Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 26070-26071 [2021-09988]

Download as PDF 26070 Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed collection OMB 1140– 0072 (Explosives Employee Possessor Questionnaire—ATF Form 5400.28) is being revised to include additional questions, and a new format and layout to improve user experience. This collection is also being published to obtain comments from the public and affected agencies. DATES: Comments are encouraged and will be accepted for 60 days until July 12, 2021. FOR FURTHER INFORMATION CONTACT: If you have additional comments, regarding 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: Shawn Stevens, Federal Explosives Licensing Center either by mail at 44 Needy Road, Martinsburg, WV 25405, by email at Shawn.Stevens@atf.gov, or by telephone at 304–616–4400. 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 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 (check justification or form 83): Revision of a currently approved collection. 2. The Title of the Form/Collection: Explosives Employee Possessor Questionnaire. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form number (if applicable): ATF Form 5400.28. Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Other (if applicable): Business or other for-profit. Abstract: The Explosives Employee Possessor Questionnaire—ATF Form 5400.28 will be used to determine if an individual is qualified to serve as an employee possessor, who can ship, transport, receive, and/or possess materials for an explosives business or operation. 5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 10,000 respondents will use the form annually, and it will take each respondent approximately 20 minutes to complete their responses. 6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 3,334 hours, which is equal to 10,000 (# of respondents) * .3333 (20 minutes). If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530. Dated: May 7, 2021. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2021–10005 Filed 5–11–21; 8:45 am] BILLING CODE 4410–FY–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–826] Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Patheon API Manufacturing, Inc., 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 July 12, 2021. Such persons may also file a written request for a hearing on the application on or before July 12, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: In accordance with 21 CFR 1301.33(a), this is notice that on March 18, 2021, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605–5420, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Tetrahydrocannabinols .................................................................................................................................................... 5-Methoxy-N-N-Dimethyltryptamine ................................................................................................................................ a-Methyltryptamine .......................................................................................................................................................... Psilocybin ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\12MYN1.SGM 12MYN1 2010 7370 7431 7432 7437 9333 9652 9668 Schedule I I I I I II II II Federal Register / Vol. 86, No. 90 / Wednesday, May 12, 2021 / Notices The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. In reference to dug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. Revenue Service’s (IRS) Statistics of Income (SOI) Annual Individual Income Tax ZIP Code Data, and the U.S. Securities and Exchange Commission’s (SEC) Electronic Data Gathering, Analysis, and Retrieval (EDGAR) System. FOR FURTHER INFORMATION CONTACT: Regina Kearney at the OMB Office of Federal Financial Management at (202) 395–3993. Shalanda Young, Acting Director. [FR Doc. 2021–09988 Filed 5–11–21; 8:45 am] BILLING CODE P [FR Doc. 2021–10025 Filed 5–11–21; 8:45 am] BILLING CODE 3110–01–P AGENCY: The Payment Integrity Information Act of 2019 (PIIA) authorizes the Office of Management and Budget (OMB) to designate databases for inclusion in Treasury’s Working System under the Do Not Pay (DNP) Initiative. PIIA further requires OMB to provide public notice and opportunity for comment prior to designating additional databases. In fulfillment of this requirement, on January 22, 2021, OMB published a Notice of Proposed Designation for 12 additional databases. OMB received one comment during the 30-day comment period for this notice; however, the suggestions found therein did not preclude further action for the formal designation of the databases into Treasury’s Working System. Effective immediately, OMB designates the following 12 databases: The United States Postal Service (USPS) Delivery Sequence File, the Census Bureau Federal Audit Clearinghouse, the Do Not Pay (DNP) Agency Adjudication Data, Fiscal Service’s Payments, Claims, and Enhanced Reconciliation (PACER) database, Bureau of Prisons (BOP) Incarceration Data, Digital Accountability and Transparency Act (DATA Act) data, Census Bureau’s American Communities Survey (ACS) Annual State and County Data Profiles, Veterans Affairs’ (VA) Beneficiary Identification Records Locator Service (BIRLS), Department of Agriculture’s National Disqualified List (NDL), Center for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES), Internal In accordance with the Federal Advisory Committee Act (Pub. L. 92– 463, as amended), the National Science Foundation (NSF) announces the following meeting: Name and Committee Code: Committee on Equal Opportunities in Science and Engineering (CEOSE) Virtual Meeting (1173). Date and Time: June 10, 2021; 1:00 p.m.–5:30 p.m.; June 11, 2021; 10:00 a.m.–3:30 p.m. Place: National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314 (Virtual). Meeting Registration: Virtual attendance information will be forthcoming on the CEOSE website at https://www.nsf.gov/ od/oia/activities/ceose/index.jsp. Type of Meeting: Open. Contact Person: Dr. Bernice Anderson, Senior Advisor and CEOSE Executive Secretary, Office of Integrative Activities (OIA), National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314. Contact Information: 703–292–8040/banderso@ nsf.gov. Minutes: Meeting minutes and other information may be obtained from the CEOSE Executive Secretary at the above address or the website at https:// www.nsf.gov/od/oia/activities/ceose/ index.jsp. Purpose of Meeting: To study data, programs, policies, and other information pertinent to the National Science Foundation and to provide advice and recommendations concerning broadening participation in science and engineering. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES NATIONAL SCIENCE FOUNDATION Committee on Equal Opportunities in Science and Engineering; Notice of Meeting Office of Management and Budget. ACTION: Notice of designation. VerDate Sep<11>2014 17:58 May 11, 2021 Jkt 253001 PO 00000 Frm 00074 Fmt 4703 Agenda Day 1: June 10, 2021 • Welcome, Introductions, Opening Remarks • Report of the CEOSE Executive Liaison • Presentation: Missing Millions and NSF Efforts • Joint Session with NSB [Focus on STEM Technical Careers] • Discussion with NSF Director and Chief Operating Officer • CEOSE Liaison Reports • Working Session: DCL and Flyer for the 2019–2020 CEOSE Report Day 2: June 11, 2021 OFFICE OF MANAGEMENT AND BUDGET Designation of Databases for Treasury’s Working System Under the Do Not Pay Initiative 26071 Sfmt 4703 • Welcome and Remarks about Subcommittee: The Future of EPSCoR • BP Accountability Data • Presentation: Broadening Participation Research • Reports of the Federal Liaisons • Presentation: NSF’s Racial Equity Task Force • Reports of the CEOSE Liaisons • Announcements, Closing Remarks, and Adjournment Dated: May 7, 2021. Crystal Robinson, Committee Management Officer. [FR Doc. 2021–10033 Filed 5–11–21; 8:45 am] BILLING CODE 7555–01–P NUCLEAR REGULATORY COMMISSION [NRC–2021–0001] Sunshine Act Meetings Weeks of May 17, 24, 31, June 7, 14, 21, 2021. PLACE: Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public. MATTERS TO BE CONSIDERED: TIME AND DATE: Week of May 17, 2021 Monday, May 17, 2021 3:00 p.m.—Affirmation Session (Public Meeting) (Tentative), Direct Final Rule: Advanced Boiling Water Reactor Design Certification Renewal (RIN 3150–AK04; NRC– 2017–0090) (Tentative) (Contact: Wesley Held: 301–287–3591) Additional Information: Due to COVID–19, there will be no physical public attendance. The public is invited to attend the Commission’s meeting live; via teleconference. Details for joining the teleconference in listen only mode may be found at https:// www.nrc.gov/pmns/mtg. E:\FR\FM\12MYN1.SGM 12MYN1

Agencies

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26070-26071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09988]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-826]


Bulk Manufacturer of Controlled Substances Application: Patheon 
API Manufacturing, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Patheon API Manufacturing, Inc., 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 July 12, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before July 12, 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 March 18, 2021, Patheon API Manufacturing, Inc., 309 
Delaware Street, Greenville, South Carolina 29605-5420, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Tetrahydrocannabinols..............            7370  I
5-Methoxy-N-N-Dimethyltryptamine...            7431  I
a-Methyltryptamine.................            7432  I
Psilocybin.........................            7437  I
Thebaine...........................            9333  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
------------------------------------------------------------------------


[[Page 26071]]

    The company plans to bulk manufacture the listed controlled 
substances as an Active Pharmaceutical Ingredient (API) for 
distribution to its customers. In reference to dug code 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture this 
drug as synthetic. No other activities for these drug codes are 
authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-09988 Filed 5-11-21; 8:45 am]
BILLING CODE P
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