[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26639-26641]
From the Federal Register Online via the Government Publishing 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: [email protected]. 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
----------------------------------------------------------------------------------------------------------------
            I. Participant Components
A. Pre-Exam:
    a. Telephone contact to set up appointment..              60               1           10/60              10
    b. Exam Appointment, Scheduling, Reminder,                55               1           35/60              32
     and Instructions...........................
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-             25               1           10/60               4
 up)............................................
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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
           I. Participant Components:
A. Pre-Exam:
    a. Telephone contact to set up apt or Health             300               1           10/60              50
     status update..............................
    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-            229               1           10/60              38
 up)............................................
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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of  respondent                   Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
            I. Participant Components
Annual Follow-up:                                                              1
    A. Records Request..........................            3212               1           15/60             803

[[Page 26641]]

 
    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
----------------------------------------------------------------------------------------------------------------
                                                                     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
----------------------------------------------------------------------------------------------------------------
(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