81 FR 61248 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 172 (September 6, 2016)

Page Range		61248-61249
FR Document		2016-21240

Federal Register, Volume 81 Issue 172 (Tuesday, September 6, 2016)

[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61248-61249]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21240]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fisher Clinical 
Services, Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefor, may file written

[[Page 61249]]

comments on or objections to the issuance of the proposed registration 
in accordance with 21 CFR 1301.34(a) on or before October 6, 2016. Such 
persons may also file a written request for a hearing on the 
application pursuant to 21 CFR 1301.43 on or before October 6, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 
requests 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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated her 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 
Deputy Assistant Administrator of the DEA Office of Diversion Control 
(``Deputy 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 June 
17, 2016, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, 
Pennsylvania 18106 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Levorphanol (9220).........................  II
Noroxymorphone (9668)......................  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import the listed substances for analytical 
research, testing, and clinical trials. This authorization does not 
extend to the import of finished FDA approved or non-approved dosage 
form for commercial distribution in the United States.
    The company plans to import an intermediate form of tapentadol 
(9780) to bulk manufacture tapentadol for distribution to its 
customers. Placement of this drug code onto the company's registration 
does not translate into automatic approval of subsequent permit 
applications to import controlled substances. Approval of permit 
applications will occur only when the registrant's business activity is 
consistent with what is authorized under to 21 U.S.C. 952(a)(2). 
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-21240 Filed 9-2-16; 8:45 am]
 BILLING CODE 4410-09-P

61248 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices

450 Fifth Street NW., Suite 7100 of this business to the number three management business and not solely to
Washington, DC 20530 company in the industry makes no Access. In this way fair and open
Telephone: (202) 598–2436 sense at all. Instead of forcing this competition for the business of any Split
Facsimile: (202) 514–9033 divestiture to a huge and growing Multi-City Customer would occur
Email: soyoung.choe@usdoj.gov company, the Department of Justice allowing either Access or any other
Certificate of Service should just simply allow those service provider to win the business.
customers affected by the merger out of The substantial benefit to any Split
I hereby certify that on this 29th day their contracts, without penalty, should Multi-City Customer is obvious. To
of August, 2016, the foregoing Notice of they chose to do so. Then those restrict the discretion of these Split
Extension of Time was filed using the customers could pick their service Multi-City Customers so that they have
Court’s CM/ECF system, which shall provider by price and service and not be to do business with Access is unfair and
send notice to all counsel of record. forced with the unhappy choice of inequitable. Also the qualification to the
lllll/s/lllll staying with company two or going to definition of Split Multi-City Customer
Soyoung Choe company three. Customers are much further has anti-competitive affects and
U.S. Department of Justice, Antitrust better served with choices. The restricts open and fair competition.
Division foundation of our pro-competition It is our sincere hope that the
Networks & Technology Enforcement philosophy is choice. The Department acquisition of Recall by Iron Mountain
Section of Justice should not engineer a not go forward. If it were to go forward
450 Fifth Street NW., Suite 7100 Proposed Final Judgment that serves to then Recall customers in the affected
Washington, DC 20530 limit customer choices. markets should be free (without penalty)
Telephone: (202) 598–2436 It is our further position that the to choose any new service provider.
Facsimile: (202) 514–9033 Proposed Final Judgment requires Should the Department of Justice move
Email: soyoung.choe@usdoj.gov changes, at a minimum, to make it more forward with this Proposed Final
May 31, 2016 equitable and to address our anti- Judgment, NRC strongly encourages the
Via Federal Express competitive concerns. Department of Justice to modify the
United States Department of Justice First, we see no reason why any proposed Final Judgment in two ways.
450 Fifth Street customer of Recall (not just a ‘‘Split-City First, to delete the qualification to the
Suite 7100 Customer’’) should not have the right to definition of Split Multi-City Customer
Washington, DC 20530 terminate its contract with Recall and second, to modify Provision IV
Attn: Maribeth Petrizzi without penalty. This is fair and Subsection J to enlarge the period from
Chief Litigation II Section reasonable. one (1) year to three (3) years and to
Antitrust Division Second, the definition for ‘‘Split allow any Split Multi-City Customer to
Multi-City Customer’’ is overly
Dear Sirs/Madam: terminate or otherwise modify its
restrictive. The definition used in the
Please accept these public comments contract with Recall so as to enable the
Proposed Final Judgment contains the
from Robert S. Moran, Jr., the Split Multi-City Customer to transfer its
qualification that ‘‘a Split Multi-City
undersigned, a partner of the law firm records without penalty or delay to any
Customer does not include a Recall
of McBreen & Kopko in connection with records storage provider and not only to
customer that has separate contracts for
the pending matter captioned United Access.
each Recall facility in which it stores The foregoing is submitted
States vs. Iron Mountain Inc. (‘‘Iron records’’. It is our belief that this
Mountain’’) and Recall Holdings Ltd. respectfully and in the interest of fair
qualifying statement should be deleted
(‘‘Recall’’); Proposed Final Judgment and open competition to enhance the
from the Split Multi-City Customer
and Competitive Impact Statement Civil opportunity for any records storage
definition.
Action No. 1–16–cv–00595. Please be In the Proposed Final Judgment company to obtain the business that is
advised that the undersigned represents Section IV ‘‘Divestitures’’, subparagraph being divested as part of this proposed
National Records Centers, Inc. (‘‘NRC’’) J it is provided that for a period of one Final Judgment.
a nationwide provider of records Thank you.
( 1) year from the date of the sale of any
management services (‘‘RMS’’) Divestiture Assets to an Acquirer, Very truly yours,
throughout the United States. NRC defendant shall allow any Split Multi- /s/ lllllllllllllllll
competes directly with Iron Mountain, City Customer to terminate or otherwise Robert S. Moran, Jr.
Recall and Access CIG, LLC (‘‘Access’’) modify its contract with Recall so as to RSM:km
in many markets. enable the Split Multi-City Customer to [FR Doc. 2016–21287 Filed 9–2–16; 8:45 am]
It is our position that the proposed transfer some or all of its records to that BILLING CODE P
acquisition will have an anticompetitive Acquirer without penalty or delay and
effect and a detrimental impact on the shall not enforce any contractual
customers of Iron Mountain, Recall and provision providing for permanent DEPARTMENT OF JUSTICE
Access throughout the United States. withdrawal fees, retrieval fees, or other
NRC urges the Department of Justice to fees associated with transferring such Drug Enforcement Administration
completely re-think the Iron Mountain/ customers’ records from a Recall
[Docket No. DEA–392]
Recall merger in its totality. Combining Management Facility to a facility
the number one company in the operated by Acquirer’’. Importer of Controlled Substances
industry with the number two company We see no reason why provision J
mstockstill on DSK3G9T082PROD with NOTICES

Application: Fisher Clinical Services,
is unfair and anticompetitive by its very does not allow that any Split Multi-City Inc.
nature. Approving such an Customer can have the discretion to
anticompetitive combination of terminate or otherwise modify its ACTION: Notice of application.
businesses by merely causing business contract with Recall so as to enable the
number two to shed some of its business Split Multi-City Customer to transfer DATES: Registered bulk manufacturers of
is clearly not enough to result in open some or all of its records to any other the affected basic classes, and
and fair competition. Forcing divestiture person or entity engaged in the records applicants therefor, may file written

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Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61249

comments on or objections to the commercial distribution in the United Administrator’’) pursuant to section 7 of
issuance of the proposed registration in States. 28 CFR part 0, appendix to subpart R.
accordance with 21 CFR 1301.34(a) on The company plans to import an In accordance with 21 CFR
or before October 6, 2016. Such persons intermediate form of tapentadol (9780) 1301.33(a), this is notice that on May 18,
may also file a written request for a to bulk manufacture tapentadol for 2016, Cody Laboratories, Inc., 601
hearing on the application pursuant to distribution to its customers. Placement Yellowstone Avenue, Cody, Wyoming
21 CFR 1301.43 on or before October 6, of this drug code onto the company’s 82414 applied to be registered as a bulk
2016. registration does not translate into manufacturer of the following basic
ADDRESSES: Written comments should automatic approval of subsequent classes of controlled substances:
be sent to: Drug Enforcement permit applications to import controlled
substances. Approval of permit Controlled substance Schedule
Administration, Attention: DEA Federal
Register Representative/ODW, 8701 applications will occur only when the
Dihydromorphine (9145) ............... I
Morrissette Drive, Springfield, Virginia registrant’s business activity is
Amphetamine (1100) .................... II
22152. All requests for hearing must be consistent with what is authorized Methamphetamine (1105) ............ II
sent to: Drug Enforcement under to 21 U.S.C. 952(a)(2). Lisdexamfetamine (1205) ............. II
Administration, Attn: Administrator, Authorization will not extend to the Methylphenidate (1724) ................ II
8701 Morrissette Drive, Springfield, import of FDA approved or non- Amobarbital (2125) ....................... II
Virginia 22152. All requests for hearing approved finished dosage forms for Pentobarbital (2270) ..................... II
commercial sale. Secobarbital (2315) ...................... II
should also be sent to: (1) Drug
4-Anilino-N-phenethyl-4-piperidine II
Enforcement Administration, Attn: Louis J. Milione, (ANPP) (8333).
Hearing Clerk/LJ, 8701 Morrissette Deputy Assistant Administrator. Cocaine (9041) ............................. II
Drive, Springfield, Virginia 22152; and [FR Doc. 2016–21240 Filed 9–2–16; 8:45 am] Codeine (9050) ............................. II
(2) Drug Enforcement Administration, Dihydrocodeine (9120) ................. II
BILLING CODE 4410–09–P
Attn: DEA Federal Register Oxycodone (9143) ........................ II
Representative/ODW, 8701 Morrissette Hydromorphone (9150) ................ II
Drive, Springfield, Virginia 22152. Diphenoxylate (9170) ................... II
DEPARTMENT OF JUSTICE Ecgonine (9180) ........................... II
SUPPLEMENTARY INFORMATION: Hydrocodone (9193) ..................... II
The Attorney General has delegated Drug Enforcement Administration Meperidine (9230) ........................ II
her authority under the Controlled [Docket No. DEA–392] Methadone (9250) ........................ II
Substances Act to the Administrator of Methadone intermediate (9254) ... II
the Drug Enforcement Administration Morphine (9300) ........................... II
Bulk Manufacturer of Controlled
(DEA), 28 CFR 0.100(b). Authority to Thebaine (9333) ........................... II
Substances Application: Cody Oxymorphone (9652) ................... II
exercise all necessary functions with Laboratories, Inc. Alfentanil (9737) ........................... II
respect to the promulgation and Remifentanil (9739) ...................... II
implementation of 21 CFR part 1301, ACTION: Notice of application. Sufentanil (9740) .......................... II
incident to the registration of Tapentadol (9780) ........................ II
manufacturers, distributors, dispensers, DATES: Registered bulk manufacturers of Fentanyl (9801) ............................ II
importers, and exporters of controlled the affected basic classes, and
substances (other than final orders in applicants therefore, may file written The company plans to manufacture
connection with suspension, denial, or comments on or objections to the the listed controlled substances in bulk
revocation of registration) has been issuance of the proposed registration in for distribution to its customers.
redelegated to the Deputy Assistant accordance with 21 CFR 1301.33(a) on
Louis J. Milione,
Administrator of the DEA Office of or before November 7, 2016.
Deputy Assistant Administrator.
Diversion Control (‘‘Deputy Assistant ADDRESSES: Written comments should
Administrator’’) pursuant to section 7 of [FR Doc. 2016–21238 Filed 9–2–16; 8:45 am]
be sent to: Drug Enforcement
28 CFR part 0, appendix to subpart R. Administration, Attention: DEA Federal BILLING CODE 4410–09–P

In accordance with 21 CFR Register Representative/ODW, 8701
1301.34(a), this is notice that on June Morrissette Drive, Springfield, Virginia
DEPARTMENT OF JUSTICE
17, 2016, Fisher Clinical Services, Inc., 22152.
7554 Schantz Road, Allentown, SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration
Pennsylvania 18106 applied to be Attorney General has delegated her
registered as an importer of the [Docket No. DEA–392]
authority under the Controlled
following basic classes of controlled Substances Act to the Administrator of
substances: Bulk Manufacturer of Controlled
the Drug Enforcement Administration Substances Application: Isosciences
(DEA), 28 CFR 0.100(b). Authority to
Controlled substance Schedule
exercise all necessary functions with ACTION: Notice of application.
Methylphenidate (1724) ................ II respect to the promulgation and
Levorphanol (9220) ...................... II implementation of 21 CFR part 1301, DATES: Registered bulk manufacturers of
Noroxymorphone (9668) .............. II incident to the registration of the affected basic classes, and
Tapentadol (9780) ........................ II manufacturers, distributors, dispensers, applicants therefore, may file written
mstockstill on DSK3G9T082PROD with NOTICES

importers, and exporters of controlled comments on or objections to the
The company plans to import the substances (other than final orders in issuance of the proposed registration in
listed substances for analytical research, connection with suspension, denial, or accordance with 21 CFR 1301.33(a) on
testing, and clinical trials. This revocation of registration) has been or before November 7, 2016.
authorization does not extend to the redelegated to the Deputy Assistant ADDRESSES: Written comments should
import of finished FDA approved or Administrator of the DEA Office of be sent to: Drug Enforcement
non-approved dosage form for Diversion Control (‘‘Deputy Assistant Administration, Attention: DEA Federal

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Document Created: 2018-02-09 12:04:00
Document Modified: 2018-02-09 12:04:00

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 therefor, 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 October 6, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 6, 2016.
FR Citation		81 FR 61248

81 FR 61248 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 172 (September 6, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration