The Framingham Study (NHLBI)

Forms and Documents

Document Name	Status
Form A7a Original Cohort Forms Form and Instruction	Removed
Form 1 Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
Form 2 Non-Participant Components Annual Follow Up Informant Contacts Form and Instruction	New
Form 2 Participant Components Annual follow-up records Health Status Update Form and Instruction	New
Form 1 Particiipant Components Annual Follow-up Records Request Form and Instruction	New
Form 6 Participant components Exam Cycle 3 Home or nursing home visit Form and Instruction	New
Form 5 Participant Components Exam Cycle 3 Consent Form and Instruction	New
Form 4 Participant Components Exam Cycle 3 Exam at study Center Form and Instruction	New
Form 3 Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions Form and Instruction	New
Form 3 Participant Components Pre-Exam Telephone contact for appointment Form and Instruction	New
Form 1 Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
Form 2 Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction	New
Form 2 Participant Components Annual follow-up records Health Status Update Form and Instruction	New
Form 2 Participant Components Annual follow-up records Request Form and Instruction	New
Form 1 Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
Form 2 Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction	New
Form 2 Participant Components Annual Follow-up Health Status Update Form and Instruction	New
Form 1 Participant Components Annual follow-up records Request Form and Instruction	New
Form A4 Generation 3 and Omni Group 2 Cohorts Form and Instruction	Removed
Form A4 Offspring and Omni Group 1 Cohorts Form and Instruction	Removed
30-day Framingham2016-09313.pdf Supplementary Document	2016-04-25
Revised_Supporting Statement A.docx Supporting Statement A	2016-07-12
Attach 12 Table of Exam components.docx Supplementary Document	2016-04-11
Attach 11 Annual Newsletter.pdf Supplementary Document	2016-04-11
Attach 9 Privacy Act Memo.pdf Supplementary Document	2016-04-11
Attach 8 IRB Approval Letters.pdf Supplementary Document	2016-04-11
Attach 7 OSMB Minutes .pdf Supplementary Document	2016-04-11
Attach 4 Publications.pdf Supplementary Document	2016-04-11
Revised_Supporting Statement B.doc Supporting Statement B	2016-07-11

IC Document Collections

IC ID	Document Title	Status
7259	Original Cohort Forms Form and Instruction	Removed
221033	Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
221032	Non-Participant Components Annual Follow Up Informant Contacts Form and Instruction	New
221031	Participant Components Annual follow-up records Health Status Update Form and Instruction	New
221030	Particiipant Components Annual Follow-up Records Request Form and Instruction	New
221026	Participant components Exam Cycle 3 Home or nursing home visit Form and Instruction	New
221024	Participant Components Exam Cycle 3 Consent Form and Instruction	New
221022	Participant Components Exam Cycle 3 Exam at study Center Form and Instruction	New
221020	Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions Form and Instruction	New
221019	Participant Components Pre-Exam Telephone contact for appointment Form and Instruction	New
221017	Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
221016	Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction	New
221015	Participant Components Annual follow-up records Health Status Update Form and Instruction	New
221014	Participant Components Annual follow-up records Request Form and Instruction	New
221012	Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction	New
221009	Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction	New
221007	Participant Components Annual Follow-up Health Status Update Form and Instruction	New
221006	Participant Components Annual follow-up records Request Form and Instruction	New
208860	Generation 3 and Omni Group 2 Cohorts Form and Instruction	Removed
183649	Offspring and Omni Group 1 Cohorts Form and Instruction	Removed

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
	Date Received in OIRA: 04/26/2016
Terms of Clearance:

	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

---

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.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

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

---

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

IC Title	Form No.	Form Name
Offspring and Omni Group 1 Cohorts	6a, 6b, 7a, A3, 1a, 1b, A14, A4	Health Status Update Form ,   Records Request Form ,   Informant Contact Form ,   Initial Telephone Contact Form ,   Food Frequency Form ,   Clinical Exam Form ,   Home Visit/Nursing Home Visit Form ,   Consent Forms
Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	2	Attachment 3 Medical History
Particiipant Components Annual Follow-up Records Request	1	Attachment 5 Medical Record Request
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
Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Participant Components Annual Follow-up Health Status Update	2	Attachment 3 Medical History
Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up)	2	Attachment 3 Medical History
Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions	3	Attachment 6 Exam Scheduling
Non-Participant Components Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Participant Components Annual follow-up records Health Status Update	2	Attachment 3 Medical History
Non-Participant Components Health Care Provide Records Request (Annual follow-up)	1	Attachment 5 Medical Record Request
Participant Components Annual follow-up records Health Status Update	2	Attachment 3 Medical History
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 Exam Cycle 3 Home or nursing home visit	6	Attachment 1 Exam Forms for Third Gen, NOS & Omni
Generation 3 and Omni Group 2 Cohorts	A4, 6a, 6b	Health Status Update Form ,   Records Request Form ,   Informant Contact Form
Participant Components Annual follow-up records Request	1	Attachment 5 Medical Record Request
Participant Components Annual follow-up records Request	2	Attachment 5 Medical Record Request
Participant Components Pre-Exam Telephone contact for appointment	3	Attachment 6 Exam Scheduling
Non-Participant Components Annual Follow Up Informant Contacts	2	Attachment 3 Medical History

---

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	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

---

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

---

Common Form ICR:  No

---

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

---