Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 49660 [05-16787]

Download as PDF 49660 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices 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). At least one portion of the meeting will be closed 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 September 8, 2005, from 8 a.m. to 6 p.m., and on September 9, 2005, from 8 a.m. to 1 p.m. Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Janet L. Scudiero, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1184, ext. 176, 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. Agenda: On September 8, 2005, 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 also hear an update on the status of recent devices brought before the committee. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for a hip joint metal/metal semi-constrained resurfacing hybrid prosthesis (cemented femoral component and uncemented acetabular component). The device is intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes. On September 9, 2005, the committee will discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain. VerDate jul<14>2003 15:23 Aug 23, 2005 Jkt 205001 Background information for the topics, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at https://www.fda.gov/cdrh/panel/ index.html. Material for the September 8 session will be posted September 7, 2005; material for the September 9 session will be posted September 8, 2005. Procedure: On September 8, 2005, from 8:30 a.m. to 6 p.m., the meeting will be open to the public. 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 29, 2005. On September 8, 2005, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of the committee deliberations and for approximately 30 minutes near the end of the deliberations. On September 9, 2005, oral presentations from the public will be scheduled from approximately 8:30 a.m. to 9:30 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 29, 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. Closed Committee Deliberations: On September 8, 2005, from 8 a.m. to 8:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) relating to pending issues and applications. 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 Shirley Meeks at 240–276–0450, ext. 105, 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). Dated: August 18, 2005. Scott Gottlieb, Deputy Commissioner for Policy. [FR Doc. 05–16787 Filed 8–23–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0240] Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending to October 28, 2005, the comment period for the draft guidance for industry entitled ‘‘Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.’’ The draft guidance is intended to assist sponsors in conducting clinical trials for drug products that treat or prevent gingivitis. It addresses specific protocol design elements as well as general concerns about drugs for this indication. FDA published a notice of availability of the draft guidance, with a comment period that closes on August 29, 2005. FDA is taking this action in response to a request for extension of the comment period to allow interested persons additional time to review the draft guidance and submit comments. DATES: Submit written or electronic comments on the draft guidance by October 28, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Frederick Hyman, Center for Drug Evaluation and Research (HFD–540), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–2020. E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Page 49660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16787]



[[Page 49660]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Orthopaedic and Rehabilitation Devices 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). At least one 
portion of the meeting will be closed 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 September 8, 2005, from 
8 a.m. to 6 p.m., and on September 9, 2005, from 8 a.m. to 1 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 
Perry Pkwy., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, 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.
    Agenda: On September 8, 2005, 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 also hear an 
update on the status of recent devices brought before the committee. 
Subsequently, the committee will discuss, make recommendations, and 
vote on a premarket approval application for a hip joint metal/metal 
semi-constrained resurfacing hybrid prosthesis (cemented femoral 
component and uncemented acetabular component). The device is intended 
to relieve hip pain and improve hip function in patients who have 
adequate bone stock and are at risk of requiring more than one hip 
joint replacement over their lifetimes.
    On September 9, 2005, the committee will discuss the design of 
clinical studies for spinal devices indicated for treatment of mild to 
moderate low back pain.
    Background information for the topics, including the agenda and 
questions for the committee, will be available to the public 1 business 
day before the meeting on the Internet at https://www.fda.gov/cdrh/
panel/. Material for the September 8 session will be posted 
September 7, 2005; material for the September 9 session will be posted 
September 8, 2005.
    Procedure: On September 8, 2005, from 8:30 a.m. to 6 p.m., the 
meeting will be open to the public. 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 29, 2005. On September 8, 2005, oral presentations 
from the public will be scheduled for approximately 30 minutes at the 
beginning of the committee deliberations and for approximately 30 
minutes near the end of the deliberations. On September 9, 2005, oral 
presentations from the public will be scheduled from approximately 8:30 
a.m. to 9:30 a.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before August 29, 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.
    Closed Committee Deliberations: On September 8, 2005, from 8 a.m. 
to 8:30 a.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential commercial information (5 
U.S.C. 552b(c)(4)) relating to pending issues and applications.
    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 Shirley Meeks at 
240-276-0450, ext. 105, 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).

    Dated: August 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16787 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.