Importer of Controlled Substances Application: Mylan Technologies, Inc., 65609-65610 [2022-23613]

Download as PDF 65609 Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1068] Importer of Controlled Substances Application: Curia New York, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Curia New York, 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 SUMMARY: on or before November 30, 2022. Such persons may also file a written request for a hearing on the application on or before November 30, 2022. ADDRESSES: The Drug Enforcement Administration 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. In accordance with 21 CFR 1301.34(a), this is notice that on July 18, 2022, Curia New York, Inc., 33 Riverside Avenue, Rensselaer, New York 12144–2951, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance ANPP (4-Anilino-N-phenethyl-4-piperidine) ........................................................................................................................... Poppy Straw Concentrate ..................................................................................................................................................... The company plans to import the listed controlled substances to manufacture bulk controlled substances for distribution to its customers. No other 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. Kristi O’Malley, Assistant Administrator. [FR Doc. 2022–23612 Filed 10–28–22; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1108] khammond on DSKJM1Z7X2PROD with NOTICES Importer of Controlled Substances Application: Mylan Technologies, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Mylan Technologies, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY SUMMARY: VerDate Sep<11>2014 17:15 Oct 28, 2022 Jkt 259001 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 November 30, 2022. Such persons may also file a written request for a hearing on the application on or before November 30, 2022. ADDRESSES: The Drug Enforcement Administration 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Schedule 8333 9670 II II 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 October 4, 2022, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478–2266, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Methylphenidate ........... Fentanyl ........................ I 1724 9801 Schedule I II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. No other 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). E:\FR\FM\31OCN1.SGM 31OCN1 65610 Federal Register / Vol. 87, No. 209 / Monday, October 31, 2022 / Notices Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Kristi O’Malley, Assistant Administrator. [FR Doc. 2022–23613 Filed 10–28–22; 8:45 am] BILLING CODE P Overview of This Information Collection DEPARTMENT OF JUSTICE [OMB Number 1121–XXXX] Agency Information Collection Activities; Proposed eCollection; eComments Requested; Existing Collection in Use Without an OMB Control Number: AVUE Digital Services—Electronic Applications Office of Justice Programs, Department of Justice. ACTION: 30 Day notice. AGENCY: The Office of Justice Programs, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: The Department of Justice encourages public comment and will accept input until November 30, 2022. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. 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 Office of Justice Progrms, 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 to be collected can be enhanced; and khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 • 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. 17:15 Oct 28, 2022 Jkt 259001 1. Type of Information Collection: Existing collection in use without an OMB Control Number. 2. The Title of the Form/Collection: The Avue Digital Services application for federal employment. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: NA. Sponsor: The Office of Justice Programs, Department of Justice. 4. Affected public who will be asked or required to respond, as well as a brief abstract: The primary respondents are public citizens who are applying for OJP federal positions. Avue is a web-based application system that provides automated support for posting federal vacancies. The applicants use the system to submit electronic applications for job vacancies. Candidates enter pertinent information and responds to a series of electronic screens and experience statements. The data is then certified and submitted for OJP HR Specialists to review and certify the applications. The candidate is automatically notified by email that his/ her application has been received when he/she certifies and submits his/her electronic application and provided other status updates throughout the hiring cycle. 5. An Estimate of the Total Number of Respondents and the Amount of Time Estimated for an Average Respondent to Respond: In calendar year 2021, there were 1,707 applications submitted for jobs at OJP. A sampling of applicants who started and completed their OJP applications on the same day in 2021 was 740 applicants and using this sample, the system reported a total of 56,832 minutes for those 740 applications, or an average of 76.8 minutes (76 minutes, 48 seconds) spent on each application. 6. An Estimate of the Total Public Burden (in hours) Associated with the collection: The estimated public burden associated with this application is 949 hours in calendar year 2021. This is based on 740 applicants spending 77 (rounded up) minutes on each application for a total of 56,980 minutes. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 If additional information is required contact: Robert Houser, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, Suite 3E.206, Washington, DC 20530. Dated: October 25, 2022 Robert Houser, Department Clearance Officer, Policy and Planning Staff, Office of the Chief Information Officer, U.S. Department of Justice. [FR Doc. 2022–23592 Filed 10–28–22; 8:45 am] BILLING CODE 4410–18–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act On October 24, 2022, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Indiana in the lawsuit entitled United States and State of Indiana v. Flexsteel Industries, Inc., Civil Action No. 3:22– cv–00893 [Docket No. 2]. The proposed Consent Decree resolves the alleged liability of Flexsteel Industries, Inc. (‘‘Flexsteel’’) at the Lane Street Ground Water Contamination Superfund Site in Elkhart, Indiana (the ‘‘Site’’) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9606, 9607, and 9613, and Ind. Code §§ 13–25–4–9, 13– 25–4–10, and 13–25–4–8, asserted in the Complaint, for payment by Flexsteel of $9.8 million. In return, the United States and State of Indiana agree not to sue Flexsteel under sections 106 and 107 of CERCLA or Ind. Code §§ 13–25–4–8 through IC 13–25–4–10 with respect to the Site. The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States and State of Indiana v. Flexsteel Industries, Inc, D.J. Ref. No. 90–11–3–11767. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. E:\FR\FM\31OCN1.SGM 31OCN1

Agencies

[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65609-65610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23613]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1108]


Importer of Controlled Substances Application: Mylan 
Technologies, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Mylan Technologies, 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 
November 30, 2022. Such persons may also file a written request for a 
hearing on the application on or before November 30, 2022.

ADDRESSES: The Drug Enforcement Administration 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 October 4, 2022, Mylan Technologies, Inc., 110 Lake 
Street, Saint Albans, Vermont 05478-2266, applied to be registered as 
an importer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate........................     1724  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically manufactured FDF. This analysis is required 
to allow the company to export domestically manufactured FDF to foreign 
markets. No other 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).

[[Page 65610]]

    Authorization will not extend to the import of Food and Drug 
Administration-approved or non-approved finished dosage forms for 
commercial sale.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23613 Filed 10-28-22; 8:45 am]
BILLING CODE P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.