Notices. DEPARTMENT OF HEALTH AND HUMAN SERVICES
1,382 words·~6 min read·
/register/2010/06/21/2010-14969·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; The National Children's Study (NCS), Vanguard (Pilot) 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 March 22, 2010, pages 14165-14168, and allowed 60 days for public comment. One comment was received. The comment questioned the value and utility of the proposed data collection, stating that this type of research is not needed. 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:* Revision, *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 National Children's Study sites. Health care professionals, community leaders, and child care personnel are also potentially affected. *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 the proposed methodological study is to evaluate the feasibility, acceptability, and cost of three separate recruitment strategies for enrollment of women into a prospective, national longitudinal study of child health and development. This Recruitment Substudy is a component of the Vanguard Phase of the National Children's Study (NCS). In combination, the studies in the Vanguard Phase will be used to inform the design of the Main Study of the National Children's Study. This data collection will evaluate the feasibility, acceptability and cost of three separate recruitment strategies for enrollment of women into the NCS. Up to 30 additional sites will be added to the NCS Vanguard Cohort, as reflected in the burden table, in order to ensure an adequate cohort size. These additional sites will be chosen from among those already identified for the Main Study of the NCS. Across these additional sites, three alternate recruitment strategies will be assessed: • An enhanced household enumeration strategy that builds on the lessons learned in the existing Vanguard Study by enhancing enumeration techniques and employing a more streamlined recruitment process; • A provider based recruitment strategy that relies on health care providers for assistance in participant identification and recruitment; and • A two-tiered recruitment strategy that relies on larger secondary sampling units to increase the number of geographically-eligible women in a given area, and allows for both higher-intensity and lower-intensity forms of data collection. The feasibility (technical performance), acceptability (respondent tolerance and impact on study infrastructure), and cost (operations, time, and effort) of each of these three strategies will be evaluated using pre-determined measures. The findings will be assessed and used to inform the strategies, or combinations of strategies, that might be used in the Main Study of the NCS. Further details pertaining to the NCS background and planning can be found at: *http://www.nationalchildrensstudy.gov.* *Burden statement:* The public burden for this study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening and the method of recruitment. The table below provides an annualized average burden per person for each stage of the Recruitment Substudy. Table A.2—Estimated Hour Burden and Cost for Recruitment Substudy Respondents—Stage 1 [July 2010 to December 2010] Recruitment strategy Activity Type of respondent Number of respondents Responses per respondent Hours per response Annual hour burden Provider-based: 10 Study Locations Projected for Stage 1 (July 2010-December 2010) *Screening Activities* Address Look-Up Age-Eligible Women 7,500 1 0.1 750 Pregnancy Screening Age-Eligible Women 1,500 1 0.42 630 *Preconception Activities* Pre-Pregnancy Interview Age-Eligible Women 123 1 0.75 92 Pregnancy Probability Group Follow Up Script Age-Eligible Women 123 6 0.1 74 *Pregnancy Activities* Women's Informed Consent Form Pregnant Women 1,500 1 0.67 1,005 Pregnancy Visit 1 Interview Pregnant Women 572 1 1 572 Pregnancy Visit 2 Interview Pregnant Women 572 1 0.75 429 *Birth-Related Activities* Birth Visit Interview Mother/Baby 299 1 0.4 120 Total—Stage 1 12,188 3,671 Enhanced Household: 10 Study Locations Projected for Stage 1 (July 2010-December 2010) *Screening Activities* Household Enumeration Script HH reporters 120,000 1 0.33 39,600 Pregnancy Screening Age-Eligible Women 51,198 1 0.42 21,503 Neighbor Report Neighbors 12,000 1 0.05 600 *Preconception Activities* Pre-Pregnancy Interview Age-Eligible Women 211 1 0.75 158 Pregnancy Probability Group Follow Up Script Age-Eligible Women 211 6 0.1 127 *Pregnancy Activities* Women's Informed Consent Form Pregnant Women 2,586 1 0.67 1,733 Pregnancy Visit 1 Interview Pregnant Women 986 1 1 986 Pregnancy Visit 2 Interview Pregnant Women 986 1 0.75 740 *Birth-Related Activities* Birth Visit Interview Mother/Baby 516 1 0.4 206 Total—Stage 1 188,695 65,653 Two Tier (Low): 10 Study Locations Across Both Tiers Projected for Stage 1 (July 2010-December 2010) *Screening Activities* Low-intensity CATI Preg. Screener Age-Eligible Women 48,000 1 0.35 16,800 Low-Intensity Consent Script Age-Eligible Women 28,800 1 0.33 9,504 *Preconception Activities* Low-intensity CATI Questionnaire Age-Eligible Women 10,057 1 0.5 5,028 Pregnancy Probability Group Follow Up Script Age-Eligible Women 10,057 6 0.1 6,034 *Pregnancy Activities* Low-intensity CATI Questionnaire Pregnant Women 518 1 0.5 259 *Birth-Related Activities* Low-intensity CATI Questionnaire Mother/Baby 166 1 0.5 83 Total—Stage 1 97,598 37,709 Two Tier (High): 10 Study Locations Across Both Tiers Projected for Stage 1 (July 2010-December 2010) *Screening Activities* Pregnancy Screening Age-Eligible Women 15,840 1 0.42 6,653 *Preconception Activities* Pre-Pregnancy Interview Age-Eligible Women 761 1 0.75 571 Pregnancy Probability Group Follow Up Script Age-Eligible Women 761 6 0.1 456 *Pregnancy Activities* Women's Informed Consent Form Pregnant Women 9,504 1 0.67 6,368 Pregnancy Visit 1 Interview Pregnant Women 3,552 1 1 3,552 Pregnancy Visit 2 Interview Pregnant Women 3,552 1 0.75 2,664 *Birth-Related Activities* Birth Visit Interview Mother/Baby 1,857 1 0.4 743 Total—Stage 1 35,826 21,006 Grand Total, Recruitment Substudy 334,308 128,039 The estimated annualized cost to respondents is $1,782,053 based on the differential hourly rate estimates in the above table. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. *Request 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: Jamelle E. Banks, M.P.H., National Institute of Child Health and Human Development, 31 Center Drive, Room 2A18, Bethesda, Maryland, 20892, or call non-toll free number
(301)443-7210, or e-mail your request, including your address to *banksj@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: June 15, 2010. Jamelle E. Banks, NICHD Project Clearance Liaison, National Institutes of Health. [FR Doc. 2010-14969 Filed 6-18-10; 8:45 am]