[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38191-38193]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16299]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


New Proposed Collection; Comment Request; Biospecimen and 
Physical Measures 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 23609-23611, and 
allowed 60 days for public comment. One written comment was received. 
The comment questioned the cost and utility of the study and federally 
funded biomedical research in general. The purpose of this notice is to 
allow an additional 30 days for public comment.
    Proposed Collection:
    Title: Biospecimen and Physical Measures 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 tests will be used to maximize the 
efficiency (measured by scientific robustness, participant and 
infrastructure burden, and cost) of biospecimen and physical 
measurement collection procedures, accompanying questionnaires, storage 
and information management processes, and assay procedures, thereby 
informing 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 conduct formative research 
featuring biospecimen and physical measurement collections.
    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 biospecimen collection procedures and physical measurements 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, infants, children, 
fathers, health care facilities and professionals, public health 
professional organizations and practitioners, and hospital 
administrators.
    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: $600,000 (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, Biological and Physical Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Estimated     Estimated number    Average burden    Estimated total
           Data collection activity                   Type of respondent             number of     of responses per      hours per        annual burden
                                                                                    respondents       respondent          response       hours requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blood:
    Adult....................................  NCS participants................             4,000                 1               0.5              2,000
                                               Members of NCS target population             4,000                 1               0.5              2,000
                                                (not NCS participants).
    Infant/Child.............................  NCS participants................             2,000                 1               0.5              1,000
                                               Members of NCS target population             2,000                 1               0.5              1,000
                                                (not NCS participants).
Urine:
    Adult....................................  NCS participants................             4,000                 1               0.25             1,000
                                               Members of NCS target population             4,000                 1               0.25             1,000
                                                (not NCS participants).
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Hair:

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    Adult....................................  NCS participants................             4,000                 1               0.25             1,000
                                               Members of NCS target population             4,000                 1               0.25             1,000
                                                (not NCS participants).
Nails:
    Adult....................................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Cervical Fluid:
    Women....................................  NCS participants................             4,000                 1               0.5              2,000
                                               Members of NCS target population             4,000                 1               0.5              2,000
                                                (not NCS participants).
Breast Milk:
    Women....................................  NCS participants................             4,000                 1               0.5              2,000
                                               Members of NCS target population             4,000                 1               0.5              2,000
                                                (not NCS participants).
Cord Blood:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Meconium:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Placenta:
    Infant...................................  NCS participants................             4,000                 1               0.25             1,000
                                               Members of NCS target population             4,000                 1               0.25             1,000
                                                (not NCS participants).
Length:
    Infant...................................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Height:
    Child....................................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Weight:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Head Circumference:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Middle Upper Arm Circumference:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (not NCS participants).
Ulnar Length:
    Infant/Child.............................  NCS participants................             2,000                 1               0.25               500
                                               Members of NCS target population             2,000                 1               0.25               500
                                                (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).

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                                               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....................................  ................................           113,000  ................  .................            60,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 e-mail 
your request, including your address to glavins@mail.nih.gov.
    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. 2011-16299 Filed 6-28-11; 8:45 am]
BILLING CODE 4140-01-P