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0925-0593 200803-0925-005
Historical Active
HHS/NIH
Pilot Study for the National Children's Study (NICHD)
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 09/22/2008
Retrieve Notice of Action (NOA) 03/28/2008
The National Children's Study Pilot cohort is approved for the first three years with the following terms of clearance: NIH has agreed to continue to work with OMB regarding clearance of the items that are still in the developmental stage, particularly the Data Access and Confidentiality plan and the consent video. In addition, NIH has agreed to submit changes to forms, protocols, and design elements, including but not limited to those that undergo additional testing, through the regular PRA process. Most of these changes will qualify as nonsubstantive changes. NIH will provide the OIRA desk officer with quarterly updates on its progress in testing the many design- and protocol-related hypotheses embedded into this pilot study. These updates should focus on the progress NIH is making in obtaining sufficient sample sizes to allow addressing the pilot questions; the analysis of the data needed to address those hypotheses; the implications of those analyses for the feasibility of the design, protocol, and data quality of the full study; the timing of additional testing that might be necessary before finalizing the design of the full study. NIH will provide OIRA with an understanding of the implications of the pilot study results before it submits the full package to OMB for review under the PRA.
  Inventory as of this Action Requested Previously Approved
09/30/2011 36 Months From Approved
64,598 0 0
13,797 0 0
0 0 0