Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting, 67879 [E6-19895]
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Federal Register / Vol. 71, No. 226 / Friday, November 24, 2006 / Notices
working closely with stakeholders and
maximizing the availability and clarity
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public. This is consistent with the
purposes of the Small Business
Representative Program, which are in
part to respond to industry inquiries,
develop educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s guidance, requirements, and
compliance policies. This workshop is
also consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121) that requires
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agencies directed to small businesses.
The goal of this public workshop is to
present information that will enable
FDA-regulated food facilities (farms,
manufacturers, processors, distributors,
retailers, and restaurants) to better
understand the regulations authorized
by the Bioterrorism Act, and food
defense guidance, especially in light of
growing concerns about food defense.
Information presented will be based on
agency position as articulated through
regulation, guidance, and information
previously made available to the public.
Topics to be discussed at the workshop
include the following: (1) Food defense
awareness, (2) ALERT: The Basics, (3)
FDA actions on bioterrorism legislation
(food supply), (4) food recalls, (5) crisis
management, and other related topics.
FDA expects that participation in this
public workshop will provide regulated
industry with greater understanding of
FDA regulations and guidance related to
food defense and increase voluntary
compliance and food defense
awareness.
Dated: November 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–19886 Filed 11–22–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Devices Dispute Resolution
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
cprice-sewell on PROD1PC66 with NOTICES
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). The meeting will be open to the
public.
VerDate Aug<31>2005
13:24 Nov 22, 2006
Jkt 211001
Name of Committee: Medical Devices
Dispute Resolution Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
scientific disputes between the Center
for Devices and Radiological Health and
sponsors, applicants, and
manufacturers.
Date and Time: The meeting will be
held on December 15, 2006, from 9 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Nancy Collazo-Braier,
Office of the Center Director (HFZ–1),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3959,
nancy.braier@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014510232. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss,
make recommendations, and vote
regarding a scientific dispute between
the agency and Acorn Corp. related to
the approvability of a premarket
approval application for the CorCap
Cardiac Support Device for patients
with dilated cardiomyopathy.
Background information for the topic,
including the attendee list, 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 (click on
Upcoming CDRH Advisory Panel/
Committee Meetings).
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 on or before December 1, 2006.
Oral presentations from the public will
be scheduled between approximately 9
a.m. and 9:30 a.m. and between
approximately 1 p.m. and 1:30 p.m. on
December 15, 2006. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person 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 on or before
December 1, 2006.
Persons attending FDA’s advisory
committee meetings are advised that the
PO 00000
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67879
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 Ann Marie
Williams, Conference Management
Staff, at 301–827–7291, 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: November 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–19895 Filed 11–22–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0451]
Guidance for Industry, Food and Drug
Administration Staff, Eye Care
Professionals, and Consumers;
Decorative, Non-Corrective Contact
Lenses; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Guidance for Industry, FDA Staff, Eye
Care Professionals, and Consumers:
Decorative, Non-Corrective Contact
Lenses.’’ This guidance document
explains recently enacted legislation
under which all contact lenses are
deemed devices within the meaning of
the Federal Food, Drug, and Cosmetic
Act (the act). All contact lenses,
including decorative, non-corrective
contact lenses, require premarket
approval or clearance by FDA and may
be dispensed only upon a lawful
prescription order by an eye care
professional. Although this guidance
document is being immediately
implemented, the agency welcomes
comments at any time in accordance
with the agency’s good guidance
practices (GGPs).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 71, Number 226 (Friday, November 24, 2006)]
[Notices]
[Page 67879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices Dispute Resolution 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). The meeting will
be open to the public.
Name of Committee: Medical Devices Dispute Resolution Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on scientific disputes between the Center
for Devices and Radiological Health and sponsors, applicants, and
manufacturers.
Date and Time: The meeting will be held on December 15, 2006, from
9 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Nancy Collazo-Braier, Office of the Center Director
(HFZ-1), Food and Drug Administration, 9200 Corporate Blvd., Rockville,
MD 20850, 240-276-3959, nancy.braier@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014510232. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote
regarding a scientific dispute between the agency and Acorn Corp.
related to the approvability of a premarket approval application for
the CorCap Cardiac Support Device for patients with dilated
cardiomyopathy. Background information for the topic, including the
attendee list, 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 (click on Upcoming CDRH
Advisory Panel/Committee Meetings).
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 on or before
December 1, 2006. Oral presentations from the public will be scheduled
between approximately 9 a.m. and 9:30 a.m. and between approximately 1
p.m. and 1:30 p.m. on December 15, 2006. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person 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
on or before December 1, 2006.
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 Ann Marie Williams,
Conference Management Staff, at 301-827-7291, 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: November 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19895 Filed 11-22-06; 8:45 am]
BILLING CODE 4160-01-S
