[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23609-23611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10170]


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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.
    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--

[[Page 23610]]

    (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 an OMB generic clearance to conduct formative research 
featuring biospecimen and physical measurement collections.
    The NCS has obtained an OMB 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 (0925-0590; 
requesting renewal). Under separate notice, the NCS is also requesting 
an OMB generic clearance to conduct formative research featuring 
environmental, neurodevelopmental, and study logistic information 
collection. These separate and distinct generic clearances are 
requested to facilitate the efficiency of submission and review of 
these projects as required by the OMB 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, NCS is requesting approval from OMB for formative 
research activities relating to the collection, storage, management, 
and assay of biospecimen and physical measurements 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 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.
    The NCS has obtained generic clearance for formative research 
activities pertaining to outreach, recruitment, and retention (0925-
0590). Under separate notice, the NCS also requests an OMB generic 
clearance for formative research featuring environmental, 
neurodevelopmental, and study logistic information collection. These 
separate and distinct generic clearances are requested to facilitate 
the efficiency of submission and review of these projects as required 
by the OMB Office of Information and Regulatory Affairs.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data collection activity                                                 Type of respondent.........    Estimated    Estimated      Average    Estimated
                                                                                                        number of    number of       burden        total
                                                                                                      respondents    responses    hours per       annual
                                                                                                                           per     response       burden
                                                                                                                    respondent                     hours
                                                                                                                                               requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blood....................................  Adult.......................  NCS participants...........        4,000            1          0.5        2,000
                                                                         Members of NCS target              4,000            1          0.5        2,000
                                                                          population (not NCS
                                                                          participants).
                                           Infant/Child................  NCS participants...........        2,000            1          0.5        1,000
                                                                         Members of NCS target              2,000            1          0.5        1,000
                                                                          population (not NCS
                                                                          participants).
Urine....................................  Adult.......................  NCS participants...........        4,000            1         0.25        1,000
                                                                         Members of NCS target              4,000            1         0.25        1,000
                                                                          population (not NCS
                                                                          participants).
                                           Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Hair.....................................  Adult.......................  NCS participants...........        4,000            1         0.25        1,000
                                                                         Members of NCS target              4,000            1         0.25        1,000
                                                                          population (not NCS
                                                                          participants).
Nails....................................  Adult.......................  NCS participants...........        2,000            1         0.25          500

[[Page 23611]]

 
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Cervical Fluid...........................  Women.......................  NCS participants...........        4,000            1          0.5        2,000
                                                                         Members of NCS target              4,000            1          0.5        2,000
                                                                          population (not NCS
                                                                          participants).
Breast Milk..............................  Women.......................  NCS participants...........        4,000            1          0.5        2,000
                                                                         Members of NCS target              4,000            1          0.5        2,000
                                                                          population (not NCS
                                                                          participants).
Cord Blood...............................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Meconium.................................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Placenta.................................  Infant......................  NCS participants...........        4,000            1         0.25         1000
                                                                         Members of NCS target              4,000            1         0.25         1000
                                                                          population (not NCS
                                                                          participants).
Length...................................  Infant......................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Height...................................  Child.......................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Weight...................................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Head Circumference.......................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Middle Upper Arm.........................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
Circumference                                                            Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
Ulnar Length.............................  Infant/Child................  NCS participants...........        2,000            1         0.25          500
                                                                         Members of NCS target              2,000            1         0.25          500
                                                                          population (not NCS
                                                                          participants).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small, focused survey and instrument design and administration           NCS participants...........        4,000            2            1        8,000
                                                                         Members of NCS target              4,000            2            1        8,000
                                                                          population (not NCS               2,000            1            1        2,000
                                                                          participants).                    2,000            1            1        2,000
                                                                         Health and Social Service
                                                                          Providers.
                                                                         Community Stakeholders.....
                                          --------------------------------------------------------------------------------------------------------------
Focus groups                                                             NCS participants...........        2,000            1            1        2,000
                                                                         Members of NCS target              2,000            1            1        2,000
                                                                          population (not NCS               2,000            1            1        2,000
                                                                          participants).                    2,000            1            1        2,000
                                                                         Health and Social Service
                                                                          Providers.
                                                                         Community Stakeholders.....
                                          --------------------------------------------------------------------------------------------------------------
Cognitive interviews                                                     NCS participants...........          500            1            2        1,000
                                                                         Members of NCS target                500            1            2        1,000
                                                                          population (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 [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: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications 
National Institute of Child Health and Human Development.
[FR Doc. 2011-10170 Filed 4-26-11; 8:45 am]
BILLING CODE 4140-01-P