Prior terms
continue. Approved consistent with the follow two terms: 1) In
advance of adding biological and environmental sampling for the
participants in the provider-based sampling arm of the Vanguard
study, NIH will consult with the IRB amount whether the time
between written consent for biosampling and the actual
implementation of this activity warrents written re-consent. 2) NIH
agrees to brief OMB/OIRA on the results of this test, particularly
the measures in Table A.16 in advance of finalizing the design for
the main study of the NCS.
Inventory as of this Action
Requested
Previously Approved
08/31/2014
08/31/2014
08/31/2014
55,748
0
55,748
22,791
0
22,791
0
0
0
The National Children's Study is an
integrated system of activities that includes a Vanguard (Pilot)
Study for operations and methods development, and an NCS Main Study
to collect data on exposure and response. The Vanguard (Pilot)
Study, which includes the Initial Vanguard Study, the Alternate
Recruitment Substudy (Phases 1 and 2), and the Provider-Based
Sampling Feasibility Study (proposed in this information collection
request), is currently underway. The Main Study is expected to
follow within the next year. This request for revision includes (1)
the addition of a Provider-Based Sampling Feasibility Study, and
(2) supplemental measures for the Alternate Recruitment Substudy
involving revised study visit assessments, physical measurements,
and additional biospecimen collections. These information
collections, revisions of instruments, physical measure
implementation, and biospecimen collections will evaluate the
feasibility, acceptability, and cost of study design elements to
inform the Main Study.
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.