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.
table that charts list comparision
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.
30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)