70 FR 68 pg. 18406 - Obstetrics and Gynecology Devices Panel of the Medical DevicesAdvisory Committee; Notice of Meeting
Type: NOTICEVolume: 70Number: 68Page: 18406
FR document: [FR Doc. 05-7131 Filed 4-8-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices Panel of the Medical DevicesAdvisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
This notice announces a forthcoming meeting of a public advisorycommittee of the Food and Drug Administration (FDA). The meeting will beopen to the public.
Name of Committee : Obstetrics and Gynecology DevicesPanel of the Medical Devices Advisory Committee.
General Function of the Committee : To provide advice andrecommendations to the agency on FDA's regulatory issues.
Date and Time : The meeting will be held on May 17, 2005,8:30 a.m. to 5 p.m.
Location : Holiday Inn, Walker/Whetstone Rooms, TwoMontgomery Village Ave., Gaithersburg, MD.
Contact Person : Michael Bailey, Center for Devices andRadiological Health (HFZ-470), Food and Drug Administration, 9200Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDAAdvisory Committee Information Line, 1-800-741-8138(301-443-0572 in the Washington, DC area), code 3014512524.Please call the Information Line for up-to-date information on thismeeting.
Agenda : The committee will hear a presentation by theOffice of Surveillance and Biometrics in the Center for Devices andRadiological Health outlining their responsibility for the review ofpostmarket study design. The committee will also discuss, makerecommendations, and vote on a premarket approval application for aspectroscopy-based cervical imaging system intended for use as an adjunctto colposcopy to enhance the identification and selection of biopsy sites.Background information, including the agenda and questions for thecommittee, will be available to the public 1 business day before themeeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html . Material for the May 17,2005, meeting will be posted on May 16, 2005.
Procedure : Interested persons may present data,information, or views, orally or in writing, on issues pending before thecommittee. Written submissions may be made to the contact person by May10, 2005. Oral presentations from the public will be scheduled betweenapproximately 9 a.m. and 9:30 a.m. and between approximately 3:30 p.m. and4 p.m. Time allotted for each presentation may be limited. Those desiringto make formal oral presentations should notify the contact person beforeMay 10, 2005, and submit a brief statement of the general nature of theevidence or arguments they wish to present, the names and addresses ofproposed participants, and an indication of the approximate time requestedto make their presentation.
Persons attending FDA's advisory committee meetings are advised that theagency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committeemeetings and will make every effort to accommodate persons with physicaldisabilities or special needs. If you require special accommodations due toa disability, please contact AnnMarie Williams, Conference ManagementStaff, at 240-276-0450, ext. 113, at least 7 days in advance ofthe meeting.
Notice of this meeting is given under the Federal Advisory Committee Act(5 U.S.C. app. 2).
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7131 Filed 4-8-05; 8:45 am]
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