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

Forms and Documents

Document Name	Status
Form 1 The Jackson Heart Study: Annual Follow-up with Third Party Respondents Form	Modified
Form 1 Jackson Heart Study Physicians Form	New
FINAL SUPPORTING STATEMENT PART B revised 12.15.09.doc Supporting Statement B	2010-03-22
Council.doc Supplementary Document	2007-05-16
april 07 OSMB minutes.doc Supplementary Document	2007-05-16
Attach #2.doc Supplementary Document	2010-03-22
Attach #4.doc Supplementary Document	2010-03-22
JHSFDAP.doc Supplementary Document	2007-05-16
Attach 8 -Known number_Death certificate contact notification.doc Supplementary Document	2010-03-22
Attach 9 -Unknown number Letter.doc Supplementary Document	2010-03-22
Attach #5.doc Supplementary Document	2010-03-22
FINAL SUPPORTING STATEMENT PART A revised 03.15.10.doc Supporting Statement A	2010-03-22

IC Document Collections

IC ID	Document Title	Status
7410	The Jackson Heart Study: Annual Follow-up with Third Party Respondents Form	Modified
192849	Jackson Heart Study Physicians Form	New

ICR Details

OMB Control No: 0925-0491	ICR Reference No: 201005-0925-002
Status: Historical Inactive	Previous ICR Reference No: 200705-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Jackson Heart Study: Annual Follow-up with Third Party Respondents
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 05/10/2010
	Date Received in OIRA: 05/10/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2010
Responses	600	0	600
Time Burden (Hours)	300	0	300
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for collection of follow-up information from third party individuals (next-of-kin descendants and physicians) for the participants in the Jackson Heart Study (JHS) Follow-up. The information is necessary to complete the determination of causes of morbidity and mortality in the JHS Cohort and will be used by the public and private sector for public health planning, medical education, other epidemiologic studies, and biomedical research.

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

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:
	75 FR 1789	01/13/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 17744	04/07/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
The Jackson Heart Study: Annual Follow-up with Third Party Respondents	1, 2, 3, 4, 5, 6, 7, 8, 9, 10	Informant interview ,   Confidential Data ,   Common Hospital Information ,   Hospital Abstraction ,   Cohort Eligibility ,   Stroke Abstraction ,   Heart Failure Survey ,   Heart Failure Diagnosis ,   Hospital Record Abstraction ,   Heart Failure Abstraction
Jackson Heart Study Physicians	1, 2	Physician Questionnniare ,   Coroner-Medical Examiner

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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:

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Annual Cost to Federal Government: $6,459,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 05/10/2010

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