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
7. Abstract (4000 characters maximum, attach additional sheets as necessary)
The purpose of this data collection 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 subsequent implementation of the 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. 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.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form C.10.5 Child Care Providers
Appendix C Revised.pdf
Itemized Burden.doc
Child Care Providers