[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65047-65048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Proposed Collection; Comment Request; Formative Research and Pilot 
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: Formative Research and Pilot Studies 
for the National Children's Study. Type of Information Collection 
Request: NEW. Need and use of information collection: The NICHD seeks 
to obtain OMB's generic approval to conduct pilot and formative 
research to be used in the development of instruments, materials, and 
procedures for the National Children's Study (NCS). The NCS is a long-
term cohort study of environmental influences on child health and 
development authorized under the Children's Health Act of 2000. The Act 
specifies a broad definition of environment, including biologic, 
chemical, physical, and psycho-social factors and authorizes the NICHD 
to plan, develop, and implement a prospective cohort study, from birth 
to adulthood, to evaluate the effects of those exposures on child 
health and human development. Further details pertaining to the NCS 
background and planning, including the NCS Research Plan, can be found 
at: http://nationalchildrensstudy.gov. The proposed data collection 
program will include community outreach materials, medical provider and 
participant materials, questionnaires and measures, use of technology 
such as Interactive Voice Recognition (IVR), and other aspects related 
to data collection. Activities will include small focused studies to 
test data collection items and methods on a specific or targeted 
population, validation of questionnaires for targeted populations, 
focus groups within the NCS communities to test forms and procedures, 
cognitive interviews to test data items, and the use of materials on 
targeted populations such as medical providers and hospitals, and 
materials translated into other languages. These activities will be 
conducted over the life of the study to develop procedures and 
materials for each stage of data collection. The results of these pilot 
tests will be used to maximize the efficiency of study procedures, 
materials, and methods for community outreach, engagement of the 
medical community, for recruiting and retaining study subjects 
prospectively across study visits and to ensure that data collection 
methodologies are efficient and valid for all potential participants. 
Without this information, NCS will be hampered in its efforts to 
effectively publicize the NCS, gain public and professional support, 
and effectively recruit and retain respondents and collect data over 
the life of the Study. Affected entities: Individuals. Types of 
respondents: People potentially affected by this action are pregnant 
women or women of childbearing age, their husbands or partners, health 
care professionals, and community leaders. The annual

[[Page 65048]]

reporting burden is as follows: Estimated Number of Respondents: 3,150. 
Frequency of Response: On occasion (see Burden table). The Estimated 
Number of Responses per Respondent: 1. Average Burden Hours Per 
Response: Varies with study type. Estimated Total Annual Burden Hours 
Requested: 5,825. The estimated annualized cost to respondents is 
$114,250 (based on rates listed in the burden table). There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.

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                                                                     Estimated
                                                     Estimated       number of        Average        Estimated
  Type of respondents  (estimated hourly rate)       number of     responses per   burden hours    total annual
                                                    respondents     respondent     per response    burden hours
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Small focused studies ($10).....................           1,250               1             1.5           1,875
Focus groups with potential participants ($10)..             350               1             3.0           1,050
Focus groups with health care professionals                  350               1             3.0           1,050
 ($50)..........................................
Focus groups with community leaders ($10).......             350               1             3.0           1,050
Medical provider feedback on materials through               700               1             0.5             350
 informal in-person contacts ($50)..............
Cognitive interviews ($10)......................             150               1             3.0             450
                                                 ---------------------------------------------------------------
    Total.......................................           3,150  ..............  ..............           5,825
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    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.

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 Ruth A. Brenner, MD, MPH, National Institute of 
Child Health and Human Development, Building 6100, 5C01, 6100 Executive 
Blvd, Bethesda, Maryland 20892, or call non-toll free number (301) 594-
9147, 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.

Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-22592 Filed 11-16-07; 8:45 am]
BILLING CODE 4140-01-P