Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS), 26639-26641 [2013-10771]
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26639
Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: Financial Sustainability of
Human Tissue Biobanking (NCI)
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 Cancer Institute (NCI),
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
based survey is to collect information
regarding the challenges that human
tissue biobanks encounter in achieving
financially sustainable operations. The
information will be used to assist the
National Cancer Institute (NCI) in
strategizing program plans to provide
increased and tailored support for
national and international biobanks.
The survey will collect a combination of
structured, quantitative, and free-text
descriptive data that characterize the
type and maturity of respondent
biobanks, their sources of funding, and
their usage of funding in conducting
operations. The survey will also collect
information describing the difficulties
in maintaining funding sources and
establishing new ones. Finally, the
survey will elicit descriptions of
techniques used to overcome the
difficulties.
It is expected that the information
generated by this survey will be used to
inform published guidance to biobanks
regarding the financial hazards to
sustained operations and the means by
which these hazards can be avoided or
overcome.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 822.
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 obtain a copy of the
data collection plans and instruments or
request more information on the
proposed project contact: Chana
Rabiner, Ph.D., Biorepositories and
Biospecimen Research Branch, Cancer
Diagnosis Program, 9609 Medical Center
Drive, Rockville, MD 20892 or call nontoll-free number 240–276–5715 or Email
your request, including your address to:
chana.rabiner@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
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: Financial
Sustainability of Human Tissue
Biobanking, 0925–NEW, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of this web-
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Category of respondents
Average time
per response
(in hours)
Frequency of
response
Total burden
hours
Estimates of Annualized Burden Hours
Private Sector ..................................................................................................
548
1
90/60
822
Totals ........................................................................................................
548
........................
........................
822
Dated: May 1, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013–10772 Filed 5–6–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
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
VerDate Mar<15>2010
18:51 May 06, 2013
Jkt 229001
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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 nontoll-free number (301) 435–0456, or
email your request, including your
address to: weig@nhlbi.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
E:\FR\FM\07MYN1.SGM
07MYN1
26640
Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices
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
respondents
Type of respondent
I. Participant Components
A. Pre-Exam:
a. Telephone contact to set up appointment ............................................
b. Exam Appointment, Scheduling, Reminder, and Instructions ..............
B. Exam—Cycle 32:
a. Clinic exam ...........................................................................................
b. Home or nursing home visit .................................................................
C. Annual Follow-up:
a. Records Request ..................................................................................
b. Health Status Update ...........................................................................
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hour
60
55
1
1
10/60
35/60
10
32
25
25
1
1
45/60
65/60
19
27
60
45
1
1
15/60
15/60
15
11
Sub-Total: Participant Components ..................................................
* 60
........................
........................
114
II. Non-Participant Components
A. Informant Contact (Pre-exam and Annual Follow-up) ................................
B. Records Request (Annual follow-up) ..........................................................
........................
25
50
........................
1
1
........................
10/60
15/60
........................
4
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
respondents
Type of respondent
I. Participant Components:
A. Pre-Exam:
a. Telephone contact to set up apt or Health status update ...................
b. Appt. or update Confirmation ...............................................................
c. Food Frequency Form ..........................................................................
B. Exam:
a. Clinic Exam ..........................................................................................
b. Home or nursing home visit .................................................................
c. Consent Forms .....................................................................................
C. Annual Follow-Up:
a. Records Request ..................................................................................
b. Health Status Update ...........................................................................
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hour
300
250
250
1
1
1
10/60
10/60
10/60
50
42
42
100
100
200
1
1
1
175/60
60/60
20/60
292
100
67
2292
1833
1
1
15/60
15/60
573
458
Sub-Total: Participant Components ..................................................
* 2292
........................
........................
1624
II. Non-Participant Components:
A. Informant contact (Pre-exam and Annual Follow-up) .................................
B. Records Request (Annual follow-up) ..........................................................
229
2292
1
1
10/60
15/60
38
573
Sub-Total: Non-Participant Components: ..........................................
2521
........................
........................
611
* Number of participants as reflected in Rows I.C.a. above.
tkelley on DSK3SPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS, GENERATION 3 COHORT AND OMNI GROUP 2 COHORT
Type of
respondent
Number of
respondents
I. Participant Components
Annual Follow-up:
A. Records Request .................................................................................
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15:24 May 06, 2013
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
3212
E:\FR\FM\07MYN1.SGM
1
1
07MYN1
Average time
per response
(in hours)
15/60
Total annual
burden hour
803
26641
Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS, GENERATION 3 COHORT AND OMNI GROUP 2 COHORT—Continued
Type of
respondent
Number of
responses per
respondent
Number of
respondents
Average time
per response
(in hours)
Total annual
burden hour
B. Health Status Update ...........................................................................
3212
1
15/60
803
Sub-Total: Participant Components ..................................................
* 3212
........................
........................
1606
Annual Follow-up:
A. Informant contacts ...............................................................................
B. Records Request .................................................................................
........................
160
1060
........................
1
1
........................
10/60
15/60
........................
27
265
Sub-Total: Non-Participant Components ...........................................
1220
........................
........................
292
II. Non-Participant Components
* Number of participants as reflected in Rows I.A. and I.B. above.
SUMMARY OF 3 TABLES COMBINED—TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Number of
responses per
respondent
Number of
respondents
Average time
per response
(in hours)
Total annual
burden hour
Participants ......................................................................................................
Non-Participants ..............................................................................................
5564
3816
1
1
36/60
14.5/60
3344
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
Mellitus Interagency Coordinating
Committee, National Institute of
Diabetes and Digestive and Kidney
Diseases, 31 Center Drive, Building 31A,
Room 9A19, MSC 2560, Bethesda, MD
20892–2560, telephone: 301–496–6623;
FAX: 301–480–6741; email:
dmicc@mail.nih.gov.
The
DMICC facilitates cooperation,
communication, and collaboration on
diabetes among government entities.
The June 6–7, 2013, DMICC workshop
will discuss new and emerging
opportunities for type 1 diabetes
research supported by the Special
Statutory Funding Program for Type 1
Diabetes Research. An agenda for the
DMICC workshop will be available by
contacting Mary Allen, The Scientific
Consulting Group, Inc.
(mallen@scgcorp.com; please put
‘‘Agenda Request for DMICC T1D
Meeting’’ in the subject line).
Any interested person may file
written comments with the Committee
by forwarding their statement to the
contact person listed on this notice. The
statement should include the name,
address, telephone number and, when
applicable, the business or professional
affiliation of the interested person.
Because of time constraints for the
workshop, there will not be time on the
agenda for oral comments from
members of the public.
Members of the public who would
like to receive email notification about
future DMICC meetings may register on
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases,
Diabetes Mellitus Interagency
Coordinating Committee Notice of
Workshop
SUMMARY: The Diabetes Mellitus
Interagency Coordinating Committee
(DMICC) will hold a 2-day workshop on
June 6–7, 2013. The workshop will be
open to the public, with attendance
limited to space available.
DATES: The workshop will be held on
June 6, 2013 from 8:15 a.m. to 6:00 p.m.,
and June 7, 2013 from 8:15 a.m. to 4:00
p.m.
ADDRESSES: The workshop will be held
at the National Institutes of Health
Neuroscience Center, Conference Room
B1/B2, 6001 Executive Boulevard,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For
further information concerning this
workshop, contact Dr. B. Tibor Roberts,
Executive Secretary of the Diabetes
VerDate Mar<15>2010
15:24 May 06, 2013
Jkt 229001
PO 00000
Frm 00031
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a listserv on the DMICC Web site:
www.diabetescommittee.gov.
Please note that seating is limited and
attendance will be first-come, firstserved. Non-federal individuals
planning to attend the workshop should
register by email to Mary Allen, The
Scientific Consulting Group, Inc.
(mallen@scgcorp.com; please put
‘‘Registration DMICC T1D Meeting’’ in
the subject line) at least 7 days prior to
the workshop. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
inform the Contact Person listed below
at least 10 days in advance of the
workshop.
Dated: April 26, 2013.
B. Tibor Roberts,
Executive Secretary, DMICC, Office of
Scientific Program and Policy Analysis,
NIDDK, National Institutes of Health.
[FR Doc. 2013–10770 Filed 5–6–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26639-26641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10771]
-----------------------------------------------------------------------
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: weig@nhlbi.nih.gov. 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
