[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]
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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
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I. PARTICIPANT COMPONENTS
ANNUAL FOLLOW-UP
a. Records Request.......................... 30 1 15/60 8
b. Health Status Update..................... 30 1 15/60 8
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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
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TOTAL: PARTICIPANT AND NON- 75 .............. .............. 25
PARTICIPANT 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
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
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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
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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
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SUB-TOTAL: NON-PARTICIPANT COMPONENTS... 1,650 .............. .............. 400
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TOTAL: PARTICIPANT AND NON- 3,350 .............. .............. 1,200
PARTICIPANT 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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Average time
Number of Number of per response Total annual
Type of respondent respondents responses per (hours per burden hour
respondent year)
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I. PARTICIPANT COMPONENTS
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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
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Sub-Total: Participant Components....... * 2,850 .............. .............. 6,830
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II. NON-PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
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A. INFORMANT CONTACTS........................... 180 1 10/60 30
B. RECORD REQUEST............................... 1,155 1 15/60 289
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Sub-Total: Non-Participant Components....... 1,335 .............. .............. 319
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Total: Participant And Non-Participant 4,185 .............. .............. 7,157
Components.............................
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* 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]
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