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