Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)

Federal Register, Volume 78 Issue 88 (Tuesday, May 7, 2013)

Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)

Notices

Pages 26639-26641

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2013-10771

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS)

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

To Submit Comments and for Further Information: 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) 435-0456, or email your request, including your address to: weig@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Page 26640

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Proposed Collection: The Framingham Heart Study, 0925-0216, Extension, 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.

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

----------------------------------------------------------------------------------------------------------------

Number of Average time

Type of respondent Number of responses per per response Total annual

respondents respondent (in hours) burden hour

----------------------------------------------------------------------------------------------------------------

1. Participant Components

   1. Pre-Exam:

      1. Telephone contact to set up appointment.. 60 1 10/60 10

      2. Exam Appointment, Scheduling, Reminder, 55 1 35/60 32

      and Instructions...........................

   2. Exam--Cycle 32:

      1. Clinic exam.............................. 25 1 45/60 19

      2. Home or nursing home visit............... 25 1 65/60 27

   3. Annual Follow-up:

      1. Records Request.......................... 60 1 15/60 15

      2. Health Status Update..................... 45 1 15/60 11

      ---------------------------------------------------------------

      Sub-Total: Participant Components....... * 60 .............. .............. 114

2. Non-Participant Components .............. .............. .............. ..............

   1. Informant Contact (Pre-exam and Annual Follow- 25 1 10/60 4

      up)............................................

   2. 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

      ----------------------------------------------------------------------------------------------------------------

      Number of Average time

      Type of respondent Number of responses per per response Total annual

      respondents respondent (in hours) burden hour

      ----------------------------------------------------------------------------------------------------------------

1. Participant Components:

   1. Pre-Exam:

      1. Telephone contact to set up apt or Health 300 1 10/60 50

         status update..............................

      2. Appt. or update Confirmation............. 250 1 10/60 42

      3. Food Frequency Form...................... 250 1 10/60 42

   2. Exam:

      1. Clinic Exam.............................. 100 1 175/60 292

      2. Home or nursing home visit............... 100 1 60/60 100

      3. Consent Forms............................ 200 1 20/60 67

   3. Annual Follow-Up:

      1. Records Request.......................... 2292 1 15/60 573

      2. Health Status Update..................... 1833 1 15/60 458

      ---------------------------------------------------------------

      Sub-Total: Participant Components....... * 2292 .............. .............. 1624

2. Non-Participant Components:

   1. Informant contact (Pre-exam and Annual Follow- 229 1 10/60 38

      up)............................................

   2. 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

      ----------------------------------------------------------------------------------------------------------------

      Number of Average time

      Type of respondent Number of responses per per response Total annual

      respondents respondent (in hours) burden hour

      ----------------------------------------------------------------------------------------------------------------

1. Participant Components

   Annual Follow-up: 1

   1. Records Request.......................... 3212 1 15/60 803

      Page 26641

   2. Health Status Update..................... 3212 1 15/60 803

      ---------------------------------------------------------------

      Sub-Total: Participant Components....... * 3212 .............. .............. 1606

2. Non-Participant Components

   Annual Follow-up: .............. .............. .............. ..............

   1. Informant contacts....................... 160 1 10/60 27

   2. 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

   ----------------------------------------------------------------------------------------------------------------

   Number of Average time

   Type of respondent Number of responses per per response Total annual

   respondents respondent (in hours) burden hour

   ----------------------------------------------------------------------------------------------------------------

   Participants.................................... 5564 1 36/60 3344

   Non-Participants................................ 3816 1 14.5/60 920

   ---------------------------------------------------------------

   Totals...................................... 9380 .............. .............. 4264

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   (Note: reported and calculated numbers differ slightly due to rounding.)

   Dated: April 25, 2013.

   Lynn Susulske,

   NHLBI Project Clearance Liaison, National Institutes of Health.

   Michael Lauer,

   Director, DCVS, National Institutes of Health.

   FR Doc. 2013-10771 Filed 5-6-13; 8:45 am

   BILLING CODE 4140-01-P