[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23735-23737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; The Framingham 
Heart Study (NHLBI)

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 12/31/2015, pages 81830-81832. No comment s were received. 
The purpose of this notice is to allow an additional 30 days for public 
comment. 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.
    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 obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Ms. Deshiree 
Belis, National Heart, Lung, and Blood Institute, National Institutes 
of Health, 6705 Rockledge Dr., Suite 6185A, Bethesda, MD 20892, or call 
non-toll-free number 301-435-1032, 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), the 
National Institutes of Health (NIH).
    Need and Use of Information Collection: This proposal is to extend 
the Framingham Study to examine the Generation Three Cohort, New 
Offspring Spouses and Omni Group 2 Cohort, as well as to continue to 
monitor the morbidity and mortality which occurs in all Framingham 
Cohorts. The contractor, with the collaborative assistance of NHLBI 
Intramural staff, will invite study participants, schedule 
appointments, administer examinations and testing, enter information 
into computer databases for editing, and prepare scientific reports of 
the information for publication in appropriate scientific journals. All 
participants have been examined previously and thus the study deals 
with a stable, carefully described group. Data are collected in the 
form of an observational health examination involving such components 
as blood pressure measurements, venipuncture, electrocardiography and a 
health interview, including questions about lifestyles and daily living 
situations. The National Heart, Lung, and Blood Institute uses the 
results of the Framingham Study to: (1) Characterize risk factors for 
cardiovascular and lung diseases so that national prevention programs 
can be designed and implemented; (2) evaluate trends in cardiovascular 
diseases and risk factors over time to measure the impact of overall 
preventive measures; and (3) understand the etiology of cardiovascular 
and lung diseases so that effective treatment and preventive modalities 
can be developed and tested. Most of the reports of study results have 
been published in peer reviewed medical journals and books.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 8,382.

Estimated Annualized Burden Hours

[[Page 23736]]



                    Table A.12-1.1--Estimate of Respondent Burden, Original Cohort Annualized
----------------------------------------------------------------------------------------------------------------
                                                                        Number of     Average time      Total
                  Type of respondent                     Number of    responses per   per response      annual
                                                        respondents    respondent      (in hours)    burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components Annual Follow-Up:
    a. Records Request (Attach #5)....................           30               1           15/60            8
    b. Health Status Update (Attach #3)...............           30               1           15/60            8
                                                       ---------------------------------------------------------
        Sub-Total: Participant Components.............         * 30  ..............  ..............           15
II. Non-Participant Components:
    A. Informant Contact (Pre-exam and Annual Follow-            15               1           10/60            3
     up) (Attach #3--pages 3-7).......................
    B. Health Care Provider Records Request (Annual              30               1           15/60            8
     follow-up) (Attach #5)...........................
                                                       ---------------------------------------------------------
        Sub-Total: Non-Participant Components.........           45  ..............  ..............           10
                                                       ---------------------------------------------------------
        Total: Participant and Non-Participant                   75              75  ..............           25
         Components...................................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Row I.b. above.


       Table A.12-1.2--Estimate of Respondent Burden, Offspring Cohort and OMNI Group 1 Cohort Annualized
----------------------------------------------------------------------------------------------------------------
                                                                        Number of     Average time      Total
                  Type of respondent                     Number of    responses per   per response      annual
                                                        respondents    respondent      (in hours)    burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components Annual Follow-Up:
    a. Records Request (Attach #5)....................         1500               1           15/60          375
    b. Health Status Update (Attach #3)...............         1700               1           15/60          425
        Sub-Total: Participant Components.............        *1700  ..............  ..............          800
II. Non-Participant Components:
    A. Informant contact (Pre-exam and Annual Follow-           150               1           10/60           25
     up) (Attach #3-pages 3-7)........................
    B. Health Care Provider Records Request (Annual            1500               1           15/60          375
     follow-up) (Attach #5)...........................
                                                       ---------------------------------------------------------
        Sub-Total: Non-Participant Components.........         1650  ..............  ..............          400
                                                       ---------------------------------------------------------
        Total: Participant and Non-Participant                 3350            3350  ..............         1200
         Components...................................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Row I.b. above.


   Table A.12--1.3--Estimate of Respondent Burden, Generation 3 Cohort, NOS and OMNI Group 2 Cohort Annualized
----------------------------------------------------------------------------------------------------------------
                                                                        Number of     Average time      Total
                  Type of respondent                     Number of    responses per   per response      annual
                                                        respondents    respondent      (in hours)    burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components:
    A. Pre-Exam
        1.Telephone contact for appointment...........        1,450               1           10/60          242
        2. Exam appointment, scheduling, reminder and         1,270               1           35/60          741
         instructions (Attach #6).....................
    B. Exam Cycle 3
        1. Exam at study center (Attach #1)...........        1,200               1           90/60        1,800
        2. Consent (Attach #10).......................        1,200               1           20/60          400
        2. Home or nursing home visit (Attach #1--               35               1               1           35
         partial as respondent is capable)............
    C. Post-Exam
    eFHS Mobile Technology for Collection of CVD Risks        1,100              18            9/60        2,970
     (Attach #2)......................................
    D. Annual Follow--Up
        1. Records Request (Attach #5)................        1,200               1           15/60          300
        2. Health Status Update (Attach #3)...........        1,400               1           15/60          350
                                                       ---------------------------------------------------------
            Sub-Total: Participant Components.........      * 2,850  ..............  ..............        6,830
II. Non-Participant Components-Annual Follow-Up:
    A. Informant Contacts (Attach #3--pages 3-7)......          180               1           10/60           30
    B. Health Care Provider Record Request (Attach #5)        1,155               1           15/60          289
                                                       ---------------------------------------------------------
            Sub-Total: Non-Participant Components.....        1,335  ..............  ..............          319
        Total: Participant and Non-Participant                4,185          28,890  ..............        7,157
         Components...................................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.1 and I.D.2 above.


[[Page 23737]]

    Estimates of annualized total hour burden are summarized in Table 
A.12-1.4 Below.

----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Participants....................................            4580               1           90/60           7,653
Non-Participants................................            3030               1           15/60             729
                                                 ---------------------------------------------------------------
    Totals......................................            7610               2  ..............           8,382
----------------------------------------------------------------------------------------------------------------
(Note: reported and calculated numbers differ slightly due to rounding.)


    Dated: April 18, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2016-09313 Filed 4-21-16; 8:45 am]
 BILLING CODE 4140-01-P