This package is being approved in stages due to breadth and complexity of the changes requested. The approval granted May 2014 ONLY covers the following elements: 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 and 42 months. Although subsequent approval must be sought before implementing new Study Visits at ages 48, 54, and 60 months, adding biospecimen sampling to prior approved visits, conducting substudies and incentive tests, and initiating the sibling cohort, no additional public comment is required for the re-submission of the refined requests for these study components because public comment has already been sought and preliminary instruments were provided in the original submission. 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
36 Months From Approved
08/31/2014
113,521
0
55,748
55,122
0
22,791
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.
As noted in A.2, program changes/adjustments that affect burden include the initiation of a new enrollment cohort, the establishment of new Study visits, and revisions to already-established Study visits. The two proposed methodological substudies are designed to understand the impact of variable incentives on participation in existing and proposed study visits. On their own, these substudies do not impose additional participant burden.
Currently, the NCS is approved for 22,911 annualized burden hours. With this ICR, the total annualized hour burden for the NCS Vanguard Study is approximately 51,402 hours, which is an increase in burden.
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
NCS Vanguard Study Request for Revision SSB_REVISED.docx
Attach. 1 NCS Vanguard Study Informed Consent 12092013.pdf
AdultUrineInstructions.doc
Father Post-Natal Interview