[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9666-9668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3809]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; New 
Proposed Collection; Comment Request Stress and Cortisol Measurement 
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.

Proposed Collection

    Title: Stress and Cortisol Measurement 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 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 
Stress and Cortisol Measurement Substudy will develop an optimized, 
item-reduced measure of self-reported stress that is supported 
empirically through convergent validity analysis of stress biomarkers. 
Specifically, key moderators of stress biomarkers will be evaluated to 
inform the efficiency and quality of measurements during pregnancy. 
Development of a scientifically robust maternal stress measure would 
measure chronic stress more efficiently, would not require biospecimen 
collection and biomarker analyses, and would thereby reduce participant 
burden and NCS Vanguard (Pilot) and NCS Main Study costs. With this 
information collection request, the NCS seeks to obtain OMB's clearance 
to conduct a substudy aimed at developing a validated questionnaire 
that will reflect specific biological and physiological measures of 
maternal stress.

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 (http://www.hhs.gov/) (including the Eunice Kennedy 
Shriver National Institute of Child Health and Human Development 
(http://www.nichd.nih.gov/) and the National Institute of Environmental 
Health Sciences (http://www.niehs.nih.gov/) of the National Institutes 
of Health (http://www.nih.gov/) and the Centers for Disease Control 
and Prevention (http://www.cdc.gov/)), and the U.S. Environmental 
Protection Agency (http://www.epa.gov/).
    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 Stress and 
Cortisol Measurement Substudy. This substudy aims to

[[Page 9667]]

determine the most reliable, acceptable, and cost-efficient approach 
for assessing maternal stress. Maternal stress is of particular 
interest to the NCS due to studies that have shown an association 
between maternal stress and negative health outcomes, including preterm 
birth which is one of the most important problems in maternal-child 
health in the US. Stress factors are also more prevalent in the 
population of socio-demographically disadvantaged women who are at an 
increased risk for preterm birth. Maternal stress is associated with 
additional health outcomes, such as still-birth, low birth weight, 
problems in offspring brain function and behavior (including lower IQ 
and impaired executive function), immune-related problems such as 
allergies and asthma, congenital malformations, infections, and 
numerous disorders of organ systems.
    Development of a scientifically robust and validated questionnaire 
to reflect specific physiological measures of stress would allow us to 
measure chronic stress more efficiently, would not require biospecimen 
collection and biomarker analyses, and would thereby reduce participant 
burden and Study costs. To develop this instrument, the NCS will 
collect several types of information from substudy participants through 
medical record abstraction, questionnaires (a series of validated 
stress measures), physiological measures (heart rate and self-reported 
stress), and several types of biospecimens.
    Frequency of Response: Annual [As needed].
    Affected Public: Pregnant women and their children.
    Type of Respondents: Pregnant women 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: $74,677 (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, Stress and Cortisol Measurements
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                     Type of         Estimated       number of        Average        Estimated
   Data collection activity        respondent        number of     responses per   burden hours    total annual
                                                    respondents     respondent     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Screening.....................  Members of NCS             2,100               1            0.08             175
                                 target
                                 population (not
                                 NCS
                                 participants).
Consent.......................  Members of NCS               700               1            0.17             117
                                 target
                                 population (not
                                 NCS
                                 participants).
Saliva Self-Collection          Members of NCS               700               1            0.25             175
 Demonstration.                  target
                                 population (not
                                 NCS
                                 participants).
Urine Self-Collection           Members of NCS               700               1            0.08              58
 Instructions.                   target
                                 population (not
                                 NCS
                                 participants).
Ecological Momentary            Members of NCS               700               1            0.50             350
 Assessment Training.            target
                                 population (not
                                 NCS
                                 participants).
Visit 1 Stress Questionnaire..  Members of NCS               700               1            1.00             700
                                 target
                                 population (not
                                 NCS
                                 participants).
Adult Blood...................  Members of NCS               700               2            0.50             700
                                 target
                                 population (not
                                 NCS
                                 participants).
Adult Urine...................  Members of NCS               700               1            0.25             175
                                 target
                                 population (not
                                 NCS
                                 participants).
Adult Hair....................  Members of NCS               700               2            0.25             350
                                 target
                                 population (not
                                 NCS
                                 participants).
Adult Saliva..................  Members of NCS               700              28            0.05             980
                                 target
                                 population (not
                                 NCS
                                 participants).
Demographic and Health          Members of NCS               700               1            1.00             700
 Interview.                      target
                                 population (not
                                 NCS
                                 participants).
Participant Contact             Members of NCS               700               1            0.08              58
 Information Sheet.              target
                                 population (not
                                 NCS
                                 participants).
Take-Home Questionnaire.......  Members of NCS               700               1            0.50             350
                                 target
                                 population (not
                                 NCS
                                 participants).
Time Diary....................  Members of NCS               700              72            0.03           1,680
                                 target
                                 population (not
                                 NCS
                                 participants).
Heart Monitoring..............  Members of NCS               700               1            0.03              23
                                 target
                                 population (not
                                 NCS
                                 participants).
Visit 2 Stress Questionnaire..  Members of NCS               700               1            0.75             525
                                 target
                                 population (not
                                 NCS
                                 participants).
Stressful Life Events Schedule  Members of NCS               700               1            0.50             350
 Checklist.                      target
                                 population (not
                                 NCS
                                 participants).
                                                 ---------------------------------------------------------------
    Total.....................  ................             700  ..............  ..............           7,467
----------------------------------------------------------------------------------------------------------------

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.

[[Page 9668]]

For Further Information

    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 Email your request, 
including your address to <a href="/cdn-cgi/l/email-protection#f1969d9087989f82b19c90989ddf9f9899df969e87"><span class="__cf_email__" data-cfemail="73141f12051a1d00331e121a1f5d1d1a1b5d141c05">[email protected]</span></a>.

Comments Due Date

    Comments regarding this information collection are best assured of 
having their full effect if received within 60 days of the date of this 
publication.

    Dated: February 10, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications, 
National Institute of Child Health and Human Development.
[FR Doc. 2012-3809 Filed 2-16-12; 8:45 am]
BILLING CODE 4140-01-P


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