho, McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801, 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 schedules I and II:
Drug Schedule CodeineNoxide (9053)..................... I
MorphineNoxide (9307).................... I
Dihydromorphine (9145)..................... II
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Morphine (9300)............................ II
Thebaine (9333)............................ II
Opium, raw (9600).......................... II
Opium extracts

Importer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

This is notice that on November 6, 2007, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the basic classes of controlled substances listed in schedule II:
Drug Schedule Raw Opium (9600)........................... II

Concentrate of Poppy Straw (9670).......... II

The company plans to import the listed controlled substances to manufacture other controlled substances.

As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745), all applicants for registration to import a basic class of any controlled substances in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a),

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on November 12, 2007, Orasure Technologies, Inc., Lehigh University, Seeley G MuddBuilding 6, 220 East First Street, Bethlehem, Pennsylvania 18015, made application by renewal to the Drug Enforcement Administration (DEA) as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II:
Drug Schedule Tetrahydrocannabinols (THC) (7370)......... I
4Methoxyamphetamine (7411)................ I
Normorphine (9313)......................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Cocaine (9041)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Benzoylecgonine (9180)..................... II
Hydrocodone (9193)......................... II
Meperidine (9230).......................... II
Me

Manufacturer of Controlled Substances; Notice of Application

Thu, Dec 27 2007 11:00:00 GMT

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 Enforc

Agency Information Collection Activities: Proposed Collection; Comments Requested

Thu, Dec 27 2007 11:00:00 GMT

The Department of Justice (DOJ), Bureau of Justice Statistics, has submitted the following information collection request to the Office of [[Page 73357]]
Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register Volume 72, Number 200, page 58895 on October 17, 2007, allowing for a sixty day period.

The purpose of this notice is to allow for an additional 30 days for public comment until January 28, 2008. This process is conducted in accordance with 5 CFR 1320.10.

If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Allen J. Beck, PhD, Bureau of Justice Statistics, 810 Seve