E7-22592. 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 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.

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

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 [phone], or e-mail your request, including your address to [e-mail].

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.