New Proposed Collection; Comment Request; Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study, 24497-24498 [2011-10500]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Neuropsychosocial Measures
Formative Research Methodology
Studies for the National Children’s
Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
mstockstill on DSKH9S0YB1PROD with NOTICES6
Proposed Collection
Title: Neuro-developmental and
Psycho-Social Measures Formative
Research Studies for the National
Children’s Study (NCS).
Type of Information Collection
Request: Generic Clearance.
Need and Use of Information
Collection: The Children’s Health Act of
2000 (Public Law 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
VerDate Mar<15>2010
17:48 Apr 29, 2011
Jkt 223001
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 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 will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of tools
to assess language, behavior, and
neurodevelopment, psychosocial stress,
and health literacy and thereby inform
data collection methodologies for the
National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain an
OMB generic clearance to conduct
formative research featuring neurodevelopmental and psycho-social
measures.
The NCS has obtained an OMB
generic clearance to conduct survey and
instrument design and administration,
focus groups, cognitive interviews, and
health and social service provider
feedback information collection
surrounding outreach, recruitment, and
retention (0925–0590; requesting
renewal). Under separate notice, the
NCS is also requesting an OMB generic
clearance to conduct formative research
featuring biospecimen and physical
measures, environmental, and study
logistic information collection. These
separate and distinct generic clearances
are requested to facilitate the efficiency
of submission and review of these
projects as required by the OMB Office
of Information and Regulatory Affairs.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
24497
Background
The National Children’s Study is a
prospective, national longitudinal study
of the interaction between environment,
genetics on child health and
development. The Study defines
‘‘environment’’ broadly, taking a number
of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. Findings
from the Study will be made available
as the research progresses, making
potential benefits known to the public
as soon as possible. The National
Children’s Study is led by a consortium
of federal partners: the U.S. Department
of Health and Human Services
(including the Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Institute of Environmental Health
Sciences of the National Institutes of
Health and the Centers for Disease
Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS was designed to
include a preliminary pilot study
known as the Vanguard Study. The
purpose of the Vanguard Study is to
assess the feasibility, acceptability, and
cost of the recruitment strategy, study
procedures, and outcome assessments
that are to be used in the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
In this submission, NCS is requesting
an OMB generic clearance for formative
research activities relating to the
collection of neuro-developmental and
psycho-social measures. The results
from these formative research projects
will inform the feasibility (scientific
robustness), acceptability (burden to
participants and study logistics) and
cost of NCS Vanguard and Main Study
neuro-developmental and psycho-social
measures in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
The NCS has obtained generic
clearance for formative research
activities pertaining to outreach,
recruitment and retention (0925–0590).
E:\FR\FM\02MYN1.SGM
02MYN1
24498
Federal Register / Vol. 76, No. 84 / Monday, May 2, 2011 / Notices
Under separate notice, the NCS also
requests an OMB generic clearance for
formative research featuring
biospecimen and physical measures,
environmental, and study logistic
information collection. Separate and
distinct generic clearances are requested
to facilitate the efficiency of submission
and review of these projects as required
by the OMB Office of Information and
Regulatory Affairs.
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, infants, children,
fathers, community leaders, members,
and organizations, health care facilities
and professionals, public health,
environmental, social and cognitive
science professional organizations and
practitioners, hospital 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: $540,000 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE
Estimated
number of
respondents
Data collection activity
Type of respondent
Adult Psychosocial Stress ................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Child Developmental Measures ........
Health Disparities ..............................
Small, focused survey and instrument design and administration.
Focus groups ....................................
Cognitive Interviews ..........................
mstockstill on DSKH9S0YB1PROD with NOTICES6
Total ...........................................
Estimated total
annual burden
hours
requested
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
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
1
1
2,000
2,000
2,000
2,000
2,000
2,000
500
500
1
1
1
1
1
1
2
2
2,000
2,000
1,000
1,000
...........................................................
45,000
........................
........................
54,000
FOR FURTHER INFORMATION CONTACT:
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, 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 non-toll free
number (301) 496–1877 or e-mail your
request, including your address to
glavins@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
To
request more information on the
17:48 Apr 29, 2011
Average
burden hours
per response
4,000
4,000
Request 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 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.
VerDate Mar<15>2010
Estimated
number of responses per
respondent
Jkt 223001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Dated: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
[FR Doc. 2011–10500 Filed 4–29–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
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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The meeting will be closed to the
public in accordance with the
E:\FR\FM\02MYN1.SGM
02MYN1
]]>Agencies
[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24497-24498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10500]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Neuropsychosocial
Measures Formative Research Methodology Studies for the National
Children's Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: Neuro-developmental and Psycho-Social Measures Formative
Research Studies for the National Children's Study (NCS).
Type of Information Collection Request: Generic Clearance.
Need and Use of Information Collection: The Children's Health Act
of 2000 (Public Law 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 will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of tools to assess language, behavior, and
neurodevelopment, psychosocial stress, and health literacy and thereby
inform data collection methodologies for the National Children's Study
(NCS) Vanguard and Main Studies. With this submission, the NCS seeks to
obtain an OMB generic clearance to conduct formative research featuring
neuro-developmental and psycho-social measures.
The NCS has obtained an OMB generic clearance to conduct survey and
instrument design and administration, focus groups, cognitive
interviews, and health and social service provider feedback information
collection surrounding outreach, recruitment, and retention (0925-0590;
requesting renewal). Under separate notice, the NCS is also requesting
an OMB generic clearance to conduct formative research featuring
biospecimen and physical measures, environmental, and study logistic
information collection. These separate and distinct generic clearances
are requested to facilitate the efficiency of submission and review of
these projects as required by the OMB Office of Information and
Regulatory Affairs.
Background
The National Children's Study is a prospective, national
longitudinal study of the interaction between environment, genetics on
child health and development. The Study defines ``environment''
broadly, taking a number of natural and man-made environmental,
biological, genetic, and psychosocial factors into account. By studying
children through their different phases of growth and development,
researchers will be better able to understand the role these factors
have on health and disease. Findings from the Study will be made
available as the research progresses, making potential benefits known
to the public as soon as possible. The National Children's Study is led
by a consortium of federal partners: the U.S. Department of Health and
Human Services (including the Eunice Kennedy Shriver National Institute
of Child Health and Human Development and the National Institute of
Environmental Health Sciences of the National Institutes of Health and
the Centers for Disease Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS was designed to include a preliminary pilot
study known as the Vanguard Study. The purpose of the Vanguard Study is
to assess the feasibility, acceptability, and cost of the recruitment
strategy, study procedures, and outcome assessments that are to be used
in the NCS Main Study. The Vanguard Study begins prior to the NCS Main
Study and will run in parallel with the Main Study. At every phase of
the NCS, the multiple methodological studies conducted during the
Vanguard phase will inform the implementation and analysis plan for the
Main Study.
In this submission, NCS is requesting an OMB generic clearance for
formative research activities relating to the collection of neuro-
developmental and psycho-social measures. The results from these
formative research projects will inform the feasibility (scientific
robustness), acceptability (burden to participants and study logistics)
and cost of NCS Vanguard and Main Study neuro-developmental and psycho-
social measures in a manner that minimizes public information
collection burden compared to burden anticipated if these projects were
incorporated directly into either the NCS Vanguard or Main Study.
The NCS has obtained generic clearance for formative research
activities pertaining to outreach, recruitment and retention (0925-
0590).
[[Page 24498]]
Under separate notice, the NCS also requests an OMB generic clearance
for formative research featuring biospecimen and physical measures,
environmental, and study logistic information collection. Separate and
distinct generic clearances are requested to facilitate the efficiency
of submission and review of these projects as required by the OMB
Office of Information and Regulatory Affairs.
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, infants, children,
fathers, community leaders, members, and organizations, health care
facilities and professionals, public health, environmental, social and
cognitive science professional organizations and practitioners,
hospital 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: $540,000 (based on $10 per hour). There
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Environmental Science
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Type of Estimated number of Average total annual
Data collection activity respondent number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Adult Psychosocial Stress..... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Child Developmental Measures.. NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Health Disparities............ NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Small, focused survey and NCS participants 4,000 2 1 8,000
instrument design and
administration.
Members of NCS 4,000 2 1 8,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
Focus groups.................. NCS participants 2,000 1 1 2,000
Members of NCS 2,000 1 1 2,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
Cognitive Interviews.......... NCS Participants 500 1 2 1,000
Members Of NCS 500 1 2 1,000
Target
Population (Not
NCS
Participants).
---------------------------------------------------------------------------------
Total..................... ................ 45,000 .............. .............. 54,000
----------------------------------------------------------------------------------------------------------------
Request 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 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. Sarah L. Glavin, Deputy Director, 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 non-toll free number (301) 496-1877 or e-mail
your request, including your address to glavins@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-10500 Filed 4-29-11; 8:45 am]
BILLING CODE 4140-01-P
