Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 4955 [2022-01815]

Download as PDF Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. CRT 142] [Docket No. DEA–933] Bulk Manufacturer of Controlled Substances Application: Navinta LLC Drug Enforcement Administration, Justice. AGENCY: ACTION: Navinta LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary 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 April 1, 2022. Such persons may also file a written request for a hearing on the application on or before April 1, 2022. 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 October 18, 2021, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code khammond on DSKJM1Z7X2PROD with NOTICES 4-Anilino-N-phenethyl-4-piperidine (ANPP). Levomethorphan ..................... Levorphanol ............................ Noroxymorphone .................... Fentanyl .................................. Schedule 8333 II 9210 9220 9739 9801 II II II II The company plans to bulk manufacture active pharmaceutical ingredients (API) quantities of the listed controlled subsances for validation purpose and the Food and Drug Adminstration approval. No other activities for these drug codes are authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2022–01815 Filed 1–28–22; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:38 Jan 28, 2022 Civil Rights Division, Department of Justice. ACTION: Notice. AGENCY: This notice announces the availability on the Department of Justice’s website of an updated report regarding the legal and evidentiary frameworks that justify the continued use of race or sex, in appropriate circumstances, by federal agencies to remedy the current and lingering effects of past discrimination in federal contracting programs. FOR FURTHER INFORMATION CONTACT: Andrew Braniff, Deputy Section Chief, Employment Litigation Section, Civil Rights Division, Department of Justice, (202) 514–3831, EMP.Lit@crt.usdoj.gov. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1–800–877–8339. SUPPLEMENTARY INFORMATION: A substantial body of evidence, both quantitative and qualitative, demonstrates the continued pervasiveness of discriminatory barriers that impede the full and fair participation of businesses owned by women and people of color in government contracting. The nature and breadth of the evidence discussed in the report updates and expands on prior reports—in 1996 and 2010—and supports the compelling interest in the continued use of federal programs that contain remedial measures to eliminate discriminatory barriers to contracting opportunities for businesses owned by women and people of color. See Adarand v. Constructors, Inc. v. Pena, 515 U.S. 200 (1995). Section I of the report provides an overview of the legal landscape surrounding constitutional challenges to the use of race and sex in contracting programs that are subject to strict and intermediate scrutiny, including a discussion of some recent cases challenging various federal and state contracting programs. Section II reviews a substantial body of statistical evidence published in the last decade, which demonstrates the existence of significant disparities in the amount of public contracting dollars going to businesses owned by women and people of color as compared to their availability for such contracts. Section III explores the various ways that discriminatory SUMMARY: Notice of application. Controlled substance Notice of Report on Lawful Uses of Race or Sex in Federal Contracting Programs Jkt 256001 PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 4955 barriers can limit access to contracting markets, resulting in the statistical disparities identified in Section II. These include race and sex discrimination by procurement agencies and prime contractors, whether overt or subtle; exclusion from business networks crucial to making the connections necessary to learn about and compete effectively for contracting opportunities; and discrimination by bonding companies and suppliers. Section IV discusses stark disparities in the formation and success of businesses owned by women and people of color as compared to other businesses. Section V addresses discriminatory barriers that impose significant burdens on businesses owned by women and people of color—affecting both their ability to access capital to form and grow businesses in the first instance as well as their ability to compete effectively for contracts. Finally, Section VI addresses how the economic downturn that began in 2020 as a result of the COVID–19 pandemic has disproportionately affected businesses owned by women and people of color. Evidence discussed in the report is listed in the three appendices. Appendix A identifies congressional hearings from 2010 to 2021 that address challenges facing business owned by women and people of color. Appendix B identifies dozens of disparity studies published between 2010 and 2021. Appendix C identifies additional studies and documentation pertaining to the issues discussed in the report. The report is available on the Department of Justice’s website at: https://www.justice.gov/crt/page/file/ 1463921/download. Dated: January 20, 2022. Johnathan Smith, Deputy Assistant Attorney General, Civil Rights Division. [FR Doc. 2022–01478 Filed 1–28–22; 8:45 am] BILLING CODE 4410–13–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA–2021–0010] Federal Advisory Council on Occupational Safety and Health Occupational Safety and Health Administration (OSHA), Labor. ACTION: Extension of Comment Period. AGENCY: The Secretary of Labor (Secretary) invites interested parties to submit nominations for individuals to SUMMARY: E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01815]



[[Page 4955]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-933]


Bulk Manufacturer of Controlled Substances Application: Navinta 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Navinta LLC, has applied to be registered as a bulk 
manufacturer of basic class(es) of controlled substance(s). Refer to 
Supplementary 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 April 1, 2022. 
Such persons may also file a written request for a hearing on the 
application on or before April 1, 2022.

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 October 18, 2021, Navinta LLC, 1499 Lower Ferry Road, 
Ewing, New Jersey 08618-1414, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                            Drug
          Controlled substance              code          Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine           8333  II
 (ANPP).
Levomethorphan..........................     9210  II
Levorphanol.............................     9220  II
Noroxymorphone..........................     9739  II
Fentanyl................................     9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture active pharmaceutical 
ingredients (API) quantities of the listed controlled subsances for 
validation purpose and the Food and Drug Adminstration approval. No 
other activities for these drug codes are authorized for this 
registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01815 Filed 1-28-22; 8:45 am]
BILLING CODE P
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