2011-2539. 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 November 15, 2010, pages 69680-69681, 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 continue the Vanguard phase of the National Children's Study (NCS) to evaluate the feasibility, acceptability, and cost of recruitment strategies and study design elements for a prospective, national longitudinal study of child health and development. In combination, the sub-studies encompassed by the Vanguard Phase will be used to inform the design of the Main Study of the National Children's Study.

We propose to continue data collection among the 37 Vanguard Study locations up to and including the visit planned to take place when the sample children have reached 24 months of age. This would align study visits approved for the initial 7 Vanguard Study locations (which extend past the birth visit to include a 3-, 6-, 9-, 12-, 18- and 24-month visit) with the study visits approved for the 30 additional Vanguard Study locations (which were initially proposed and approved up to and including the birth visit). Extending the data collection of the 30 additional Vanguard Study locations to 24 months of age would support rigorous, empirical evaluation of participant retention as it may relate to recruitment strategy. A strong understanding of how to encourage retention of study participants, particularly during the infancy and early childhood years, will be essential to planning the Main Study. Additionally, continuing data collection post-birth among the alternate recruitment strategy study locations allows us to generate additional data to inform the development of study visit procedures, both for future Vanguard Study efforts and the Main Study.

We also propose reintroduction of a limited set of study visit measures to all 37 of the Vanguard Study locations engaged in data collection. Recall that extensive measures, including biospecimens, were previously approved for use in the initial 7 Vanguard Study locations. When the additional 30 locations were added, we streamlined data collection to allow focus on improving recruitment rates. Now that we have the training for those new locations (and retraining for the initial locations) completed, it is an opportune time to reintroduce selected measures that have the benefit of field experience. That field experience has been used to improve their scientific robustness, burden, and cost. These improved measures now require field testing to best inform their suitability for the Main Study. Specifically, we would like to reincorporate a father interview; maternal blood and urine collection; infant cord blood collection; home tap water and dust collection; a pregnancy health care log; and an infant and child health care log. In addition to supporting further testing of refined items, including these measures in the Recruitment Substudy would result in a data collection scope more closely mirroring the anticipated scope of the Main Study, thereby allowing better gauge of data collection scope and resources and the relationship with retention and study logistics over time.

We will evaluate the feasibility (technical performance), acceptability (respondent tolerance and impact on study infrastructure), and cost (operations, time, and effort) of each recruitment and retention strategy using pre-determined measures. We will compare these findings and use them as a basis 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 additional public burden for this study will vary depending on the method of recruitment. The table below provides the annualized average burden per person over the two-year data collection period for all three alternate recruitment strategies.

The additional annualized cost to respondents over the two-year data collection period for the 30 locations engaged in the alternate recruitment strategies to extend data collection from birth to age 2 is estimated at $82,000 (based on $10 per hour) and the differential time estimates in Table A.2.e, below. To reintroduce the proposed measures into the 30 locations engaged in the alternate recruitment strategies, the annualized cost to respondents over the same period is estimated at an additional $79,000 (based on $10 per hour) and the differential time estimates in Table A.2.e, below. 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 [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 30-days of the date of this publication.

Dated: January 28, 2011.

Jamelle E. Banks,

NICHD Project Clearance Liaison, National Institutes of Health.