Submission for OMB Review; 30-Day Comment Request; The Framingham Heart Study (NHLBI), 20659-20661 [2016-08032]
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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
anticipate receiving a large number of
samples for analysis which would
exceed their capacity. A collaborator
with the expertise and capacity for
implementing a CLIA or FDA approved
test for this genetic variant is sought.
A Cooperative Research and
Development Agreement (CRADA) is
the anticipated collaborative agreement
to be entered into with NIAID pursuant
to the Federal Technology Transfer Act
of 1986, codified as 15 U.S.C. 3710a,
and Executive Order 12591 of April 10,
1987, as amended. A CRADA is an
agreement designed to enable certain
collaborations between Government
laboratories and non-Government
laboratories. A CRADA is not a grant,
and it is not a contract for the
procurement of goods/services. The
NIAID is prohibited from transferring
funds to a CRADA collaborator. Under
a CRADA, NIAID can contribute
facilities, staff, materials, and expertise.
The CRADA collaborator can contribute
facilities, staff, materials, expertise, and
funds. The CRADA collaborator will
also have an option to negotiate the
terms of an exclusive or non-exclusive
commercialization license to subject
inventions arising under the CRADA.
The goals of the CRADA include the
rapid publication of research results and
timely commercialization of products,
diagnostics, and treatments that result
from the research.
The expected duration of the CRADA
with be two (2) to three (3) years.
Dated: April 2, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2016–08100 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
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National Institute of Environmental
Health Sciences; 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.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
Jkt 238001
Dated: April 5, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08094 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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 comments 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
SUMMARY:
National Institutes of Health
17:48 Apr 07, 2016
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; NIH Loan Repayment
Program (Clinical and Pediatric Researchers).
Date: April 22, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: NIEHS/National Institutes of Health,
Keystone Building, 530 Davis Drive, Research
Triangle Park, NC 27709 (Virtual Meeting).
Contact Person: Rose Anne M. McGee,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709, (919) 541–
0752, mcgee1@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Submission for OMB Review; 30-Day
Comment Request; The Framingham
Heart Study (NHLBI)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Frm 00054
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20659
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, OIRA_submission@
omb.eop.gov 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
deshiree.belis@nih.gov. 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
E:\FR\FM\08APN1.SGM
08APN1
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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
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
respondents
Type of respondent
Number of
responses
per
respondent
Average time
per response
(in hours)
Total annual
burden hour
I. Participant Components
Annual Follow-up:
a. Records Request (Attach #5) .........................................................................
b. Health Status Update (Attach #3) ..................................................................
30
30
1
1
15/60
15/60
8
8
Subtotal: Participant Components ...............................................................
*30
......................
......................
15
A. Informant Contact (Pre-exam and Annual Follow-up) (Attach #3—pages 3–
7) .....................................................................................................................
B. Health Care Provider Records Request (Annual follow-up) (Attach #5) .......
15
30
1
1
10/60
15/60
3
8
Subtotal: Non-Participant Components .......................................................
45
......................
......................
10
Total: Participant and Non-Participant Components ............................
75
75
......................
25
II. Non-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
respondents
Type of respondent
Number of
responses
per
respondent
Average time
per response
(in hours)
Total annual
burden hour
I. Participant Components
Annual Follow-up
a. Records Request (Attach #5) .........................................................................
b. Health Status Update (Attach #3) ..................................................................
1,500
1,700
1
1
15/60
15/60
375
425
Sub-total: Participant Components .............................................................
*1,700
......................
......................
800
A. Informant contact (Pre-exam and Annual Follow-up) (Attach #3—pages 3–
7) .....................................................................................................................
B. Health Care Provider Records Request (Annual follow-up) (Attach #5) .......
150
1,500
1
1
10/60
15/60
25
375
Sub-total: Non-Participant Components ......................................................
1,650
......................
......................
400
Total: Participant and Non-Participant Components ............................
3,350
3,350
......................
1,200
II. Non-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
Number of
respondents
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Type of respondent
Number of
responses
per
respondent
Average time
per response
(hours per
year)
Total annual
burden hour
I. Participant Components
A. Pre-Exam:
1. Telephone contact for appointment ...............................................................
2. Exam appointment, scheduling, reminder and instructions (Attach #6) ........
B. Exam Cycle 3:
1. Exam at study center (Attach #1) ..................................................................
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17:48 Apr 07, 2016
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1,450
1,270
1
1
10/60
35/60
242
741
1,200
1
90/60
1,800
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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
TABLE A.12–1.3—ESTIMATE OF RESPONDENT BURDEN, GENERATION 3 COHORT, NOS AND OMNI GROUP 2 COHORT
ANNUALIZED—Continued
Number of
responses
per
respondent
Number of
respondents
Type of respondent
Average time
per response
(hours per
year)
Total annual
burden hour
2. Consent (Attach #10) .....................................................................................
2. Home or nursing home visit (Attach #1—partial as respondent is capable)
C. Post-Exam:
eFHS Mobile Technology for Collection of CVD Risks (Attach #2) ...................
D. Annual Follow-Up:
1. Records Request (Attach #5) .........................................................................
2. Health Status Update (Attach #3) ..................................................................
1,200
35
1
1
20/60
1
400
35
1,100
18
9/60
2,970
1,200
1,400
1
1
15/60
15/60
300
350
Sub-total: Participant Components .............................................................
2,850*
......................
......................
6,830
II. Non-Participant Components—Annual Follow-Up
A. Informant Contacts (Attach #3—pages 3–7) .................................................
B. Health Care Provider Record Request (Attach #5) .......................................
180
1,155
1
1
10/60
15/60
30
289
Sub-total: Non-Participant Components ......................................................
1,335
......................
......................
319
Total: Participant and Non-Participant Components ............................
4,185
28,890
......................
7,157
* Number of participants as reflected in Rows I.A.1 and I.D.2 above.
ESTIMATES OF ANNUALIZED TOTAL HOUR BURDEN ARE SUMMARIZED IN TABLE A.12–1.4 BELOW
Type of
respondent
Number of
respondents
Participants ................................................................................................................
Non-Participants ........................................................................................................
Totals ..................................................................................................................
Number of
responses
per
respondent
4580
3,030
7,610
Average time
per response
(in hours)
1
1
2
Total annual
burden hour
90/60
15/60
......................
7,653
729
8,382
Note: reported and calculated numbers differ slightly due to rounding.
Dated: April 4, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2016–08032 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2016–0002]
Final Flood Hazard Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Final notice.
AGENCY:
Flood hazard determinations,
which may include additions or
modifications of Base Flood Elevations
(BFEs), base flood depths, Special Flood
Hazard Area (SFHA) boundaries or zone
designations, or regulatory floodways on
the Flood Insurance Rate Maps (FIRMs)
and where applicable, in the supporting
Flood Insurance Study (FIS) reports
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SUMMARY:
VerDate Sep<11>2014
17:48 Apr 07, 2016
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have been made final for the
communities listed in the table below.
The FIRM and FIS report are the basis
of the floodplain management measures
that a community is required either to
adopt or to show evidence of having in
effect in order to qualify or remain
qualified for participation in the Federal
Emergency Management Agency’s
(FEMA’s) National Flood Insurance
Program (NFIP). In addition, the FIRM
and FIS report are used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for buildings and the contents of
those buildings.
DATES: The effective date of July 6, 2016
which has been established for the
FIRM and, where applicable, the
supporting FIS report showing the new
or modified flood hazard information
for each community.
ADDRESSES: The FIRM, and if
applicable, the FIS report containing the
final flood hazard information for each
community is available for inspection at
the respective Community Map
Repository address listed in the tables
below and will be available online
through the FEMA Map Service Center
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
at www.msc.fema.gov by the effective
date indicated above.
FOR FURTHER INFORMATION CONTACT: Luis
Rodriguez, Chief, Engineering
Management Branch, Federal Insurance
and Mitigation Administration, FEMA,
500 C Street SW., Washington, DC
20472, (202) 646–4064, or (email)
Luis.Rodriguez3@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at
www.floodmaps.fema.gov/fhm/fmx_
main.html.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) makes the final determinations
listed below for the new or modified
flood hazard information for each
community listed. Notification of these
changes has been published in
newspapers of local circulation and 90
days have elapsed since that
publication. The Deputy Associate
Administrator for Mitigation has
resolved any appeals resulting from this
notification.
This final notice is issued in
accordance with section 110 of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and 44 CFR part 67.
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]]>Agencies
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20659-20661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08032]
-----------------------------------------------------------------------
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 comments 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, OIRA_submission@omb.eop.gov 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 deshiree.belis@nih.gov. 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
[[Page 20660]]
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
Number of responses per Total
Type of respondent respondents per response annual
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
------------------------------------------------------
Subtotal: Participant Components................. *30 ............ ............ 15
----------------------------------------------------------------------------------------------------------------
II. Non-Participant Components
----------------------------------------------------------------------------------------------------------------
A. Informant Contact (Pre-exam and Annual Follow-up) 15 1 10/60 3
(Attach #3--pages 3-7)..............................
B. Health Care Provider Records Request (Annual 30 1 15/60 8
follow-up) (Attach #5)..............................
------------------------------------------------------
Subtotal: Non-Participant Components............. 45 ............ ............ 10
------------------------------------------------------
Total: Participant and Non-Participant 75 75 ............ 25
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
Number of responses per Total
Type of respondent respondents per response annual
respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. Participant Components
----------------------------------------------------------------------------------------------------------------
Annual Follow-up
a. Records Request (Attach #5)....................... 1,500 1 15/60 375
b. Health Status Update (Attach #3).................. 1,700 1 15/60 425
------------------------------------------------------
Sub-total: Participant Components................ *1,700 ............ ............ 800
----------------------------------------------------------------------------------------------------------------
II. Non-Participant Components
----------------------------------------------------------------------------------------------------------------
A. Informant contact (Pre-exam and Annual Follow-up) 150 1 10/60 25
(Attach #3--pages 3-7)..............................
B. Health Care Provider Records Request (Annual 1,500 1 15/60 375
follow-up) (Attach #5)..............................
------------------------------------------------------
Sub-total: Non-Participant Components............ 1,650 ............ ............ 400
------------------------------------------------------
Total: Participant and Non-Participant 3,350 3,350 ............ 1,200
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
----------------------------------------------------------------------------------------------------------------
Number of Average time
Number of responses per response Total
Type of respondent respondents per (hours per annual
respondent year) 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
[[Page 20661]]
2. Consent (Attach #10).............................. 1,200 1 20/60 400
2. Home or nursing home visit (Attach #1--partial as 35 1 1 35
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.
Estimates of Annualized Total Hour Burden are Summarized in Table A.12-1.4 Below
----------------------------------------------------------------------------------------------------------------
Number of Average time
Number of responses per Total
Type of respondent respondents per response annual
respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Participants............................................. 4580 1 90/60 7,653
Non-Participants......................................... 3,030 1 15/60 729
Totals............................................... 7,610 2 ............ 8,382
----------------------------------------------------------------------------------------------------------------
Note: reported and calculated numbers differ slightly due to rounding.
Dated: April 4, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2016-08032 Filed 4-7-16; 8:45 am]
BILLING CODE 4140-01-P
