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Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS)

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Information about this document as published in the Federal Register.

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SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 7, 2013, pages 26639-41 and allowed 60-days for public comment. No public comments were received. The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.Start Printed Page 58319

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

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FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD, 20892-7936, or call non-toll-free number (301) 435-0416, or email your request, including your address to: weig@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection: The Framingham Heart Study, 0925-0216, Revision National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH).

Need and Use of Information Collection: The Framingham Heart Study will continue to conduct morbidity and mortality follow-up, as well as examinations, for the purpose of studying the determinants of cardiovascular disease. Morbidity and mortality follow-up will continue to occur in all of the cohorts (Original, Offspring, Third Generation, Omni Group 1, and Omni Group 2). Examinations will continue to be conducted on the Original, Offspring, and Omni Group 1 Cohorts. The numbers of Offspring and Omni Group 1 participants to be examined for this OMB submission are much smaller than those during the last OMB approval period. This is because a great majority of these two cohorts have already completed their examinations. The small number of participants remaining to be examined is reflected in the decrease in the estimated annualized burden hours for these two cohorts as well as for the entire study, compared to the last OMB approval period.

OMB approval is requested for 3 years. There is no cost to the respondents other than their time. The total estimated annualized burden hours are 4264.

Estimated Annualized Burden Hours, Original Cohort

Type of respondentNumber of respondentsNumber of responses per respondentAverage time per response (in hours)Total annual burden hour
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:
a. Telephone contact to set up appointment60110/6010
b. Exam Appointment, Scheduling, Reminder, and Instructions55135/6032
B. EXAM—Cycle 32:
a. Clinic exam25145/6019
b. Home or nursing home visit25165/6027
C. ANNUAL FOLLOW-UP:
a. Records Request60115/6015
b. Health Status Update45115/6011
SUB-TOTAL: PARTICIPANT COMPONENTS*60114
II. NON-PARTICIPANT COMPONENTS
A. Informant Contact (Pre-exam and Annual Follow-up)25110/604
B. Records Request (Annual follow-up)50115/6013
SUB-TOTAL: NON-PARTICIPANT COMPONENTS7517
* Number of participants as reflected in Rows I.A.a and I.C.a. above

Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort

Type of respondentNumber of respondentsNumber of responses per respondentAverage time per response (in hours)Total annual burden hour
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:
a. Telephone contact to set up apt or Health status update300110/6050
b. Appt. or update Confirmation250110/6042
c. Food Frequency Form250110/6042
B. EXAM:
a. Clinic Exam1001175/60292
b. Home or nursing home visit100160/60100
c. Consent Forms200120/6067
C. ANNUAL FOLLOW-UP:
a. Records Request2292115/60573
b. Health Status Update1833115/60458
SUB-TOTAL: PARTICIPANT COMPONENTS*22921624
II. NON-PARTICIPANT COMPONENTS
A. Informant contact (Pre-exam and Annual Follow-up)229110/6038
B. Records Request (Annual follow-up)2292115/60573
SUB-TOTAL: NON-PARTICIPANT COMPONENTS2521611
* Number of participants as reflected in Rows I.C.a. above.
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Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort

Type of respondentNumber of respondentsNumber of responses per respondentAverage time per response (in hours)Total annual burden hour
I. PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP
A. Records Request3212115/60803
B. Health Status Update3212115/60803
SUB-TOTAL: PARTICIPANT COMPONENTS* 32121606
II. NON-PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP
A. Informant contacts160110/6027
B. Records Request1060115/60265
SUB-TOTAL: NON-PARTICIPANT COMPONENTS1220292
* Number of participants as reflected in Rows I.A. and I.B. above.

Summary of 3 Tables Combined—Total Estimated Annualized Burden Hours

Type of respondentNumber of respondentsNumber of responses per respondentAverage time per response (in hours)Total annual burden hour
Participants5564136/603344
Non-Participants3816114.5/60920
Totals93804264
(Note: reported and calculated numbers differ slightly due to rounding.)
Start Signature

Lynn Susulske,

NHLBI Project Clearance Liaison, National Institutes of Health.

Michael Lauer,

Director, DCVS, National Institutes of Health.

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[FR Doc. 2013-23060 Filed 9-20-13; 8:45 am]

BILLING CODE 4140-01-P