[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3840-3842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on the Proposed Framework for Developing 
Study Content and Protocols for the National Children's Study

SUMMARY: The National Children's Study (NCS) is soliciting comments and 
suggestions from the public on the proposed Study content framework. 
The questions solicited in this Request for Information (RFI) focus on 
the validity and acceptability of the using a composite outcome for the 
higher-level functions of a healthy 21-year-old person as an important 
operational construct to help frame data collection throughout the 
duration of the study. Responses to this RFI will be used to inform 
Study protocol development.

DATES: The National Children's Study Request for Information is open 
for public comment for a period of 30 days. Comments must be received 
by February 24, 2014 to ensure consideration. After the public comment 
period has closed, the comments received by the NCS will be considered 
in a timely manner by the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development and the National Children's Study.

ADDRESSES: Questions about this request for information should be 
directed to Kate Winseck, MSW, The National Children's Study, Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development, National Institutes of Health, 6100 Executive Blvd., Rm. 
5C01, Bethesda, MD 20891, [email protected], 301-594-9147.

SUPPLEMENTARY INFORMATION: The National Children's Study is a 
congressionally-mandated longitudinal birth cohort study intended to 
examine the effects of environmental exposures on the growth, 
development, and wellbeing of children. The NCS was mandated by the 
Children's Health Act of 2000 (Pub. L. 106-310).

1. Goals and Requirements

    The primary objective of the NCS is to conduct a national 
longitudinal study of environmental influences (including physical, 
chemical, biological, and psychosocial) on children's health and 
development. These factors include environmental exposures (with a 
broad definition of environment) and biological/genetic contexts. The 
Study objectives stated in the Children's Health Act of 2000 include: 
(1) Evaluate the effects of both chronic and intermittent exposures on 
child health and human development; (2) investigate basic mechanisms of 
developmental disorders and environmental factors; (3) 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; (4) 
gather data from diverse populations of children including prenatal 
exposures; and (5) consider health disparities among children.

2. Proposed Study Content Framework

    The NCS proposes to organize data collection priorities to support 
measurement of health and healthy development at critical stages. This 
requires understanding and identifying

[[Page 3841]]

known and potential factors that may influence health outcomes and 
characteristics along the developmental spectrum. For example, data 
collected during pregnancy are designed to look not only at antecedents 
of disease but also to look for factors associated with health. Which 
exposures are associated with a healthy, full term infant? What factors 
are predictive of a normal birth weight? What factors are associated 
with normal neurologic development? Areas that will be examined 
include, but are not limited to (1) physical factors such as maternal 
and paternal height, weight and Body Mass Index (BMI); (2) health 
behaviors such as sleep, diet and physical activity; (3) outcomes of 
past pregnancies and other medical conditions and history; (4) 
medication use (including alternative and complementary medicines); (5) 
presence or absence of components of the physical environment, such as 
noise, mold and mildew, pets, chemicals, and environmental tobacco 
smoke; and (6) psychosocial factors, such as social support, social 
networks, and psychological well-being and other factors that may 
protect and mediate reactions to stress. Biological and environmental 
samples will be collected to allow examination of in-utero exposures.
    The NCS intends to follow all children from birth until they reach 
age 21, an endpoint consistent with the Food and Drug Administration 
Amendments Act of 2007 that defines ``pediatric patients'' as ``those 
who are 21 years of age or younger at the time of diagnosis or 
treatment (FDA Amendments Act of 2007).'' As such it is important to 
identify the characteristics of a healthy 21-year-old person. Reaching 
age 21 is one of many important developmental milestones and it serves 
as a useful life stage for illustration of how the NCS data collection 
framework can be organized.
    To ensure the Study content framework is comprehensive, the NCS is 
working with subject matter experts to characterize health. As 
developmental trajectories are multi-dimensional, multi-directional, 
and multi-level, this effort not only helps characterize the distal end 
of the childhood developmental trajectory, but also identifies 
potential antecedent factors that could be measured earlier in life in 
assessing exposures that may contribute to later outcomes. For example, 
supportive family relationships during adolescence has been associated 
with positive outcomes ranging from reduced risk of poor mental health 
to higher levels of interpersonal and occupational functioning; these 
outcomes being independent of any effect of gender, socioeconomic 
status, or family disruption, for example death or divorce (Child 
Adolescent Mental Health 16(1): 30-37).
    At 21 years old, the thriving individual is a manifestation of 
complex, dynamic, non-linear developmental processes that are products 
of personal characteristics (including genetics), person-to-person, and 
person-to-environment interactions in the broadest sense. This 
characterization is consistent with the World Health Organization (WHO) 
construct (http://www.who.int/hia/evidence/doh/en/) which recognizes 
the following determinants of health:

     The social and economic environment
     The physical environment
     The person's individual characteristics and behaviors

    A healthy 21-year-old person may possess such attributes as a BMI 
between 19 and 25, blood pressure about 120/80 mm mercury, sound mental 
health, and the ability to develop and maintain relationships with 
other people. A healthy 21-year-old person may be able to obtain 
employment if desired or circumstances warrant. A healthy 21-year-old 
person should be able to provide food, clothing, and shelter for 
themselves and, if desired or if circumstances warrant, for others. One 
would expect that a 21-year-old person would possess a solid foundation 
in literacy (including written and oral communication skills), 
numeracy, and problem solving skills. As young adults, they may have 
positive relationships with friends or family, a network of peers, and 
feel that they are part of a community. Furthermore, a healthy 21-year-
old person is not defined on the basis of an individual who is free of 
disease or disability. If an individual has a limitation, she or he may 
still be able to function well, and even thrive, in society with the 
proper access to care, social support, and adaptations.
    The NCS will measure health as well as the presence or absence of 
disease-related signs, symptoms, and limitations. This requires a data 
collection protocol that captures a full description of an individual--
a health profile--rather than just known determinants of disease and 
subsequent outcomes. This is consistent with the Life Course Health 
Development model which ``not only measures an individual's deficits 
but also calculates his or her health assets (The Millbank Quarterly 
80(3): 433).''
    As an organizing principle, the construction of a data collection 
approach around the characteristics of a healthy 21-year-old person 
allows the NCS to identify and measure the full range of experiences 
that may later influence individual outcomes. Measures must address the 
range of potential influences, from individuals, family, peers, the 
environment, communities or the larger society. This collection will 
supplement the conventional measurement of known or theorized 
antecedents of disease-related outcomes. The NCS does not intend to 
evaluate each participant using a particular paradigm as a preferred 
outcome, but rather to ensure that generally accepted health 
characteristics can be captured across the spectrum of the NCS. The NCS 
is not and cannot be a national screening program for various 
conditions but should be able to identify a wide range of phenotypic 
characteristics. The NCS will emphasize recording primary signs and 
symptoms, capacities and limitations, and a description of the whole 
person rather than diagnosing individuals as having particular diseases 
or conditions. Nonetheless, all relevant information from medical 
records, therapeutic interventions, and descriptions from participants 
and care takers will be captured and become part of the analytic data 
sets.
    In such a model, however, the linking of a particular participant 
with a particular disease or condition may not offer all the necessary 
or even accurate information about either that individual or the 
population at large. By maintaining a focus on primary signs and 
symptoms, performance, any limitations, trends, developmental progress, 
experience, adaptation to changes in environment and context and 
relationships to the people and world around each participant, the NCS 
intends to maintain flexibility and precision for future analyses.
    Health disparities will be addressed using a definition from the 
Centers for Disease Control and Prevention that notes disease burden, 
injury, violence, and health potential as key parameters (CDC, HHS, 
2008). Each participant in the NCS will be evaluated for each of these 
parameters, regardless of any other demographic or socioeconomic 
characteristics. Through this approach, the NCS can maintain continuity 
of purpose through the ever-present changes in a dynamic society.
    In sum, the NCS is proposing the use of a framework of distal 
outcomes, health determinants, primary signs and symptoms, phenotypic 
and environmental descriptions, and capture

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of parameters associated with health disparities to guide the selection 
of the specific assessments along with their sequence and frequency. 
Related materials with additional information can be found here: http://www.nationalchildrensstudy.gov/about/organization/advisorycommittee/Pages/January-2014-NCSAC-Meeting-Briefing-Book.aspx.

3. Information Requested

    This RFI invites the scientific community, health professionals, 
and the general public to provide comments and suggestions on the 
proposed framework of using the characteristics of a healthy, 
functional 21-year-old person, plus the other principles and factors 
noted, above for developing Study content and protocols. Given the 
requirements as stated in the Children's Health Act of 2000, please 
include in responses to the questions below whether the Study proposed 
content framework balances the complex requirements.
    1. Please comment on the validity and acceptability of using a 
composite outcome--the higher-level functions of a healthy 21-year-old 
person--as an operational construct to help frame data collection.
    2. Are there additional outcomes or developmental endpoints that 
should be considered?
    3. What factors should the NCS use to prioritize assessments? Some 
examples of factors to consider are:

a. Potential public health impact.
b. Technical feasibility, including timing of data collection with 
regard to potential developmental vulnerability.
c. Scientific opportunity to address knowledge gaps and illuminate 
developmental pathways.

    This RFI is for planning purposes only and should not be construed 
as a solicitation for applications or proposals, or as an obligation in 
any way on the part of the United States Federal government. The 
Federal government will not pay for the preparation of any information 
submitted or for the government's use. Additionally, the government 
cannot guarantee the confidentiality of the information provided.

    Dated: January 15, 2014.
Dean J. Coppola,
Acting Director, National Children's Study, Eunice Kennedy Shriver 
National Institute of Child Health and Human Development.
[FR Doc. 2014-01339 Filed 1-22-14; 8:45 am]
BILLING CODE 4140-01-P