This package is being approved in stages due to breadth and complexity of the changes requested. As of August 2014, the following aspects of the request are approved for implementation by OMB: a) the continuation of already established data collection events (age-defined Study Visits or trigger-based collections) including all associated instruments protocols and consent documents, b) revision to the previously approved 30 month Study Visit, c) establishment of new Study Visits at 36 , 42, 48, 54, and 60 months, d) implementing the noise and physical activity substudies in a subsample of 200 children, and e) update the consent form.
Separate requests must be submitted to OMB before adding biospecimen sampling to prior approved visits, conducting additional substudies and incentive tests, and/or initiating the sibling cohort. Additional discussion is also required to ensure that datasets are made available to non-NCS researchers in a manner consistent with the context in which they were approved
Inventory as of this Action
Requested
Previously Approved
06/30/2017
06/30/2017
06/30/2017
113,521
0
113,521
55,122
0
55,122
0
0
0
The purpose of the Vanguard (Pilot) Study is to assess the feasibility, acceptability, and cost of the recruitment strategy, study logistics and operations, and study visit assessments that will be used in the NCS Main Study. This Information Collection Request (ICR) serves as a formal request for renewal of the Vanguard Study clearance. It also covers several other important requests, including initiating a new cohort to be enrolled, revisions to the NCS protocol with both new and revised Study visits, and the initiation of methodological substudies. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures. The NCS Main Study design is being informed by the experience obtained in the NCS Vanguard Study, substudies and methodological research projects.
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 45.1 Father Post-Natal Interview
VS Stage 2 Non-sub Change Memo_071814.docx
Attach. 1 NCS Vanguard Study Informed Consent 12092013.pdf
AdultUrineInstructions.doc
Father Post-Natal Interview