[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5856-5857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1688]


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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: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Child Health and Human 
Development (NICHD), the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on November 19, 2007, pages 65047-8, and allowed 60 days for 
public comment. One comment was received questioning the utility of the 
proposed data collection. 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 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 formative research and 
pilot studies 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. 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 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)..............

[[Page 5857]]

 
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: 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 the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. 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 30 days 
of the date of this publication.

    Dated: January 23, 2008.
Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. E8-1688 Filed 1-30-08; 8:45 am]
BILLING CODE 4140-01-P