[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23603-23605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10191]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 childrens 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 an OMB 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 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, neurodevelopmental, and study
logistic information collection. These separate and distinct generic
clearances will 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 request, the NCS is requesting a generic clearance 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.
The NCS has obtained generic clearance for formative research
activities pertaining to outreach, recruitment and retention (0925-
0590). Under separate notice, the NCS also requests an OMB generic
clearance for formative research featuring biospecimen and physical
measures, neurodevelopmental measures, 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.
[[Page 23604]]
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
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Environmental Science
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Estimated Estimated number Average burden Estimated total
Data collection activity Type of respondent number of of responses per hours per annual burden hours
respondents respondent response requested
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Home Air.................................... NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
Home Water.................................. NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
Home Dust................................... NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
School and Child Care Facility Air.......... NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
School and Child Care Facility Water........ NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
School and Child Care Facility Dust......... NCS participants.............. 4,000 1 1 4,000
Members of NCS target 4,000 1 1 4,000
population (not NCS
participants).
Small, focused survey and instrument design NCS participants.............. 4,000 2 1 8,000
and administration.
Members of NCS target 4,000 2 1 8,000
population (not NCS
participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders........ 2,000 1 1 2,000
Focus groups................................ NCS participants.............. 2,000 1 1 2,000
Members of NCS target 2,000 1 1 2,000
population (not NCS
participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders........ 2,000 1 1 2,000
Cognitive interviews........................ NCS participants.............. 500 1 2 1,000
Members of NCS target 500 1 2 1,000
population (not NCS
participants).
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Total................................... .............................. 69,000 ................ ................ 78,000 hrs
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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
[[Page 23605]]
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 [email protected].
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 Communication,
National Institute of Child Health and Human Development.
[FR Doc. 2011-10191 Filed 4-26-11; 8:45 am]
BILLING CODE 4140-01-P