[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38670-38671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


New Proposed Collection; Comment Request; Neuropsychosocial 
Measures 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. 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. No comments were received. The purpose of 
this notice is to allow an additional 30 days for public comment.

Proposed Collection

    Title: Neuro-developmental and Psycho-Social Measures Formative 
Research 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 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, Environmental Science
----------------------------------------------------------------------------------------------------------------
                                                                     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
----------------------------------------------------------------------------------------------------------------
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.

[[Page 38671]]

 
                                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 hrs
----------------------------------------------------------------------------------------------------------------

    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].

DATES: 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: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications, 
National Institute of Child Health and Human Development.
[FR Doc. 2011-16612 Filed 6-30-11; 8:45 am]
BILLING CODE 4140-01-P