[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Notices]
[Pages 66724-66726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: New Proposed 
Collection, Neuropsychosocial Measures 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 has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on May 2, 2011, pages 24497-24498, 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: Neuro-developmental and Psycho-Social 
Measures Formative Research 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

[[Page 66725]]

    (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 tools to assess language, behavior, and 
neurodevelopment, psychosocial stress, and health literacy 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 conduct formative research featuring 
neuro-developmental and psycho-social measures.
    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 neuro-developmental and psycho-social measures 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, 
infants, children, 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: $540,000 
(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, Neuropsychosocial Measures
----------------------------------------------------------------------------------------------------------------
                                                                     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
----------------------------------------------------------------------------------------------------------------
Adult Psychosocial Stress.....  NCS participants           4,000               1               1           4,000
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Child Developmental Measures..  NCS participants           4,000               1               1           4,000
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Health Disparities............  NCS participants           4,000               1               1           4,000
                                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).
                                                 ---------------------------------------------------------------
    Total.....................  ................          45,000  ..............  ..............          54,000
----------------------------------------------------------------------------------------------------------------

    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

[[Page 66726]]

[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: October 20, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development, National Institutes of Health.
[FR Doc. 2011-27843 Filed 10-26-11; 8:45 am]
BILLING CODE 4140-01-P