Notice of Public Meeting, 4408-4409 [2010-1570]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES 4408 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Deborah Falls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512513. 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 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient’s epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when they begin), with or without secondary generalization that are refractory to antiepileptic medications. ‘‘Secondary generalization’’ is used to describe a partial-onset seizure that later spreads to the whole brain. ‘‘Refractory’’ to antiepileptic medications means that the patient’s epilepsy does not respond to approved medications. 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/ AdvisoryCommittees/Calendar/ default.htm. 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 March 5, 2010. Oral presentations from the public will be scheduled at approximately 1 p.m., VerDate Nov<24>2008 16:22 Jan 26, 2010 Jkt 220001 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 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 February 25, 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 February 26, 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, Conference Management Staff, 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: January 19, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–1519 Filed 1–26–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute Of General Medical Sciences; 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 material, 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 of General Medical Sciences Special Emphasis Panel; Interventions RFA Grant Review. Date: February 25, 2010. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike, Rockville, MD 20852. Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Administrator, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN12C, Bethesda, MD 20892, 301–594–2772, templeocm@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: January 20, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–1651 Filed 1–26–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Public Meeting The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH) announce a public meeting to obtain public comment on ‘‘A Public Health Action Plan to Combat Antimicrobial Resistance (Part I: Domestic Issues)’’. Time and Date: 12–1:30 p.m. EST, February 3, 2010. Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, Maryland 20814 (One Bethesda Metro Center). Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 200 people. Purpose: The purpose of the meeting is to present the annual report of E:\FR\FM\27JAN1.SGM 27JAN1 srobinson on DSKHWCL6B1PROD with NOTICES Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices progress by Federal agencies in accomplishing activities outlined in ‘‘A Public Health Action Plan to Combat Antimicrobial Resistance (Part I: Domestic Issues)’’ and obtain comments from the public regarding the annual report. ‘‘The Action Plan’’ serves as a blueprint for activities of Federal agencies to address the issue of antimicrobial resistance. The focus of the plan is on domestic issues. A copy of the plan and annual report can be found at https://www.cdc.gov/ drugresistance/actionplan/index.htm. Matters to be Discussed: The agenda will consist of welcome and introductory comments, executive summary (including a progress report on revising the Action Plan) and brief reports in each of four focus areas: Surveillance, Prevention and Control, Research, and Product Development. A general discussion will follow the brief reports. Comments and suggestions from the public for the Federal agencies related to each of the focus areas will be taken under advisement by the Antimicrobial Resistance Interagency Task Force. The agenda does not include development of consensus positions, guidelines, or discussions or endorsement of specific commercial products. Limited time will be available for oral questions, comments and suggestions from the public. Depending on the number of individuals wishing to comment, a time limit of three minutes per individual may be imposed. In the interest of time, visual aids will not be permitted, although written material may be submitted for subsequent review by the Task Force. Persons who anticipate attending the meeting are asked to send written notification to the contact person below by January 28, 2010. Notification information should include name, organization (if applicable), address, phone number, fax number, and e-mail address. Written comments and suggestions from the public are also encouraged and may be submitted to the contact person or email listed below but must be submitted for consideration no later than March 31, 2010. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Marsha A. Jones, Office of Antimicrobial Resistance, National Center for Emerging and Zoonotic Infectious Diseases (proposed), Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop A–07, Atlanta, Georgia 30333; telephone: 404–639– 4052; fax 404–718–2147; e-mail aractionplan@cdc.gov. VerDate Nov<24>2008 16:22 Jan 26, 2010 Jkt 220001 ‘‘The Public Health Action Plan to Combat Antimicrobial Resistance’’ (Action Plan) was developed by the Interagency Task Force on Antimicrobial Resistance. The Task Force, created in 1999, is cochaired by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Other Federal agencies that are members of the Task Force include the Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Department of Agriculture (USDA), the Department of Defense (DoD), the Department of Veterans Affairs (VA), and the Environmental Protection Agency (EPA). The Action Plan reflects a broadbased consensus of Federal agencies on actions needed to address antimicrobial resistance. Input from State and local health agencies, universities, professional organizations, pharmaceutical companies, health care delivery organizations, agricultural producers, consumer groups, and other members of the public was important in developing the plan. While some actions are already underway, complete implementation of this plan will require close collaboration with all of these partners, which is a major objective of this process. The 2001 Action Plan is under revision and is expected to be completed in 2010. Upon completion, the revised Action Plan will be available for public comment. SUPPLEMENTARY INFORMATION: Dated: January 20, 2010. Tanja Popovic, Chief Science Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–1570 Filed 1–26–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Ryan White HIV/AIDS Program Part D— Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of non-competitive replacement award. SUMMARY: The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 4409 award from the previous grantee, Orlando Health, Incorporated’s HUG– ME Program, to the Orange County Health Department, Orlando, Florida, that will ensure continuity of Part D HIV/AIDS care and treatment services without disruption to HIV/AIDSinfected women, infants and children in Orange County and the surrounding areas. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Orange County Health Department, Orlando, Florida. Amount of the Award: $750,576.00 Period of Support: The period of the supplemental support is from October 1, 2009 through July 31, 2010. Authority: This activity is under the authority of the Public Health Service Act as amended, Section 2671, (42 USC 300ff–71). The authority for the exception to competition is HHS Grants Policy Directive 2.04, Awarding Grants. Catalogue of Federal Domestic Assistance Number: 93.153. Justification for the Exception to Competition: Critical funding for HIV/ AIDS care and treatment to the target populations in Orange County, Orlando, Florida, and surrounding areas will be continued through a temporary, noncompetitive replacement award to the Orange County Health Department. This temporary award is needed because the former grantee, Orlando Health, Incorporated, has relinquished, effective September 30, 2009, the HUG–ME Program and the HRSA Grant Award supporting it (original Project Period August 1, 2008, through July 31, 2013). The Orange County Health Department is known Statewide as an exceptional site for HIV/AIDS care and treatment services, and has administered its own HRSA Ryan White HIV/AIDS Program Part D—Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth Grant for the past 9 years. It is well suited to undertake operations of the HUG–ME Program under the previously approved scope of project activities. Additionally, this organization has a thorough understanding of the characteristics and needs of HIV/AIDS-infected populations. The HIV/AIDS Bureau and its Division of Community Based Programs are not aware of any other organization that could provide good quality care and treatment services to the impacted service populations without additional time and resources being devoted to bringing that organization’s service capacity up to the level needed under the project scope of this award. This non-competitive replacement award will permit the E:\FR\FM\27JAN1.SGM 27JAN1

Agencies

[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Notices]
[Pages 4408-4409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1570]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Notice of Public Meeting

    The Centers for Disease Control and Prevention (CDC), Food and Drug 
Administration (FDA), and National Institutes of Health (NIH) announce 
a public meeting to obtain public comment on ``A Public Health Action 
Plan to Combat Antimicrobial Resistance (Part I: Domestic Issues)''.
    Time and Date: 12-1:30 p.m. EST, February 3, 2010.
    Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, 
Maryland 20814 (One Bethesda Metro Center).
    Status: Open to the public, limited only by the space available. 
The meeting room accommodates approximately 200 people.
    Purpose: The purpose of the meeting is to present the annual report 
of

[[Page 4409]]

progress by Federal agencies in accomplishing activities outlined in 
``A Public Health Action Plan to Combat Antimicrobial Resistance (Part 
I: Domestic Issues)'' and obtain comments from the public regarding the 
annual report. ``The Action Plan'' serves as a blueprint for activities 
of Federal agencies to address the issue of antimicrobial resistance. 
The focus of the plan is on domestic issues. A copy of the plan and 
annual report can be found at https://www.cdc.gov/drugresistance/actionplan/index.htm.
    Matters to be Discussed: The agenda will consist of welcome and 
introductory comments, executive summary (including a progress report 
on revising the Action Plan) and brief reports in each of four focus 
areas: Surveillance, Prevention and Control, Research, and Product 
Development. A general discussion will follow the brief reports.
    Comments and suggestions from the public for the Federal agencies 
related to each of the focus areas will be taken under advisement by 
the Antimicrobial Resistance Interagency Task Force. The agenda does 
not include development of consensus positions, guidelines, or 
discussions or endorsement of specific commercial products.
    Limited time will be available for oral questions, comments and 
suggestions from the public. Depending on the number of individuals 
wishing to comment, a time limit of three minutes per individual may be 
imposed. In the interest of time, visual aids will not be permitted, 
although written material may be submitted for subsequent review by the 
Task Force. Persons who anticipate attending the meeting are asked to 
send written notification to the contact person below by January 28, 
2010. Notification information should include name, organization (if 
applicable), address, phone number, fax number, and e-mail address.
    Written comments and suggestions from the public are also 
encouraged and may be submitted to the contact person or email listed 
below but must be submitted for consideration no later than March 31, 
2010.
    Agenda items are subject to change as priorities dictate.
    Contact Person for More Information: Marsha A. Jones, Office of 
Antimicrobial Resistance, National Center for Emerging and Zoonotic 
Infectious Diseases (proposed), Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE., Mailstop A-07, Atlanta, Georgia 
30333; telephone: 404-639-4052; fax 404-718-2147; e-mail 
aractionplan@cdc.gov.

SUPPLEMENTARY INFORMATION: ``The Public Health Action Plan to Combat 
Antimicrobial Resistance'' (Action Plan) was developed by the 
Interagency Task Force on Antimicrobial Resistance. The Task Force, 
created in 1999, is co-chaired by the Centers for Disease Control and 
Prevention (CDC), the Food and Drug Administration (FDA), and the 
National Institutes of Health (NIH). Other Federal agencies that are 
members of the Task Force include the Agency for Healthcare Research 
and Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), 
the Health Resources and Services Administration (HRSA), the Department 
of Agriculture (USDA), the Department of Defense (DoD), the Department 
of Veterans Affairs (VA), and the Environmental Protection Agency 
(EPA).
    The Action Plan reflects a broad-based consensus of Federal 
agencies on actions needed to address antimicrobial resistance. Input 
from State and local health agencies, universities, professional 
organizations, pharmaceutical companies, health care delivery 
organizations, agricultural producers, consumer groups, and other 
members of the public was important in developing the plan. While some 
actions are already underway, complete implementation of this plan will 
require close collaboration with all of these partners, which is a 
major objective of this process.
    The 2001 Action Plan is under revision and is expected to be 
completed in 2010. Upon completion, the revised Action Plan will be 
available for public comment.

    Dated: January 20, 2010.
Tanja Popovic,
Chief Science Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-1570 Filed 1-26-10; 8:45 am]
BILLING CODE 4163-18-P

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