NIH may resubmit
without additional public comment after coordinating measures with
CDC to the extent feasible and consulting with a survey
statistician regarding the implications of the new design for the
conclusions that can be drawn.
Inventory as of this Action
Requested
Previously Approved
01/31/2015
36 Months From Approved
01/31/2015
90,880
0
90,880
33,145
0
33,145
0
0
0
The following submission provides
information on Wave 2 of the National Heart, Lung, and Blood
Institute's (NHLBI) planned "Healthy Communities Study (HCS): How
Communities Shape Children's Health." An Information Collection
Request (ICR) package was previously submitted to the Office of
Management and Budget (OMB) and approval obtained for the first
three years of planned data collection activities for the HCS,
including Wave 1 of the study (OMB Notice of Approval 0925-0649
expiration date 1/31/2015). Four Communities were part of Wave 1
and the data was collected over the summer of 2012; Wave 2 consists
of 264 new communities. Due to changes to the study protocol that
resulted from the Wave 1 experience, a new ICR package is being
submitted for Wave 2 of the study. The information is organized to
respond directly to the 18 itemized subsections of Section A
(Justification) of the Supporting Statement for Paperwork Reduction
Act Submissions. A general description of the scope of work for the
study is included below, as well as specific items in the
Supporting Statement for Paperwork Reduction Act Submissions.
Please refer to Attachment 1 for a list of study glossary of
terms.
This study represents a
revision for The Healthy Communities Study (OMB control number
0924-0649, expiration date 01/31/2015). An ICR package for the HCS
was previously submitted to the Office of Management and Budget
(OMB) and approval obtained for the first three years of planned
data collection activities for the HCS (OMB control number
0925-0649 expiration date: January 31, 2015). Data collection for
Wave 1 of the HCS occurred during the Spring and Summer of 2012.
Based upon findings from Wave 1, and feedback from the HCS
Observational Study Monitoring Board (OSMB), an independent
third-party oversight group that is required by the National Heart,
Lung, and Blood Institute (NHLBI), modifications have been made to
the study design and protocol that have resulted in this revision
for Wave 2 of the study. The study changes will be cost-effective
for the government, will decrease participant burden, and will
improve recruitment of families into the study, while minimally
impacting the study aims and power.
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.