The Jackson Heart Study: Annual Follow-up with Third Party Respondents (NHLBI)

Forms and Documents

Document Name	Status
Form 1 Families Form and Instruction	Modified
Form 1 Communities Form and Instruction	New
Form 1 Physicians Form and Instruction	Modified
Supporting Statement Part B JHS FINAL12 20 12.docx Supporting Statement B	2013-01-14
Attachment 7-JHS Certificate of Confidentiality.pdf Supplementary Document	2013-01-14
Attachment 6-JHS OSMB and Advisory Council Minutes.pdf Supplementary Document	2013-01-14
FINAL SUPPORTING STATEMENT PART A FINAL 01.16.13 (yellow highlights).doc Supporting Statement A	2013-01-24

IC Document Collections

IC ID	Document Title	Status
7410	Families Form and Instruction	Modified
205559	Communities Form and Instruction	New
192889	Physicians Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0491	ICR Reference No: 201301-0925-002
Status: Historical Inactive	Previous ICR Reference No: 201005-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No: 18516
Title: The Jackson Heart Study: Annual Follow-up with Third Party Respondents (NHLBI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 03/27/2013
	Date Received in OIRA: 01/28/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved	06/30/2013
Responses	400	0	400
Time Burden (Hours)	84	0	84
Cost Burden (Dollars)	0	0	0

---

Abstract: The Jackson Heart Study (JHS) is a multi-center investigation of predictors of cardiovascular disease (CVD) in 5301 African Americans living in Hinds, Madison, and Rankin Counties surrounding the Jackson, MS, metropolitan area. The JHS was initiated in 1998 as a collaborative effort among three Jackson-area academic institutions. At the close of the current contracts in May 2013, the JHS will have completed three back-to-back cohort examinations that have produced extensive longitudinal data on traditional and putative CVD risk factors, socioeconomic and sociocultural factors and biochemical analytes; measures of subclinical disease from echocardiography, cardiac magnetic resonance imaging (MRI), computed tomography (CT) scans of the heart, aorta and abdomen; and stored biological samples. Eighty percent (80%) of the surviving JHS participants (N = 4203) completed Exam 2; projected retention for Exam 3 is eighty-six percent (86%) (N = 4082). In addition, the JHS has conducted annual cohort follow-up contacts for incident clinical events of interest, a variety of community education and outreach activities to promote healthy lifestyles to reduce disease risk burden, and level-appropriate training programs to promote and support public health research.

---

Authorizing Statute(s): US Code: 42 USC 285b-3 Name of Law: Publics Health Service Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65002	10/24/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 5188	01/24/2013
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Physicians	1	Physician Questionaire
Communities	2, 3, 4, 5, 1	Pre-Post Testing Forms CHAN ,   My Habits Pre-Post test ,   CHA Diary ,   Train the Trainer Pre-Post Test ,   Checklist
Families	1, 2, 3	Known Informant Letter ,   Unknown Informant Letter ,   Informant Interview Form (IFI)

---

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $6,849,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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

---

Common Form ICR:  No

---

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: 01/28/2013

---