Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management, 40844-40845 [2010-17068]
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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
specific topic evaluated by the ICH Q4B
process.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: July 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
National Institutes of Health
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
National Institute of Mental Health;
Notice of Closed Meeting
emcdonald on DSK2BSOYB1PROD with NOTICES
[FR Doc. 2010–17129 Filed 7–13–10; 8:45 am]
Town Hall Discussion With the Director
of the Center for Devices and
Radiological Health and Other Senior
Center Management
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
Jkt 220001
Dated: July 8, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[Docket No. FDA–2010–N–0321]
BILLING CODE 4160–01–S
16:07 Jul 13, 2010
Name of Committee: National Institute of
Mental Health Special Emphasis Panel, HIV/
AIDS Intervention Development.
Date: July 22, 2010.
Time: 9 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852. (Telephone
Conference Call)
Contact Person: Enid Light, PhD, Scientific
Review Officer, Division of Extramural
Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001
Executive Blvd., Room 6132, MSC 9608,
Bethesda, MD 20892–9608. 301–443–0322.
elight@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review funding
cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Food and Drug Administration
[FR Doc. 2010–17055 Filed 7–13–10; 8:45 am]
VerDate Mar<15>2010
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
ACTION: Notice of public meeting;
request for comments.
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled: ‘‘Town Hall Discussion With
the Director of the Center for Devices
and Radiological Health and Other
Senior Center Management.’’ The
purpose of this meeting is to present the
Center for Devices and Radiological
Health (CDRH) Fiscal Year (FY) 2010
Priorities. In addition, FDA is interested
in engaging in discussions about issues
that are of importance to the medical
device industry.
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Date and Time: The public meeting
will be held on October 7, 2010, from
8 a.m. to 12 noon.
Location: The public meeting will be
held at the Hilton Irvine/Orange County
Airport Hotel, 18800 MacArthur Blvd.,
Irvine, CA 92612. The meeting will not
be videotaped or webcast.
Contact: Heather Howell, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 66, rm. 4320,
Silver Spring, MD 20993, 301–796–
5718, email: heather.howell@fda.hhs.
gov.
Registration and Requests for Oral
Presentations: If you wish to attend the
public meeting, you must register online
at https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm215113.htm. Those without Internet
access may contact Heather Howell (see
Contact).
Provide complete contact information
for each attendee, including name, title,
company or organization, address,
email, telephone and fax number.
Registration requests must be received
by 5 p.m. on Wednesday, September 22,
2010.
If you wish to make an oral
presentation during any of the
discussions at the meeting (see section
II of this document, Public Meeting),
you must indicate this at the time of
registration. FDA will do its best to
accommodate requests to speak.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin.
Registration is free and will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the public
meeting will be provided on a spaceavailable basis beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan at 301–796–5661 or by email:
susan.monahan@fda.hhs.gov at least 7
days in advance.
Comments: FDA is holding this public
meeting to share information and
discuss issues of importance to the
medical device industry. CDRH is
specifically interested in addressing the
following question: What mechanism(s)
would you prefer or suggest for FDA to
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
engage with industry? The deadline for
responding to this question and for
submitting other comments related to
this public meeting is September 22,
2010.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments
regarding this document. Submit
electronic comments to https://www.
regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville MD 20852. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK2BSOYB1PROD with NOTICES
I. Background
CDRH has announced four priority
areas of activity for FY 2010, each of
which presents significant opportunities
to improve the Center’s effectiveness in
fulfilling our public health mission.
More information, including specific
goals and actions associated with each
priority, is available under ‘‘CDRH
Strategic Planning’’ at www.fda.gov/
AboutFDA/CentersOffices/CDRH.
II. Public Meeting
The objective of this public meeting is
to present the CDRH FY 2010 priorities.
In addition, FDA is interested in
engaging in discussions about issues
that are of importance to the medical
device industry. CDRH wishes to obtain
feedback/ideas for facilitating two-way
communication between CDRH and the
medical device industry.
The meeting will open with an
introduction of CDRH Senior Staff in
attendance. Following introductions, Dr.
Jeffrey Shuren, the Director of CDRH,
will present the FY 2010 CDRH
priorities. Industry representatives and
other members of the public will then
be given the opportunity to present
comments to CDRH Senior Staff.
Attendees from CDRH may respond to
questions presented by industry and
other members of the public.
In advance of the meeting, additional
information, including a meeting agenda
with a speakers’ schedule, will be made
available on the Internet. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at https://
www.regulations.gov. This information
VerDate Mar<15>2010
16:07 Jul 13, 2010
Jkt 220001
will also be available at https://www.fda.
gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm
(select the appropriate meeting from the
list).
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations
.gov. The transcript may be viewed at
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: July 8, 2010.
Nancy Stade,
Acting Associate Director for Regulations and
Policy, Center for Devices and Radiological
Health.
[FR Doc. 2010–17068 Filed 7–13–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH 141–A]
Preventing Deaths and Injuries of Fire
Fighters Using Risk Management
Principles at Structure Fires
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of issuance of Final
Guidance Publication.
SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the availability of the
publication entitled ‘‘Preventing Deaths
and Injuries of Fire Fighters Using Risk
Management Principles at Structure
Fires.’’
The final document can be found at:
https://www.cdc.gov/niosh/docs/2010153/.
Background and Summary of
Document: NIOSH has developed this
publication to assist the U.S. fire service
in preventing fire fighter injuries and
deaths at structure fires. Established fire
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40845
service risk management principles
suggest that caution should be exercised
in abandoned, vacant and unoccupied
structures and in situations where there
is no clear evidence indicating that
people are trapped inside the structure
and can be saved. This publication
summarizes fatality statistics from the
National Fire Protection Association as
well as the NIOSH Fire Fighter Fatality
Investigation and Prevention Program
(FFFIPP) databases. The publication
describes four case studies on the deaths
of five fire fighters and injuries to 10
others during fire suppression
operations in and around structures
with considerable fire involvement
where there were indications that the
structures were unoccupied. The
publication presents a number of
recommendations for preventing similar
occurrences of fire fighter injuries and
deaths. The primary audiences are
expected to be fire commissioners, fire
chiefs, fire department and municipal
managers, fire fighters, labor unions,
safety and health professionals, trainers,
fire investigators, State fire marshals,
and other interested parties.
This guidance publication does not
have the force and effect of law.
Document Review Process: Following
development of the initial draft, the
document was reviewed by peers and
external stakeholders within the fire
service and revisions were made based
upon these reviews. The revised draft
document was posted in the Federal
Register for public review and comment
from January 5 to March 9, 2009. Public
comments submitted to NIOSH Public
Docket 141 can be viewed at the Web
site https://www.cdc.gov/niosh/docket/
nioshdocket0141.html. The draft
document was revised to address these
public comments. The most substantive
revisions were to change the title and
focus of the document from fighting
fires in unoccupied structures to using
established risk management principles
at all structure fires, regardless of the
occupancy status. The majority of
comments received during the public
comment period made it clear that the
U.S. fire service would not support the
recommendation that fire fighters avoid
entering unoccupied structures, the
focus of the original draft. A final draft
containing revisions made to address
comments received during the public
comment period was reviewed by
representatives from both the
International Association of Fire Chiefs
(IAFC) and the International Association
of Fire Fighters (IAFF).
FOR FURTHER INFORMATION CONTACT:
Timothy R. Merinar, Safety Engineer,
Division of Safety Research, CDC/
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40844-40845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17068]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0321]
Town Hall Discussion With the Director of the Center for Devices
and Radiological Health and Other Senior Center Management
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Town Hall Discussion With the Director of the
Center for Devices and Radiological Health and Other Senior Center
Management.'' The purpose of this meeting is to present the Center for
Devices and Radiological Health (CDRH) Fiscal Year (FY) 2010
Priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
Date and Time: The public meeting will be held on October 7, 2010,
from 8 a.m. to 12 noon.
Location: The public meeting will be held at the Hilton Irvine/
Orange County Airport Hotel, 18800 MacArthur Blvd., Irvine, CA 92612.
The meeting will not be videotaped or webcast.
Contact: Heather Howell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg.
66, rm. 4320, Silver Spring, MD 20993, 301-796-5718, email:
heather.howell@fda.hhs.gov.
Registration and Requests for Oral Presentations: If you wish to
attend the public meeting, you must register online at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215113.htm. Those without Internet access may contact Heather Howell
(see Contact).
Provide complete contact information for each attendee, including
name, title, company or organization, address, email, telephone and fax
number. Registration requests must be received by 5 p.m. on Wednesday,
September 22, 2010.
If you wish to make an oral presentation during any of the
discussions at the meeting (see section II of this document, Public
Meeting), you must indicate this at the time of registration. FDA will
do its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan at 301-796-5661 or by email:
susan.monahan@fda.hhs.gov at least 7 days in advance.
Comments: FDA is holding this public meeting to share information
and discuss issues of importance to the medical device industry. CDRH
is specifically interested in addressing the following question: What
mechanism(s) would you prefer or suggest for FDA to
[[Page 40845]]
engage with industry? The deadline for responding to this question and
for submitting other comments related to this public meeting is
September 22, 2010.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments regarding this
document. Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville MD 20852. It is only necessary to send one set of comments.
It is no longer necessary to send two copies of mailed comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH has announced four priority areas of activity for FY 2010,
each of which presents significant opportunities to improve the
Center's effectiveness in fulfilling our public health mission. More
information, including specific goals and actions associated with each
priority, is available under ``CDRH Strategic Planning'' at
www.fda.gov/AboutFDA/CentersOffices/CDRH.
II. Public Meeting
The objective of this public meeting is to present the CDRH FY 2010
priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
CDRH wishes to obtain feedback/ideas for facilitating two-way
communication between CDRH and the medical device industry.
The meeting will open with an introduction of CDRH Senior Staff in
attendance. Following introductions, Dr. Jeffrey Shuren, the Director
of CDRH, will present the FY 2010 CDRH priorities. Industry
representatives and other members of the public will then be given the
opportunity to present comments to CDRH Senior Staff. Attendees from
CDRH may respond to questions presented by industry and other members
of the public.
In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule, will be made available on the
Internet. This information will be placed on file in the public docket
(docket number found in brackets in the heading of this document),
which is available at https://www.regulations.gov. This information will
also be available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list).
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. The transcript may be
viewed at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: July 8, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-17068 Filed 7-13-10; 8:45 am]
BILLING CODE 4160-01-S
