National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 80061-80062 [2010-32025]

Download as PDF Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 80061 TABLE 1—Continued Committee name Tentative date(s) of meeting(s) CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee ........................................................................ March 30–31. CENTER FOR TOBACCO PRODUCTS Tobacco Products Scientific Advisory Committee ................................... January 10–11, March 17–18, May, July, September, and November date(s), if needed, to be determined. CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee ................................................ April 11, September 12. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board ........................................................................... Dated: December 16, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–31961 Filed 12–20–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0626] Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. DATES: Effective December 21, 2010. FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: On October 7, 2010, FDA requested that Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules from the market, based on FDA’s recent analysis of clinical trial data from the Sibutramine Cardiovascular Outcomes srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 November 9–10. Trial (SCOUT) that indicated that MERIDIA poses an increased risk of heart attack and stroke. In a letter dated October 12, 2010, Abbott requested that FDA withdraw approval of NDA 20–632 for MERIDIA (sibutramine HCl) oral capsules under § 314.150(d) (21 CFR 314.150(d)). In that letter, Abbott also waived its opportunity for a hearing, provided under § 314.150(a). In FDA’s acknowledgment letter of November 1, 2010, the agency stated that based on the review of the SCOUT data and the assessment of the September 15, 2010, meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee at which the SCOUT data were reviewed, we find the benefits of MERIDIA (sibutramine HCl) oral capsules, indicated for the management of obesity, including weight loss and maintenance of weight loss, no longer outweigh the risks in any identifiable patient population. FDA also acknowledged that Abbott waived its opportunity for a hearing. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), § 314.150(d), and under authority delegated by the Commissioner of Food and Drugs to the Director, Center for Drug Evaluation and Research, approval of NDA 20–632, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: December 6, 2010. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 2010–31986 Filed 12–20–10; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Unsolicited Multi-Project (P01) Grant Applications. Date: January 12, 2011. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817. (Telephone Conference Call.) Contact Person: Roberta Binder, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, Room 3130, Bethesda, MD 20892–7616. 301– 496–7966. rbinder@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) E:\FR\FM\21DEN1.SGM 21DEN1 80062 Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices Dated: December 15, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–32025 Filed 12–20–10; 8:45 am] 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 Meetings srobinson on DSKHWCL6B1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Novel Therapies for NIDDM P01 Application. Date: January 27, 2011. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: D.G. Patel, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892–5452. (301) 594–7682. pateldg@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Ancillary Studies to major ongoing Clinical Research Studies in CKD (R01): PAR–09–247. Date: February 1, 2011. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: Najma Begum, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 749, 6707 Democracy Boulevard, Bethesda, MD 20892–5452. (301) 594–8894. begumn@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 Special Emphasis Panel, R14 Seeding Application. Date: February 18, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: D.G. Patel, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, Bethesda, MD 20892–5452. (301) 594–7682. pateldg@niddk.nih.gov. (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 15, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Lisa A. Newman, SCD, Scientific Review Officer, National Institutes of Health, National Center for Research Resources, Office of Review, Room 1074, 6701 Democracy Blvd., MSC 4874, Bethesda, MD 20892, 301–435–0965, newmanla2@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA Related Construction Awards, National Institutes of Health, HHS) Dated: December 15, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–32024 Filed 12–20–10; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2010–32026 Filed 12–20–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting National Center for Research Resources; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 Center for Research Resources Special Emphasis Panel; Biotechnology 2011. Date: February 23–24, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Lee Warren Slice, PhD, Scientific Review Officer, Office of Review, National Center for Research Resources, 6701 Democracy Blvd., Room 1068, Bethesda, MD 20892, 301–435–0965. Name of Committee: National Center for Research Resources Special Emphasis Panel. Date: February 23, 2011. Time: 8 a.m. to 5 p.m. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Virus Infection Analysis. Date: January 11, 2011. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Eleazar Cohen, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, Room 3129, 6700 B Rockledge Drive, Bethesda, MD 20892. 301– 435–3564. ec17w@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Pages 80061-80062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), 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.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel, Unsolicited Multi-Project (P01) 
Grant Applications.
    Date: January 12, 2011.
    Time: 1 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6700B Rockledge Drive, 
Bethesda, MD 20817. (Telephone Conference Call.)
    Contact Person: Roberta Binder, PhD, Scientific Review Officer, 
Scientific Review Program, Division of Extramural Activities, NIAID/
NIH/DHHS, 6700B Rockledge Drive, Room 3130, Bethesda, MD 20892-7616. 
301-496-7966. rbinder@niaid.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)



[[Page 80062]]


    Dated: December 15, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-32025 Filed 12-20-10; 8:45 am]
BILLING CODE 4140-01-P
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