[Federal Register: July 22, 2005 (Volume 70, Number 140)]
[Notices]               
[Page 42345-42346]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy05-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
General Hospital and Personal Use Devices Panel of the Medical 
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 the Committee: General Hospital and Personal Use 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 August 9, 2005, from 8 
a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Scott A. Colburn, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-6892, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512520. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will hear a presentation by the Office of 
Surveillance and Biometrics in the Center for Devices and Radiological 
Health outlining their responsibility for the review of postmarket 
study design. The committee will discuss and make recommendations on 
methods to assess the potential of disease transmission by multiple-use 
nozzle jet injectors (i.e., jet injectors for which the fluid path for 
the injection is used more than once). The discussion will include 
premarket testing recommendations to address this issue.
    Background information for the topic, including the agenda and 
questions for the committee, will be available to the public 1 business 
day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html
.

    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 by August 3, 
2005. Oral presentations from the public will be scheduled for 
approximately 30 minutes at the beginning of deliberations and for 
approximately 30 minutes near the end of deliberations. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before August 3, 
2005, 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.
    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 240-276-0450, ext. 113, at least 7 days 
in advance of the meeting.

[[Page 42346]]

    Notice of this meeting is given under the Federal Advisory 
committee Act (5 U.S.C. app. 2).

    Dated: July 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14455 Filed 7-21-05; 8:45 am]

BILLING CODE 4160-01-S