[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Notices]
[Pages 30294-30297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Submission for OMB Review; Comment Request; Stress and Cortisol 
Measurement 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 February 17, 2012, pages 9666-9668 (Volume 77, Number 33) 
of the Federal Register and allowed 60 days for public comment. One 
comment was received. The commenter questioned the value of the 
National Children's Study overall and suggested that the NCS be 
eliminated. The NCS is implemented to meet the requirements of the 
Children's Health Act of 2000 (Pub. L. 106-310). 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: 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

[[Page 30295]]

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 (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 Stress and 
Cortisol Measurement Substudy. This substudy aims to 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 U.S. 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: $73,500 (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, Stress and Cortisol Measurements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Estimated    Average burden                     Estimated
                                                                             Estimated       number of       hours per       Estimated     total annual
         Data collection activity                Type of respondent          number of     responses per   response (in    total annual     respondent
                                                                            respondents     respondent        hours)       burden hours        cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening.................................  Members of NCS target                  2,100               1            5/60             175          $1,750
                                             population (not NCS
                                             participants).
Saliva Self-Collection Demonstration......  Members of NCS target                    700               1           15/60             175           1,750
                                             population (not NCS
                                             participants).

[[Page 30296]]

 
Urine Self-Collection Instructions........  Members of NCS target                    700               1            5/60              58             583
                                             population (not NCS
                                             participants).
Ecological Momentary Assessment Training..  Members of NCS target                    700               1           30/60             350           3,500
                                             population (not NCS
                                             participants).
Visit 1 Stress Questionnaire..............  Members of NCS target                    700               1           60/60             700           7,000
                                             population (not NCS
                                             participants).
Adult Blood...............................  Members of NCS target                    700               2           30/60             700           7,000
                                             population (not NCS
                                             participants).
Adult Urine...............................  Members of NCS target                    700               1           15/60             175           1,750
                                             population (not NCS
                                             participants).
Adult Hair................................  Members of NCS target                    700               2           15/60             350           3,500
                                             population (not NCS
                                             participants).
Adult Saliva..............................  Members of NCS target                    700              28            3/60             980           9,800
                                             population (not NCS
                                             participants).
Demographic and Health Interview..........  Members of NCS target                    700               1           60/60             700           7,000
                                             population (not NCS
                                             participants).
Participant Contact Information Sheet.....  Members of NCS target                    700               1            5/60              58             583
                                             population (not NCS
                                             participants).
Take-Home Questionnaire...................  Members of NCS target                    700               1           30/60             350           3,500
                                             population (not NCS
                                             participants).
Time Diary................................  Members of NCS target                    700              72            2/60           1,680          16,800
                                             population (not NCS
                                             participants).
Heart Monitoring..........................  Members of NCS target                    700               1            2/60              23             233
                                             population (not NCS
                                             participants).
Visit 2 Stress Questionnaire..............  Members of NCS target                    700               1           45/60             525           5,250
                                             population (not NCS
                                             participants).
Stressful Life Events Schedule Checklist..  Members of NCS target                    700               1           30/60             350           3,500
                                             population (not NCS
                                             participants).
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................           2,100  ..............  ..............           7,350          73,500
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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.


[[Page 30297]]


    Dated: May 16, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development.
[FR Doc. 2012-12367 Filed 5-21-12; 8:45 am]
BILLING CODE 4140-01-P