[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Pages 38840-38842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: Child Health 
Disparities Substudy 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 Institute of Child Health and Human 
Development (NICHD), the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on March 16, 2012, pages 15780-15782 (Volume 77, Number 52) of 
the Federal Register and allowed 60 days for public comment. No written 
comments were received. 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: Child Health Disparities Substudy for 
the National Children's Study (NCS). Type of Information Collection 
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

[[Page 38841]]

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 Child 
Health Disparities Substudy will validate measures needed for studying 
health disparities and selected biomarkers. Utilizing cognitive 
interview techniques and components of standardized questionnaires, 
responses will be used to assess and validate measures of health 
literacy, discrimination, parenting self-efficacy, and health care 
accessibility. Acceptability and feasibility of saliva collection from 
a subsample of women and young children will also be evaluated. The 
incorporation of saliva measurements will increase understanding of 
biological responses to environmental factors and how these may be 
correlated with health disparities within this population.
    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.
    In this information collection request, the NCS requests approval 
from OMB to perform a multi-center substudy called the Child Health 
Disparity Substudy. This substudy aims to validate measures needed for 
studying health disparities and selected biomarkers. Developing optimum 
measures for studying health disparities is of particular interest to 
the NCS because studies have shown that health literacy, 
discrimination, parenting self-efficacy, health care (access, 
utilization, and quality) contribute to health disparities. 
Additionally, aspects of the social environment such as social 
isolation, lack of control and contingency and social support, 
violence, discrimination, challenging and changing social 
relationships, and restricted access to health care are thought to 
interact with biological processes. Variation in these processes has 
been associated with negative emotional states, cognitive deficits, 
problem behavior, and a variety of metabolic and immune-related 
processes. Alone, or particularly in combination with other commonly 
collected measures of social forces and family relationships, salivary 
analytes have the potential to advance our understanding of maternal 
and child health and development. This project will make its 
contribution to the NCS Main Study and to the health disparities field 
as a whole by constructing a validated set of questionnaire measures 
and biomarker analyses that can be used among pregnant women and 
mothers of young children for the purpose of investigating disparities.
    Frequency of Response: One-time data collection conducted in 
multiple phases.
    Affected Public: Pregnant women, mothers with young children, and 
their children.
    Type of Respondents: Pregnant women, mothers with young children, 
and their children who are not geographically eligible to enroll in the 
NCS Vanguard Study.
    Annual reporting burden: See Table 1. The annualized cost to 
respondents is estimated at $25,000 (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 and Cost Summary, Child Health Disparities Substudy
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                  Data collection activity                      Type of respondent     Estimated    Estimated     Average       Estimated     Estimated
                                                                                       number of    number of    burden per   total annual      total
                                                                                      respondents   responses     response    burden hours      annual
                                                                                                       per       (in hours)                   respondent
                                                                                                    respondent                                   cost
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Screening for Cognitive Interview...  Mothers of children     Members of NCS target           100            1         5/60               8          $83
                                       ages 0-5.               population (not NCS
                                                               participants).
Screening for Primary Data            Women.................  Members of NCS target         2,000            1         5/60             167        1,667
 Collection.                                                   population (not NCS
                                                               participants).
Screening for Saliva Collection.....  Women.................  Members of NCS target           600            1         5/60              50          500
                                                               population (not NCS
                                                               participants).
Cognitive Interview.................  Mothers of children     Members of NCS target            60            1        75/60              75          750
                                       ages 0-5.               population (not NCS
                                                               participants).

[[Page 38842]]

 
Primary Data Collection.............  Pregnant Women/Mothers  Members of NCS target           600            2        65/60           1,300       13,000
                                       of children ages 0-5.   population (not NCS
                                                               participants).
                                      Mothers of children                                     600            1        65/60             650        6,500
                                       ages 0-5.
Saliva Collection...................  Pregnant Women/Mothers  Members of NCS target           200            2        15/60             100        1,000
                                       of children ages 0-5.   population (not NCS
                                                               participants).
                                      Additional mothers of                                   200            1        15/60              50          500
                                       children ages 0-5.
                                      Children ages 0-5.....                                  400            1        15/60             100      * 1,000
                                                                                     -------------------------------------------------------------------
    Total...........................  ......................  ......................        4,760  ...........  ...........           2,500       25,000
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* The allotted hourly wage rate accounts for the mother's time associated with the data collection activity.

    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.
    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 Email 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 Email 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: June 19, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development.
[FR Doc. 2012-16028 Filed 6-28-12; 8:45 am]
BILLING CODE 4140-01-P