[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41508-41509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17735]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; 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 
(NIH) has submitted to the Office of Management and Budget (OMB) a 
request for reinstatement of approval of the information collection 
listed below. 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. 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: Formative Research Studies for the 
National Children's Study (NCS) 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 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. 
Type of Review: Reinstatement of OMB 0925-0590, Expiration 
June 30, 2011. 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

[[Page 41509]]

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).

                               Table 1--Estimated Annual Reporting Burden Summary
----------------------------------------------------------------------------------------------------------------
                                                                         Estimated
                                                            Estimated    number of     Average       Estimated
     Data collection activity         Type of respondent    number of    responses      burden     total annual
                                                           respondents      per       hours per    burden hours
                                                                         respondent    response      requested
----------------------------------------------------------------------------------------------------------------
Small, focused survey and           NCS participants.....        4,000            2            1           8,000
 instrument design and
 administration.
                                    Members of NCS target        4,000            2            1           8,000
                                     population (not NCS
                                     participants).
                                    Health and Social            2,000            1            1           2,000
                                     Service Providers.
                                    Community                    2,000            1            1           2,000
                                     Stakeholders.
Focus groups......................  NCS participants.....        2,000            1            2           2,000
                                    Members of NCS target        2,000            1            2           2,000
                                     population (not NCS
                                     participants).
                                    Health and Social            2,000            1            2           2,000
                                     Service Providers.
                                    Community                    2,000            1            2           2,000
                                     Stakeholders.
Cognitive interviews..............  NCS participants.....          500            1            2           1,000
                                    Members of NCS target          500            1            2           1,000
                                     population (not NCS
                                     participants).
                                                          ------------------------------------------------------
    Total.........................  .....................       21,000  ...........  ...........          30,000
----------------------------------------------------------------------------------------------------------------

    Requests 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 to be 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: July 8, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and 
Communications National Institute of Child Health and Human 
Development.
[FR Doc. 2011-17735 Filed 7-13-11; 8:45 am]
BILLING CODE 4140-01-P