[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41508-41509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; 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 23608-23609,
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: Formative Research Studies for the
National Children's Study (NCS) 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 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 obtain OMB's generic
approval to conduct survey and instrument design and administration,
focus groups, cognitive interviews, and health and social service
provider information collection surrounding outreach, engagement,
recruitment, consent and questionnaire design, and retention
activities.
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.
Type of Review: Reinstatement of OMB 0925-0590, Expiration
June 30, 2011. 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, community leaders,
members, and organizations, health care facilities and professionals,
public health, environmental, social and cognitive science professional
organizations and practitioners, hospital
[[Page 41509]]
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).
Table 1--Estimated Annual Reporting Burden Summary
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Estimated
Estimated number of Average Estimated
Data collection activity Type of respondent number of responses burden total annual
respondents per hours per burden hours
respondent response requested
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Small, focused survey and NCS participants..... 4,000 2 1 8,000
instrument design and
administration.
Members of NCS target 4,000 2 1 8,000
population (not NCS
participants).
Health and Social 2,000 1 1 2,000
Service Providers.
Community 2,000 1 1 2,000
Stakeholders.
Focus groups...................... NCS participants..... 2,000 1 2 2,000
Members of NCS target 2,000 1 2 2,000
population (not NCS
participants).
Health and Social 2,000 1 2 2,000
Service Providers.
Community 2,000 1 2 2,000
Stakeholders.
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......................... ..................... 21,000 ........... ........... 30,000
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Requests 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 to be 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 OIRA_submission@omb.eop.gov, 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
banksj@mail.nih.gov.
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: July 8, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications National Institute of Child Health and Human
Development.
[FR Doc. 2011-17735 Filed 7-13-11; 8:45 am]
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