National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Formative Research and Pilot Studies for the National Children's Study, 5856-5857 [E8-1688]

Download as PDF 5856 Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices ensuring that the Advisory Committee includes the areas of subject matter expertise noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the ACOT. Nominations shall state that the nominee is willing to serve as a member of the ACOT and appears to have no conflict of interest that would preclude the ACOT membership. Potential candidates will be asked to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations of the Committee to permit evaluation of possible sources of conflicts of interest. A nomination package should include the following information for each nominee: (1) A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes, perspectives, and/or skills does the individual possess that would benefit the workings of ACOT), and the nominee’s field(s) of expertise; (2) a biographical sketch of the nominee and a copy of his/her curriculum vitae; and (3) the name, return address, and daytime telephone number at which the nominator can be contacted. The Department of Health and Human Services has special interest in assuring that women, minority groups, and the physically disabled are adequately represented on advisory committees; and therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or disabled candidates. Dated: January 22, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8–1730 Filed 1–30–08; 8:45 am] BILLING CODE 4165–15–P 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: https://nationalchildrensstudy.gov. The proposed data collection program will include community outreach materials, Estimated number of respondents rwilkins on PROD1PC63 with NOTICES Type of respondents (estimated hourly rate) Small focused studies ($10) ............................................................................ Focus groups with potential participants ($10) ................................................ Focus groups with health care professionals ($50) ........................................ Focus groups with community leaders ($10) .................................................. Medical provider feedback on materials through informal in-person contacts ($50) ............................................................................................................. VerDate Aug<31>2005 18:07 Jan 30, 2008 Jkt 214001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 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. Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours 1,250 350 350 350 1 1 1 1 1.5 3.0 3.0 3.0 1,875 1,050 1,050 1,050 700 1 0.5 350 E:\FR\FM\31JAN1.SGM 31JAN1 5857 Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices Estimated number of responses per respondent Estimated number of respondents Type of respondents (estimated hourly rate) Average burden hours per response Estimated total annual burden hours 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: rwilkins on PROD1PC63 with NOTICES 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 ncsinfo@mail.nih.gov. 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 VerDate Aug<31>2005 18:07 Jan 30, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development Proposed Collection; Comment Request; Pilot Study 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 65049–65050, 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: Pilot Study for the National Children’s Study, Type of Information Collection Request: New, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18–49 years of age, their husbands or partners, and their children who live in selected areas within seven (7) National Children’s Study Vanguard sites. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of this Study is to pilot test protocols, policies, and procedures for the National Children’s Study (NCS) with the goal of improving the efficiency of study procedures and enhancing the PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 subsequent implementation of the NCS, a long-term cohort study of environmental influences on child health and development authorized under the Children’s Health Act of 2000. This data collection will test procedures for population-based sampling and recruitment of pregnant women and women of child-bearing age, test study logistics, and estimates of subject burden, and evaluate data collection strategies including interviews and acquisition of biologic and environmental samples. In addition, participants will also be asked to provide qualitative and quantitative input on their feelings regarding participation in this study. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: https://nationalchildrensstudy.gov. The Pilot Study is intended to begin with household enumeration and enrollment of women, proceed through pregnancy and birth, and continue with follow-up of children for up to 21 years. This application is for the first three years of data collection, which includes data collection through the visits at which some of the children will be 24 months old. Details of data collections beyond this period will be addressed at the time of renewal or in future applications. Women who are pregnant will be eligible for participation if, at the time of household enumeration and screening, they are within the first trimester of pregnancy. Women who are not pregnant will be eligible if, at the time of household enumeration and screening, they are 18–49 years of age, are neither surgically nor medically sterile, and can participate in the consent process. A subset of age-eligible women with a high likelihood of pregnancy (e.g., planning to become pregnant) will be enrolled to enable assessment of peri-conceptional exposures, should they become pregnant. The remainder of the study population will comprise women enrolled early in pregnancy. The seven centers combined will follow approximately 1000 infants born to women enrolled in the first year of this Pilot Study. Home visits before and during pregnancy will include collection of interview data, E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5856-5857]
From the Federal Register Online via the Government Printing 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: https://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.

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

    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 
ncsinfo@mail.nih.gov.
    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
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