[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54474-54476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request New proposed 
collection, Biospecimen and Physical Measures Formative Research 
Methodology Studies for the National Children's Study

SUMMARY: Under the provisions of Section (3507(a)(1)(D)) of the 
Paperwork Reduction Act of 1995, the National Institutes of Health has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. 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. Two written comments and two verbal comments were 
received. The verbal comments expressed support for the broad scope of 
the study. The written comments were identical and questioned the cost 
and utility of the study. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Institutes of 
Health may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.
    Proposed Collection: Title: Biospecimen and Physical Measures 
Formative Research Methodology Studies for the National Children's 
Study (NCS). Type of Information Request: NEW. 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
                                     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
----------------------------------------------------------------------------------------------------------------
Blood:
    Adult.....................  NCS participants           4,000               1             0.5           2,000

[[Page 54475]]

 
                                Members of NCS             4,000               1             0.5           2,000
                                 target
                                 population (not
                                 NCS
                                 participants).
    Infant/Child..............  NCS participants           2,000               1             0.5           1,000
                                Members of NCS             2,000               1             0.5           1,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Urine:
    Adult.....................  NCS participants           4,000               1            0.25           1,000
                                Members of NCS             4,000               1            0.25           1,000
                                 target
                                 population (not
                                 NCS
                                 participants).
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Hair:
    Adult.....................  NCS participants           4,000               1            0.25           1,000
                                Members of NCS             4,000               1            0.25           1,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Nails:
    Adult.....................  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Cervical Fluid:
    Women.....................  NCS participants           4,000               1             0.5           2,000
                                Members of NCS             4,000               1             0.5           2,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Breast Milk:
    Women.....................  NCS participants           4,000               1             0.5           2,000
                                Members of NCS             4,000               1             0.5           2,000
                                 target
                                 population (not
                                 NCS
                                 participants).
Cord Blood:
    Infant/ Child.............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Meconium:
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Placenta:
    Infant....................  NCS participants           4,000               1            0.25            1000
                                Members of NCS             4,000               1            0.25            1000
                                 target
                                 population (not
                                 NCS
                                 participants).
Length:
    Infant....................  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Height:
    Child.....................  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Weight:
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Head Circumference:
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Middle Upper Arm
 Circumference:
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 target
                                 population (not
                                 NCS
                                 participants).
Ulnar Length:
    Infant/Child..............  NCS participants           2,000               1            0.25             500
                                Members of NCS             2,000               1            0.25             500
                                 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.

[[Page 54476]]

 
                                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.....................  ................         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 enhance the quality, utility, and 
clarity of the information collected; and (4) 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to Office of Management and Budget, Office of Information and 
Regulatory Affairs, Attn: NIH Desk Officer, by E-mail to [email protected], or by fax to 202-395-6974. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and instruments, contact Ms. Jamelle E. Banks, Public 
Health Analyst, 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 a 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 30 days 
of the date of this publication.

    Dated: August 25, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development.
[FR Doc. 2011-22456 Filed 8-31-11; 8:45 am]
BILLING CODE 4140-01-P