Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Impact of Japanese Encephalitis Vaccination in Cambodia, Funding Opportunity Announcement (FOA) CK10-003, Initial Review, 9423 [2010-4288]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with NOTICES Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation 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 March 23, 2010, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Tracy Phillips, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6150, Tracy.Phillips@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512521. 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 March 23, 2010, the committee will discuss and make recommendations on issues relevant to FDA’s reevaluation of the ReGen Collagen Scaffold (CS) device (marketed as the Menaflex®), which FDA cleared in K082079 on December 18, 2008, sponsored by ReGen Biologics, Inc. The indications for use statement for this device states that the device is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure. 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 VerDate Nov<24>2008 15:07 Mar 01, 2010 Jkt 220001 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present views, orally or in writing, on issues pending before the committee. These views may be submitted in writing to the contact person on or before March 16, 2010. Oral presentations from the public will be scheduled at approximately 1 p.m., immediately following lunch. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the 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 8, 2010. 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 9, 2010. 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, at 301–796–5966, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 24, 2010. Joanne Less, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–4260 Filed 3–1–10; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 9423 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Impact of Japanese Encephalitis Vaccination in Cambodia, Funding Opportunity Announcement (FOA) CK10–003, Initial Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 12 p.m.–2 p.m., May 3, 2010 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters to be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Impact of Japanese Encephalitis Vaccination in Cambodia, FOA CK10–003.’’ Contact Person for More Information: Gregory Anderson, M.S., M.P.H., Scientific Review Officer, CDC, 1600 Clifton Road, NE., Mailstop E60, Atlanta, GA 30333, Telephone: (404) 498–2293. 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 CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 24, 2010. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2010–4288 Filed 3–1–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Agency Information Collection Activities: African Growth and Opportunity Act Certificate of Origin AGENCY: U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day Notice and request for comments; Extension of an existing collection of information: 1651–0082. SUMMARY: As part of its continuing effort to reduce paperwork and respondent E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Page 9423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Disease, Disability, and Injury Prevention and Control Special 
Emphasis Panel (SEP): Impact of Japanese Encephalitis Vaccination in 
Cambodia, Funding Opportunity Announcement (FOA) CK10-003, Initial 
Review

    In accordance with Section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the aforementioned meeting:

    Time and Date: 12 p.m.-2 p.m., May 3, 2010 (Closed).
    Place: Teleconference.
    Status: The meeting will be closed to the public in accordance 
with provisions set forth in Section 552b(c)(4) and (6), Title 5 
U.S.C., and the Determination of the Director, Management Analysis 
and Services Office, CDC, pursuant to Public Law 92-463.
    Matters to be Discussed: The meeting will include the initial 
review, discussion, and evaluation of applications received in 
response to ``Impact of Japanese Encephalitis Vaccination in 
Cambodia, FOA CK10-003.''
    Contact Person for More Information: Gregory Anderson, M.S., 
M.P.H., Scientific Review Officer, CDC, 1600 Clifton Road, NE., 
Mailstop E60, Atlanta, GA 30333, Telephone: (404) 498-2293.
    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 CDC and the Agency for Toxic Substances and 
Disease Registry.

    Dated: February 24, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2010-4288 Filed 3-1-10; 8:45 am]
BILLING CODE 4163-18-P
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