Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 17422-17423 [2011-7259]
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17422
Federal Register / Vol. 76, No. 60 / Tuesday, March 29, 2011 / Notices
as a support for management decision
making.
Respondents: 55 State Developmental
Disabilities Councils.
ANNUAL BURDEN ESTIMATES
Plan ..................................................................................................
Estimated Total Annual Burden
Hours:
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–7157 Filed 3–28–11; 8:45 am]
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Number of responses per respondent
Number of respondents
Instrument
55
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
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). 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 May 12, 2011, from 8 a.m. to 6
p.m.
Location: Hilton, Washington DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877.
Contact Person: Margaret McCabeJanicki, Food and Drug Administration,
Center for Devices and Radiological
Health, 10903 New Hampshire Ave.,
Bldg. 66, rm. 1535, Silver Spring, MD
20993–0002, 301–796–7029, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 May 12, 2011, the
committee will discuss, make
PO 00000
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Average burden
hours per response
1
367
Total burden
hours
20,185
recommendations, and vote on
information related to the premarket
approval application (PMA) for the
Augment Bone Graft, sponsored by
Biomimetic Therapeutics, Inc. The
intended use of the device is as an
alternative bone grafting substitute to
autologous bone graft in applications to
facilitate fusion in the ankle and foot
without necessitating an additional
invasive procedure to harvest the graft.
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. 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 May 5, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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 April 25,
2011. 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 April 28, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
E:\FR\FM\29MRN1.SGM
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17423
Federal Register / Vol. 76, No. 60 / Tuesday, March 29, 2011 / Notices
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 Ms.
AnnMarie Williams, Conference
Management Staff, 301–796–5966, at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
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: March 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7259 Filed 3–28–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirements
of Section 3506(c)(2)(A) of Public Law
104–13, the Paperwork Reduction Act of
1995, the Health Resources and Services
Administration publishes summaries of
proposed data collection projects for
public comment. Comments are invited
regarding the following: (a) The
necessity of the proposed collection of
information for the proper performance
of the functions of the agency; (b) the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Teaching Health
Center Graduate Medical Education
(GME) Program—NEW
The Teaching Health Center Graduate
Medical Education (GME) program
(Section 340H of the Public Health
Service Act) was established by Section
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Number of respondents
Form
Responses
per respondent
5508 of Public Law 111–148, the Patient
Protection and Affordable Care Act. The
program supports training for primary
care residents (including residents in
family medicine, internal medicine,
pediatrics, internal medicine-pediatrics,
obstetrics and gynecology, psychiatry,
general dentistry, pediatric dentistry,
and geriatrics) in community-based
ambulatory patient care settings.
The statute provides that eligible
Teaching Health Centers receive
payments for both direct and indirect
costs associated with training residents
in community-based ambulatory patient
care centers. Direct payments are
designed to compensate eligible
Teaching Health Centers for those
expenses directly associated with
resident training, while indirect
payments are intended to compensate
for the additional costs of training
residents in such programs. Payments
are made at the beginning of the funding
cycle; however, the statute provides for
a reconciliation process, through which
overpayments may be recouped and
underpayments may be adjusted at the
end of the fiscal year. This data
collection instrument will gather
information relating to the numbers of
residents in Teaching Health Center
GME training programs in order to
reconcile payments for both direct and
indirect costs.
The annual estimate of burden is as
follows:
Total responses
Hours per response
Total burden
hours
11
1
11
10
110
Total ..............................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
Reconciliation form ..............................................................
11
........................
11
10
110
To request more information on this
proposed project or to obtain a copy of
the draft data collection plans and
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: March 23, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–7317 Filed 3–28–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Laboratory Animal Welfare: Proposed
Adoption and Implementation of the
Eighth Edition of the Guide for the
Care and Use of Laboratory Animals
AGENCY:
National Institutes of Health,
HHS.
Notice of Extension of Public
Comment Period.
ACTION:
The National Institutes of
Health (NIH) is extending the period for
public comments on (1) NIH’s adoption
of the eighth edition of the Guide for the
Care and Use of Laboratory Animals
(Guide) as a basis for evaluation of
institutional programs receiving or
SUMMARY:
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proposing to receive Public Health
Service (PHS) support for activities
involving animals; and (2) if NIH
decides to adopt the eighth edition of
the Guide, NIH’s proposed
implementation plan, which would
require that institutions complete at
least one semiannual program and
facility evaluation using the eighth
edition of the Guide as the basis for
evaluation by March 31, 2012. NIH will
consider comments on (1) the adoption
of the Guide and (2) the implementation
plan. The notice on the proposed
adoption and implementation plan for
the eighth edition of the Guide was
published in the Federal Register on
February 24, 2011 (76 FR 10379). The
comment period is extended by 30 days
and thus will end on April 24, 2011.
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[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Notices]
[Pages 17422-17423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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). 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 May 12, 2011, from 8
a.m. to 6 p.m.
Location: Hilton, Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Margaret McCabe-Janicki, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-
796-7029, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), and follow the prompts to
the desired center or product area. 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 May 12, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application (PMA) for the Augment Bone Graft, sponsored by
Biomimetic Therapeutics, Inc. The intended use of the device is as an
alternative bone grafting substitute to autologous bone graft in
applications to facilitate fusion in the ankle and foot without
necessitating an additional invasive procedure to harvest the graft.
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. 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 May
5, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
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 April 25, 2011. 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 April 28, 2011.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 17423]]
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 Ms. AnnMarie
Williams, Conference Management Staff, 301-796-5966, at least 7 days in
advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/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: March 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7259 Filed 3-28-11; 8:45 am]
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