Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 36100-36101 [2010-15309]

Download as PDF 36100 Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from July 1, 2009, through September 30, 2009, and from October 1, 2009, through December 31, 2009. There were no denial actions during either period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2009, THROUGH DECEMBER 31, 2009. PMA No. Docket No. Applicant Trade Name Approval Date P070022 FDA–2009–M–0317 Hologic, Inc. ADIANA PERMANENT CONTRACEPTION SYSTEM July 6, 2009 P060008/S11 FDA–2009–M–0369 Boston Scientific Corp. TAXUS LIBERTE LONG PACLITAXEL ELUING STENT SYSTEM July 13, 2009 P030050/S2 FDA–2009–M–0370 Sanofi Aventis, LLC SCULPTRA AESTHETIC July 28, 2009 P080013 FDA–2009–M–0485 Confluent Surgical, Inc. DURASEAL XACT SEALANT SYSTEM September 4, 2009 P080008 FDA–2009–M–0536 bioMerieux, Inc. VIDAS FREE PSA RT (fPSA) ASSAY October 8, 2009 P030042 FDA–2009–M–0540 Wright Medical Technology, Inc. CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM November 3, 2009 II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: June 17, 2010. Nancy Stade, Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health. [FR Doc. 2010–15259 Filed 6–23–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health emcdonald on DSK2BSOYB1PROD with NOTICES Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 contract proposals and VerDate Mar<15>2010 16:47 Jun 23, 2010 Jkt 220001 the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Dated: June 18, 2010. Anna P. Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel National Childrens Study. Date: July 12, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5B01, Bethesda, MD 20892–9304, (301) 435–6680, skandasa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 [FR Doc. 2010–15311 Filed 6–23–10; 8:45 am] BILLING CODE 4140–01–P 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 (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 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Geisha. Date: July 13, 2010. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Norman Chang, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 496–1485, changn@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS). Dated: June 18, 2010. Anna P. Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–15309 Filed 6–23–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting emcdonald on DSK2BSOYB1PROD 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 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 Child Health and Human Development Special Emphasis Panel Slack and Slick Channels. Date: July 12, 2010. Time: 12:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852. VerDate Mar<15>2010 16:47 Jun 23, 2010 Jkt 220001 Contact Person: Norman Chang, PhD, Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, (301) 496–1485, changn@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: June 18, 2010. Anna P. Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–15312 Filed 6–23–10; 8:45 am] BILLING CODE 4140–01–P 36101 Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Robert Garofalo, PhD, Scientific Review Officer, Center for Scientifice Review, National Institute of Health, 6701 Rockledge Drive, Room 6156, MSC 7892, Bethesda, MD 20892, 301–435– 1043, garofalors@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 18, 2010. Anna P. Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–15314 Filed 6–23–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Center for Scientific Review; Notice of Closed Meetings Food and Drug Administration 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. [Docket No. FDA–2010–N–0001] Name of Committee: AIDS and Related Research Integrated Review Group; AIDS Immunology and Pathogenesis Study Section. Date: July 16, 2010. Time: 8 a.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: The Westin Seattle, 1900 5th Avenue, Seattle, WA 98101. Contact Person: Mary Clare Walker, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–08– 160: Metabolic Effects of Psychotropic Medications. Date: July 20, 2010. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22–340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22–340 and, as needed, may schedule an advisory committee meeting in the future. FOR FURTHER INFORMATION CONTACT: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, e-mail: Yvette.Waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512534. Please call the Information Line for up-to-date information on this meeting. E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Pages 36100-36101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15309]


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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 (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

[[Page 36101]]

applications, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Geisha.
    Date: July 13, 2010.
    Time: 2 p.m. to 4 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6100 Executive Boulevard, 
Rockville, MD 20852 (Telephone Conference Call).
    Contact Person: Norman Chang, PhD, Scientific Review 
Administrator, Division of Scientific Review, National Institute of 
Child Health and Human Development, NIH, 6100 Executive Blvd., Room 
5B01, Bethesda, MD 20892, (301) 496-1485, changn@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS).

    Dated: June 18, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-15309 Filed 6-23-10; 8:45 am]
BILLING CODE 4140-01-P
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