The Framingham Study (NHLBI)

Forms and Documents

Document Name	Status
Form A7a Original Cohort Forms Form and Instruction	Modified
Form A4 Generation 3 and Omni Group 2 Cohorts Form and Instruction	New
Form 6a Offspring and Omni Group 1 Cohorts Form and Instruction	Modified
0925-0216 SSB FINAL 09 16 13.doc Supporting Statement B	2013-09-17
Attachment 13 - Consent Forms, Offspring & Omni Grp 1.pdf Supplementary Document	2013-09-25
Attachment 8- OSMB Minutes.pdf Supplementary Document	2013-09-25
Attachment 15- Description of Tables A.12-1.1-A.12-1.3.doc Supplementary Document	2013-09-25
Attachment 5- Publications 2011-2012.pdf Supplementary Document	2013-09-17
Attachment 14- Annual Newsletter.pdf Supplementary Document	2013-09-17
Attachment 11- IRB Approval Omni Grp 2.pdf Supplementary Document	2013-09-17
Attachment 10- IRB Approval Omni Grp 1.pdf Supplementary Document	2013-09-17
Attachment 9- FHS IRB Approval.pdf Supplementary Document	2013-09-17
Attachment 12- Privacy Act Memo.pdf Supplementary Document	2013-09-17
0925-0216 SSA FINAL 09 16 13.doc Supporting Statement A	2013-09-17

IC Document Collections

IC ID	Document Title	Status
7259	Original Cohort Forms Form and Instruction	Modified
208860	Generation 3 and Omni Group 2 Cohorts Form and Instruction	New
183649	Offspring and Omni Group 1 Cohorts Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0216	ICR Reference No: 201309-0925-008
Status: Historical Active	Previous ICR Reference No: 201011-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No: 20523
Title: The Framingham Study (NHLBI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/31/2013
	Date Received in OIRA: 09/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2016	36 Months From Approved	11/30/2013
Responses	9,380	0	6,921
Time Burden (Hours)	4,264	0	6,091
Cost Burden (Dollars)	0	0	0

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Abstract: The Framingham Study will continue to conduct examinations and morbidity and mortality follow-up in original, offspring and third generation participants to study the determinants of cardiovascular disease.

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Authorizing Statute(s): US Code: 42 USC 285b-3 Name of Law: Public 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:
	78 FR 26639	05/07/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 58318	09/23/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Original Cohort Forms	A7a, A4, A7b, A2a, A6a, A2b, A6b	Telephone Call to Set up Meeting ,   Medical Status Update Form ,   Exam Scheduling Form ,   Clinical Exam Form -Original ,   Records Request Form ,   Home Visit form-Original ,   Informant Contact Form
Offspring and Omni Group 1 Cohorts	6a, 6b, 7a, A3, 1a, 1b, A14, A4	Records Request Form ,   Informant Contact Form ,   Initial Telephone Contact Form ,   Food Frequency Form ,   Clinical Exam Form ,   Home Visit/Nursing Home Visit Form ,   Consent Forms ,   Health Status Update Form
Generation 3 and Omni Group 2 Cohorts	A4, 6a, 6b	Health Status Update Form ,   Records Request Form ,   Informant Contact Form

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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	9,380	6,921	0	2,459	0	0
Annual Time Burden (Hours)	4,264	6,091	0	-1,827	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: A revision to the previous OMB submission is requested because the numbers of Offspring and Omni Group 1 participants to be examined for the 2014-2016 time period are much smaller than those during the last OMB approval period. This is because a great majority of these two cohorts will have completed their examinations by the end of the 2013. The small number of participants remaining to be examined is reflected in the decrease in the estimated annualized burden hours for these two cohorts as well as for the entire study, compared to the last OMB approval period.

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Annual Cost to Federal Government: $8,306,000

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

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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: 09/30/2013

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