Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 54155-54156 [2010-22087]

Download as PDF 54155 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and 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 April 1, 2010, through June 30, 2010. There were no denial actions during this 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 APRIL 1, 2010, THROUGH JUNE 30, 2010 PMA No. Docket No. Applicant TRADE NAME Approval Date P090018 FDA–2010–M–0244 Envoy Medical Corp. ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM March 17, 2010 P080029 FDA–2010–M–0220 Interventional Therapies, LLC QUICK CLOSE VASCULAR SUTURING SYSTEM April 8, 2010 P090022 FDA–2010–M–0219 Lenstec, Inc. SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) April 12, 2010 P080032 FDA–2010–0242 Asthmatix, Inc. ALAIR BRONCHIAL THERMOPLASTY April 27, 2010 P090007 FDA–2010–M–0261 Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE COBAS E411 IMMUNOASSAY ANALYZER April 29, 2010 P090008 FDA–2010–M–0262 Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE COBAS E601 IMMUNOASSAY ANALYZER April 29, 2010 P090009 FDA–2010–M–0264 Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 ANALYZER April 29, 2010 P050027 FDA–2010–M–0294 Karl Storz endoscopy— America, Inc. PHOTODYNAMIC DIAGNOSTIC D-LIGHT C May 28, 2010 P060029 FDA–2010–M–0285 Ethicon, Inc. OMNEX SURGICAL SEALANT June 3, 2010 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSKHWCL6B1PROD with NOTICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. National Institutes of Health Dated: August 31, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2010–22085 Filed 9–2–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 15:33 Sep 02, 2010 Jkt 220001 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. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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. E:\FR\FM\03SEN1.SGM 03SEN1 54156 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Review of T32 Applications on Clinical and Developmental Pharmacology. Date: September 29, 2010. Time: 1 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: Sathasiva B. Kandasamy, PhD, Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 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) Dated: August 30, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–22087 Filed 9–2–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 on Aging Initial Review Group, Neuroscience of Aging Review Committee. Date: October 4–5, 2010. Time: 4 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20892. Contact Person: William Cruce, PhD, Scientific Review Administrator, National Institute On Aging, Scientific Review Office, Gateway Building 2C–212, 7201 Wisconsin VerDate Mar<15>2010 20:02 Sep 02, 2010 Jkt 220001 Ave., Bethesda, MD 20814, 301–402–7704, crucew@nia.nih.gov. Name of Committee: National Institute on Aging Initial Review Group, Clinical Aging Review Committee. Date: October 7–8, 2010. Time: 7 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20892. Contact Person: Alicja L. Markowska, PhD, DSC, National Institute On Aging, National Institutes of Health, Gateway Building 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–496–9666, markowsa@nia.nih.gov. Name of Committee: National Institute on Aging Initial Review Group, Biological Aging Review Committee. Date: October 7, 2010. Time: 12 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Bita Nakhai, PhD., Scientific Review Officer, Scientific Review Branch, National Institute On Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402– 7701, nakhaib@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 27, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–22089 Filed 9–2–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Language and Communication Study Section, October 4, 2010, 8 a.m. to October 5, 2010, 5 p.m., Ritz Carlton Hotel, 1150 22nd Street, NW., Washington, DC 20037 which was published in the Federal Register on August 25, 2010, 75 FR 52357. The meeting will be one day only October 4, 2010. The meeting time and location remain the same. The meeting is closed to the public. Dated: August 26, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–22090 Filed 9–2–10; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 (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: Oncology 2— Translational Clinical Integrated Review Group, Basic Mechanisms of Cancer Therapeutics Study Section. Date: October 4–5, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Marina del Rey Hotel, 13534 Bali Way, Marina del Rey, CA 90292. Contact Person: Lambratu Rahman, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, 301–451– 3493, rahmanl@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group, Clinical Research and Field Studies of Infectious Diseases Study Section. Date: October 7–8, 2010. Time: 8:30 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: The Churchill Hotel, 1914 Connecticut Avenue, NW., Washington, DC 20009. Contact Person: Soheyla Saadi, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301–435– 0903, saadisoh@csr.nih.gov. Name of Committee: Oncology 2— Translational Clinical Integrated Review Group, Clinical Oncology Study Section. Date: October 11–12, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Long Beach and Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA 90831. Contact Person: Malaya Chatterjee, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6192, MSC 7804, Bethesda, MD 20892, 301–451– 0131, chatterm@csr.nih.gov. E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54155-54156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22087]


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


[[Page 54156]]


    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Review of T32 Applications on 
Clinical and Developmental Pharmacology.
    Date: September 29, 2010.
    Time: 1 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: Sathasiva B. Kandasamy, PhD, Scientific Review 
Officer, Division of Scientific Review, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, NIH, 6100 
Executive Blvd., Room 5B01, Bethesda, MD 20892, 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)

    Dated: August 30, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-22087 Filed 9-2-10; 8:45 am]
BILLING CODE 4140-01-P
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