Approved consistent with the understanding that NIH will continue to collaborate with CDC on related projects and that the relationship between renewals or revisions of this ICR will include a dicussion of the interaction with and relationship to CDC collections investigating similar issues and/or outcomes.
Inventory as of this Action
Requested
Previously Approved
08/31/2016
36 Months From Approved
01/31/2015
69,010
0
90,880
29,505
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.