82 FR 37114 - Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 151 (August 8, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37114-37115 | |
| FR Document | 2017-16699 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37114-37115] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16699] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI) ACTION: Notice of application. ----------------------------------------------------------------------- [[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
![37114 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
registration. Id. (citing 21 U.S.C. suspended Registrant’s medical license in which she engages in professional
824(a)(3); 21 CFR 1301.37(b)). and stated that the suspension was practice. See, e.g., Calvin Ramsey, 76 FR
The Show Cause Order notified ‘‘effective immediately.’’ GX 3, at 1. On 20034, 20036 (2011); Sheran Arden
Registrant of her right to request a November 16, 2016, the Louisiana State Yeates, M.D., 71 FR 39130, 39131
hearing on the allegations or to submit Board of Pharmacy ‘‘indefinitely (2006); Dominick A. Ricci, 58 FR 51104,
a written statement in lieu of a hearing, suspended’’ Registrant’s controlled 51105 (1993); Bobby Watts, 53 FR
the procedure for electing either option, substance license ‘‘in accordance with 11919, 11920 (1988); Blanton, 43 FR
and the consequence for failing to elect the suspension of her medical license by 27616 (1978).
either option. Id. (citing 21 CFR the Louisiana State Board of Medical Moreover, because ‘‘the controlling
1301.43). The Show Cause Order also Examiners on May 6, 2016.’’ GX 4, at 1. question’’ in a proceeding brought
notified Registrant of her right to submit Based on the above, I find that under 21 U.S.C. 824(a)(3) is whether the
a corrective action plan. Id. at 2–3 Registrant does not currently have holder of a practitioner’s registration ‘‘is
(citing 21 U.S.C. 824(c)(2)(C)). authority under the laws of Louisiana to currently authorized to handle
The Government states that on March dispense controlled substances. controlled substances in the [S]tate,’’
16, 2017, ‘‘[p]ersonnel from DEA’s New Hooper, 76 FR at 71371 (quoting Anne
Orleans Field Division served the Order Discussion
Lazar Thorn, 62 FR 12847, 12848
on Registrant.’’ Government Request for Pursuant to 21 U.S.C. 824(a)(3), the (1997)), the Agency has also long held
Final Agency Action (RFFA), at 1 (citing Attorney General is authorized to that revocation is warranted even where
Government Exhibit (GX) 5). suspend or revoke a registration issued a practitioner has lost her state authority
Specifically, a DEA Diversion under section 823 of Title 21, ‘‘upon a by virtue of the State’s use of summary
Investigator (DI) and DEA Task Force finding that the registrant . . . has had process and the State has yet to provide
Officer traveled to a medical center in [her] State license . . . suspended [or] a hearing to challenge the suspension.
Louisiana on March 16, 2017, where the revoked . . . by competent State Bourne Pharmacy, 72 FR 18273, 18274
nursing staff escorted them to her room authority and is no longer authorized by (2007); Wingfield Drugs, 52 FR 27070,
where they found the Registrant. GX5, at State law to engage in the . . . 27071 (1987). Thus, it is of no
1. The DI advised Registrant that he had dispensing of controlled substances.’’ consequence that the Louisiana State
a Show Cause Order to serve on her. Id. With respect to a practitioner, DEA has Board of Medical Examiners has
According to the DI’s affidavit, the long held that the possession of employed summary process in
Registrant then responded ‘‘ ‘You will authority to dispense controlled suspending Registrant’s state medical
not take my DEA number’ and she substances under the laws of the State
license. What is consequential is that
refused to take the [Show Cause Order] in which a practitioner engages in
Registrant is no longer currently
document.’’ Id. The DI ‘‘then placed the professional practice is a fundamental
authorized to dispense controlled
[Order] on the night stand next to condition for obtaining and maintaining
substances in Louisiana, the State in
[Registrant’s] bed.’’ Id. a registration. See, e.g., James L. Hooper,
which she is registered. I will therefore
On May 19, 2017, the Government 76 FR 71371 (2011), pet. for rev. denied,
order that her registration be revoked.
forwarded its Request for Final Agency 481 Fed. Appx. 826 (4th Cir. 2012); see
Action and an evidentiary record to my also Frederick Marsh Blanton, 43 FR Order
Office. Therein, the Government 27616 (1978) (‘‘State authorization to Pursuant to the authority vested in me
represents that Registrant has neither dispense or otherwise handle controlled by 21 U.S.C. 823(f) and 824(a), as well
requested a hearing nor ‘‘otherwise substances is a prerequisite to the
as 28 CFR 0.100(b), I order that DEA
corresponded or communicated with issuance and maintenance of a Federal
Certificate of Registration No.
DEA regarding’’ the Show Cause Order. controlled substances registration.’’).
This rule derives from the text of two BF5029574, issued to Leia A. Frickey,
RFFA, at 2. Based on the Government’s M.D., be, and it hereby is, revoked. I
representation and the record, I find that provisions of the CSA. First, Congress
defined ‘‘the term ‘practitioner’ [to] further order that any pending
more than 30 days have passed since the application of Leia A. Frickey to renew
Order to Show Cause was served on mean[] a . . . physician . . . or other
person licensed, registered or otherwise or modify the above registration, or any
Registrant, and she has neither pending application of Leia A. Frickey
requested a hearing nor submitted a permitted, by . . . the jurisdiction in
which he practices . . . to distribute, for any other registration, be, and it
written statement in lieu of a hearing. hereby is, denied. This Order is effective
Id. at 2 (citing 21 CFR 1301.43(d)). dispense, [or] administer . . . a
controlled substance in the course of immediately.
Accordingly, I find that Registrant has
waived her right to a hearing or to professional practice.’’ 21 U.S.C. Dated: July 31, 2017.
submit a written statement and issue 802(21). Second, in setting the Chuck Rosenberg,
this Decision and Order based on requirements for obtaining a Acting Administrator.
relevant evidence submitted by the practitioner’s registration, Congress [FR Doc. 2017–16700 Filed 8–7–17; 8:45 am]
Government. I make the following directed that ‘‘[t]he Attorney General BILLING CODE 4410–09–P
findings. shall register practitioners . . . if the
applicant is authorized to dispense . . .
Findings of Fact controlled substances under the laws of DEPARTMENT OF JUSTICE
Registrant is a physician who is the State in which [s]he practices.’’ 21
asabaliauskas on DSKBBXCHB2PROD with NOTICES
registered as a practitioner in schedules U.S.C. 823(f). Because Congress has Drug Enforcement Administration
II–V pursuant to Certificate of clearly mandated that a practitioner
Registration BF5029574, at the address possess state authority in order to be [Docket No. DEA–392]
of 3312 South I–10 Service Road, deemed a practitioner under the Act,
Metairie, Louisiana. GX 1, at 1. The DEA has held repeatedly that revocation Importer of Controlled Substances
registration does not expire until of a practitioner’s registration is the Application: Almac Clinical Services
September 30, 2017. Id. appropriate sanction whenever she is no Incorp (ACSI)
On May 6, 2016, the Louisiana State longer authorized to dispense controlled
ACTION: Notice of application.
Board of Medical Examiners summarily substances under the laws of the State
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![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37115
DATES: Registered bulk manufacturers of substances in dosage form to conduct We will provide a paper copy of the
the affected basic classes, and clinical trials. consent decree upon written request
applicants therefore, may file written Dated: August 2, 2017. and payment of reproduction costs.
comments on or objections to the Demetra Ashley, Please mail your request and payment
issuance of the proposed registration in Acting Assistant Administrator.
to: Consent Decree Library, U.S. DOJ–
accordance with 21 CFR 1301.34(a) on ENRD, P.O. Box 7611, Washington, DC
[FR Doc. 2017–16699 Filed 8–7–17; 8:45 am]
or before September 7, 2017. Such 20044–7611.
BILLING CODE 4410–09–P
persons may also file a written request Please enclose a check or money order
for a hearing on the application for $5.25 (25 cents per page
pursuant to 21 CFR 1301.43 on or before DEPARTMENT OF JUSTICE reproduction cost) payable to the United
September 7, 2017. States Treasury.
ADDRESSES: Written comments should Notice of Lodging of Proposed Henry S. Friedman,
be sent to: Drug Enforcement Consent Decree Under the Assistant Section Chief, Environmental
Administration, Attention: DEA Federal Comprehensive Environmental Enforcement Section, Environment and
Register Representative/DRW, 8701 Response, Compensation, and Liability Natural Resources Division.
Morrissette Drive, Springfield, Virginia Act [FR Doc. 2017–16695 Filed 8–7–17; 8:45 am]
22152. All requests for hearing must be
On August 1, 2017, the Department of BILLING CODE P
sent to: Drug Enforcement
Justice lodged a proposed consent
Administration, Attn: Administrator,
decree with the United States District
8701 Morrissette Drive, Springfield,
Court for the Central District of DEPARTMENT OF LABOR
Virginia 22152. All request for hearing
California in the lawsuit entitled United
should also be sent to: (1) Drug Bureau of Labor Statistics
States v. The Bionetics Corporation,
Enforcement Administration, Attn:
Civil Action No. 17–5677.
Hearing Clerk/LJ, 8701 Morrissette The United States filed this lawsuit Information Collection Activities,
Drive, Springfield, Virginia 22152; and under the Comprehensive Comment Request
(2) Drug Enforcement Administration, Environmental Response,
Attn: DEA Federal Register AGENCY: Bureau of Labor Statistics,
Compensation, and Liability Act Department of Labor.
Representative/DRW, 8701 Morrissette (CERCLA) for the recovery of costs that
Drive, Springfield, Virginia 22152. ACTION: Notice of information collection,
the United States incurred responding
SUPPLEMENTARY INFORMATION: The to releases of hazardous substances at request for comment.
Attorney General has delegated his certain Installation Restoration Program SUMMARY: The Department of Labor, as
authority under the Controlled (IRP) Sites at Vandenberg Air Force Base part of its continuing effort to reduce
Substances Act to the Administrator of in Santa Barbara County, California. The paperwork and respondent burden,
the Drug Enforcement Administration consent decree requires the defendant conducts a pre-clearance consultation
(DEA), 28 CFR 0.100(b). Authority to The Bionetics Corporation to pay program to provide the general public
exercise all necessary functions with $219,000 to the United States. In return, and Federal agencies with an
respect to the promulgation and the United States agrees not to sue the opportunity to comment on proposed
implementation of 21 CFR part 1301, defendant under sections 106 and 107 of and/or continuing collections of
incident to the registration of CERCLA at certain IRP Sites at information in accordance with the
manufacturers, distributors, dispensers, Vandenberg Air Force Base. Paperwork Reduction Act of 1995. This
importers, and exporters of controlled The publication of this notice opens program helps to ensure that requested
substances (other than final orders in a period for public comment on the data can be provided in the desired
connection with suspension, denial, or consent decree. Comments should be format, reporting burden (time and
revocation of registration) has been addressed to the Assistant Attorney financial resources) is minimized,
redelegated to the Assistant General, Environment and Natural collection instruments are clearly
Administrator of the DEA Diversion Resources Division, and should refer to understood, and the impact of collection
Control Division (‘‘Assistant United States v. The Bionetics requirements on respondents can be
Administrator’’) pursuant to section 7 of Corporation, D.J. Ref. No. 90–11–3– properly assessed. The Bureau of Labor
28 CFR part 0, appendix to subpart R. 10477/4. All comments must be
In accordance with 21 CFR Statistics (BLS) is soliciting comments
submitted no later than thirty (30) days concerning the proposed revision of the
1301.34(a), this is notice that on March after the publication date of this notice.
7, 2017, Almac Clinical Services Incorp ‘‘The Consumer Expenditure Surveys:
Comments may be submitted either by The Quarterly Interview and the Diary.’’
(ACSI), 25 Fretz Road, Souderton, email or by mail:
Pennsylvania 18964 applied to be A copy of the proposed information
registered as an importer of the collection request can be obtained by
To submit Send them to: contacting the individual listed below
following basic classes of controlled comments:
substances: in the ADDRESSES section of this notice.
By email ......... pubcomment-ees.enrd@ DATES: Written comments must be
usdoj.gov. submitted to the office listed in the
Drug
Controlled substance Schedule By mail ........... Assistant Attorney General,
code ADDRESSES section of this notice on or
asabaliauskas on DSKBBXCHB2PROD with NOTICES
U.S. DOJ–ENRD, P.O.
Box 7611, Washington, before October 10, 2017.
Oxycodone ............... 9143 II
Hydromorphone ........ 9150 II D.C. 20044–7611. ADDRESSES: Send comments to Nora
Morphine ................... 9300 II Kincaid, BLS Clearance Officer,
Tapentadol ................ 9780 II During the public comment period, Division of Management Systems,
Fentanyl .................... 9801 II the consent decree may be examined Bureau of Labor Statistics, Room 4080,
and downloaded at this Justice 2 Massachusetts Avenue NE.,
The company plans to import small Department Web site: https:// Washington, DC 20212. Written
quantities of the listed controlled www.justice.gov/enrd/consent-decrees. comments also may be transmitted by
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37265/page/2.svg)
Document Created: 2017-08-08 00:17:43
Document Modified: 2017-08-08 00:17:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| 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. | |
| FR Citation | 82 FR 37114 |
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