[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58318-58320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23060]


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

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, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

[[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.

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: [email protected]. 
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
----------------------------------------------------------------------------------------------------------------
                                                                  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                     60                1            10/60               10
         appointment........................
        b. Exam Appointment, Scheduling,                   55                1            35/60               32
         Reminder, 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                        *60  ...............  ...............              114
             COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
II. NON-PARTICIPANT COMPONENTS
    A. Informant Contact (Pre-exam and                     25                1            10/60                4
     Annual Follow-up)......................
    B. Records Request (Annual follow-up)...               50                1            15/60               13
----------------------------------------------------------------------------------------------------------------
            SUB-TOTAL: NON-PARTICIPANT                     75  ...............  ...............               17
             COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
* 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                300               1           10/60              50
         Health 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                229               1           10/60              38
     Follow-up).................................
    B. Records Request (Annual follow-up).......            2292               1           15/60             573
                                                 ---------------------------------------------------------------
            SUB-TOTAL: NON-PARTICIPANT                      2521  ..............  ..............             611
             COMPONENTS.........................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.C.a. above.


[[Page 58320]]


                 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
    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
----------------------------------------------------------------------------------------------------------------
                                                                     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.)


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