Proposed Collection; Comment Request Healthy Communities Study: How Communities Shape Children's Health (HCS), 13350-13351 [2013-04528]
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13350
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
Dated: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04536 Filed 2–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK2VPTVN1PROD with NOTICES
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: Ophthalmic
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 April 8, 2013, from 8:30 a.m. to
6 p.m.
Location: Hilton Washington, DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993–0002,
Natasha.Facey@fda.hhs.gov, 301–796–
5290, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). 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 at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On April 8, 2013, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
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approval application for the Trulign
Toric posterior chamber intraocular lens
sponsored by Bausch and Lomb. The
Trulign Toric posterior chamber
intraocular lens is intended for primary
implantation in the capsular bag of the
eye for visual correction of aphakia and
postoperative refractive astigmatism
secondary to removal of a cataractous
lens in adult patients with or without
presbyopia, who desire improved
uncorrected distance vision and
reduction of residual refractive cylinder.
Trulign Toric provides approximately
one diopter of monocular
accommodation, which allows for near,
intermediate, and distance vision
without spectacles.
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 meeting
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 April 1, 2013. 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 March
22, 2013. 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 March 26, 2013.
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
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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 AnnMarie
Williams at
Annmarie.Williams@fda.hhs.gov or
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: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–04534 Filed 2–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request Healthy Communities Study:
How Communities Shape Children’s
Health (HCS)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 30, 2012, Pages
71426–71427 allowed 60-days for public
comment. Two (2) comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection
Title: Healthy Communities Study:
How Communities Shape Children’s
Health (HCS). Type of Information
Collection Request: Revision—OMB#
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13351
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices
0925–0649. Need and Use of
Information Collection: The HCS will
address the need for a cross-cutting
national study of community programs
and policies and their relationship to
childhood obesity. The HCS is an
observational study of communities that
aims to (1) determine the associations
between community programs/policies
and body mass index (BMI), diet, and
physical activity for children; (2)
identify the community, family, and
child factors that modify or mediate the
associations between community
programs/policies and BMI, diet, and
physical activity in children; and (3)
assess the associations between
programs/policies and BMI, diet and
physical activity in children in
communities that have a high
proportion of African American, Latino,
and/or low-income residents. A total of
264 communities and over 21,000
elementary and middle school children
and their parents will be part of this
study. A HCS community is defined as
a high school catchment area. The study
examines quantitative and qualitative
information obtained from communitybased initiatives; community
characteristics (e.g., school
environment); measurements of
children’s physical activity levels and
dietary practices; and children’s and
parents’ BMIs. Results from the Healthy
Communities Study may influence the
future development and funding of
policies and programs to reduce
childhood obesity. Furthermore, HCS
results will be published in scientific
journals and will be used for the
development of future research
Estimated
number of
respondents
Type of respondents
initiatives targeting childhood obesity.
Frequency of Response: One time.
Affected Public: Families or households;
businesses, other for-profit, and nonprofit. Type of Respondents: Parents,
children, community key informants
(who have knowledge about community
programs/policies related to nutrition,
physical activity, and weight of
children), food service personnel,
physical education instructors, school
liaisons, and physicians or medical
secretaries. The annual reporting burden
is as follows: Estimated number of
respondents: 69,010; Estimated Number
of Responses per Respondent: 1; and
Estimated Total Burden Hours
Requested: 29,657. The annualized cost
to respondents is estimated at $381,841.
There are no capital, operating, or
maintenance costs to report.
Estimated
number of
responses per
respondent
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
requested
39,600
7,128
3,564
880
7,128
3,520
1,056
352
88
352
352
4,990
1
1
1
1
1
1
1
1
1
1
1
1
10/60
1.56
7/60
10/60
1.04
5/60
2.25
5/60
30/60
15/60
25/60
10/60
6,732
11,120
428
150
7,413
282
2,376
28
44
88
148
848
Total ..........................................................................................................
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Parents (screening) .........................................................................................
Parents/Caregivers ..........................................................................................
Second Parents ...............................................................................................
Parents who refuse to participate ....................................................................
Children ............................................................................................................
Key Informants (screening) .............................................................................
Key Informants .................................................................................................
Food Service Personnel ..................................................................................
District Food Service Administrator/Manager ..................................................
Physical Education Instructors ........................................................................
School Liaisons ................................................................................................
Physicians/medical secretaries ........................................................................
69,010
........................
........................
29,657
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s 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 the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
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instruments contact: Dr. Sonia Arteaga,
NIH, NHLBI, 6701 Rockledge Drive,
MSC 7936, Bethesda, MD 20892–7936,
or call non-toll free number (301) 435–
0377 or Email your request, including
your address to: hcs@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: February 19, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013–04528 Filed 2–26–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: Clinical Mythteries:
A Video Game About Clinical Trials
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 13, 2012,
page 35407 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
E:\FR\FM\27FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13350-13351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request Healthy Communities Study:
How Communities Shape Children's Health (HCS)
Summary:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health has submitted to the Office
of Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on November
30, 2012, Pages 71426-71427 allowed 60-days for public comment. Two (2)
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection
Title: Healthy Communities Study: How Communities Shape Children's
Health (HCS). Type of Information Collection Request: Revision--
OMB
[[Page 13351]]
0925-0649. Need and Use of Information Collection: The HCS will address
the need for a cross-cutting national study of community programs and
policies and their relationship to childhood obesity. The HCS is an
observational study of communities that aims to (1) determine the
associations between community programs/policies and body mass index
(BMI), diet, and physical activity for children; (2) identify the
community, family, and child factors that modify or mediate the
associations between community programs/policies and BMI, diet, and
physical activity in children; and (3) assess the associations between
programs/policies and BMI, diet and physical activity in children in
communities that have a high proportion of African American, Latino,
and/or low-income residents. A total of 264 communities and over 21,000
elementary and middle school children and their parents will be part of
this study. A HCS community is defined as a high school catchment area.
The study examines quantitative and qualitative information obtained
from community-based initiatives; community characteristics (e.g.,
school environment); measurements of children's physical activity
levels and dietary practices; and children's and parents' BMIs. Results
from the Healthy Communities Study may influence the future development
and funding of policies and programs to reduce childhood obesity.
Furthermore, HCS results will be published in scientific journals and
will be used for the development of future research initiatives
targeting childhood obesity. Frequency of Response: One time. Affected
Public: Families or households; businesses, other for-profit, and non-
profit. Type of Respondents: Parents, children, community key
informants (who have knowledge about community programs/policies
related to nutrition, physical activity, and weight of children), food
service personnel, physical education instructors, school liaisons, and
physicians or medical secretaries. The annual reporting burden is as
follows: Estimated number of respondents: 69,010; Estimated Number of
Responses per Respondent: 1; and Estimated Total Burden Hours
Requested: 29,657. The annualized cost to respondents is estimated at
$381,841.
There are no capital, operating, or maintenance costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per per response burden hours
respondents respondent (in hours) requested
----------------------------------------------------------------------------------------------------------------
Parents (screening)............................. 39,600 1 10/60 6,732
Parents/Caregivers.............................. 7,128 1 1.56 11,120
Second Parents.................................. 3,564 1 7/60 428
Parents who refuse to participate............... 880 1 10/60 150
Children........................................ 7,128 1 1.04 7,413
Key Informants (screening)...................... 3,520 1 5/60 282
Key Informants.................................. 1,056 1 2.25 2,376
Food Service Personnel.......................... 352 1 5/60 28
District Food Service Administrator/Manager..... 88 1 30/60 44
Physical Education Instructors.................. 352 1 15/60 88
School Liaisons................................. 352 1 25/60 148
Physicians/medical secretaries.................. 4,990 1 10/60 848
---------------------------------------------------------------
Total....................................... 69,010 .............. .............. 29,657
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's 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 the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments contact: Dr. Sonia Arteaga, NIH, NHLBI, 6701 Rockledge
Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll free number
(301) 435-0377 or Email your request, including your address to:
hcs@nhlbi.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: February 19, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael S. Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-04528 Filed 2-26-13; 8:45 am]
BILLING CODE 4140-01-P
