Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc., 59064-59065 [2013-23287]

Download as PDF 59064 Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES Here, the Government’s Expert provided substantial evidence that Registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the TFOs. As the Expert explained, and notwithstanding the Florida Board’s ‘‘Evaluation of the Patient’’ standard, Registrant did not conduct an adequate evaluation of the TFOs in that he failed to take a complete medical history, did not make ‘‘a serious inquiry into the cause of each [TFO’s] pain,’’ and did not ‘‘conduct an adequate physical examination of’’ of either TFO. GX 10, at 2. The Expert further observed that during the examination of the TFOs, ‘‘neither officer demonstrated pain sufficient to justify the repeated prescribing of controlled substances’’ and that Registrant did not adequately address ‘‘the effect of pain on the officers’ physical and psychological function.’’ Id. The Expert thus concluded that ‘‘Registrant failed to establish a sufficient doctor patient relationship with either TFO . . . and that [his] prescribing of controlled substances [to them] was outside the usual course of professional practice and for other than a legitimate medical purpose.’’ 7 Id. at 2. Accordingly, I find that Respondent 7 The Expert also noted that Registrant ‘‘failed to create and/or document a sufficient treatment plan’’; failed to order ‘‘further diagnostic evaluations,’’ even though each TFO’s MRI ‘‘failed to demonstrate serious enough pathology for the officer to receive the large amounts of controlled substances that were prescribed’’; and that the pathologies observed on their MRIs ‘‘can usually be addressed by other means, such as physical therapy, exercise, work strengthening programs, abdominal core training, anti-inflammatories, and at times, . . . nerve blocks with corticosteroids.’’ GX 10, at 2–3. As further support for his conclusion, the Expert noted that Registrant had increased the amount of controlled substances he prescribed to the two TFOs, notwithstanding that he expressed doubt as to whether either TFO needed the medications they were getting. Id. at 3. As the found above, Registrant told TFO One that he ‘‘may not need medications’’ because his ‘‘MRI [didn’t] show any compression of the nerves.’’ GX 4, at 11. And as for TFO Two, Registrant noted that 190 dosage units of oxycodone 30 mg ‘‘is a big dose,’’ and that it was ‘‘difficult to understand’’ why TFO Two had ‘‘so much pain in there’’ given that the TFO did not ‘‘have any compression of the nerves, or the spinal column, or the nerve root.’’ GX 5, at 16–17. Finally, the Expert noted that with respect to TFO One, Registrant increased the prescriptions based solely on the TFO’s request that he do so because he might miss his next appointment, and that with respect to TFO Two, Registrant gave him an additional prescription for 100 dosage units of oxycodone 15mg based solely on the TFO’s representation that the doctor he had previously seen at the clinic had promised him additional medication for breakthrough pain and did so ‘‘without consulting the medical record.’’ GX 10, at 3. VerDate Mar<15>2010 17:20 Sep 24, 2013 Jkt 229001 violated the CSA’s prescription regulation and that he knowingly or intentionally diverted controlled substances when he prescribed oxycodone to the TFOs. See 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1); see also Fla. Stat. §§ 893.05(1), 893.13(1)(a). I therefore hold that the Government’s evidence with respect to factors two and four establishes that Registrant ‘‘has committed such acts as would render his registration . . . inconsistent with the public interest.’’ 21 U.S.C. 824(a)(4).8 Because Registrant waived his right to a hearing (or to submit a written statement in lieu of a hearing), there is no evidence in the record to refute the conclusion that his continued registration is ‘‘inconsistent with the public interest.’’ Id. Accordingly, I will order that Registrant’s registration be revoked and that any pending applications be denied. DEPARTMENT OF JUSTICE Order The company plans to import the listed substances for clinical trials, analytical research and testing. The import of the above listed basic classes of controlled substances will be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance 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 written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than October 25, 2013. 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 classes 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 Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration AS9790420, issued to Gabriel Sanchez, M.D., be, and hereby is, revoked. I further order that any pending application of Gabriel Sanchez, M.D., to renew or modify the above registration be, and it hereby is, denied. This Order is effective October 25, 2013. Dated: September 17, 2013. Michele M. Leonhart, Administrator. [FR Doc. 2013–23285 Filed 9–24–13; 8:45 am] BILLING CODE 4410–09–P 8 While the Government alleged in the Show Cause Order that Registrant’s prescribing of carisoprodol also lacked a legitimate medical purpose, it is noted that carisoprodol was not federally controlled at the time of the events at issue here. See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330 (Dec. 12, 2011) (final rule). However, the Expert opined that Registrant did not have a legitimate medical justification for prescribing carisoprodol, which was then controlled under Florida law, to either TFO. See GX 10, at 4; Fla. Stat. § 893.03(4)(jjj) (2010). While the Expert’s opinion would support a finding that Registrant violated Florida law in prescribing carisoprodol to the TFOs, see Fla. Stat. §§ 893.05(1), 893.13(1)(a), and such a violation is relevant in assessing a registrant’s likelihood of future compliance with the CSA (under either factor four or five), see John V. Scalera, 78 FR 12092, 12100 (2013) (citing cases), the Government did not rely on this conduct in its Request for Final Agency Action. Accordingly, nor do I. PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations (CFR) 1301.34 (a), this is notice that on June 21, 2013, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug Methyphendiate (1724) ................ Levorphanol (9220 ....................... Noroxymorphone (9668) .............. Tapentadol (9780) ........................ E:\FR\FM\25SEN1.SGM 25SEN1 Schedule II II II II Federal Register / Vol. 78, No. 186 / Wednesday, September 25, 2013 / Notices 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: September 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–23287 Filed 9–24–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Office of Justice Programs Gregory K. Ridgeway, Acting Director, National Institute of Justice. [OJP (NIJ) Docket No. 1632] [FR Doc. 2013–23298 Filed 9–24–13; 8:45 am] Interview Room Recording System Standard and License Plate Reader Standard Workshops BILLING CODE 4410–18–P National Institute of Justice, Department of Justice. ACTION: Notice of the Interview Room Recording System Standard and License Plate Reader Standard Workshops. AGENCY: The National Institute of Justice (NIJ) and the International Association of Chiefs of Police (IACP) are hosting two workshops in conjunction with the 120th Annual IACP Conference and Exposition in Philadelphia, PA. The focus of the workshops is the development of NIJ performance standards for Interview Room Recording Systems and License Plate Readers used by criminal justice agencies. Sessions are intended to inform manufacturers, test laboratories, certification bodies, and other interested parties of these standards development efforts. These workshops are being held specifically to discuss recent progress made toward the standards and to receive input, comments, and recommendations. Space is limited at each workshop, and as a result, only 50 participants will be allowed to register for each session. We request that each organization limit their representatives to no more than two per organization. Exceptions to this limit may occur, should space allow. Participants planning to attend are responsible for their own travel arrangements. SUMMARY: Both workshops will be held on Saturday, October 19, 2013. The License Plate Reader standard session will take place from 2:00 p.m. to 3:00 p.m. The Interview Room Recording System standard session will take place from 3:00 p.m. to 4:00 p.m. ADDRESSES: Pennsylvania Convention Center, 1101 Arch Street, Philadelphia, PA 19107, Room 103A. mstockstill on DSK4VPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 17:20 Sep 24, 2013 For information about the NIJ Interview Room Recording System or License Plate Reader standards under development, please contact Mark Greene, by telephone at (202) 307–3384 [Note: this is not a toll-free telephone number], or by email at mark.greene2@usdoj.gov. To RSVP for the workshops, please contact Michael Fergus at fergus@theiacp.org. For general information about NIJ standards, please visit http://www.nij.gov/ standards or http://www.justnet.org/ standards. FOR FURTHER INFORMATION CONTACT: Jkt 229001 DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice Requirements of the Health Care Continuation Coverage Provisions ACTION: Notice. The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ‘‘Notice Requirements of the Health Care Continuation Coverage Provisions,’’ to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before October 25, 2013. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www. reginfo.gov/public/do/PRAViewICR?ref_ nbr=201307-1210-001 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_ PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–EBSA, Office of Management and Budget, Room 10235, SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 59065 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: OIRA_ submission@omb.eop.gov. Commenters are encouraged, but not required, to send a courtesy copy of any comments to the U.S. Department of LaborOASAM, Office of the Chief Information Officer, Attn: Information Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210, email: DOL_PRA_PUBLIC@dol.gov. FOR FURTHER INFORMATION CONTACT: Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at DOL_PRA_ PUBLIC@dol.gov. Authority: 44 U.S.C. 3507(a)(1)(D). The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) provides that, under certain circumstances, a group health plan participant or beneficiary who meets the COBRA qualified beneficiaries definition may elect to continue group health coverage temporarily following a qualifying event that would otherwise result in loss of coverage. The COBRA provides that the Secretary of Labor has the authority under Employee Retirement Income Security Act of 1974 (ERISA) section 608 to carry out the provisions of ERISA Title I Part 6. The DOL issued regulations to implement the ERISA section 606 notice requirements, because providing timely and adequate notifications regarding COBRA rights and responsibilities is critical to a qualified beneficiary’s ability to obtain health continuation coverage. In addition, the DOL believes, regulatory guidance was necessary to establish clearer standards for administering and processing COBRA notices. This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1210–0123. OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval is scheduled to expire on September 30, SUPPLEMENTARY INFORMATION: E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59064-59065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23287]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application; Fisher 
Clinical Services, Inc.

    Pursuant to Title 21 Code of Federal Regulations (CFR) 1301.34 (a), 
this is notice that on June 21, 2013, Fisher Clinical Services, Inc., 
7554 Schantz Road, Allentown, Pennsylvania 18106, made application by 
renewal to the Drug Enforcement Administration (DEA) for registration 
as an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methyphendiate (1724)......................  II
Levorphanol (9220..........................  II
Noroxymorphone (9668)......................  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import the listed substances for clinical 
trials, analytical research and testing.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
FDA approved or non-approved dosage form for commercial distribution in 
the United States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic class of controlled 
substance 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 written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than October 25, 2013.
    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 classes 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

[[Page 59065]]

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: September 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-23287 Filed 9-24-13; 8:45 am]
BILLING CODE 4410-09-P