Information Collection Request

The Framingham Study (NHLBI)

ICR 201604-0925-002 · OMB 0925-0216 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form A7a Original Cohort Forms Form and Instruction Removed Available
Form 1 Non-Participant Components Annual Follow Up Health Care Provide Records Request (Annual follow-up) Form and Instruction New Available
Form 2 Non-Participant Components Annual Follow Up Informant Contacts Form and Instruction New Repair queued
Form 2 Participant Components Annual follow-up records Health Status Update Form and Instruction New Repair queued
Form 1 Particiipant Components Annual Follow-up Records Request Form and Instruction New Repair queued
Form 6 Participant components Exam Cycle 3 Home or nursing home visit Form and Instruction New Available
Form 5 Participant Components Exam Cycle 3 Consent Form and Instruction New Repair queued
Form 4 Participant Components Exam Cycle 3 Exam at study Center Form and Instruction New Available
Form 3 Participant Components Pre-Exam Exam appointment scheduling, reminder and instructions Form and Instruction New Repair queued
Form 3 Participant Components Pre-Exam Telephone contact for appointment Form and Instruction New Repair queued
Form 1 Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction New Repair queued
Form 2 Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction New Available
Form 2 Participant Components Annual follow-up records Health Status Update Form and Instruction New Repair queued
Form 2 Participant Components Annual follow-up records Request Form and Instruction New Repair queued
Form 1 Non-Participant Components Health Care Provide Records Request (Annual follow-up) Form and Instruction New Repair queued
Form 2 Non-Participant Components Informant Contact (Pre-exam and Annual Follow-up) Form and Instruction New Available
Form 2 Participant Components Annual Follow-up Health Status Update Form and Instruction New Available
Form 1 Participant Components Annual follow-up records Request Form and Instruction New Available
Form A4 Generation 3 and Omni Group 2 Cohorts Form and Instruction Removed Repair queued
Form A4 Offspring and Omni Group 1 Cohorts 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 Repair queued
Attach 8 IRB Approval Letters.pdf Supplementary Document Uploaded 2016-04-11 Available
Attach 7 OSMB Minutes .pdf Supplementary Document Uploaded 2016-04-11 Repair queued
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
IC IDCollectionTypeStatusForm
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
0925-0216 201604-0925-002
Historical Active 201309-0925-008
HHS/NIH 20523
The Framingham Study (NHLBI)
Revision of a currently approved collection   No
Regular
Approved with change 07/19/2016
Retrieve Notice of Action (NOA) 04/26/2016
  Inventory as of this Action Requested Previously Approved
07/31/2019 36 Months From Approved 10/31/2016
14,045 0 9,380
5,414 0 4,264
0 0 0

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.

US Code: 42 USC 285b-3 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 81830 12/31/2015
81 FR 23735 04/22/2016
No

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

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Revision

$6,553,562
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/26/2016