Cardiovascular Health and Needs Assessment in Washington, DC - Development of a Community-Based Behavioral Weight Loss Intervention (NHLBI)

Forms and Documents

Document Name	Status
Form 1 Device Return Form and Instruction	New
Form 1 Health Data Monitoring Form and Instruction	New
Form 1 Device Training Form and Instruction	New
Form 1 Survey Instrument Form and Instruction	New
Form 1 Clinical Evaluation Form and Instruction	New
Form 1 Registration/Consent Process Form and Instruction	New
Attachment 2 Letter of Protocol Approval from NHLBI Institutional Review Board.pdf Supplementary Document	2014-03-19
Attachment 6 Community Advisory Board Meeting Notes - Dated July 22 2013.docx Supplementary Document	2014-03-19
Attachment 5 Community Advisory Board Meeting Notes - Dated May 6 2013.docx Supplementary Document	2014-03-19
Attachment 4 NHLBI Protocol 13-H-0183 Consent Document.pdf Supplementary Document	2014-03-19
SSA Cardiovascular Health and Needs Assessment in Washington DC - Development of a Community-Based Behavioral Weight Loss Intervention (NHLBI) V6.docx Supporting Statement A	2014-05-08

IC Document Collections

IC ID	Document Title	Status
210866	Device Return Form and Instruction	New
210865	Health Data Monitoring Form and Instruction	New
210864	Device Training Form and Instruction	New
210863	Survey Instrument Form and Instruction	New
210862	Clinical Evaluation Form and Instruction	New
210861	Registration/Consent Process Form and Instruction	New

ICR Details

OMB Control No: 0925-0696	ICR Reference No: 201403-0925-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 21593
Title: Cardiovascular Health and Needs Assessment in Washington, DC - Development of a Community-Based Behavioral Weight Loss Intervention (NHLBI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/16/2014
	Date Received in OIRA: 03/21/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	12/31/2015
Responses	715	0	0
Time Burden (Hours)	2,380	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this collection of information is to conduct a community health and needs assessment for individuals in predominantly African-American churches in Washington, District of Columbia (DC), based on principles of community-based participatory research (CBPR). African Americans disproportionately have poorer cardiovascular health and a greater burden of cardiovascular disease as compared to other racial and ethnic groups. Therefore, interventions that improve cardiovascular health in the African American community are essential. Past studies suggest that community-based interventions are needed to improve cardiovascular health in the African-American community. Interventions based on CBPR principles develop in collaboration with community partners and allow an intervention's components to be tailored to the unique needs of the community members. Community assessments provide understanding of the health status of the community members, identifying health issues on which to focus intervention resources. They also aid in building capacity for future interventions by enabling community members to interpret and disseminate assessment results to broader constituencies. Most of all, community assessments provide context for community-based projects and foster trust with community members. To remain consistent with CBPR principles, a community health and needs assessment is necessary to understand the needs of the target population. This assessment is being conducted in partnership with DC community leaders.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 141	01/02/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 14518	03/14/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Survey Instrument	1	Survey Instrument
Device Training	1	Device Training
Health Data Monitoring	1	Health Data monitoring
Device Return	1	Device Training
Registration/Consent Process	1	Patient Registration Form
Clinical Evaluation	1	Clinical Evaluation

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	715	0	0	715	0	0
Annual Time Burden (Hours)	2,380	0	0	2,380	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $122,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/21/2014

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