The Framingham Study (NHLBI)

Forms and Documents

Document Name	Status
Form 10 Individuals Form and Instruction	Modified
Form 6 Physicians Form and Instruction	Modified
Attach #fram14.doc Supplementary Document	2010-11-29
Attach #fram13.doc Supplementary Document	2010-11-29
Attach #fram12.doc Supplementary Document	2010-11-29
Attach #fram11.pdf Supplementary Document	2010-11-29
Attach #fram10.pdf Supplementary Document	2010-11-29
Attach #fram9.rtf Supplementary Document	2010-11-29
Attach #fram8.doc Supplementary Document	2010-11-29
Attach #fram5.doc Supplementary Document	2010-11-29
Attach #fram3.doc Supplementary Document	2010-11-29
Fram Supporting Statement Part B FINAL.DOC Supporting Statement B	2010-11-17
fram SSA framingham.doc Supporting Statement A	2010-11-17

IC Document Collections

IC ID	Document Title	Status
7259	Individuals Form and Instruction	Modified
183649	Physicians Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0216	ICR Reference No: 201011-0925-006
Status: Historical Active	Previous ICR Reference No: 200801-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
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: 11/29/2010
	Date Received in OIRA: 11/23/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved	04/30/2011
Responses	6,921	0	5,794
Time Burden (Hours)	6,091	0	5,794
Cost Burden (Dollars)	0	0	0

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Abstract: The Framingham Study will 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:
	75 FR 25863	05/10/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 54886	09/09/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Individuals	10, 1, 2, 4, 7, 15, 16, 17	form ,   survey ,   survey ,   survey ,   survey ,   survey ,   survey ,   survey
Physicians	6	survey

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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	6,921	5,794	0	1,127	0	0
Annual Time Burden (Hours)	6,091	5,794	0	297	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: Changing Forms

Short Statement: A revision to the previous OMB submission is requested because different Cohorts will be re-examined for the 2011-2013 time period (please see Table A.15-1). Re-examination of the Original Cohort will continue. The Offspring and the Omni Group 1 Cohorts will also be re-examined during this cycle; the Generation Three Cohort will not be re-examined. CT examinations of the Offspring Cohort will not occur during this period. Further, morbidity and mortality (surveillance) on the three Framingham Cohorts as well as the two Omni Cohorts will be monitored biennially by means of the Medical History Update Form (Attachment 4) The Omni Cohort is now being included in the Framingham Heart Study contract under the Government's Statement of Work.

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Annual Cost to Federal Government: $8,169,000

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: 11/23/2010

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