Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 37114-37115 [2017-16699]

Download as PDF 37114 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices asabaliauskas on DSKBBXCHB2PROD with NOTICES registration. Id. (citing 21 U.S.C. 824(a)(3); 21 CFR 1301.37(b)). The Show Cause Order notified Registrant of her right to request a hearing on the allegations or to submit a written statement in lieu of a hearing, the procedure for electing either option, and the consequence for failing to elect either option. Id. (citing 21 CFR 1301.43). The Show Cause Order also notified Registrant of her right to submit a corrective action plan. Id. at 2–3 (citing 21 U.S.C. 824(c)(2)(C)). The Government states that on March 16, 2017, ‘‘[p]ersonnel from DEA’s New Orleans Field Division served the Order on Registrant.’’ Government Request for Final Agency Action (RFFA), at 1 (citing Government Exhibit (GX) 5). Specifically, a DEA Diversion Investigator (DI) and DEA Task Force Officer traveled to a medical center in Louisiana on March 16, 2017, where the nursing staff escorted them to her room where they found the Registrant. GX5, at 1. The DI advised Registrant that he had a Show Cause Order to serve on her. Id. According to the DI’s affidavit, the Registrant then responded ‘‘ ‘You will not take my DEA number’ and she refused to take the [Show Cause Order] document.’’ Id. The DI ‘‘then placed the [Order] on the night stand next to [Registrant’s] bed.’’ Id. On May 19, 2017, the Government forwarded its Request for Final Agency Action and an evidentiary record to my Office. Therein, the Government represents that Registrant has neither requested a hearing nor ‘‘otherwise corresponded or communicated with DEA regarding’’ the Show Cause Order. RFFA, at 2. Based on the Government’s representation and the record, I find that more than 30 days have passed since the Order to Show Cause was served on Registrant, and she has neither requested a hearing nor submitted a written statement in lieu of a hearing. Id. at 2 (citing 21 CFR 1301.43(d)). Accordingly, I find that Registrant has waived her right to a hearing or to submit a written statement and issue this Decision and Order based on relevant evidence submitted by the Government. I make the following findings. Findings of Fact Registrant is a physician who is registered as a practitioner in schedules II–V pursuant to Certificate of Registration BF5029574, at the address of 3312 South I–10 Service Road, Metairie, Louisiana. GX 1, at 1. The registration does not expire until September 30, 2017. Id. On May 6, 2016, the Louisiana State Board of Medical Examiners summarily VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 suspended Registrant’s medical license and stated that the suspension was ‘‘effective immediately.’’ GX 3, at 1. On November 16, 2016, the Louisiana State Board of Pharmacy ‘‘indefinitely suspended’’ Registrant’s controlled substance license ‘‘in accordance with the suspension of her medical license by the Louisiana State Board of Medical Examiners on May 6, 2016.’’ GX 4, at 1. Based on the above, I find that Registrant does not currently have authority under the laws of Louisiana to dispense controlled substances. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of Title 21, ‘‘upon a finding that the registrant . . . has had [her] State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ With respect to a practitioner, DEA has long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (‘‘State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.’’). This rule derives from the text of two provisions of the CSA. First, Congress defined ‘‘the term ‘practitioner’ [to] mean[] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.’’ 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress directed that ‘‘[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which [s]he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever she is no longer authorized to dispense controlled substances under the laws of the State PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 in which she engages in professional practice. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR 27616 (1978). Moreover, because ‘‘the controlling question’’ in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a practitioner’s registration ‘‘is currently authorized to handle controlled substances in the [S]tate,’’ Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner has lost her state authority by virtue of the State’s use of summary process and the State has yet to provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the Louisiana State Board of Medical Examiners has employed summary process in suspending Registrant’s state medical license. What is consequential is that Registrant is no longer currently authorized to dispense controlled substances in Louisiana, the State in which she is registered. I will therefore order that her registration be revoked. Order 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 No. BF5029574, issued to Leia A. Frickey, M.D., be, and it hereby is, revoked. I further order that any pending application of Leia A. Frickey to renew or modify the above registration, or any pending application of Leia A. Frickey for any other registration, be, and it hereby is, denied. This Order is effective immediately. Dated: July 31, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017–16700 Filed 8–7–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI) ACTION: E:\FR\FM\08AUN1.SGM Notice of application. 08AUN1 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 7, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 7, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on March 7, 2017, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic classes of controlled substances: asabaliauskas on DSKBBXCHB2PROD with NOTICES DATES: Controlled substance Oxycodone ............... Hydromorphone ........ Morphine ................... Tapentadol ................ Fentanyl .................... Drug code Schedule 9143 9150 9300 9780 9801 II II II II II The company plans to import small quantities of the listed controlled VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 substances in dosage form to conduct clinical trials. Dated: August 2, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–16699 Filed 8–7–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act On August 1, 2017, the Department of Justice lodged a proposed consent decree with the United States District Court for the Central District of California in the lawsuit entitled United States v. The Bionetics Corporation, Civil Action No. 17–5677. The United States filed this lawsuit under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for the recovery of costs that the United States incurred responding to releases of hazardous substances at certain Installation Restoration Program (IRP) Sites at Vandenberg Air Force Base in Santa Barbara County, California. The consent decree requires the defendant The Bionetics Corporation to pay $219,000 to the United States. In return, the United States agrees not to sue the defendant under sections 106 and 107 of CERCLA at certain IRP Sites at Vandenberg Air Force Base. The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. The Bionetics Corporation, D.J. Ref. No. 90–11–3– 10477/4. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ......... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ–ENRD, P.O. Box 7611, Washington, D.C. 20044–7611. By mail ........... During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site: https:// www.justice.gov/enrd/consent-decrees. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 37115 We will provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ– ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $5.25 (25 cents per page reproduction cost) payable to the United States Treasury. Henry S. Friedman, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2017–16695 Filed 8–7–17; 8:45 am] BILLING CODE P DEPARTMENT OF LABOR Bureau of Labor Statistics Information Collection Activities, Comment Request Bureau of Labor Statistics, Department of Labor. ACTION: Notice of information collection, request for comment. AGENCY: The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed revision of the ‘‘The Consumer Expenditure Surveys: The Quarterly Interview and the Diary.’’ A copy of the proposed information collection request can be obtained by contacting the individual listed below in the ADDRESSES section of this notice. DATES: Written comments must be submitted to the office listed in the ADDRESSES section of this notice on or before October 10, 2017. ADDRESSES: Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by SUMMARY: E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37114-37115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16699]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Almac Clinical 
Services Incorp (ACSI)

ACTION: Notice of application.

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[[Page 37115]]


DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before September 7, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 7, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on March 
7, 2017, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, 
Souderton, Pennsylvania 18964 applied to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Oxycodone.............................       9143  II
Hydromorphone.........................       9150  II
Morphine..............................       9300  II
Tapentadol............................       9780  II
Fentanyl..............................       9801  II
------------------------------------------------------------------------

    The company plans to import small quantities of the listed 
controlled substances in dosage form to conduct clinical trials.

    Dated: August 2, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-16699 Filed 8-7-17; 8:45 am]
 BILLING CODE 4410-09-P