[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23605-23606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10189]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Study Logistic
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: Study Logistics 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 new and existing study measures, participant
communication techniques, and technologies being utilized, 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 relating
to instrument design and modality with a view to reduce item and unit
non-response to Study instruments while preserving scientific quality.
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
neurodevelopmental and psycho-social 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 request, NCS is requesting approval from OMB for formative
research activities relating to instrument design and modality with a
view to reduce item and unit non-response to Study instruments while
preserving scientific quality. 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 instrument design and modality in a manner
that minimizes public information collection burden compared to burden
anticipated if these instruments 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, environmental samples, and
[[Page 23606]]
neurodevelopmental measures. 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.
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, health
care facilities and professionals, public health 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: $300,000 (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, Study Operations
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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
----------------------------------------------------------------------------------------------------------------
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).
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Total..................... ................ 21,000 .............. .............. 30,000
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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
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 Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-10189 Filed 4-26-11; 8:45 am]
BILLING CODE 4140-01-P