Manufacturer of Controlled Substances; Notice of Registration, 51664-51665 [E7-17767]

Download as PDF 51664 Federal Register / Vol. 72, No. 174 / Monday, September 10, 2007 / Notices the payroll system, and updating the applicable routine uses. In accordance with 5 U.S.C. 552a(e)(4) and (11) the public is given a 30-day period in which to comment; and the Office of Management and Budget (OMB), which has oversight responsibility under the Privacy Act, requires a 40-day period in which to conclude its review of the system. Therefore, please submit any comments by October 22, 2007. The public, OMB and the Congress are invited to submit any comments to Joo Chung, Counsel, Privacy and Civil Liberties Office, Office of the Deputy Attorney General, 950 Pennsylvania Ave., NW., Washington, DC 20530, facsimile number 202–616– 9627. In accordance with 5 U.S.C. 552a(r), the Department has provided a report to OMB and the Congress. Dated: September 4, 2007. Lee J. Lofthus, Assistant Attorney General for Administration. JUSTICE/JMD–003 SYSTEM NAME: Department of Justice Payroll System, Justice/JMD–003. * * * * * CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: ebenthall on PRODPC61 with NOTICES * * * * [CHANGE THE SECOND INTRODUCTORY PARAGRAPH TO READ AS FOLLOWS.] In accordance with an interagency agreement, as provided for in Office of Management and Budget (OMB) implementing guidelines (40 FR 28948), the DOJ may disclose records to the U.S. Department of Agriculture (USDA), National Finance Center (NFC), in order to effect all financial transactions on behalf of the DOJ related to employee pay. * * * * * [CORRECT ROUTINE USE C, TO READ AS FOLLOWS.] C. To State and local courts of competent jurisdiction for the enforcement of child support, alimony, or both, pursuant to 42 U.S.C. 659. * * * * * [DELETE ROUTINE USE G AND SUBSTITUTE THE FOLLOWING ROUTINE USE.] G. To appropriate agencies, entities, and persons when (1) The Department 15:27 Sep 07, 2007 Jkt 211001 BILLING CODE 4410–CP–P Drug Enforcement Administration ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES: VerDate Aug<31>2005 [FR Doc. E7–17754 Filed 9–7–07; 8:45 am] DEPARTMENT OF JUSTICE Current and former DOJ employees. * * * * * * suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department’s efforts to respond to the suspected or confirmed compromise and prevent, minimize or remedy such harm. * * * * * [DELETE THE GENERAL SERVICES ADMINISTRATION FROM ROUTINE USE O, TO READ AS FOLLOWS.] O. To the National Archives and Records Administration for purposes of records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906. * * * * * Importer of Controlled Substances; Notice of Application 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) 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 July 19, 2007, 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. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such 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), 2401 JeffersonDavis Highway, Alexandria, Virginia 22301; and must be filed no later than October 10, 2007. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e) and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, (40 FR 43745–46), all applicants for registration to import a basic class of any controlled substance listed 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), and 21 CFR 1301.34(b), (c), (d), (e) and (f) are satisfied. Dated: August 28, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–17766 Filed 9–7–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated May 10, 2007, and published in the Federal Register on May 18, 2007, (72 FR 28073), Cody Laboratories, Inc., 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 Dihydromorphine (9145) ............... Amphetamine (1100) .................... E:\FR\FM\10SEN1.SGM 10SEN1 Schedule I II Federal Register / Vol. 72, No. 174 / Monday, September 10, 2007 / Notices Drug Schedule Methamphetamine (1105) ............ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Cocaine (9041) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Meperidine (9230) ........................ Oxymorphone (9652) ................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ II II II II II II II II II II II II The company plans on manufacturing the listed controlled substances in bulk for sale to its customers. 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 Cody Laboratories, Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Cody Laboratories, Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of the company’s background and history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed. Dated: August 28, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–17767 Filed 9–7–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ebenthall on PRODPC61 with NOTICES Randi M. Germaine, M.D.; Revocation of Registration On December 14, 2006, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Randi M. Germaine, M.D. (Respondent), of Casa Grande, Arizona. The Show Cause Order proposed the revocation of Respondent’s DEA Certificate of Registration, BG3717278, as a practitioner, as well as the denial of any pending applications for renewal or modification of the registration, on the ground that his continued registration is VerDate Aug<31>2005 15:27 Sep 07, 2007 Jkt 211001 inconsistent with the public interest. Show Cause Order at 1. The Show Cause Order specifically alleged that during the execution of a search warrant at the Morenci Healthcare Center (Respondent’s former employer), copies of patient charts were obtained which were then sent to a medical expert for review. Id. at 2. The Show Cause Order alleged that the expert had concluded that Respondent’s ‘‘prescribing practices concerning controlled substances did not meet the usual standard of care.’’ Id. Relatedly, the Show Cause Order alleged that background checks on some of Respondent’s patients indicated that they ‘‘were receiving excessive and unnecessary amounts of controlled substances,’’ that they were known to law enforcement to be ‘‘drug abusers,’’ and that some of them had committed controlled-substance offenses. Id. Relatedly, the Show Cause Order alleged that some of Respondent’s patients ‘‘were known to area pharmacists as ‘doctor shoppers’ and ‘chronic early refillers.’ ’’ Id. Moreover, ‘‘a number of [Respondent’s] patients were family members receiving the same prescriptions for controlled substances.’’ Id. The Show Cause Order further alleged that the ‘‘autopsy reports for two of [Respondent’s] patients * * * showed [that] the cause of death [was] drug overdoses resulting from controlled substances prescribed by’’ Respondent. Id. The Show Cause Order also alleged that another of Respondent’s patients had ‘‘died after obtaining invalid prescriptions from [him] for controlled substances.’’ Id. On January 8, 2007, the Show Cause Order, which also notified Respondent of his right to a hearing, was served on him as evidenced by the signed returnreceipt card. Because (1) More than thirty days have passed since service of the Show Cause Order, and (2) Respondent did not timely request a hearing, I conclude that Respondent has waived his right to a hearing. See 21 CFR 1309.53(c). I therefore enter this Final Order without a hearing based on relevant material found in the investigative file and make the following findings. Findings Respondent is the holder of DEA Certificate of Registration, BG3717278, which authorizes him to handle controlled substances as a practitioner at the registered location of Harvest Medical Clinic, Inc., 1856 E. Florence Blvd., Casa Grande, Arizona. Respondent’s registration does not expire until September 30, 2008. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 51665 On August 25, 2003, the Greenlee County Sheriff’s Office contacted the DEA Tucson Diversion Group regarding Respondent’s termination from the Morenci Healthcare Center based on the allegation that he over-prescribed narcotic controlled substances. The Sheriff’s Office also informed DEA Investigators that R.S., a thirty-one year old male inmate at the county jail and patient of Respondent, had died and that the autopsy report had found both methadone and benzodiazepines in his blood. While the autopsy report noted that the cause of death could not be determined and that the ‘‘[t]oxicology findings may be equivocal due to decomposition,’’ R.S. was known to local law enforcement as a drug abuser. The Sheriff’s Office further related that Respondent had prescribed methadone (10 mg. tablets) for R.S. for back pain. Subsequently, R.S.’s medical records were sent to Ted Parran, M.D., a boardcertified internist and Associate Clinical Professor of Medicine and Family Medicine at the Case Western Reserve University School of Medicine and Director of its Addiction Fellowship Programs.1 According to Dr. Parran’s report (hereinafter, Expert Report), R.S. died four days after Respondent started him on methadone and ‘‘had demonstrated much drug seeking behavior over the past two years.’’ Expert Report at 2. Dr. Parran noted that R.S. ‘‘had [a]n MRI scanning demonstrating little pathology, had longstanding complaints and office behavior out of proportion to evidence of illness, and [a history] of noncompliance with [physical therapy] referrals.’’ Id. Dr. Parran further noted that R.S. ‘‘had been pretty much off of opioid analgesics (except for a few Vicodin or Percocet) and in [j]ail for a while when for some reason he was started on [m]ethadone * * * on 5/30/ 02.’’ Id. Dr. Parran concluded that ‘‘[t]his prescribing is difficult to imagine, fails to meet usual standards of care and concern when prescribing controlled drugs, appears to be for other than [a] legitimate medical purpose, and appears to have played a direct role in the patient’s death.’’ Id. On or about May 31, 2003, D.K., a twenty-five year old female and another of Respondent’s patients, died of a drug overdose. According to the toxicology report, hydrocodone, oxycodone, diazepam, and nordiazepam were present in D.K.’s blood. Furthermore, the examining pathologist found that 1 Dr. Parran has also performed research and issued written educational materials on addiction and controlled-substance prescribing. He has also developed a remedial education course on controlled-substance prescribing. E:\FR\FM\10SEN1.SGM 10SEN1

Agencies

[Federal Register Volume 72, Number 174 (Monday, September 10, 2007)]
[Notices]
[Pages 51664-51665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17767]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated May 10, 2007, and published in the Federal Register 
on May 18, 2007, (72 FR 28073), Cody Laboratories, Inc., 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

[[Page 51665]]

 
Methamphetamine (1105).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Cocaine (9041).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Meperidine (9230)..........................  II
Oxymorphone (9652).........................  II
Sufentanil (9740)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans on manufacturing the listed controlled substances 
in bulk for sale to its customers.
    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 
Cody Laboratories, Inc. to manufacture the listed basic class of 
controlled substance is consistent with the public interest at this 
time. DEA has investigated Cody Laboratories, Inc. to ensure that the 
company's registration is consistent with the public interest. The 
investigation has included inspection and testing of the company's 
physical security systems, verification of the company's compliance 
with state and local laws, and a review of the company's background and 
history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with 
21 CFR 1301.33, the above named company is granted registration as a 
bulk manufacturer of the basic classes of controlled substances listed.

    Dated: August 28, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
 [FR Doc. E7-17767 Filed 9-7-07; 8:45 am]
BILLING CODE 4410-09-P