Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 38532-38533 [2010-16139]

Download as PDF 38532 Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Notices recruitment, and are discussed throughout the application where there is any implication for information privacy. These evaluations have provided volumes of data, reports, and presentations on the progression of CDC–INFO, an innovative, multimillion dollar, Federal public health contact center. The outcome of this feedback is tangible, with the average number of incoming calls to CDC–INFO reaching new heights on an annual basis, and consumer satisfaction hovering around the best practice benchmark of 75 percent of callers participating in a satisfaction survey endorsing the highest level of satisfaction—very satisfied. Sample size, respondent burden, and intrusiveness have been minimized to be consistent with national evaluation objectives. There is no cost to the respondent, other than the amount of time required to respond to the survey. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Form name General Callers ......................... Email Inquirers .......................... Callers (follow-up) ..................... General Public .......................... Professionals ............................ General Public .......................... Satisfaction survey ................... Satisfaction survey ................... Follow-up survey ...................... Special event/Outreach survey Special event/Outreach survey Emergency response survey— Level 1. Emergency response survey— Level 1. Emergency response survey— Level 2. Emergency response survey— Level 2. Emergency response survey— Level 3. Emergency response survey— Level 3. Emergency response survey— Level 4. Emergency response survey— Level 4. Professionals ............................ General Public .......................... Professionals ............................ General Public .......................... Professional .............................. General Public .......................... Professional .............................. Total Burden Hours ........... ................................................... Dated: June 24, 2010. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–16200 Filed 7–1–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2010–M–0068, FDA– 2010–M–0078, FDA–2010–M–0063, FDA– 2010–M–0135, FDA–2010–M–0158] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications emcdonald on DSK2BSOYB1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and VerDate Mar<15>2010 18:27 Jul 01, 2010 Jkt 220001 1 1 1 1 1 1 4 60 1,658 1 5 60 ⁄ 138 8,637 1 5 60 ⁄ 720 1,727 1 5 60 ⁄ 144 35,185 1 5 60 ⁄ 2,932 7,037 1 5 60 ⁄ 586 129,126 1 5 60 ⁄ 10,761 29,825 1 5 60 ⁄ 2,485 ............................ ............................ ............................ 26,227 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) Frm 00077 Fmt 4703 Sfmt 4703 ⁄ ⁄ ⁄ 7⁄60 5⁄60 5⁄60 Total burden hours 92,000 1,460 5,290 5,120 2,080 8,288 effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993–0002, 301–796–6570. SUPPLEMENTARY INFORMATION: PO 00000 Average burden per response (in hrs) Number of responses per respondent Number of respondents 3 60 9 60 6,133 73 794 597 173 691 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 E:\FR\FM\02JYN1.SGM 02JYN1 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]
[Pages 38532-38533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16139]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-M-0068, FDA-2010-M-0078, FDA-2010-M-0063, FDA-
2010-M-0135, FDA-2010-M-0158]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
premarket approval applications (PMAs) that have been approved. This 
list is intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness data to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Please cite the appropriate docket number as listed in table 
1 of this document when submitting a written request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:  Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

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 Sec.  
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

[[Page 38533]]

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 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                                               Approval
       No.            Applicant            Trade Name            Date
------------------------------------------------------------------------
P010047            Neomend, Inc.   PROGEL PLEURAL AIR LEAK    January
FDA-2010-M-0068                     SEALANT                    14, 2010
------------------------------------------------------------------------
P060040/S005       Thoratec Corp.  THORATEC HEARTMATE II      January
FDA-2010-M-0078                     LEFT VENTRICULAR ASSIST    20, 2010
                                    SYSTEM (LVAS)
------------------------------------------------------------------------
H080002            Medtronic,      MEDTRONIC MELODY           January
FDA-2010-M-0063     Inc.            TRANSCATHETER PULMONARY    25, 2010
                                    VALVE (MODEL PB10) AND
                                    MEDTRONIC ENSEMBLE
                                    TRANSCATHETER VALVE
                                    DELIVERY SYSTEM (NU10)
------------------------------------------------------------------------
P090003            Boston          EXPRESS LD LLIAC           March 5,
FDA-2010-M-0135     Scientific      PREMOUNTED STENT SYSTEM    2010
                    Corp.
------------------------------------------------------------------------
P090006            Medtronic       COMPLETE SE VASCULAR       March 17,
FDA-2010-M-0158     Vascular        STENT SYSTEM               2010
------------------------------------------------------------------------

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

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