National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 38533 [2010-16037]

Download as PDF Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Notices 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 38533 Internet from January 1, 2010, through March 31, 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 JANUARY 1, 2010, THROUGH MARCH 31, 2010 PMA No. Docket No. Applicant Trade Name Approval Date P010047 FDA–2010–M–0068 Neomend, Inc. PROGEL PLEURAL AIR LEAK SEALANT January 14, 2010 P060040/S005 FDA–2010–M–0078 Thoratec Corp. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) January 20, 2010 H080002 FDA–2010–M–0063 Medtronic, Inc. MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE (MODEL PB10) AND MEDTRONIC ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (NU10) January 25, 2010 P090003 FDA–2010–M–0135 Boston Scientific Corp. EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM March 5, 2010 P090006 FDA–2010–M–0158 Medtronic Vascular COMPLETE SE VASCULAR STENT SYSTEM March 17, 2010 would constitute a clearly unwarranted invasion of personal privacy. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: June 28, 2010. Nancy Stade, Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health. [FR Doc. 2010–16139 Filed 7–1–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health emcdonald on DSK2BSOYB1PROD with NOTICES National Institute on Alcohol Abuse and Alcoholism; 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 materials, and personal information concerning individuals associated with the grant applications, the disclosure of which VerDate Mar<15>2010 18:27 Jul 01, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel ZAA1 HH01—AA3 Member Conflicts. Date: July 30, 2010. Time: 11 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. Contact Person: Lorraine Gunzerath, PhD, MBA, Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, Office of Extramural Activities, Extramural Project Officer, 5635 Fishers Lane, Room 2121, Bethesda, MD 20892–9304, 301–443– 2369. Centers for Medicare & Medicaid Services (Catalogue of Federal Domestic Assistance Program Nos.) Dated: June 25, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–16037 Filed 7–1–10; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 [CMS–1571–N] Medicare Program; Second SemiAnnual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—August 23 & 24, 2010 AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. SUMMARY: This notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2010. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel’s advice as we prepare the final rule that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2011. DATES: Meeting Dates: We are scheduling the second semi-annual E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Notices]
[Page 38533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Alcohol Abuse and Alcoholism; 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 materials, 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 Special Emphasis Panel ZAA1 HH01--AA3 Member Conflicts.
    Date: July 30, 2010.
    Time: 11 a.m. to 12 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5635 Fishers Lane, 
Bethesda, MD 20892.
    Contact Person: Lorraine Gunzerath, PhD, MBA, Scientific Review 
Officer, National Institute on Alcohol Abuse and Alcoholism, Office 
of Extramural Activities, Extramural Project Officer, 5635 Fishers 
Lane, Room 2121, Bethesda, MD 20892-9304, 301-443-2369.

(Catalogue of Federal Domestic Assistance Program Nos.)
    Dated: June 25, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-16037 Filed 7-1-10; 8:45 am]
BILLING CODE 4140-01-P
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