Importer of Controlled Substances Application: ANI Pharmaceuticals Inc., 12982 [2022-04803]

Download as PDF 12982 Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–04806 Filed 3–7–22; 8:45 am] BILLING CODE P Drug Enforcement Administration Psilocybin ..................... Levorphanol .................. [Docket No. DEA–961] Importer of Controlled Substances Application: ANI Pharmaceuticals Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: ANI Pharmaceuticals Inc. has applied to be registered as an importer 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 submit electronic comments on or objections to the issuance of the proposed registration on or before April 7, 2022. Such persons may also file a written request for a hearing on the application on or before April 7, 2022. ADDRESSES: The DEA requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: 20:36 Mar 07, 2022 Drug code Controlled substance DEPARTMENT OF JUSTICE VerDate Sep<11>2014 Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on January 6, 2022, ANI Pharmaceuticals Inc., 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Jkt 256001 I 7437 9220 Schedule I I II The substance Levorphanol (9220) will be used to manufacture the Food and Drug Administration-approved dosage forms for distribution in the United States. The substance Psilocybin (7437) will be used to support formulation development and clinical trial research. No other activity for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food Drug Administrationapproved or non-approved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–04803 Filed 3–7–22; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [OMB Number 1117–0006] Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Individual Manufacturing Quota for a Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine; DEA Form 189 Drug Enforcement Administration, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice, Drug Enforcement Administration (DEA), will be submitting the following information collection request to the SUMMARY: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995. This information collection is also associated with the proposed rulemaking ‘‘Management of Quotas for Controlled Substances and List I Chemicals.’’ It is likely that the final rule will not be published before this information collection expires on June 30, 2022. If the final rule does publish prior to the expiration, it will be published as the 30-Day Notice. DATES: Comments are encouraged and will be accepted for 60 days until May 9, 2022. FOR FURTHER INFORMATION CONTACT: If you have comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Scott A. Brinks, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776–2265. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information proposed to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection 1. Type of Information Collection: Extension of a currently approved collection. E:\FR\FM\08MRN1.SGM 08MRN1

Agencies

[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Page 12982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04803]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-961]

Importer of Controlled Substances Application: ANI
Pharmaceuticals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: ANI Pharmaceuticals Inc. has applied to be registered as an
importer 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
April 7, 2022. Such persons may also file a written request for a
hearing on the application on or before April 7, 2022.

ADDRESSES: The DEA requires that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides
the ability to type short comments directly into the comment field on
the web page or attach a file for lengthier comments. Please go to
https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon submission of your comment, you will
receive a Comment Tracking Number. Please be aware that submitted
comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
your comment has been successfully submitted and there is no need to
resubmit the same comment. All requests for a hearing must be sent to:
(1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests
for a hearing should also be sent to: Drug Enforcement Administration,
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia
22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 6, 2022, ANI Pharmaceuticals Inc., 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
Levorphanol............................ 9220 II
------------------------------------------------------------------------

The substance Levorphanol (9220) will be used to manufacture the
Food and Drug Administration-approved dosage forms for distribution in
the United States. The substance Psilocybin (7437) will be used to
support formulation development and clinical trial research. No other
activity for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2).
Authorization will not extend to the import of Food Drug
Administration-approved or non-approved finished dosage forms for
commercial sale.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04803 Filed 3-7-22; 8:45 am]
BILLING CODE P

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