[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)] [Notices] [Pages 32474-32476] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2010-13705] ----------------------------------------------------------------------- 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, Recruitment Substudy Phase 1 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 [[Page 32475]] 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 1--Estimated Hour Burden and Cost for Recruitment Substudy Respondents--Stage 1 [July 2010 to December 2010] ---------------------------------------------------------------------------------------------------------------- Type of Number of Responses per Hours per Annual hour Recruitment strategy/activity respondent respondents respondent response burden ---------------------------------------------------------------------------------------------------------------- Provider-based: 10 Study Locations--Projected for Stage 1 (July 2010-December 2010) ---------------------------------------------------------------------------------------------------------------- Screening Activities Address Look-Up........... Age-Eligible 7,500 1 0.1 750 Women. Pregnancy Screening....... Age-Eligible 1,500 1 0.42 630 Women. Preconception Activities Pre-Pregnancy Interview... Age-Eligible 123 1 0.75 92 Women. PPG Follow Up Script...... Age-Eligible 123 6 0.1 74 Women. Pregnancy Activities Women's Informed Consent Pregnant Women.. 1,500 1 0.67 1,005 Form. First Pregnancy Interview. Pregnant Women.. 572 1 1 572 Second Pregnancy 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 HH reporters.... 120,000 1 0.33 39,600 Script. Pregnancy Screening....... Age-Eligible 51,198 1 0.42 21,503 Women. Neighbor Report........... Neighbors....... 12,000 1 0.05 600 Preconception Activities Pre-Pregnancy Interview... Age-Eligible 211 1 0.75 158 Women. PPG Follow Up Script...... Age-Eligible 211 6 0.1 127 Women. Pregnancy Activities Women's Informed Consent Pregnant Women.. 2,586 1 0.67 1,733 Form. First Pregnancy Interview. Pregnant Women.. 986 1 1 986 Second Pregnancy 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. Age-Eligible 48,000 1 0.35 16,800 Screener. Women. Low Intensity Consent Age-Eligible 28,800 1 0.33 9,504 Script. Women. Preconception Activities [[Page 32476]] Low-intensity CATI Age-Eligible 10,057 1 0.5 5,028 Questionnaire. Women. PPG Follow Up Script...... Age-Eligible 10,057 6 0.1 6,034 Women. Pregnancy Activities Low-intensity CATI Pregnant Women.. 518 1 0.5 259 Questionnaire. Birth-Related Activities Low-intensity CATI Mother/Baby..... 166 1 0.5 83 Questionnaire. --------------------------------------------------------------------------------- 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 15,840 1 0.42 6,653 Women. Preconception Activities Pre-Pregnancy Interview... Age-Eligible 761 1 0.75 571 Women. PPG Follow Up Script...... Age-Eligible 761 6 0.1 456 Women. Pregnancy Activities Women's Informed Consent Pregnant Women.. 9,504 1 0.67 6,368 Form. First Pregnancy Interview. Pregnant Women.. 3,552 1 1 3,552 Second Pregnancy 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, ................ 334,308 .............. .............. 176,876 Recruitment Substudy. ---------------------------------------------------------------------------------------------------------------- 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: Sarah L. Glavin, Ph.D., National Institute of Child Health and Human Development, 31 Center Drive, Room 2A18, Bethesda, Maryland, 20892, or call non-toll free number (301) 496-1877, 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: June 2, 2010. Sarah L. Glavin, NICHD Project Clearance Liaison, National Institutes of Health. [FR Doc. 2010-13705 Filed 6-7-10; 8:45 am] BILLING CODE 4140-01-P