The Framingham Study (NHLBI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form A6b Informant Contact Form	Form and Instruction	Removed	Available
Form A2b Home Visit form-Original	Form and Instruction	Removed	Available
Form A6a Records Request Form	Form and Instruction	Removed	Available
Form A2a Clinical Exam Form -Original	Form and Instruction	Removed	Available
Form A7b Exam Scheduling Form	Form and Instruction	Removed	Available
Form A4 Medical Status Update Form	Form and Instruction	Removed	Available
Form A7a Telephone Call to Set up Meeting	Form and Instruction	Removed	Available
Form 1 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 1 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 6 Attachment 1 Exam Forms for Third Gen, NOS & Omni	Form and Instruction	New	Available
Form 5 Attachment 10 Consents	Form and Instruction	New	Available
Form 4 Attachment 1 Exam Forms for Third Gen, NOS & Omni	Form and Instruction	New	Available
Form 3 Attachment 6 Exam Scheduling	Form and Instruction	New	Available
Form 3 Attachment 6 Exam Scheduling	Form and Instruction	New	Available
Form 1 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 2 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 1 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 2 Attachment 3 Medical History	Form and Instruction	New	Available
Form 1 Attachment 5 Medical Record Request	Form and Instruction	New	Available
Form 6b Informant Contact Form	Form and Instruction	Removed	Available
Form 6a Records Request Form	Form and Instruction	Removed	Available
Form A4 Health Status Update Form	Form and Instruction	Removed	Available
Form A4 Health Status Update Form	Form and Instruction	Removed	Available
Form A14 Consent Forms	Form and Instruction	Removed	Available
Form 1b Home Visit/Nursing Home Visit Form	Form and Instruction	Removed	Available
Form 1a Clinical Exam Form	Form and Instruction	Removed	Available
Form A3 Food Frequency Form	Form and Instruction	Removed	Available
Form 7a Initial Telephone Contact Form	Form and Instruction	Removed	Available
Form 6b Informant Contact Form	Form and Instruction	Removed	Available
Form 6a Records Request Form	Form and Instruction	Removed	Available
30-day Framingham2016-09313.pdf	Supplementary Document	Uploaded 2016-04-25	Available
Revised_Supporting Statement A.docx	Supporting Statement A	Uploaded 2016-07-12	Available
Attach 12 Table of Exam components.docx	Supplementary Document	Uploaded 2016-04-11	Available
Attach 11 Annual Newsletter.pdf	Supplementary Document	Uploaded 2016-04-11	Available
Attach 9 Privacy Act Memo.pdf	Supplementary Document	Uploaded 2016-04-11	Available
Attach 8 IRB Approval Letters.pdf	Supplementary Document	Uploaded 2016-04-11	Available
Attach 7 OSMB Minutes .pdf	Supplementary Document	Uploaded 2016-04-11	Available
Attach 4 Publications.pdf	Supplementary Document	Uploaded 2016-04-11	Available
Revised_Supporting Statement B.doc	Supporting Statement B	Uploaded 2016-07-11	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7259	Original Cohort Forms	Form and Instruction	Removed	Informant Contact Form
7259	Original Cohort Forms	Form and Instruction	Removed	Home Visit form-Original
7259	Original Cohort Forms	Form and Instruction	Removed	Records Request Form
7259	Original Cohort Forms	Form and Instruction	Removed	Clinical Exam Form -Original
7259	Original Cohort Forms	Form and Instruction	Removed	Exam Scheduling Form
7259	Original Cohort Forms	Form and Instruction	Removed	Medical Status Update Form
7259	Original Cohort Forms	Form and Instruction	Removed	Telephone Call to Set up Meeting
221033	Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up)	Form and Instruction	New	Attachment 5 Medical Record Request
221032	Non-Participant Components Annual Follow Up Informant Contacts	Form and Instruction	New	Attachment 3 Medical History
221031	Participant Components Annual follow-up records Health Status Update	Form and Instruction	New	Attachment 3 Medical History
221030	Particiipant Components Annual Follow-up Records Request	Form and Instruction	New	Attachment 5 Medical Record Request
221026	Participant components Exam Cycle 3 Home or nursing home visit	Form and Instruction	New	Attachment 1 Exam Forms for Third Gen, NOS & Omni
221024	Participant Components Exam Cycle 3 Consent	Form and Instruction	New	Attachment 10 Consents
221022	Participant Components Exam Cycle 3 Exam at study Center	Form and Instruction	New	Attachment 1 Exam Forms for Third Gen, NOS & Omni
221020	Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions	Form and Instruction	New	Attachment 6 Exam Scheduling
221019	Participant Components Pre-Exam Telephone contact for appointment	Form and Instruction	New	Attachment 6 Exam Scheduling
221017	Non-Participant Components Health Care Provide Records Request (Annual follow-up)	Form and Instruction	New	Attachment 5 Medical Record Request
221016	Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	Form and Instruction	New	Attachment 3 Medical History
221015	Participant Components Annual follow-up records Health Status Update	Form and Instruction	New	Attachment 3 Medical History
221014	Participant Components Annual follow-up records Request	Form and Instruction	New	Attachment 5 Medical Record Request
221012	Non-Participant Components Health Care Provide Records Request (Annual follow-up)	Form and Instruction	New	Attachment 5 Medical Record Request
221009	Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	Form and Instruction	New	Attachment 3 Medical History
221007	Participant Components Annual Follow-up Health Status Update	Form and Instruction	New	Attachment 3 Medical History
221006	Participant Components Annual follow-up records Request	Form and Instruction	New	Attachment 5 Medical Record Request
208860	Generation 3 and Omni Group 2 Cohorts	Form and Instruction	Removed	Informant Contact Form
208860	Generation 3 and Omni Group 2 Cohorts	Form and Instruction	Removed	Records Request Form
208860	Generation 3 and Omni Group 2 Cohorts	Form and Instruction	Removed	Health Status Update Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Health Status Update Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Consent Forms
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Home Visit/Nursing Home Visit Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Clinical Exam Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Food Frequency Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Initial Telephone Contact Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Informant Contact Form
183649	Offspring and Omni Group 1 Cohorts	Form and Instruction	Removed	Records Request Form

ICR Details

OMB Control No: 0925-0216	ICR Reference No: 201604-0925-002
Status: Historical Active	Previous ICR Reference No: 201309-0925-008
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 with change	Conclusion Date: 07/19/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/26/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	36 Months From Approved	10/31/2016
Responses	14,045	0	9,380
Time Burden (Hours)	5,414	0	4,264
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. The project examines the incidence and prevalence of cardiovascular disease (CVD) and its risk factors, trends in CVD incidence and its risk factors over time, and family patterns of CVD and risk factors. Other objectives include the estimation of incidence rates of disease, a description of the natural history of CVD, including the sequence of clinical signs and systems that precede the clinically recognizable syndrome, and the consequences and course of clinically manifest 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:
	80 FR 81830	12/31/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 23735	04/22/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 17

table that charts list of burden

IC Title	Form No.	Form Name
Generation 3 and Omni Group 2 Cohorts	A4, 6a, 6b	Health Status Update Form ,   Records Request Form ,   Informant Contact Form
Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Non-Participant Components Annual Follow Up Informant Contacts	2	Attachment 3 Medical History
Non-Participant Components Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Non-Participant Components Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	2	Attachment 3 Medical History
Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	2	Attachment 3 Medical History
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
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
Particiipant Components Annual Follow-up Records Request	1	Attachment 5 Medical Record Request
Participant Components Annual Follow-up Health Status Update	2	Attachment 3 Medical History
Participant Components Annual follow-up records Health Status Update	2	Attachment 3 Medical History
Participant Components Annual follow-up records Health Status Update	2	Attachment 3 Medical History
Participant Components Annual follow-up records Request	2	Attachment 5 Medical Record Request
Participant Components Annual follow-up records Request	1	Attachment 5 Medical Record Request
Participant Components Exam Cycle 3 Consent	5	Attachment 10 Consents
Participant Components Exam Cycle 3 Exam at study Center	4	Attachment 1 Exam Forms for Third Gen, NOS & Omni
Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions	3	Attachment 6 Exam Scheduling
Participant Components Pre-Exam Telephone contact for appointment	3	Attachment 6 Exam Scheduling
Participant components Exam Cycle 3 Home or nursing home visit	6	Attachment 1 Exam Forms for Third Gen, NOS & Omni

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ICR Summary of Burden

table that charts list 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	14,045	9,380	0	4,665	0	0
Annual Time Burden (Hours)	5,414	4,264	0	1,150	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: Revision

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Annual Cost to Federal Government: $6,553,562

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: 04/26/2016

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