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