Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 64506-64507 [2021-25161]

Download as PDF 64506 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: [FR Doc. 2021–25103 Filed 11–17–21; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1195] Approval is withdrawn as of December 20, 2021. DATES: Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications AGENCY: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. ACTION: Notice. The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant ANDA 040619 ......... Methimazole Tablets, 15 milligrams (mg) ............................. ANDA 070254 ......... Naloxone Hydrochloride (HCl) Injection, 0.4 mg/milliliters (mL). Bupivacaine HCl Injection, 0.25% ......................................... Morphine Sulfate Injection, 1 mg/mL .................................... Desmopressin Acetate Injection, 0.004 mg/mL .................... Tretinoin Cream, 0.05% ........................................................ Ciprofloxacin Injection, 200 mg/20 mL (10 mg/mL) and 400 mg/40 mL (10 mg/mL). Lidocaine HCl Solution, 4% ................................................... Chloroprocaine HCl Injection, 3% ......................................... Chloroprocaine HCl Injection, 2% ......................................... Levocetirizine Dihydrochloride Tablets, 5 mg ....................... Discovery Therapeutics, LLC, 2831 Deer Hound Way, Palm Harbor, FL 34683. Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045. Do. Do. Do. ZO Skin Health, Inc., 9685 Research Dr., Irvine, CA 92618. Hospira, Inc. ANDA ANDA ANDA ANDA ANDA 070586 071850 075220 076498 077245 ......... ......... ......... ......... ......... ANDA ANDA ANDA ANDA 080409 087446 087447 201653 ......... ......... ......... ......... ANDA 202524 ......... ANDA 202857 ......... ANDA 203885 ......... ANDA 207864 ......... ANDA 209489 ......... ANDA 210283 ......... ANDA 210855 ......... khammond on DSKJM1Z7X2PROD with NOTICES Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. Levetiracetam Extended Release Tablets, 500 mg and 750 mg. Daptomycin Powder for Injection, 500 mg/vial ...................... Amiodarone HCl Injection, 50 mg/mL ................................... Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL .............. Caspofungin Acetate Powder for Injection, 50 mg/vial and 70 mg/vial. Clofarabine Injection, 20 mg/20 mL (1 mg/mL) .................... Sodium Nitroprusside Injection, 25 mg/mL ........................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 20, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on December 20, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. VerDate Sep<11>2014 Do. Do. Do. Sun Pharmaceutical Industries, Inc., U.S. Agent for Sun Pharmaceutical Industries Ltd., 270 Prospect Plains Rd., Cranbury, NJ 08512. Rouses Point Pharmaceuticals, LLC, 11 Commerce Dr., Cranford, NJ 07016. Hospira, Inc. Do. The WhiteOak Group, LLC, U.S. Agent for Hybio Pharmaceutical Co., Ltd., 1629 K St. NW, Suite 300, Washington, DC 20006. Cipla USA, Inc., U.S. Agent for Cipla Limited, 10 Independence Blvd., Suite 300, Warren, NJ 07059. Hospira, Inc. Cipla USA, Inc. 17:11 Nov 17, 2021 Jkt 256001 Dated: November 12, 2021. Lauren K. Roth, Associate Commissioner for Policy. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NICHD. Name of Committee: Board of Scientific Counselors, NICHD. Date: December 3, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: A report by the Acting Scientific Director, NICHD, on the status of the NICHD [FR Doc. 2021–25111 Filed 11–17–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices Division of Intramural Research; current organizational structure; to review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, 31 Center Drive, Bethesda, MD 20892, (VideoAssisted Meeting). Contact Person: Chris J. McBain, Ph.D., Acting Scientific Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 10 Center Drive, Room 10D39, Bethesda, MD 20892, (301) 594–5984, mcbainc@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/advisory/bsc, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: November 15, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–25161 Filed 11–17–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [1651–0139] Electronic Visa Update System (EVUS) U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day notice and request for comments; revision of an existing collection of information. AGENCY: The Department of Homeland Security, U.S. Customs and Border Protection 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 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. DATES: Comments are encouraged and must be submitted (no later than January 18, 2022) to be assured of consideration. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651–0139 in the subject line and the agency name. Please use the following method to submit comments: ADDRESSES: VerDate Sep<11>2014 17:11 Nov 17, 2021 Jkt 256001 Email: Submit comments to: CBP_ PRA@cbp.dhs.gov. Due to COVID–19-related restrictions, CBP has temporarily suspended its ability to receive public comments by mail. FOR FURTHER INFORMATION CONTACT: Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229–1177, Telephone number 202–325–0056 or via email CBP_PRA@cbp.dhs.gov. Please note that the contact information provided here is solely for questions regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877–227–5511, (TTY) 1–800–877–8339, or CBP website at https://www.cbp.gov/ . SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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; (2) 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; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to 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. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record. Overview of This Information Collection Title: Electronic Visa Update System (EVUS). OMB Number: 1651–0139. Form Number: N/A. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 64507 Current Actions: Revision of an existing information collection. Type of Review: Revision. Affected Public: Individuals. Abstract: DHS developed the Electronic Visa Update System (EVUS) to assure robust screening of foreign nationals prior to travel to the United States. EVUS provides for robust traveler screening and verification to better identify foreign nationals who may be inadmissible to the United States. This results in enhanced national security, improved public safety, and a reduced number of delays upon arrival in the United States, all while facilitating legitimate travel. Initially, the program is limited to nonimmigrant aliens presenting passports issued by the People’s Republic of China (PRC) containing unrestricted, maximum validity B–1 (business visitor), B–2 (visitor for pleasure), or combination B–1/B–2 visas, generally valid for 10 years. PRC membership in EVUS became possible on November 12, 2014, when, in a reciprocal agreement, the U.S. Department of State expanded the validity of U.S. visitor visas issued to PRC nationals from one to ten years. To ensure compliance with the Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015, Public Law 114–113, 129 Stat. 2242, CBP will continuously update the application question with the list of nationals ineligible from traveling to the United States, as designated in accordance with section 217(a)(12) of the Immigration and Nationality Act, as amended (8 U.S.C. 1187(a)(12)). Recent Changes On May 31, 2019, the Department of State updated its immigrant and nonimmigrant visa application forms to request additional information, specifically social media identifiers, from most U.S. visa applicants worldwide. As a result, DHS is changing the EVUS application social media data field from optional to mandatory. National security is the top priority when adjudicating EVUS applications, and every prospective traveler to the United States undergoes extensive security screening. CBP is continually working to find mechanisms to improve our screening processes to protect U.S. visitors while supporting legitimate travel to the United States. DHS already requests information on contacts, travel history, and family members from all EVUS applicants. Changing the social medial field to mandatory in the EVUS application will enhance our vetting capabilities and assist in confirming applicants’ identities. While the field is E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64506-64507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25161]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of a meeting of the Board of Scientific 
Counselors, NICHD.
    The meeting will be closed to the public as indicated below in 
accordance with the provisions set forth in sections 552b(c)(4) and 
552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and 
evaluation of individual intramural programs and projects conducted by 
the Eunice Kennedy Shriver National Institute of Child Health and Human 
Development, including consideration of personnel qualifications and 
performance, and the competence of individual investigators, the 
disclosure of which would constitute a clearly unwarranted invasion of 
personal privacy.

    Name of Committee: Board of Scientific Counselors, NICHD.
    Date: December 3, 2021.
    Time: 10:00 a.m. to 5:00 p.m.
    Agenda: A report by the Acting Scientific Director, NICHD, on 
the status of the NICHD

[[Page 64507]]

Division of Intramural Research; current organizational structure; 
to review and evaluate personnel qualifications and performance, and 
competence of individual investigators.
    Place: National Institutes of Health, 31 Center Drive, Bethesda, 
MD 20892, (Video-Assisted Meeting).
    Contact Person: Chris J. McBain, Ph.D., Acting Scientific 
Director, Eunice Kennedy Shriver National Institute of Child Health 
and Human Development, NIH, 10 Center Drive, Room 10D39, Bethesda, 
MD 20892, (301) 594-5984, [email protected].

    Information is also available on the Institute's/Center's home 
page: https://www.nichd.nih.gov/about/advisory/bsc, where an agenda 
and any additional information for the meeting will be posted when 
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.865, 
Research for Mothers and Children, National Institutes of Health, 
HHS)

    Dated: November 15, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-25161 Filed 11-17-21; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.