[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38401-38403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Revision to Proposed Collection; Comment Request; 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 23608-23609, 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 specifically and of 
federally funded biomedical research overall. The purpose of this 
notice is to allow an additional 30 days for public comment.
    Proposed Collection:
    Title: Formative Research Studies for the National Children's Study 
(NCS)
    Type of Information Collection Request: RENEWAL of OMB Clearance 
0925-0590, Expiration June 30, 2011
    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

[[Page 38402]]

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 and pilot tests will be used to maximize 
the efficiency of NCS procedures, materials, and methods for outreach, 
engagement of stakeholders, recruitment and retention of Study 
subjects, and to ensure scientifically robust 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 
approval to conduct survey and instrument design and administration, 
focus groups, cognitive interviews, and health and social service 
provider information collection surrounding outreach, engagement, 
recruitment, consent and questionnaire design, and retention 
activities.
    The results from formative research and pilot tests proposed will 
inform the feasibility (scientific robustness), acceptability (burden 
to participants and study logistics) and cost of NCS Vanguard and Main 
Study recruitment, retention, study visit measures and study logistics.
    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, community 
leaders, members, and organizations, health care facilities and 
professionals, public health, environmental, social and cognitive 
science professional organizations and practitioners, hospital 
administrators, cultural and faith-based centers, 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: $300,000 (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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Estimated                       Estimated
                                                                                             Estimated       number of        Average      total annual
            Data collection activity                        Type of respondent               number of     responses per   burden  hours   burden hours
                                                                                            respondents     respondent     per  response     requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small, focused survey and instrument design and  NCS participants.......................           4,000               2               1           8,000
 administration.
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not             4,000               2               1           8,000
                                                  NCS participants).
                                                --------------------------------------------------------------------------------------------------------
                                                 Health and Social Service Providers....           2,000               1               1           2,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Community Stakeholders.................           2,000               1               1           2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus groups...................................  NCS participants.......................           2,000               1               2           2,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not             2,000               1               2           2,000
                                                  NCS participants).
                                                --------------------------------------------------------------------------------------------------------
                                                 Health and Social Service Providers....           2,000               1               2           2,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Community Stakeholders.................           2,000               1               2           2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interviews...........................  NCS participants.......................             500               1               2           1,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not               500               1               2           1,000
                                                  NCS participants).
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total......................................  .......................................          21,000  ..............  ..............      30,000 hrs
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 30 days 
of the date of this publication.


[[Page 38403]]


    Dated: June 27, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications, 
National Institute of Child Health and Human Development.
[FR Doc. 2011-16528 Filed 6-29-11; 8:45 am]
BILLING CODE 4140-01-P