Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting, 13288-13289 [E7-5152]

Download as PDF 13288 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Notices the agreement and proposed order or to modify in any way their terms. Prevention and the Agency for Toxic Substances and Disease Registry. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 07–1403 Filed 3–20–07; 8:45 am] Dated: March 14, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 07–1374 Filed 3–20–07; 8:45 am] BILLING CODE 6750–01–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration jlentini on PROD1PC65 with NOTICES CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment In accordance with section l0(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention and the Health Resources and Services Administration announce the following meeting of the aforementioned committee. Times and Dates: 8 a.m. – 5 p.m., May 7, 2007. 8 a.m. – 12:30 p.m., May 8, 2007. Place: Embassy Suites Hotel Atlanta Buckhead, 3285 Peachtree Road, NE., Atlanta, Georgia, Telephone 404/261– 7733, Fax 404/262–0522. Status: Open to the public, limited only by the space available. The meeting room will accommodate approximately 100 people. Purpose: This Committee is charged with advising the Director, CDC and the Administrator, HRSA, regarding activities related to prevention and control of HIV/AIDS and other STDs, the support of health care services to persons living with HIV/AIDS, and education of health professionals and the public about HIV/AIDS and other STDs. Matters To Be Discussed: Agenda items include issues pertaining to (1) Priorities for STD Prevention (2) HIV Strategic Plan Implementation and (3) Leveraging Federal Partnerships for HIV/STD Prevention. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Margie Scott-Cseh, Committee Management Specialist, National Center for HIV, STD, and TB Prevention, 1600 Clifton Road, NE., Mailstop E–07, Atlanta, Georgia 30333. Telephone 404/ 639–8317, Fax 404/639–8600, e-mail zkr7@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and VerDate Aug<31>2005 17:08 Mar 20, 2007 Jkt 211001 Medical Devices Dispute Resolution 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: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on scientific disputes between the Center for Devices and Radiological Health and sponsors, applicants, and manufacturers. Date and Time: The meeting will be held on April 19, 2007, from 8:30 a.m. to 5:30 p.m. Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Nancy Collazo-Braier, Center for Devices and Radiological Health (HFZ–1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3959, email: nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014510232. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Cardima Inc. related to the not-approvable determination for the premarket approval application (PMA) for the REVELATION Tx Microcatheter with NavAblator Ablation System, indicated for the treatment of drug refractory paroxysmal atrial fibrillation. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 FDA intends to make background material available to the public no later than 1 business day 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 April 5, 2007. Oral presentations from the public will be scheduled between approximately 9 a.m. and 9:30 a.m. and between approximately 1:30 p.m. and 2 p.m. 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 March 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 March 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 Ann Marie Williams, Conference Management Staff, at 301–827–7291, 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). E:\FR\FM\21MRN1.SGM 21MRN1 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Notices Dated: March 14, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–5152 Filed 3–20–07; 8:45 am] (4) Are the current NARMS international activities adequate to address the worldwide spread of antimicrobial-resistant foodborne bacteria? BILLING CODE 4160–01–S The subcommittee will discuss the NARMS Program and hear comments on the NARMS Program, including oral presentations from the public on scope, strengths, weaknesses, and areas for improvement. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Antimicrobial Resistance Monitoring System Program Subcommittee of the Science Advisory Board to the Food and Drug Administration; Notice of Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. jlentini on PROD1PC65 with NOTICES The Food and Drug Administration (FDA) is announcing the following public meeting: Science Board to the FDA National Antimicrobial Resistance Monitoring System (NARMS) Program Subcommittee meeting. The topic to be discussed is the National Antimicrobial Resistance Monitoring System (NARMS) Program. The subcommittee will provide advice to the Science Advisory Board to FDA regarding the NARMS program. Date and Time: The public meeting will be held on April 10, 2007, beginning at 9 a.m. Location: The DoubleTree Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner (HF–33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B–08), Rockville, MD 20857, 301–827–3340, email: Carlos.Pena@fda.hhs.gov. Agenda: The subcommittee will evaluate the NARMS program and address four questions relevant to the continued success of the program including: (1) Are there inherent biases in the sampling strategies employed in NARMS? If so, how can they be improved to ensure that the data and interpretation are scientifically sound given current resources? (2) Are there epidemiological and/or microbiological research studies that would better serve the goals of NARMS and the regulatory work of FDA? (3) Are current plans for data harmonization and reporting appropriate? If not, what are the top priorities for advancing harmonized reporting? and VerDate Aug<31>2005 17:08 Mar 20, 2007 Jkt 211001 Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone and fax number, and e-mail address), and written material and requests to make oral presentations, to the contact person on or before March 28, 2007. Interested persons may present data, information, or views, orally or in writing, on the issues pending before this subcommittee. Written submissions may be made to the contact person on or before March 28, 2007. Oral presentations from the public will be scheduled to begin at 11 a.m. on April 10, 2007. 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 March 20, 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 pubic hearing session. The contact person will notify interested person regarding their request to speak by March 20, 2007. If you need special accommodations due to a disability, please notify the hotel (301–468–1100) at least 7 days in advance of the meeting. Transcripts: Transcripts of the public meeting may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Dated: March 14, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–5153 Filed 3–20–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 13289 DEPARTMENT OF HOMELAND SECURITY Office of Grants and Training Assistance to Firefighters Grant Program AGENCY: Office of Grants and Training, DHS. ACTION: Notice of guidance. SUMMARY: This Notice is to provide guidelines that describe the application process for grants and the criteria for awarding grants in the 2007 Assistance to Firefighters Grant program year, as well as an explanation for any differences with the guidelines recommended to the Department by representatives of the Nation’s fire service leadership during the annual Criteria Development meeting held November 1–2, 2006. The program makes grants directly to fire departments and nonaffiliated emergency medical services organizations for the purpose of enhancing first-responders’ abilities to protect the health and safety of the public as well as that of first-responder personnel facing fire and fire-related hazards. In addition, the authorizing statute requires that a minimum of five percent of appropriated funds be expended for fire prevention and safety grants, which are also made directly to local fire departments and to local, regional, state or national entities recognized for their expertise in the field of fire prevention and firefighter safety research and development. As in prior years, this year’s grants will be awarded on a competitive basis to the applicants that best reflect the program’s criteria and funding priorities, and best address statutory award requirements. As referenced above, this Notice describes the criteria and funding priorities recommended by a panel of representatives of the Nation’s fire service leadership (criteria development panel) and accepted by the Department of Homeland Security, unless otherwise noted herein. This Notice contains details regarding the guidance and competitive process descriptions that the Department has provided to applicants and also provides information on how and why the Department deviated from recommendations of the criteria development panel. Authority: 15 U.S.C. 2229, 2229a. FOR FURTHER INFORMATION CONTACT: Brian Cowan, Director, Assistance to Firefighters Program Office, U.S. Department of Homeland Security, 245 E:\FR\FM\21MRN1.SGM 21MRN1

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[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Notices]
[Pages 13288-13289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Medical Devices Dispute Resolution 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: Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on scientific disputes between the Center 
for Devices and Radiological Health and sponsors, applicants, and 
manufacturers.
    Date and Time: The meeting will be held on April 19, 2007, from 
8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Nancy Collazo-Braier, Center for Devices and 
Radiological Health (HFZ-1), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3959, e-mail: 
nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014510232. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
regarding a scientific dispute between the agency and Cardima Inc. 
related to the not-approvable determination for the premarket approval 
application (PMA) for the REVELATION Tx Microcatheter with NavAblator 
Ablation System, indicated for the treatment of drug refractory 
paroxysmal atrial fibrillation.
    FDA intends to make background material available to the public no 
later than 1 business day 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 
April 5, 2007. Oral presentations from the public will be scheduled 
between approximately 9 a.m. and 9:30 a.m. and between approximately 
1:30 p.m. and 2 p.m. 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 
March 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 March 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 Ann Marie Williams, 
Conference Management Staff, at 301-827-7291, 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).


[[Page 13289]]


    Dated: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5152 Filed 3-20-07; 8:45 am]
BILLING CODE 4160-01-S

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