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.

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 

http://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

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 http://

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.

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49661

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 28, 

2005 (70 FR 37102), FDA published a 

notice announcing the availability of a 

draft guidance for industry entitled 

‘‘Gingivitis: Development and 

Evaluation of Drugs for Treatment or 

Prevention.’’ This guidance is intended 

to assist sponsors in conducting clinical 

trials for drug products that treat or 

prevent gingivitis. The guidance 

document provides assistance in several 

ways. It addresses specific design 

elements such as choosing inclusionary 

and exclusionary criteria, selecting 

relevant endpoints, assessing gingivitis, 

determining the clinical significance of 

the effect, and collecting meaningful 

safety data. It also provides comments 

on general concerns (e.g., prevention 

versus treatment claims, over-thecounter versus prescription status, 

special population enrollment, and 

nonclinical development issues related 

to products that are intended for 

administration within the oral cavity for 

the treatment or prevention of 

gingivitis). The initial comment period 

closes on August 29, 2005.

II. Extension of Time

On July 15, 2005, the Consumer 

Healthcare Products Association 

requested a 60-day extension beyond 

the August 29, 2005, deadline for the 

submission of comments. The request 

stated that additional time is needed to 

assemble a comprehensive submission 

that requires coordinating extensive 

input from representatives of their 

member companies. FDA considers an 

extension of time for submission of 

comments to be in the public interest. 

Accordingly, FDA is extending the 

comment period for 60 days to October 

28, 2005, as requested.

III. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/

ohrms/dockets/default.htm.

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16754 Filed 8–23–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Request for Nominations for 

Voting Members

AGENCY: Health Resources and Services 

Administration, HHS.

ACTION: Notice; amendment.

SUMMARY: The Health Resources and 

Services Administration is amending a 

notice that appeared in the Federal 

Register of July 8, 2005, FR Doc. 13422, 

pages 39517–38518, requesting 

nominations for voting members to fill 

three vacancies on the Advisory 

Commission on Childhood Vaccines. 

The deadline date for receiving 

nominations was on or before August 8, 

2005. This document amends the notice 

by extending the deadline date for 

receiving nominations.

DATES: The agency must receive 

nominations on or before September 16, 

2005.

FOR FURTHER INFORMATION CONTACT: Ms. 

Cheryl Lee at 301–443–2124 or e-mail 

clee@hrsa.gov.

Dated: August 18, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 05–16789 Filed 8–23–05; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on the 

National Health Service Corps; Notice 

of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: National Advisory Council on the 

National Health Service Corps. 

Dates and Times: September 8, 2005, 1 

p.m.–7:30 p.m.; September 9, 2005, 8:30 

a.m.–6 p.m.; and September 10, 2005, 9 a.m.–

5:30 p.m. 

Place: Hamilton Crowne Plaza, 1001 14th 

Street NW., Washington, DC 20005, 202–

682–0111. 

Status: The meeting will be open to the 

public. 

Agenda: The Council will continue its 

discussion on the National Health Service 

Corps legislation in preparation for the 

upcoming reauthorization. Program staff and 

Agency management will provide guidance 

on program operations possible implications 

of legislative changes. 

For Further Information Contact: Tira 

Robinson-Patterson, Division of National 

Health Service Corps, Bureau of Health 

Professions, Health Resources and Services 

Administration, Parklawn Building, Room 

8A–55, 5600 Fishers Lane, Rockville, MD 

20857; telephone: (301) 594–4140.

Dated: August 17, 2005. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 05–16791 Filed 8–23–05; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Training in 

Primary Care Medicine and Dentistry; 

Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: Advisory Committee on Training in 

Primary Care Medicine and Dentistry. 

Date and Time: September 29, 2005, 8:30 

a.m.–4:30 p.m. and September 30, 2005, 8 

a.m.–2 p.m. 

Place: The Holiday Inn Select, 8120 

Wisconsin Avenue, Bethesda, Maryland 

20814. 

Status: The meeting will be open to the 

public. 

Purpose: The Advisory Committee 

provides advice and recommendations on a 

broad range of issues dealing with programs 

and activities authorized under section 747 

of the Public Health Service Act as amended 

by The Health Professions Education 

Partnership Act of 1998, Public Law 105–

392. At this meeting the Advisory Committee 

will begin work on its sixth report which will 

be submitted to Congress and to the Secretary 

of the Department of Health and Human 

Services in November 2006. The report will 

focus on the role of Title VII, section 747 

grant programs in preparing primary care 

practitioners to care for underserved highrisk groups and vulnerable populations. 

Agenda: The meeting on Thursday, 

September 29, will begin with opening 

comments from the Chair of the Advisory 

Committee who will welcome new members. 

Introductory remarks will be given by the