[Federal Register Volume 77, Number 48 (Monday, March 12, 2012)]
[Notices]
[Pages 14530-14531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; New 
Proposed Collection; Comment Request; Environmental Science 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.
    Proposed Collection:
    Title: Environmental Science Formative Research Methodology 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 environmental sample collection procedures and 
technology, storage procedures, accompanying questionnaires, and 
assays, 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 collect 
environmental samples from homes and child care settings, and conduct 
accompanying short surveys related to the physical and chemical 
environment.
    The NCS has obtained OMB's generic clearance to conduct survey and 
instrument design and administration, focus groups, cognitive 
interviews, and health and social service provider feedback information 
collection surrounding outreach, recruitment and retention (OMB 
 0925-0590; Expiration Date 9/30/2014). Under separate notice, 
the NCS is also requesting generic clearance to conduct formative 
research featuring biospecimen and physical measures (OMB  
0925-0647, Expiration Date 1/31/2015), neurodevelopmental (pending 
clearance), and study logistic (pending clearance) information 
collection. Separate and distinct generic clearances are requested to 
facilitate the efficiency of submissions and review of these projects 
as requested by the Office of Information and Regulatory Affairs.
    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 request, the NCS is requesting generic approval from OMB 
for formative research activities relating to the collection, storage, 
management, and assay of environmental samples and accompanying 
questionnaires. 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 environmental sample and information collection 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, fathers, public health and environmental 
science professional organizations and practitioners, 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: $780,000 (based on $10 per hour). 
There

[[Page 14531]]

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 burden   total annual
   Data collection activity        respondent        number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Home Air......................  NCS participants           4,000               1               1           4,000
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Home Water....................  NCS participants           4,000               1               1           4,000
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Home Dust.....................  NCS participants           4,000               1               1           4,000
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
School and Child Care Facility  NCS participants           4,000               1               1           4,000
 Air.
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
School and Child Care Facility  NCS participants           4,000               1               1           4,000
 Water.
                                Members of NCS             4,000               1               1           4,000
                                 target
                                 population (not
                                 NCS
                                 participants).
School and Child Care Facility  NCS participants           4,000               1               1           4,000
 Dust.
                                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.
                                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.....................  ................          69,000  ..............  ..............          78,000
----------------------------------------------------------------------------------------------------------------

    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 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 60 days 
of the date of this publication.

    Dated: March 6, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications 
National Institute of Child Health and Human Development.
[FR Doc. 2012-5946 Filed 3-9-12; 8:45 am]
BILLING CODE 4140-01-P