The Framingham Study

Forms and Documents

Document Name	Status
Form 1 Individuals Form and Instruction	Modified
Form 11 Physicians Form and Instruction	New
Supporting Statement Part B (3).doc Supporting Statement B	2008-01-09
HIPPA form OMB December 2007.doc Supplementary Document	2008-01-10
IRB.doc Supplementary Document	2008-01-10
Publications 2006-2007.pdf Supplementary Document	2008-01-10
Publications 2005-2006.doc Supplementary Document	2008-01-10
Participant components.doc Supplementary Document	2008-01-10
AHA Comment to Fed Reg Notice.pdf Supplementary Document	2008-01-09
Comment in response to 60-day notice.doc Supplementary Document	2008-01-09
OSMB meeting minutes.doc Supplementary Document	2008-01-09
NHLBI Council minutes.doc Supplementary Document	2008-01-09
ParticipantResultsLetters.doc Supplementary Document	2008-01-24
CTIncidentalFindingReport.doc Supplementary Document	2008-01-24
OriginalandGen3ConsentForms.doc Supplementary Document	2008-01-24
CTConsentForm.doc Supplementary Document	2008-01-24
LettertoParticipantsnottakingExam.doc Supplementary Document	2008-01-24
0216-SSA.doc Supporting Statement A	2008-01-31

IC Document Collections

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

ICR Details

OMB Control No: 0925-0216	ICR Reference No: 200801-0925-004
Status: Historical Active	Previous ICR Reference No: 200410-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Framingham Study
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/11/2008
	Date Received in OIRA: 01/31/2008
Terms of Clearance: NIH must pay more attention to submitting ICRs for renewal before they expire.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	36 Months From Approved
Responses	5,794	0	0
Time Burden (Hours)	5,794	0	0
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:
	72 FR 62659	11/06/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 3732	01/22/2008
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	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11	Form ,   Form ,   Form ,   Form ,   Form ,   Form ,   Form ,   Form ,   Form ,   Form ,   Form
Physicians	11	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	5,794	0	0	5,794	0	0
Annual Time Burden (Hours)	5,794	0	0	5,794	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: The annual hours requested is reduced slightly from the current OMB inventory. The reduction is due to a smaller number of participants being examined than was previously estimated.

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Annual Cost to Federal Government: $8,035

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)? Uncollected

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: 01/31/2008

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