[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
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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...................................
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* 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
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Number of Average time Total
Type of respondent Number of responses per per response annual
respondents respondent (in hours) burden hour
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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...................................
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* 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
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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.
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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
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(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