Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 41334-41335 [E7-14600]

Download as PDF 41334 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices jlentini on PROD1PC65 with NOTICES physician services under the Medicare program in the previous year. Each nomination must state that the nominee has expressed a willingness to serve as a Council member and must be accompanied by a short resume or description of the nominee’s experience. All candidates are advised to consider the time commitment of 1 full-day meeting, quarterly. If a candidate’s current responsibilities preclude this level of commitment, we urge the individual to reconsider his or her nomination. To permit an evaluation of possible sources of conflicts of interest, potential candidates will be asked to provide detailed information concerning financial holdings, consultant positions, research grants, and contracts. Consideration will be given to each nominee with regard to his or her leadership credentials, geographic and demographic factors, and projected PPAC needs. Final selections will incorporate these criteria to maintain a committee membership that is fairly balanced in terms of points of view represented and the committee’s function. Selections will be made by February 2008 with new members sworn in during the May 2008 meeting. Nominations to fill vacancies on the Council will be considered if received at the address listed in the ADDRESSES section of the notice, no later than date listed in the DATES section of this notice. All nominating organizations will be notified in writing of those candidates selected for committee membership. III. Meeting Format and Agenda The meeting will commence with the Council’s Executive Director providing a status report, and the CMS responses to the recommendations made by the Council at the May 21, 2007 meeting, as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics: • Coverage with Evidence Development. • Recovery Audit Contract (RAC) Update. • Medically Unlikely Edits (MUE) Update. • Physician Fee Schedule Proposed Rule. • Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rules. • Medicare Contractor Provider Satisfaction Survey (MCPSS). • National Provider Identifier (NPI) Data Dissemination Notice. VerDate Aug<31>2005 16:53 Jul 26, 2007 Jkt 211001 For additional information and clarification on these topics, contact the DFO as provided in the FOR FURTHER INFORMATION CONTACT section of this notice. Individual physicians or medical organizations that represent physicians wishing to present a 5-minute oral testimony on agenda issues must register with the DFO by the date listed in the DATES section of this notice. Testimony is limited to agenda topics only. The number of oral testimonies may be limited by the time available. A written copy of the presenter’s oral remarks must be submitted to the DFO for distribution to Council members for review before the meeting by the date listed in the DATES section of this notice. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution by the date listed in the DATES section of this notice. section of this notice by the date listed in the DATES section of this notice. Authority: (Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, section 10(a)).) Dated: June 28, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7–14072 Filed 7–26–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, IV. Meeting Registration and Security Information ACTION: The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at (410) 786–6132 by the date specified in the DATES section of this notice. Since this meeting will be held in a Federal Government Building, the CMS Central Office, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. To gain access to the building, participants will be required to show a government-issued photo identification (for example, driver’s license, or passport), and must be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the CMS Central Office and will not be permitted to attend the Council meeting. All persons entering the building must pass through a metal detector. In addition, all items brought to the CMS Central Office, whether personal or for the purpose of presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, setup, safety, or timely arrival of any personal belongings or items used for the purpose of presentation. Individuals requiring sign language interpretation or other special accommodation must contact the DFO via the contact information specified in the FOR FUTHER INFORMATION CONTACT This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 19, 2007, from 8 a.m. to 6 p.m., and September 20, 2007, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Swink, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4179, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On September 19, 2007, the committee will discuss, make PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 HHS. E:\FR\FM\27JYN1.SGM Notice. 27JYN1 41335 Federal Register / Vol. 72, No. 144 / Friday, July 27, 2007 / Notices recommendations and vote on a premarket approval application, sponsored by SyntheMed, Inc., for the REPEL-CV, which is a surgical adjuvant indicated for reducing the incidence, severity and extent of post-operative adhesion formation in patients undergoing cardiac surgery. On September 20, 2007, the committee will discuss and make recommendations regarding clinical trial designs for cardiac ablation devices designed to treat patients with medically refractory atrial fibrillation. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 5, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations on each day and for approximately 30 minutes near the end of the deliberations on each day. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 28, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 29, 2007. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240–276–8932, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 23, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–14600 Filed 7–26–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) Number of respondents Type of form Responses per respondent publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The National Health Service Corps Loan Repayment Program (OMB No. 0915–0127)— Extension The National Health Service Corps (NHSC) Loan Repayment Program (LRP) was established to assure an adequate supply of trained primary care health care professionals to provide services in the neediest Health Professional Shortage Areas (HPSAs) of the United States. Under this program, the Department of Health and Human Services agrees to repay the educational loans of the primary care health professionals. In return, the health professionals agree to serve for a specified period of time in a federallydesignated HPSA approved by the Secretary for LRP participants. The NHSC LRP forms provide information that is needed for selecting participants and making determinations regarding repayment of qualifying loans for education. The LRP forms include the following: The NHSC LRP Application; the Loan Information and Verification form; the Community Site Information form; the Applicant Checklist; the Payment Information form; and the Authorization to Release Information form. The estimated annual burden is as follows: Total number of responses Hours per response Total burden hours 1920 1920 1920 1920 1920 80 1 1 3 1 1 1 1920 1920 5760 1920 1920 80 .5 .25 .25 .1 .2 .25 960 480 1440 192 384 20 Total ............................................................................ jlentini on PROD1PC65 with NOTICES NHSC LRP Application ...................................................... Community Site Information form ...................................... Loan Information and Verification form ............................. Authorization to Release Information ................................ Applicant Checklist ............................................................. Lenders .............................................................................. 2000 ........................ 9680 1.55 3476 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov VerDate Aug<31>2005 16:53 Jul 26, 2007 Jkt 211001 or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ PO 00000 Dated: July 5, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–14525 Filed 7–26–07; 8:45 am] BILLING CODE 4165–15–P Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Notices]
[Pages 41334-41335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14600]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 19, 2007, from 
8 a.m. to 6 p.m., and September 20, 2007, from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512625. Please call the Information Line for up-to-date 
information on this meeting. A notice in the Federal Register about 
last minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the agency's Web site 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On September 19, 2007, the committee will discuss, make

[[Page 41335]]

recommendations and vote on a premarket approval application, sponsored 
by SyntheMed, Inc., for the REPEL-CV, which is a surgical adjuvant 
indicated for reducing the incidence, severity and extent of post-
operative adhesion formation in patients undergoing cardiac surgery.
    On September 20, 2007, the committee will discuss and make 
recommendations regarding clinical trial designs for cardiac ablation 
devices designed to treat patients with medically refractory atrial 
fibrillation.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and scroll down to the appropriate advisory committee 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
September 5, 2007. Oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of committee 
deliberations on each day and for approximately 30 minutes near the end 
of the deliberations on each day. Those desiring to make formal oral 
presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before August 28, 2007. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by August 
29, 2007.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 240-276-8932, at least 7 days in 
advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 23, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14600 Filed 7-26-07; 8:45 am]
BILLING CODE 4160-01-S

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