National Institute of Environmental Health Sciences; Notice of Closed Meeting, 33452-33453 [E9-16565]
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Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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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: 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 August 18 and 19, 2009, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Ronald P. Jean,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 240–276–3676, 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. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 18, 2009, the
committee will discuss, make
recommendations and vote on a
premarket approval application (PMA)
for the CoMplete Acetabular Hip
System, sponsored by DePuy
Orthopaedics. This device system is
intended for use as a primary joint
replacement prosthesis in total hip
arthroplasty, and is indicated for
skeletally mature patients suffering
severe pain and disability due to
structural damage in the hip joint from
non-inflammatory degenerative joint
disease and its composite diagnoses of
osteoarthritis or post-traumatic arthritis.
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On August 19, 2009, the committee will
discuss, make recommendations and
vote on a PMA for Durolane, sponsored
by Q–Med AB. This device is indicated
for the treatment of pain caused by
osteoarthritis of the knee in patients
who have failed to respond adequately
to conservative non-pharmacological
therapy and simple analgesics, e.g.,
acetaminophen.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm, click on the year 2009 and
scroll down to the appropriate advisory
committee link.
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 August 4, 2009. Oral
presentations from the public will be
scheduled at approximately 1 p.m.,
immediately following lunch on both
days. 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 July 27,
2009. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 28, 2009.
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, 301–796–5966, at least 7 days in
advance of the meeting.
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FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittee/
AboutAdvisoryCommittee/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 1, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–16409 Filed 7–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
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 material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; ARRA Stem Cell
Competitive Supplement Review.
Date: July 27, 2009.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709 (Telephone
Conference Call).
Contact Person: Sally Eckert-Tilotta, PhD,
Scientific Review Administrator, Nat.
Institute of Environmental Health Sciences,
Office of Program Operations, Scientific
Review Branch, P.O. Box 12233, Research
Triangle Park, NC 27709. (919) 541–1446.
Eckertt1@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
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Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
Dated: July 7, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–16565 Filed 7–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–693, Revision of a
Currently Approved Information
Collection; Comment Request
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION: 30–Day Notice of Information
Collection Under Review: Form I–693,
Report of Medical Examination and
Vaccination Record, OMB Control No.
1615–0033.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on April 24, 2009, at 74 FR
18737, allowing for a 60-day public
comment period. USCIS received one
comment.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until August 12,
2009. This process is conducted in
accordance with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB), USCIS
Desk Officer. Comments may be
submitted to: USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, Washington, DC
20529–2210. Comments may also be
submitted to DHS via facsimile to 202–
272–8352 or via e-mail at
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21:29 Jul 10, 2009
Jkt 217001
rfs.regs@dhs.gov, and to the OMB USCIS
Desk Officer via facsimile at 202–395–
5806 or via e-mail at
oira_submission@omb.eop.gov.
When submitting comments by email, please make sure to add OMB
Control No. 1615–0033 in the subject
box. Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of this information
collection:
(1) Type of Information Collection:
Revision of a currently approved
information collection.
(2) Title of the Form/Collection:
Report of Medical Examination and
Vaccination Record.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–693.
U.S. Citizenship and Immigration
Services.
(4) Affected public who will be asked
or required to respond, as well as brief
abstract: Primary: Individuals or
households. The information on the
application will be used by USCIS in
considering the eligibility for
adjustment of status under 8 CFR part
209 and 8 CFR 210.5, 245.1, and 245a.3.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 800,000 responses at 2.5 hours
per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 2,000,000 annual burden
hours.
If you need a copy of the information
collection instrument, please visit the
Web site at: https://www.regulations.
gov/.
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We may also be contacted at: USCIS,
Regulatory Products Division, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210,
Telephone number 202–272–8377.
Dated: July 8, 2009.
Stephen Tarragon,
Deputy Chief, Regulatory Products Division,
U.S. Citizenship and Immigration Services.
[FR Doc. E9–16541 Filed 7–10–09; 8:45 am]
BILLING CODE 9111–97–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–730; Extension of an
Existing Information Collection;
Comment Request
ACTION: 60-Day Notice of Information
Collection Under Review; Form I–730,
Refugee/Asylee Relative Petition; OMB
Control No. 1615–0037.
The Department Homeland Security,
U.S. Citizenship and Immigration
Services (USCIS) has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted for
sixty days until September 11, 2009.
During this 60 day period, USCIS will
be evaluating whether to revise the
Form I–730. Should USCIS decide to
revise Form I–730 we will advise the
public when we publish the 30-day
notice in the Federal Register in
accordance with the Paperwork
Reduction Act. The public will then
have 30 days to comment on any
revisions to the Form I–730.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Clearance Officer,
111 Massachusetts Avenue, NW.,
Washington, DC 20529–2210.
Comments may also be submitted to
DHS via facsimile to 202–272–8352 or
via e-mail at rfs.regs@dhs.gov. When
submitting comments by e-mail, please
make sure to add OMB Control No.
1615–0037 in the subject box. Written
comments and suggestions from the
public and affected agencies concerning
the collection of information should
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Agencies
[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Notices]
[Pages 33452-33453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16565]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; Notice of
Closed Meeting
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 material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Environmental Health
Sciences Special Emphasis Panel; ARRA Stem Cell Competitive
Supplement Review.
Date: July 27, 2009.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: Nat. Inst. of Environmental Health Sciences, Building
101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research
Triangle Park, NC 27709 (Telephone Conference Call).
Contact Person: Sally Eckert-Tilotta, PhD, Scientific Review
Administrator, Nat. Institute of Environmental Health Sciences,
Office of Program Operations, Scientific Review Branch, P.O. Box
12233, Research Triangle Park, NC 27709. (919) 541-1446.
Eckertt1@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.115,
Biometry and Risk Estimation--Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
[[Page 33453]]
Hazardous Substances--Basic Research and Education; 93.894,
Resources and Manpower Development in the Environmental Health
Sciences; 93.113, Biological Response to Environmental Health
Hazards; 93.114, Applied Toxicological Research and Testing; 93.701,
ARRA Related Biomedical Research and Research Support Awards.,
National Institutes of Health, HHS)
Dated: July 7, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-16565 Filed 7-10-09; 8:45 am]
BILLING CODE 4140-01-P