[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81830-81832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32940]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60 Day Comment Request; The Framingham Heart 
Study (NHLBI)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 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.

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: Paul Sorlie, 
6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll-
free number (301) 435-0456, or Email your request to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Comments 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, Revision, 0925-
0216 Expiration Date: 10/31/2016, 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

[[Page 81831]]

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

                         Table A.12-1.1--Estimate of Respondent Burden, Original Cohort
                                                  [Annualized]
----------------------------------------------------------------------------------------------------------------
                                                                     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..........................              30               1           15/60               8
    b. Health Status Update.....................              30               1           15/60               8
                                                 ---------------------------------------------------------------
        SUB-TOTAL: PARTICIPANT COMPONENTS.......            * 30  ..............  ..............              15
II. NON-PARTICIPANT COMPONENTS
    A. Informant Contact (Pre-exam and Annual                 15               1           10/60               3
     Follow-up).................................
    B. Records Request (Annual follow-up).......              30               1           15/60               8
                                                 ---------------------------------------------------------------
        SUB-TOTAL: NON-PARTICIPANT COMPONENTS...              45  ..............  ..............              10
                                                 ---------------------------------------------------------------
            TOTAL: PARTICIPANT AND NON-                       75  ..............  ..............              25
             PARTICIPANT 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
               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..........................           1,500               1           15/60             375
    b. Health Status Update.....................           1,700               1           15/60             425
                                                 ---------------------------------------------------------------
        SUB-TOTAL: PARTICIPANT COMPONENTS.......         * 1,700  ..............  ..............             800
II. NON-PARTICIPANT COMPONENTS
    A. Informant contact (Pre-exam and Annual                150               1           10/60              25
     Follow-up).................................
    B. Records Request (Annual follow-up).......           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
        SUB-TOTAL: NON-PARTICIPANT COMPONENTS...           1,650  ..............  ..............             400
                                                 ---------------------------------------------------------------
            TOTAL: PARTICIPANT AND NON-                    3,350  ..............  ..............           1,200
             PARTICIPANT 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]
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
                                                     Number of       Number of     per response    Total annual
               Type of respondent                   respondents    responses per    (hours per      burden hour
                                                                    respondent         year)
----------------------------------------------------------------------------------------------------------------
                                            I. PARTICIPANT COMPONENTS
----------------------------------------------------------------------------------------------------------------
A. PRE-EXAM:
    1.Telephone contact for appointment.........           1,450               1           10/60             242
    2. Exam appointment, scheduling, reminder              1,270               1           35/60             741
     and instructions...........................
B. EXAM CYCLE 3:
    1. Exam at study center.....................           1,200               1          110/60           2,200

[[Page 81832]]

 
    2. Home or nursing home visit...............              35               1           60/60              35
C. POST-EXAM:
    eFHS Mobile Technology for Collection of CVD           1,100              18            9/60           2,970
     Risks......................................
D. ANNUAL FOLLOW-UP:
    1. Records Request..........................           1,200               1           15/60             300
    2. Health Status Update.....................           1,400               1           15/60             350
                                                 ---------------------------------------------------------------
        Sub-Total: Participant Components.......         * 2,850  ..............  ..............           6,830
----------------------------------------------------------------------------------------------------------------
                                II. NON-PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
----------------------------------------------------------------------------------------------------------------
A. INFORMANT CONTACTS...........................             180               1           10/60              30
B. RECORD REQUEST...............................           1,155               1           15/60             289
                                                 ---------------------------------------------------------------
    Sub-Total: Non-Participant Components.......           1,335  ..............  ..............             319
                                                 ---------------------------------------------------------------
        Total: Participant And Non-Participant             4,185  ..............  ..............           7,157
         Components.............................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.1 and I.D.2 above.


    Dated: December 22, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-32940 Filed 12-30-15; 8:45 am]
BILLING CODE 4140-01-P