Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability; Extension of Comment Period, 49660-49661 [05-16754]
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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.
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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]
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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
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
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
https://www.fda.gov/cder/guidance/
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
index.htm or https://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]
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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
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49661
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]
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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
E:\FR\FM\24AUN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49660-49661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16754]
-----------------------------------------------------------------------
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 self-addressed 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.
[[Page 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-the-counter
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 https://www.fda.gov/cder/guidance/index.htm or https://
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]
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