# Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-23060 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** September 23, 2013 - **Citation:** 78 FR 58318 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: The Framingham Heart Study (FHS) 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. 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. 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 respondent Number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hour I. PARTICIPANT COMPONENTS A. PRE-EXAM: a. Telephone contact to set up appointment 60 1 10/60 10 b. Exam Appointment, Scheduling, Reminder, and Instructions 55 1 35/60 32 B. EXAM—Cycle 32: a. Clinic exam 25 1 45/60 19 b. Home or nursing home visit 25 1 65/60 27 C. ANNUAL FOLLOW-UP: a. Records Request 60 1 15/60 15 b. Health Status Update 45 1 15/60 11 SUB-TOTAL: PARTICIPANT COMPONENTS *60 114 II. NON-PARTICIPANT COMPONENTS A. Informant Contact (Pre-exam and Annual Follow-up) 25 1 10/60 4 B. Records Request (Annual follow-up) 50 1 15/60 13 SUB-TOTAL: NON-PARTICIPANT COMPONENTS 75 17 * 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 respondent Number of respondents Number of responses per respondent Average 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 update 300 1 10/60 50 b. Appt. or update Confirmation 250 1 10/60 42 c. Food Frequency Form 250 1 10/60 42 B. EXAM: a. Clinic Exam 100 1 175/60 292 b. Home or nursing home visit 100 1 60/60 100 c. Consent Forms 200 1 20/60 67 C. ANNUAL FOLLOW-UP: a. Records Request 2292 1 15/60 573 b. Health Status Update 1833 1 15/60 458 SUB-TOTAL: PARTICIPANT COMPONENTS *2292 1624 II. NON-PARTICIPANT COMPONENTS A. Informant contact (Pre-exam and Annual Follow-up) 229 1 10/60 38 B. Records Request (Annual follow-up) 2292 1 15/60 573 SUB-TOTAL: NON-PARTICIPANT COMPONENTS 2521 611 * Number of participants as reflected in Rows I.C.a. above. Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort Type of respondent Number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hour I. PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP A. Records Request 3212 1 15/60 803 B. Health Status Update 3212 1 15/60 803 SUB-TOTAL: PARTICIPANT COMPONENTS * 3212 1606 II. NON-PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP A. Informant contacts 160 1 10/60 27 B. Records Request 1060 1 15/60 265 SUB-TOTAL: NON-PARTICIPANT COMPONENTS 1220 292 * 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 respondent Number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hour Participants 5564 1 36/60 3344 Non-Participants 3816 1 14.5/60 920 Totals 9380 4264 ( Note: reported and calculated numbers differ slightly due to rounding.) Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. Michael Lauer, Director, DCVS, National Institutes of Health. [FR Doc. 2013-23060 Filed 9-20-13; 8:45 am] BILLING CODE 4140-01-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-23060. Public record. Not legal advice.