[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23608-23609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10171]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Revision to Proposed Collection; Comment Request; 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: Formative Research and Pilot Methodology Studies for the
National Children's Study (NCS).
Type of Information Collection Request: RENEWAL of OMB Clearance
0925-0590, Expiration June 30, 2011.
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 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 renew its 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,
engagement, recruitment, consent and questionnaire design, and
retention activities. Under separate notice, the NCS also requests OMB
generic clearance for formative research featuring environmental,
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.
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
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.
With this submission, the NCS seeks to renew its 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,
engagement, recruitment, consent and questionnaire design, and
retention activities. Under separate notice, the NCS also requests OMB
generic clearance for formative research featuring environmental,
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.
Frequency of Response: Annual [As needed on an on-going and
concurrent basis].
[[Page 23609]]
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
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). There
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
Table 1--Estimated Annual Reporting Burden Summary
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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 2 2,000
Members of NCS 2,000 1 2 2,000
target
population (not
NCS
participants).
Health and 2,000 1 2 2,000
Social Service
Providers.
Community 2,000 1 2 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..................... ................ 21,000 .............. .............. 30,000 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
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. 2011-10171 Filed 4-26-11; 8:45 am]
BILLING CODE 4140-01-P