[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62077-62079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25868]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OBM Review; Comment Request; New Proposed
Collection, Environmental Science Formative Research Methodology
Studies for the National Children's Study
SUMMARY: Under the provisions of Section (3507(a)(1)(D)) of the
Paperwork Reduction Act of 1995, the National Institutes of Health
(NIH) has submitted to the Office of Management and Budget (OMB) a
request for reinstatement of approval of the information collection
listed below. This proposed information collection was previously
published in the Federal Register on April 27, 2011, pages 23603-23605,
and allowed 60 days for public comment. Two written comments and two
verbal comments were received. The verbal comments expressed support
for the broad scope of the study. The written comments were identical
and questioned the cost and utility of the study. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Institutes of Health may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
Proposed Collection: Title: Environmental Science Formative
Research Methodology Studies for the National Children's Study (NCS).
Type of Information Request: New. 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.
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(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 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
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
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).
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[[Page 62079]]
Total..................... ................ 69,000 .............. .............. 78,000
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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 enhance the quality, utility, and
clarity of the information collected; and (4) 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to Office of Management and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk Officer, by E-mail to [email protected], or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Ms. Jamelle E. Banks, Public
Health Analyst, 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 a 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 30-days
of the date of this publication.
Dated: September 30, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development.
[FR Doc. 2011-25868 Filed 10-5-11; 8:45 am]
BILLING CODE 4140-01-P