National Institute of Dental & Craniofacial Research; Notice of Meeting, 83975-83976 [2020-28354]

Download as PDF Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices Application No. NDA NDA NDA NDA 019916 020593 020634 021241 ............. ............. ............. ............. NDA 206544 ............. NDA 208399 ............. Drug Applicant Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL ............................................. Depacon (valproate sodium) Injection, Equivalent to (EQ) 100 mg base/mL ...... Levaquin (levofloxacin) Tablets, 250 mg, 500 mg, and 750 mg .......................... Ortho Tri-Cyclen Lo (ethinyl estradiol and norgestimate) Oral-28 (White) Tablets, 0.025 mg ethinyl estradiol and 0.18 mg norgestimate; (Light Blue) Tablets, 0.025 mg ethinyl estradiol and 0.215 mg norgestimate; (Dark Blue) Tablets, 0.025 mg ethinyl estradiol and 0.250 mg norgestimate. MorphaBond ER (morphine sulfate) Extended-Release Tablets, 15 mg, 30 mg, 60 mg, and 100 mg. Varubi (rolapitant HCl) Injectable Emulsion, EQ 166.5 mg base/92.5 mL (EQ 1.8 mg base/mL). NDA 209203 ............. Duzallo (allopurinol and lesinurad) Tablets, 200 mg/200 mg and 300 mg/200 mg. NDA 210895 ............. Welchol (colesevelam HCl) Chewable Bars, 3.75 g ............................................ Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 22, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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 January 22, 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. Dated: December 16, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–28346 Filed 12–22–20; 8:45 am] BILLING CODE 4164–01–P revising the last sentence in the ‘‘Summary’’ section. FOR FURTHER INFORMATION CONTACT: Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of Strategy, Policy, Planning, and Requirements, Suite 5440—O’Neill House Office Building, 200 C Street SW, Washington, DC 20201, (202) 260–0365. SUPPLEMENTARY INFORMATION: I. Correction of Errors In FR Doc. 2020–16458 of July 30, 2020 (85 FR 45895–45897), make the following corrections: On page 48596, first full column, SUMMARY section, change second to last sentence to ‘‘This notice, issued on July 23, 2020, extends the March 25 Designation Notice to January 19, 2021.’’ The expiration date, January 19, 2021 is not 120 days from the date of issuance so remove that reference. Wilma Robinson, Deputy Executive Secretary, Department of Health and Human Services. [FR Doc. 2020–28374 Filed 12–22–20; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4150–28–P Office of the Secretary DEPARTMENT OF HEALTH AND HUMAN SERVICES Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID–19 Hoarding Prevention Measures; Correction of Extension Date Office of the Secretary (OS), DHHS. ACTION: Correction. jbell on DSKJLSW7X2PROD with NOTICES AGENCY: SUMMARY: This document updates the July 30, 2020, Federal Register Notice entitled ‘‘Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID–19 Hoarding Prevention Measures,’’ by VerDate Sep<11>2014 21:21 Dec 22, 2020 Jkt 253001 National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Dental and Craniofacial Research Council. The meeting will be open to the public via NIH videocast. The URL link to this meeting is https:// videocast.nih.gov/watch=38984. PO 00000 Frm 00093 Fmt 4703 83975 Sfmt 4703 Do. AbbVie, Inc. Janssen Pharmaceuticals, Inc. Do. Daiichi Sankyo, Inc., 211 Mount Airy Rd., Basking Ridge, NJ 07920. TerSera Therapeutics LLC, 520 Lake Cook Rd., suite 500, Deerfield, IL 60015. Ironwood Pharmaceuticals, Inc., 100 Summer St., suite 2300, Boston, MA 02110. Daiichi Sankyo, Inc. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Dental and Craniofacial Research Council. Date: January 27, 2021. Open: 10:00 a.m. to 1:05 p.m. Agenda: Report of the Director, NIDCR Place: National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Room 662 Bethesda, MD 20892, (Virtual Meeting). Closed: 1:20 p.m. to 2:00 p.m. Agenda: Grant applications. Place: National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Room 662 Bethesda, MD 20892, (Virtual Meeting). Contact Person: Alicia J. Dombroski, Ph.D., Director, Division of Extramural Activities, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Room 662, Bethesda, MD 20892, 301–594–4805, adombroski@ nidcr.nih.gov. Any interested person may file written comments with the committee no later than 15 days after the meeting by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nidcr.nih.gov/about, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) E:\FR\FM\23DEN1.SGM 23DEN1 83976 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices Dated: December 17, 2020. Patricia B. Hansberger, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) National Institutes of Health [FR Doc. 2020–28354 Filed 12–22–20; 8:45 am] National Institute on Aging; Notice of Meeting Dated: December 18, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. jbell on DSKJLSW7X2PROD with NOTICES Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Fellowships in Digestive Diseases and Nutrition. Date: February 11–12, 2021. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Room 7011, Bethesda, MD 20892 (Video Meeting). Contact Person: Jian Yang, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7111, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 594–7799, yangj@ extra.niddk.nih.go.v (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: December 18, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–28350 Filed 12–22–20; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 21:21 Dec 22, 2020 Jkt 253001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Aging. The meeting will be open to the public as indicated below, with a short public comment period at the end. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov). The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Aging. Date: September 14–15, 2021. Closed: September 14, 2021, 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Virtual Meeting). Open: September 15, 2021, 8:00 a.m. to 1:00 p.m. Agenda: Call to order and report from the Director; Discussion of future meeting dates; Consideration of minutes of last meeting; Reports from Task Force on Minority Aging Research, Working Group on Program; Council Speaker; Program Highlights. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Kenneth Santora, Ph.D., Director, Office of Extramural Activities, National Institute on Aging, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20814, (301) 496–9322, ksantora@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: www.nia.nih.gov/about/naca, where an agenda and any additional information for the meeting will be posted when available. PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 [FR Doc. 2020–28397 Filed 12–22–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group Epidemiology, Prevention and Behavior Research Review Subcommittee. Date: March 1–2, 2021. Time: 9:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Health, National Institute on Alcohol Abuse and Alcoholism, 6700 B Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Anna Ghambaryan, M.D., Ph.D., Scientific Review Officer, Extramural Project Review Branch, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Room 2120, MSC 6902, Bethesda, MD 20892, 301–443–4032, anna.ghambaryan@ nih.gov. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group Biomedical Research Review Subcommittee. Date: March 9, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Health, National Institute on Alcohol Abuse and Alcoholism, 6700 B Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Philippe Marmillot, Ph.D., Scientific Review Officer, Extramural Project Review Branch, National Institutes of Health, E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83975-83976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Dental & Craniofacial Research; Notice of 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of a meeting of the National Advisory 
Dental and Craniofacial Research Council.
    The meeting will be open to the public via NIH videocast. The URL 
link to this meeting is https://videocast.nih.gov/watch=38984.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Advisory Dental and Craniofacial 
Research Council.
    Date: January 27, 2021.
    Open: 10:00 a.m. to 1:05 p.m.
    Agenda: Report of the Director, NIDCR
    Place: National Institute of Dental and Craniofacial Research, 
National Institutes of Health, 6701 Democracy Boulevard, Room 662 
Bethesda, MD 20892, (Virtual Meeting).
    Closed: 1:20 p.m. to 2:00 p.m.
    Agenda: Grant applications.
    Place: National Institute of Dental and Craniofacial Research, 
National Institutes of Health, 6701 Democracy Boulevard, Room 662 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Alicia J. Dombroski, Ph.D., Director, Division 
of Extramural Activities, National Institute of Dental and 
Craniofacial Research, National Institutes of Health, 6701 Democracy 
Boulevard, Room 662, Bethesda, MD 20892, 301-594-4805, 
[email protected].

    Any interested person may file written comments with the 
committee no later than 15 days after the meeting by forwarding the 
statement to the Contact Person listed on this notice. The statement 
should include the name, address, telephone number and when 
applicable, the business or professional affiliation of the 
interested person.
    Information is also available on the Institute's/Center's home 
page: https://www.nidcr.nih.gov/about, where an agenda and any 
additional information for the meeting will be posted when 
available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral 
Diseases and Disorders Research, National Institutes of Health, HHS)


[[Page 83976]]


    Dated: December 17, 2020.
Patricia B. Hansberger,
Supervisory Program Analyst, Office of Federal Advisory Committee 
Policy.
[FR Doc. 2020-28354 Filed 12-22-20; 8:45 am]
BILLING CODE 4140-01-P

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