[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26639-26641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request: The Framingham Heart
Study (FHS)
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 be submitted 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.
To Submit Comments and for Further Information: To request more
information on the proposed project or to obtain a copy of data
collection plans and instruments, contact Dr. Gina Wei, Division of
Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701
Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-
free number (301) 435-0456, or email your request, including your
address to: [email protected]. Formal requests for additional plans
and instruments must be requested in writing.
[[Page 26640]]
Comment 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, 0925-0216,
Extension, National Heart, Lung, and Blood Institute (NHLBI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The Framingham Heart Study
will continue to conduct morbidity and mortality follow-up, as well as
examinations, for the purpose of studying the determinants of
cardiovascular disease. Morbidity and mortality follow-up will continue
to occur in all of the cohorts (Original, Offspring, Third Generation,
Omni Group 1, and Omni Group 2). Examinations will continue to be
conducted on the Original, Offspring, and Omni Group 1 Cohorts.
OMB approval is requested for 3 years. There is no cost to the
respondents other than their time. The total estimated annualized
burden hours are 4264.
Estimated Annualized Burden Hours, Original Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components
A. Pre-Exam:
a. Telephone contact to set up appointment.. 60 1 10/60 10
b. Exam Appointment, Scheduling, Reminder, 55 1 35/60 32
and Instructions...........................
B. Exam--Cycle 32:
a. Clinic exam.............................. 25 1 45/60 19
b. Home or nursing home visit............... 25 1 65/60 27
C. Annual Follow-up:
a. Records Request.......................... 60 1 15/60 15
b. Health Status Update..................... 45 1 15/60 11
---------------------------------------------------------------
Sub-Total: Participant Components....... * 60 .............. .............. 114
II. Non-Participant Components .............. .............. .............. ..............
A. Informant Contact (Pre-exam and Annual Follow- 25 1 10/60 4
up)............................................
B. Records Request (Annual follow-up)........... 50 1 15/60 13
---------------------------------------------------------------
Sub-Total: Non-Participant Components... 75 .............. .............. 17
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.a and I.C.a. above.
Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components:
A. Pre-Exam:
a. Telephone contact to set up apt or Health 300 1 10/60 50
status update..............................
b. Appt. or update Confirmation............. 250 1 10/60 42
c. Food Frequency Form...................... 250 1 10/60 42
B. Exam:
a. Clinic Exam.............................. 100 1 175/60 292
b. Home or nursing home visit............... 100 1 60/60 100
c. Consent Forms............................ 200 1 20/60 67
C. Annual Follow-Up:
a. Records Request.......................... 2292 1 15/60 573
b. Health Status Update..................... 1833 1 15/60 458
---------------------------------------------------------------
Sub-Total: Participant Components....... * 2292 .............. .............. 1624
II. Non-Participant Components:
A. Informant contact (Pre-exam and Annual Follow- 229 1 10/60 38
up)............................................
B. Records Request (Annual follow-up)........... 2292 1 15/60 573
---------------------------------------------------------------
Sub-Total: Non-Participant Components:.. 2521 .............. .............. 611
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.C.a. above.
Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort
----------------------------------------------------------------------------------------------------------------
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: 1
A. Records Request.......................... 3212 1 15/60 803
[[Page 26641]]
B. Health Status Update..................... 3212 1 15/60 803
---------------------------------------------------------------
Sub-Total: Participant Components....... * 3212 .............. .............. 1606
II. Non-Participant Components
Annual Follow-up: .............. .............. .............. ..............
A. Informant contacts....................... 160 1 10/60 27
B. Records Request.......................... 1060 1 15/60 265
---------------------------------------------------------------
Sub-Total: Non-Participant Components... 1220 .............. .............. 292
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A. and I.B. above.
Summary of 3 Tables Combined--Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Participants.................................... 5564 1 36/60 3344
Non-Participants................................ 3816 1 14.5/60 920
---------------------------------------------------------------
Totals...................................... 9380 .............. .............. 4264
----------------------------------------------------------------------------------------------------------------
(Note: reported and calculated numbers differ slightly due to rounding.)
Dated: April 25, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-10771 Filed 5-6-13; 8:45 am]
BILLING CODE 4140-01-P