Submission for OMB Review; Comment Request; Formative Research Methodology Studies for the National Children's Study, 41508-41509 [2011-17735]
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Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
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Jill Hartzler Warner,
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Medical Programs.
[FR Doc. 2011–17695 Filed 7–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Formative
Research Methodology Studies for the
National Children’s Study
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 reinstatement of
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 27, 2011,
pages 23608–23609, and allowed 60
days for public comment. Two written
comments and two verbal comments
were received. The verbal comments
expressed support for the broad scope of
the study. The written comments were
identical and questioned the cost and
utility of the study. 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: Formative
Research Studies for the National
Children’s Study (NCS) Need and Use of
Information Collection: The Children’s
Health Act of 2000 (Pub. L. 106–310)
states:
(a) Purpose.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) In General.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) Investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) Requirement.—The study under
subsection (b) shall—
(1) Incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) Gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) Consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research and pilot tests will
be used to maximize the efficiency of
NCS procedures, materials, and
methods for outreach, engagement of
stakeholders, recruitment and retention
of Study subjects, and to ensure
scientifically robust data collection
methodologies for the National
Children’s Study (NCS) Vanguard and
Main Studies. With this submission, the
NCS seeks to obtain OMB’s generic
approval to conduct survey and
instrument design and administration,
focus groups, cognitive interviews, and
health and social service provider
information collection surrounding
outreach, engagement, recruitment,
consent and questionnaire design, and
retention activities.
The results from formative research
and pilot tests proposed will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study recruitment,
retention, study visit measures and
study logistics. Type of Review:
Reinstatement of OMB #0925–0590,
Expiration June 30, 2011. Frequency of
Response: Annual [As needed on an ongoing and concurrent basis]. Affected
Public: Members of the public,
researchers, practitioners, and other
health professionals. Type of
Respondents: Women of child-bearing
age, fathers, community leaders,
members, and organizations, health care
facilities and professionals, public
health, environmental, social and
cognitive science professional
organizations and practitioners, hospital
E:\FR\FM\14JYN1.SGM
14JYN1
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Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices
administrators, cultural and faith-based
centers, and schools and child care
organizations. These include both
persons enrolled in the NCS Vanguard
Study and their peers who are not
participating in the NCS Vanguard
Study.
Annual reporting burden: See Table 1.
The annualized cost to respondents is
estimated at: $300,000 (based on $10 per
hour).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY
Estimated
number of
respondents
Estimated
number of
responses
per respondent
Average
burden
hours per
response
Estimated total
annual burden
hours
requested
Data collection activity
Type of respondent
Small, focused survey and instrument
design and administration.
NCS participants ....................................
4,000
2
1
8,000
Members of NCS target population (not
NCS participants).
Health and Social Service Providers .....
Community Stakeholders .......................
NCS participants ....................................
Members of NCS target population (not
NCS participants).
Health and Social Service Providers .....
Community Stakeholders .......................
NCS participants ....................................
Members of NCS target population (not
NCS participants).
4,000
2
1
8,000
2,000
2,000
2,000
2,000
1
1
1
1
1
1
2
2
2,000
2,000
2,000
2,000
2,000
2,000
500
500
1
1
1
1
2
2
2
2
2,000
2,000
1,000
1,000
................................................................
21,000
....................
....................
30,000
Focus groups ..........................................
Cognitive interviews ................................
wreier-aviles on DSKGBLS3C1PROD with NOTICES
Total .................................................
Requests for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) 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) 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) 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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: 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 Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attn: NIH Desk Officer, by e-mail to
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Ms.
Jamelle E. Banks, Public Health Analyst,
Office of Science Policy, Analysis and
Communication, National Institute of
VerDate Mar<15>2010
14:55 Jul 13, 2011
Jkt 223001
Child Health and Human Development,
31 Center Drive, Room 2A18, Bethesda,
Maryland 20892, or call a non-toll free
number (301) 496–1877 or E-mail your
request, including your address to
banksj@mail.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: July 8, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science
Policy, Analysis and Communications
National Institute of Child Health and Human
Development.
[FR Doc. 2011–17735 Filed 7–13–11; 8:45 am]
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HUMAN SERVICES
National Institutes of Health
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Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
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Name of Committee: Center for Scientific
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Agenda: To review and evaluate grant
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Place: National Institutes of Health, 6701
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(Virtual Meeting).
Contact Person: Jose H Guerrier, PhD,
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Scientific Review, National Institutes of
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Contact Person: Robert Freund, PhD,
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MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
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93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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14JYN1
]]>Agencies
[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41508-41509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17735]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Formative Research
Methodology Studies for the National Children's Study
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 reinstatement of approval of the information collection
listed below. This proposed information collection was previously
published in the Federal Register on April 27, 2011, pages 23608-23609,
and allowed 60 days for public comment. Two written comments and two
verbal comments were received. The verbal comments expressed support
for the broad scope of the study. The written comments were identical
and questioned the cost and utility of the study. 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: Formative Research Studies for the
National Children's Study (NCS) Need and Use of Information Collection:
The Children's Health Act of 2000 (Pub. L. 106-310) states:
(a) Purpose.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
physical, chemical, biological, and psychosocial) on children's
health and development.
(b) In General.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) Plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
(2) Investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence
health and developmental processes.
(c) Requirement.--The study under subsection (b) shall--
(1) Incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of the
physical, chemical, biological, and psychosocial environmental
influences on children's well-being;
(2) Gather data on environmental influences and outcomes on
diverse populations of children, which may include the consideration
of prenatal exposures; and
(3) Consider health disparities among children, which may
include the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the
results of formative research and pilot tests will be used to maximize
the efficiency of NCS procedures, materials, and methods for outreach,
engagement of stakeholders, recruitment and retention of Study
subjects, and to ensure scientifically robust data collection
methodologies for the National Children's Study (NCS) Vanguard and Main
Studies. With this submission, the NCS seeks to obtain OMB's generic
approval to conduct survey and instrument design and administration,
focus groups, cognitive interviews, and health and social service
provider information collection surrounding outreach, engagement,
recruitment, consent and questionnaire design, and retention
activities.
The results from formative research and pilot tests proposed will
inform the feasibility (scientific robustness), acceptability (burden
to participants and study logistics) and cost of NCS Vanguard and Main
Study recruitment, retention, study visit measures and study logistics.
Type of Review: Reinstatement of OMB 0925-0590, Expiration
June 30, 2011. Frequency of Response: Annual [As needed on an on-going
and concurrent basis]. Affected Public: Members of the public,
researchers, practitioners, and other health professionals. Type of
Respondents: Women of child-bearing age, fathers, community leaders,
members, and organizations, health care facilities and professionals,
public health, environmental, social and cognitive science professional
organizations and practitioners, hospital
[[Page 41509]]
administrators, cultural and faith-based centers, and schools and child
care organizations. These include both persons enrolled in the NCS
Vanguard Study and their peers who are not participating in the NCS
Vanguard Study.
Annual reporting burden: See Table 1. The annualized cost to
respondents is estimated at: $300,000 (based on $10 per hour).
Table 1--Estimated Annual Reporting Burden Summary
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average Estimated
Data collection activity Type of respondent number of responses burden total annual
respondents per hours per burden hours
respondent response requested
----------------------------------------------------------------------------------------------------------------
Small, focused survey and NCS participants..... 4,000 2 1 8,000
instrument design and
administration.
Members of NCS target 4,000 2 1 8,000
population (not NCS
participants).
Health and Social 2,000 1 1 2,000
Service Providers.
Community 2,000 1 1 2,000
Stakeholders.
Focus groups...................... NCS participants..... 2,000 1 2 2,000
Members of NCS target 2,000 1 2 2,000
population (not NCS
participants).
Health and Social 2,000 1 2 2,000
Service Providers.
Community 2,000 1 2 2,000
Stakeholders.
Cognitive interviews.............. NCS participants..... 500 1 2 1,000
Members of NCS target 500 1 2 1,000
population (not NCS
participants).
------------------------------------------------------
Total......................... ..................... 21,000 ........... ........... 30,000
----------------------------------------------------------------------------------------------------------------
Requests for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) 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) 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) 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 those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: 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 Office of Management and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk Officer, by e-mail to OIRA_submission@omb.eop.gov, or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Ms. Jamelle E. Banks, Public
Health Analyst, Office of Science Policy, Analysis and Communication,
National Institute of Child Health and Human Development, 31 Center
Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free
number (301) 496-1877 or E-mail your request, including your address to
banksj@mail.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: July 8, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications National Institute of Child Health and Human
Development.
[FR Doc. 2011-17735 Filed 7-13-11; 8:45 am]
BILLING CODE 4140-01-P
