Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc., 42902 [2021-16690]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 42902 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices Final Judgment are] so inconsonant with the allegations charged as to fall outside of the ‘reaches of the public interest.’’’ Microsoft, 56 F.3d at 1461 (quoting W. Elec. Co., 900 F.2d at 309). Moreover, the Court’s role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its complaint, and does not authorize the Court to ‘‘construct [its] own hypothetical case and then evaluate the decree against that case.’’ Microsoft, 56 F.3d at 1459; see also U.S. Airways, 38 F. Supp. 3d at 75 (noting that the court must simply determine whether there is a factual foundation for the government’s decisions such that its conclusions regarding the proposed settlements are reasonable); InBev, 2009 U.S. Dist. LEXIS 84787, at *20 (‘‘[T]he ‘public interest’ is not to be measured by comparing the violations alleged in the complaint against those the court believes could have, or even should have, been alleged’’). Because the ‘‘court’s authority to review the decree depends entirely on the government’s exercising its prosecutorial discretion by bringing a case in the first place,’’ it follows that ‘‘the court is only authorized to review the decree itself,’’ and not to ‘‘effectively redraft the complaint’’ to inquire into other matters that the United States did not pursue. Microsoft, 56 F.3d at 1459–60. In its 2004 amendments to the APPA, Congress made clear its intent to preserve the practical benefits of using judgments proposed by the United States in antitrust enforcement, Public Law 108–237 § 221, and added the unambiguous instruction that ‘‘[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.’’ 15 U.S.C. 16(e)(2); see also U.S. Airways, 38 F. Supp. 3d at 76 (indicating that a court is not required to hold an evidentiary hearing or to permit intervenors as part of its review under the Tunney Act). This language explicitly wrote into the statute what Congress intended when it first enacted the Tunney Act in 1974. As Senator Tunney explained: ‘‘[t]he court is nowhere compelled to go to trial or to engage in extended proceedings which might have the effect of vitiating the benefits of prompt and less costly settlement through the consent decree process.’’ 119 Cong. Rec. 24,598 (1973) (statement of Sen. Tunney). ‘‘A court can make its public interest determination based on the competitive impact statement and response to public comments alone.’’ U.S. Airways, 38 F. VerDate Sep<11>2014 17:07 Aug 04, 2021 Jkt 253001 Supp. 3d at 76 (citing Enova Corp., 107 F. Supp. 2d at 17). XVI. Determinative Documents There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment. Dated: July 28, 2021. Respectfully submitted, lllllllllllllllllllll Brendan Sepulveda (D.C. Bar #1025074), United States Department of Justice, Antitrust Division, 450 Fifth Street NW, Suite 7000, Washington, DC 20530, Telephone: (202) 316–7258, Facsimile: (202) 514–6381, Email: brendan.sepulveda@usdoj.gov. Controlled substance Oxymorphone .................. Noroxymorphone ............. I Drug code Schedule 9652 9668 II II I The company plans to manufacture the above listed controlled substances in bulk for distribution to its customers. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2021–16690 Filed 8–4–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [FR Doc. 2021–16682 Filed 8–4–21; 8:45 am] Foreign Claims Settlement Commission BILLING CODE 4410–11–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [F.C.S.C. Meeting and Hearing Notice No. 03–21] Sunshine Act Meeting [Docket No. DEA–876] Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc. Drug Enforcement Administration, Justice. AGENCY: ACTION: Notice of application. Cambrex High Point, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. SUMMARY: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 4, 2021. Such persons may also file a written request for a hearing on the application on or before October 4, 2021 DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on July 9, 2021, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265–8017, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows: TIME AND DATE: Tuesday, August 17, 2021, at 10:00 a.m. PLACE: This meeting will be held by teleconference. There will be no physical meeting place. STATUS: Open. Members of the public who wish to observe the meeting via teleconference should contact Patricia M. Hall, Foreign Claims Settlement Commission, Tele: (202) 616–6975, two business days in advance of the meeting. Individuals will be given callin information upon notice of attendance to the Commission. MATTERS TO BE CONSIDERED: 10:00 a.m.— Issuance of Proposed Decisions under the Guam World War II Loyalty Recognition Act, Title XVII, Public Law 114–328. CONTACT PERSON FOR MORE INFORMATION: Requests for information, advance notices of intention to observe an open meeting, and requests for teleconference dial-in information may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 441 G St NW, Room 6234, Washington, DC 20579. Telephone: (202) 616–6975. Jeremy R. LaFrancois, Chief Administrative Counsel. [FR Doc. 2021–16859 Filed 8–3–21; 4:15 pm] BILLING CODE 4410–BA–P E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16690]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-876]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
High Point, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Cambrex High Point, Inc., has applied to be registered as a 
bulk manufacturer of basic class(es) of controlled substance(s). Refer 
to Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before October 4, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before October 4, 2021

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

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on July 9, 2021, Cambrex High Point, Inc., 4180 
Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied 
to be registered as a bulk manufacturer of the following basic 
class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Oxymorphone.............................    9652  II
Noroxymorphone..........................    9668  II
------------------------------------------------------------------------

    The company plans to manufacture the above listed controlled 
substances in bulk for distribution to its customers. No other 
activities for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-16690 Filed 8-4-21; 8:45 am]
BILLING CODE P
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