National Institute on Aging; Notice of Closed Meeting, 19788-19789 [2018-09426]

Download as PDF 19788 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 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. Application No. Drug Applicant ANDA 040259 ......... Hydrocortisone Acetate Cream USP, 2.5% .......................... ANDA 040457 ......... Pyridostigmine Bromide Tablets USP, 60 milligrams (mg) ... ANDA 061806 ......... Cloxapen (cloxacillin sodium) Capsules, Equivalent to (EQ) 250 mg base and EQ 500 mg base. Vancomycin Hydrochloride (HCl) Capsules USP, EQ 125 mg base and EQ 250 mg base. Calcitriol Injection, 1 microgram (mcg)/milliliter (mL) and 2 mcg/mL. Rimantadine HCl Tablets USP, 100 mg ................................ Glyburide and Metformin HCl Tablets USP, 1.25 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg. Fluconazole in Sodium Chloride 0.9% Injection, 200 mg/ 100 mL and 400 mg/200 mL. Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220. Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. GlaxoSmithKline, LLC, 5 Crescent Dr., Philadelphia, PA 19112. Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Do. ANDA 065453 ......... ANDA 075836 ......... ANDA 075916 ......... ANDA 076731 ......... ANDA 076889 ......... ANDA 088572 ......... Impax Laboratories, Inc. Do. Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. Abbott Laboratories, One Abbott Park Rd., Abbott Park, IL 60064. Pediatric LTA Kit (lidocaine HCl) Solution, 2% ..................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 4, 2018. 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 June 4, 2018 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: May 1, 2018. Leslie Kux, Associate Commissioner for Policy. Application Due Date has been modified. Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443– 2114; or the Division of Grants Management main line (301) 443–5204, or Fax: (301)–594–0899. FOR FURTHER INFORMATION CONTACT: Correction In the FR notice of April 17, 2018, (FR 2018–07941), the correction is: Key Dates: Under the heading Key Dates, the Application Due Date should read as: • Application Due Date: June 18, 2018 The other dates in the Key Dates section remain as originally published. Dated: April 27, 2018. Michael D. Weahkee, RADM, Assistant Surgeon General, U.S. Public Health Service, Acting Director, Indian Health Service. [FR Doc. 2018–09534 Filed 5–3–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2018–09506 Filed 5–3–18; 8:45 am] BILLING CODE 4160–16–P Indian Health Service amozie on DSK3GDR082PROD with NOTICES ACTION: Dated: April 27, 2018. Michael D. Weahkee, Assistant Surgeon General, U.S. Public Health Service, Acting Director, Indian Health Service. The Indian Health Service published a notice in the Federal Register (FR) on April 17, 2018, for the Negotiation Cooperative Agreement, Funding Announcement Number: HHS– 2018–IHS–TSGN–0001. The SUMMARY: Jkt 244001 BILLING CODE 4165–16–P Indian Health Service Notice; Correction of due date. 18:16 May 03, 2018 In the FR notice of April 17, 2018, (FR 83 FR 16885), the correction is: Key Dates: Under the heading Key Dates, the Application Due Date should read as: • Application Due Date: June 18, 2018 The other dates in the Key Dates section remain as originally published. [FR Doc. 2018–09507 Filed 5–3–18; 8:45 am] Indian Health Service, HHS. VerDate Sep<11>2014 Correction DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Tribal Self-Governance; Negotiation Cooperative Agreement; Correction of Due Date AGENCY: Register on April 17, 2018, for the Planning Cooperative Agreement, Funding Announcement Number: HHS– 2018–IHS–TSGP–0001. The Application Due Date has been modified. FOR FURTHER INFORMATION CONTACT: Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443– 2114; or the Division of Grants Management main line (301) 443–5204, or Fax: (301) 594–0899. DEPARTMENT OF HEALTH AND HUMAN SERVICES Planning Cooperative Agreement; Correction of Due Date National Institutes of Health Office of Tribal SelfGovernance, Indian Health Service, HHS. ACTION: Notice; correction of due date. AGENCY: The Indian Health Service published a notice in the Federal SUMMARY: PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 National Institute on Aging; 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. E:\FR\FM\04MYN1.SGM 04MYN1 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 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 Institute on Aging Special Emphasis Panel; AD Data Analysis. Date: June 4, 2018. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Nijaguna Prasad, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue,Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–496–9667, nijaguna.prasad@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: April 30, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–09426 Filed 5–3–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health amozie on DSK3GDR082PROD with NOTICES National Cancer Institute; 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 grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; ImmunoOncology Translation Network. Date: May 31–June 1, 2018. VerDate Sep<11>2014 18:16 May 03, 2018 Jkt 244001 Time: 8:00 p.m. to 12:00 p.m. Agenda: To review and evaluate grant application. Place: Canopy by Hilton Washington DC Bethesda North, 940 Rose Avenue, North Bethesda, MD 20852. Contact Person: Eun Ah Cho, Ph.D., Scientific Review Officer, Special Review Branch Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W104, Bethesda, MD 20892–9750, 240–276–6342, choe@ mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Research Specialist Award (R50). Date: June 7, 2018. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W242, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Zhiqiang Zou, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W242, Bethesda, MD 20892–9750, 240–276–6372, zouzhiq@ mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; SEP–5: Clinical and Translational R21 and Omnibus R03. Date: June 8, 2018. Time: 7:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Jennifer C. Schiltz, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W122, Bethesda, MD 20892–9750, 240–276–5864, jennifer.schiltz@ nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Utilizing the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Biospecimens Resources (U01). Date: June 11, 2018. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W248, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Anita T. Tandle, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W248, Bethesda, MD 20892–9750, 240–276–5007, tandlea@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI U01 Small Cell Lung Cancer Consortium. Date: June 11, 2018. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 19789 Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W618, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Mukesh Kumar, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W618, Bethesda, MD 20892–9750, 240–276–6611, mukesh.kumar3@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Clincal R01 Review. Date: June 13, 2018. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W122, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Sanita Bharti, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W122, Bethesda, MD 20892–9750, 240–276–5909, sanitab@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: May 1, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–09552 Filed 5–3–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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. E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19788-19789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging; 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.

[[Page 19789]]

    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 Institute on Aging Special Emphasis 
Panel; AD Data Analysis.
    Date: June 4, 2018.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute on Aging, Gateway Building, Suite 
2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone 
Conference Call).
    Contact Person: Nijaguna Prasad, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute on Aging, 7201 
Wisconsin Avenue,Gateway Building, Suite 2W200, Bethesda, MD 20892, 
301-496-9667, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging 
Research, National Institutes of Health, HHS)

    Dated: April 30, 2018.
Melanie J. Pantoja,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-09426 Filed 5-3-18; 8:45 am]
 BILLING CODE 4140-01-P
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