National Institute of Child Health and Human Development; New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study, 14530-14531 [2012-5946]
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Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
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 6, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–5818 Filed 3–9–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; New Proposed
Collection; Comment Request;
Environmental Science 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.
Proposed Collection:
Title: Environmental Science
Formative Research Methodology
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 (Pub.
L. 106–310) states:
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
(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.
VerDate Mar<15>2010
14:55 Mar 09, 2012
Jkt 226001
(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
environmental sample collection
procedures and technology, storage
procedures, accompanying
questionnaires, and assays, 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
OMB’s generic clearance to collect
environmental samples from homes and
child care settings, and conduct
accompanying short surveys related to
the physical and chemical environment.
The NCS has obtained OMB’s 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 (OMB # 0925–0590; Expiration
Date 9/30/2014). Under separate notice,
the NCS is also requesting generic
clearance to conduct formative research
featuring biospecimen and physical
measures (OMB # 0925–0647,
Expiration Date 1/31/2015),
neurodevelopmental (pending
clearance), and study logistic (pending
clearance) information collection.
Separate and distinct generic clearances
are requested to facilitate the efficiency
of submissions and review of these
projects as requested by the 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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 request, the NCS is requesting
generic approval from OMB for
formative research activities relating to
the collection, storage, management,
and assay of environmental samples and
accompanying questionnaires. 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 environmental sample and
information collection 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.
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, public health and
environmental science professional
organizations and practitioners, 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:
$780,000 (based on $10 per hour). There
E:\FR\FM\12MRN1.SGM
12MRN1
14531
Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices
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
Home Air ...........................................
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 ..............................
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 ..............................
Home Water ......................................
Home Dust ........................................
School and Child Care Facility Air ....
School and Child Care Facility Water
School and Child Care Facility Dust
Small, focused survey and instrument design and administration.
Focus groups ....................................
Cognitive interviews ..........................
pmangrum on DSK3VPTVN1PROD with NOTICES
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
4,000
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
...........................................................
69,000
........................
........................
78,000
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
FOR FURTHER INFORMATION CONTACT:
14:55 Mar 09, 2012
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 226001
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 Email 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: March 6, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications National
Institute of Child Health and Human
Development.
[FR Doc. 2012–5946 Filed 3–9–12; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
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Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Web-Based Assessment of
the NHLBI Clinical Studies Support
Center (CSSC)
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 Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: Web-Based
Assessment of the Clinical Studies
Support Center (CSSC). Type of
Information Collection Request: New.
SUMMARY:
E:\FR\FM\12MRN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 48 (Monday, March 12, 2012)]
[Notices]
[Pages 14530-14531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5946]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development; New
Proposed Collection; Comment Request; Environmental Science 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: Environmental Science Formative Research Methodology 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 (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 will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of environmental sample collection procedures and
technology, storage procedures, accompanying questionnaires, and
assays, 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 OMB's generic clearance to collect
environmental samples from homes and child care settings, and conduct
accompanying short surveys related to the physical and chemical
environment.
The NCS has obtained OMB's 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 (OMB
0925-0590; Expiration Date 9/30/2014). Under separate notice,
the NCS is also requesting generic clearance to conduct formative
research featuring biospecimen and physical measures (OMB
0925-0647, Expiration Date 1/31/2015), neurodevelopmental (pending
clearance), and study logistic (pending clearance) information
collection. Separate and distinct generic clearances are requested to
facilitate the efficiency of submissions and review of these projects
as requested by the 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 request, the NCS is requesting generic approval from OMB
for formative research activities relating to the collection, storage,
management, and assay of environmental samples and accompanying
questionnaires. 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 environmental sample and information collection 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.
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, public health and environmental
science professional organizations and practitioners, 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: $780,000 (based on $10 per hour).
There
[[Page 14531]]
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 burden total annual
Data collection activity respondent number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Home Air...................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Home Water.................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Home Dust..................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Air.
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Water.
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Dust.
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..................... ................ 69,000 .............. .............. 78,000
----------------------------------------------------------------------------------------------------------------
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 Email
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: March 6, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications
National Institute of Child Health and Human Development.
[FR Doc. 2012-5946 Filed 3-9-12; 8:45 am]
BILLING CODE 4140-01-P
