Notice of Public Meeting, 9096-9097 [E9-4318]
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9096
Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Notices
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–4313 Filed 2–27–09; 8:45 am]
Dated: February 19, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–4316 Filed 2–27–09; 8:45 am]
BILLING CODE 4163–18–P
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Notice of Public Meeting
National Center for Injury Prevention
and Control Initial Review Group
(NCIPC, IRG)
erowe on PROD1PC63 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Time and Date: 9 a.m.–9:30 a.m., March
19, 2009 (Open). 9:30 a.m.–6 p.m., March 19,
2009 (Closed).
Place: Embassy Suites of Buckhead, 3285
Peachtree Road, Atlanta, GA 30305,
telephone: (404) 261–7733.
Status: Portions of the meetings will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5, U.S.C., and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Section
10(d) of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services, and the Director, CDC, concerning
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
injury research that focuses on prevention
and control.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of individual research grant
applications submitted in response to Fiscal
Year 2009 Requests for Applications related
to the following individual research
announcement: RFA–CE–09–005, ‘‘Research
Priorities in Acute Injury Care (R01)’’.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Jane
Suen, Dr.P.H., M.S., NCIPC, CDC, 4770
Buford Highway, NE., Mailstop F–62,
Atlanta, Georgia 30341, telephone: (770) 488–
4281; fax (770) 488–4422.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
VerDate Nov<24>2008
12:24 Feb 27, 2009
Jkt 217001
AGENCY: The 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 public meeting.
SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the following public
meeting: ‘‘Partnerships to Advance the
National Occupational Research Agenda
(NORA).’’
Public Meeting Time and Date: 10
a.m.–4 p.m. EDT, June 17, 2009.
Place: Patriots Plaza, 395 E Street,
SW., Conference Room 9000,
Washington, DC 20201.
Purpose of Meeting: The National
Occupational Research Agenda (NORA)
has been structured to engage partners
with each other and/or with NIOSH to
advance NORA priorities. The NORA
Liaison Committee continues to be an
opportunity for representatives from
organizations with national scope to
learn about NORA progress and to
suggest possible partnerships based on
their organization’s mission and
contacts. This opportunity is now
structured as a public meeting via the
internet to attract participation by a
larger number of organizations and to
further enhance the success of NORA.
Some of the types of organizations of
national scope that are especially
encouraged to participate are employers,
unions, trade associations, labor
associations, professional associations,
and foundations. Others are welcome.
This meeting will include updates
from NIOSH leadership on NORA as
well as updates from approximately half
of the Sector Councils on their progress,
priorities, and implementation plans to
date, including the Construction Sector;
Manufacturing Sector; Services Sector;
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Public Safety Sub-Sector; and Wholesale
and Retail Trade Sector. Updates will
also be given on cross-council
coordination activities in the areas of
surveillance and safety culture. After
each update, there will be time to
discuss partnership opportunities.
Status: The meeting is open to the
public, limited only by the capacities of
the conference call and conference room
facilities. There is limited space
available in the meeting room (capacity
34). Therefore, information to allow
participation in the meeting through the
internet (to see the slides) and a
teleconference call (capacity 50) will be
provided to registered participants.
Participants are encouraged to consider
attending by this method. Each
participant is requested to register for
the free meeting by sending an e-mail to
noracoordinator@cdc.gov containing the
participant’s name, organization name,
contact telephone number on the day of
the meeting, and preference for
participation by web meeting
(requirements include: computer,
internet connection, and telephone,
preferably with ‘‘mute’’ capability) or in
person. An e-mail confirming
registration will include the details
needed to participate in the web
meeting. Non-US citizens are
encouraged to participate in the web
meeting. Non-US citizens registering to
attend in person after June 3 will not
have time to comply with security
procedures.
Background: NORA is a partnership
program to stimulate innovative
research in occupational safety and
health leading to improved workplace
practices. Unveiled in 1996, NORA has
become a research framework for the
nation. Diverse parties collaborate to
identify the most critical issues in
workplace safety and health. Partners
then work together to develop goals and
objectives for addressing those needs
and to move the research results into
practice. The NIOSH role is facilitator of
the process. For more information about
NORA, see https://www.cdc.gov/niosh/
nora/about.html.
Since 2006, NORA has been
structured according to industrial
sectors. Eight sector groups have been
defined using the North American
Industrial Classification System
(NAICS). After receiving public input
through the web and town hall
meetings, NORA Sector Councils have
been working to define sector-specific
strategic plans for conducting research
and moving the results into widespread
practice. During 2008–09, most of these
Councils have posted draft strategic
plans for public comment. Two have
posted finalized National Sector
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02MRN1
Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Notices
Agendas after considering comments on
the drafts. For more information, see the
link above and choose ‘‘Sector-based
Approach,’’ ‘‘NORA Sector Councils,’’
‘‘Sector Agendas’’ and ‘‘Comment on
Draft Sector Agendas’’ from the rightside menu.
Contact Person for Technical
Information: Sidney C. Soderholm, PhD,
NORA Coordinator, e-mail
noracoordinator@cdc.gov, telephone
(202) 245–0665.
Dated: February 18, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–4318 Filed 2–27–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0092]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Class II Special
Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
AGENCY:
Food and Drug Administration,
HHS.
erowe on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information concerning
class II special controls for automated
blood cell separator device operating by
centrifugal or filtration separation
principle.
DATES: Submit written or electronic
comments on the collection of
information by May 1, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
VerDate Nov<24>2008
12:24 Feb 27, 2009
Jkt 217001
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle (OMB Control
Number 0910–0594)—Extension
Under the Safe Medical Devices Act
of 1990 (Public Law 101–629, 104 Stat.
4511), FDA may establish special
controls, including performance
standards, postmarket surveillance,
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9097
patient registries, guidelines, and other
appropriate actions it believes necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
The special control guidance serves to
support the reclassification from class
III to class II of the automated blood cell
separator device operating on a
centrifugal separation principle
intended for the routine collection of
blood and blood components as well as
the special control for the automated
blood cell separator device operating on
a filtration separation principle
intended for the routine collection of
blood and blood components
reclassified as class II (§ 864.9245 (21
CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA for 3 consecutive years an
annual report on the anniversary date of
the device reclassification from class III
to class II or, on the anniversary date of
the section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
act should be included in the annual
report. Also, a manufacturer of a device
determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components, should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the act (21 U.S.C. 360e),
and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval under part 814, subpart E
(21 CFR part 814, subpart E), including
E:\FR\FM\02MRN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 39 (Monday, March 2, 2009)]
[Notices]
[Pages 9096-9097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Public Meeting
AGENCY: The 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 public meeting.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the following public meeting: ``Partnerships to Advance the
National Occupational Research Agenda (NORA).''
Public Meeting Time and Date: 10 a.m.-4 p.m. EDT, June 17, 2009.
Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000,
Washington, DC 20201.
Purpose of Meeting: The National Occupational Research Agenda
(NORA) has been structured to engage partners with each other and/or
with NIOSH to advance NORA priorities. The NORA Liaison Committee
continues to be an opportunity for representatives from organizations
with national scope to learn about NORA progress and to suggest
possible partnerships based on their organization's mission and
contacts. This opportunity is now structured as a public meeting via
the internet to attract participation by a larger number of
organizations and to further enhance the success of NORA. Some of the
types of organizations of national scope that are especially encouraged
to participate are employers, unions, trade associations, labor
associations, professional associations, and foundations. Others are
welcome.
This meeting will include updates from NIOSH leadership on NORA as
well as updates from approximately half of the Sector Councils on their
progress, priorities, and implementation plans to date, including the
Construction Sector; Manufacturing Sector; Services Sector; Public
Safety Sub-Sector; and Wholesale and Retail Trade Sector. Updates will
also be given on cross-council coordination activities in the areas of
surveillance and safety culture. After each update, there will be time
to discuss partnership opportunities.
Status: The meeting is open to the public, limited only by the
capacities of the conference call and conference room facilities. There
is limited space available in the meeting room (capacity 34).
Therefore, information to allow participation in the meeting through
the internet (to see the slides) and a teleconference call (capacity
50) will be provided to registered participants. Participants are
encouraged to consider attending by this method. Each participant is
requested to register for the free meeting by sending an e-mail to
noracoordinator@cdc.gov containing the participant's name, organization
name, contact telephone number on the day of the meeting, and
preference for participation by web meeting (requirements include:
computer, internet connection, and telephone, preferably with ``mute''
capability) or in person. An e-mail confirming registration will
include the details needed to participate in the web meeting. Non-US
citizens are encouraged to participate in the web meeting. Non-US
citizens registering to attend in person after June 3 will not have
time to comply with security procedures.
Background: NORA is a partnership program to stimulate innovative
research in occupational safety and health leading to improved
workplace practices. Unveiled in 1996, NORA has become a research
framework for the nation. Diverse parties collaborate to identify the
most critical issues in workplace safety and health. Partners then work
together to develop goals and objectives for addressing those needs and
to move the research results into practice. The NIOSH role is
facilitator of the process. For more information about NORA, see http:/
/www.cdc.gov/niosh/nora/about.html.
Since 2006, NORA has been structured according to industrial
sectors. Eight sector groups have been defined using the North American
Industrial Classification System (NAICS). After receiving public input
through the web and town hall meetings, NORA Sector Councils have been
working to define sector-specific strategic plans for conducting
research and moving the results into widespread practice. During 2008-
09, most of these Councils have posted draft strategic plans for public
comment. Two have posted finalized National Sector
[[Page 9097]]
Agendas after considering comments on the drafts. For more information,
see the link above and choose ``Sector-based Approach,'' ``NORA Sector
Councils,'' ``Sector Agendas'' and ``Comment on Draft Sector Agendas''
from the right-side menu.
Contact Person for Technical Information: Sidney C. Soderholm, PhD,
NORA Coordinator, e-mail noracoordinator@cdc.gov, telephone (202) 245-
0665.
Dated: February 18, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-4318 Filed 2-27-09; 8:45 am]
BILLING CODE 4163-18-P
