[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38189-38190]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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. This proposed information collection was previously published 
in the Federal Register on April 27, 2011, pages 23603-23605, and 
allowed 60 days for public comment. One written comment was received. 
The comment questioned the cost and utility of the study specifically 
and of federally funded biomedical research in general. The purpose of 
this notice is to allow an additional 30 days for public comment.

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 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 
are no Capital Costs to report. There are no Operating or Maintenance 
Costs to report.

                                        Table 1--Estimated Annual Reporting Burden Summary, Environmental Science
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                                                                                                        Estimated
                                                                                      Estimated         number of      Average burden    Estimated total
           Data collection activity                    Type of respondent             number of       responses per       hours per       annual burden
                                                                                     respondents       respondent         response       hours requested
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Home Air......................................  NCS participants................             4,000                 1                 1             4,000

[[Page 38190]]

 
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
Home Water....................................  NCS participants................             4,000                 1                 1             4,000
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
Home Dust.....................................  NCS participants................             4,000                 1                 1             4,000
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
School and Child Care Facility Air............  NCS participants................             4,000                 1                 1             4,000
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
School and Child Care Facility Water..........  NCS participants................             4,000                 1                 1             4,000
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
School and Child Care Facility Dust...........  NCS participants................             4,000                 1                 1             4,000
                                                Members of NCS target population             4,000                 1                 1             4,000
                                                 (not NCS participants).
Small, focused survey and instrument design     NCS participants................             4,000                 2                 1             8,000
 and administration.
                                                Members of NCS target population             4,000                 2                 1             8,000
                                                 (not NCS participants).
                                                Health and Social Service                    2,000                 1                 1             2,000
                                                 Providers.
                                                Community Stakeholders..........             2,000                 1                 1             2,000
Focus groups..................................  NCS participants................             2,000                 1                 1             2,000
                                                Members of NCS target population             2,000                 1                 1             2,000
                                                 (not NCS participants).
                                                Health and Social Service                    2,000                 1                 1             2,000
                                                 Providers.
                                                Community Stakeholders..........             2,000                 1                 1             2,000
Cognitive interviews..........................  NCS participants................               500                 1                 2             1,000
                                                Members of NCS target population               500                 1                 2             1,000
                                                 (not NCS participants).
                                                                                 -----------------------------------------------------------------------
    Total.....................................  ................................            69,000  ................  ................            78,000
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    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 E-mail 
your request, including your address to glavins@mail.nih.gov.

DATES: 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 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications, 
National Institute of Child Health and Human Development.
[FR Doc. 2011-16300 Filed 6-28-11; 8:45 am]
BILLING CODE 4140-01-P