[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20659-20661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08032]


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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 comments 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

[[Page 20660]]

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

                    Table A.12-1.1--Estimate of Respondent Burden, Original Cohort Annualized
----------------------------------------------------------------------------------------------------------------
                                                                           Number of   Average time
                                                             Number of     responses        per         Total
                    Type of respondent                      respondents       per        response       annual
                                                                          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
                                                          ------------------------------------------------------
        Subtotal: Participant Components.................           *30  ............  ............           15
----------------------------------------------------------------------------------------------------------------
                                         II. Non-Participant Components
----------------------------------------------------------------------------------------------------------------
    A. Informant Contact (Pre-exam and Annual Follow-up)             15             1         10/60            3
     (Attach #3--pages 3-7)..............................
    B. Health Care Provider Records Request (Annual                  30             1         15/60            8
     follow-up) (Attach #5)..............................
                                                          ------------------------------------------------------
        Subtotal: 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
                                                             Number of     responses        per         Total
                    Type of respondent                      respondents       per        response       annual
                                                                          respondent    (in hours)   burden hour
----------------------------------------------------------------------------------------------------------------
                                            I. Participant Components
----------------------------------------------------------------------------------------------------------------
Annual Follow-up
    a. Records Request (Attach #5).......................         1,500             1         15/60          375
    b. Health Status Update (Attach #3)..................         1,700             1         15/60          425
                                                          ------------------------------------------------------
        Sub-total: Participant Components................        *1,700  ............  ............          800
----------------------------------------------------------------------------------------------------------------
                                         II. Non-Participant Components
----------------------------------------------------------------------------------------------------------------
    A. Informant contact (Pre-exam and Annual Follow-up)            150             1         10/60           25
     (Attach #3--pages 3-7)..............................
    B. Health Care Provider Records Request (Annual               1,500             1         15/60          375
     follow-up) (Attach #5)..............................
                                                          ------------------------------------------------------
        Sub-total: Non-Participant Components............         1,650  ............  ............          400
                                                          ------------------------------------------------------
            Total: Participant and Non-Participant                3,350         3,350  ............        1,200
             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
                                                             Number of     responses   per response     Total
                    Type of respondent                      respondents       per       (hours per      annual
                                                                          respondent       year)     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

[[Page 20661]]

 
    2. Consent (Attach #10)..............................         1,200             1         20/60          400
    2. Home or nursing home visit (Attach #1--partial as             35             1             1           35
     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.


                Estimates of Annualized Total Hour Burden are Summarized in Table A.12-1.4 Below
----------------------------------------------------------------------------------------------------------------
                                                                           Number of   Average time
                                                             Number of     responses        per         Total
                    Type of respondent                      respondents       per        response       annual
                                                                          respondent    (in hours)   burden hour
----------------------------------------------------------------------------------------------------------------
Participants.............................................          4580             1         90/60        7,653
Non-Participants.........................................         3,030             1         15/60          729
    Totals...............................................         7,610             2  ............        8,382
----------------------------------------------------------------------------------------------------------------
Note: reported and calculated numbers differ slightly due to rounding.


    Dated: April 4, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2016-08032 Filed 4-7-16; 8:45 am]
 BILLING CODE 4140-01-P