Submission for OMB Review; 30-Day Comment Request; The Framingham Heart Study (NHLBI), 23735-23737 [2016-09313]
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Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
Dated: April 18, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: April 18, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–09314 Filed 4–21–16; 8:45 am]
[FR Doc. 2016–09316 Filed 4–21–16; 8:45 am]
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Submission for OMB Review; 30-Day
Comment Request; The Framingham
Heart Study (NHLBI)
mstockstill on DSK4VPTVN1PROD with NOTICES
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 grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Research Centers in Trauma, Burn and
Perioperative Injury.
Date: May 6, 2016.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3An. 12N, 45 Center
Drive, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Brian R. Pike, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892, 301–594–3907, pikbr@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
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19:18 Apr 21, 2016
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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, 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,
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
23735
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
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
E:\FR\FM\22APN1.SGM
22APN1
23736
Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
TABLE A.12–1.1—ESTIMATE OF RESPONDENT BURDEN, ORIGINAL COHORT ANNUALIZED
Number of
respondents
Type of respondent
I. Participant Components Annual Follow-Up:
a. Records Request (Attach #5) .......................................................................
b. Health Status Update (Attach #3) ................................................................
Number of
responses per
respondent
30
30
1
1
Sub-Total: Participant Components ..........................................................
II. Non-Participant Components:
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) .....
45
Total: Participant and Non-Participant Components .................................
75
Total annual
burden hour
15/60
15/60
* 30
Sub-Total: Non-Participant Components ...................................................
Average time
per response
(in hours)
8
8
15
15
30
1
1
10/60
15/60
3
8
10
75
25
* 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
I. Participant Components Annual Follow-Up:
a. Records Request (Attach #5) .......................................................................
b. Health Status Update (Attach #3) ................................................................
Sub-Total: Participant Components ..........................................................
II. Non-Participant Components:
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) .....
Number of
responses per
respondent
1500
1700
*1700
1
1
15/60
15/60
375
425
800
150
1500
1
1
10/60
15/60
25
375
Sub-Total: Non-Participant Components ...................................................
1650
Total: Participant and Non-Participant Components .................................
3350
Average time
per response
(in hours)
Total annual
burden hour
400
3350
1200
* 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
Type of respondent
mstockstill on DSK4VPTVN1PROD with NOTICES
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) .........................................................
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) .........................................................
Number of
responses per
respondent
1,450
1,270
1
1
10/60
35/60
242
741
1,200
1,200
1
1
90/60
20/60
1,800
400
35
1
1
35
1,100
18
9/60
2,970
1,200
1,400
1
1
15/60
15/60
300
350
Sub-Total: Participant Components ...................................................
II. Non-Participant Components–Annual Follow-Up:
A. Informant Contacts (Attach #3—pages 3–7) ...............................................
B. Health Care Provider Record Request (Attach #5) .....................................
* 2,850
180
1,155
1
1
Sub-Total: Non-Participant Components ...........................................
Total: Participant and Non-Participant Components .................................
1,335
4,185
28,890
Average time
per response
(in hours)
6,830
* Number of participants as reflected in Rows I.A.1 and I.D.2 above.
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19:18 Apr 21, 2016
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E:\FR\FM\22APN1.SGM
Total annual
burden hour
22APN1
10/60
15/60
30
289
319
7,157
23737
Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
Estimates of annualized total hour
burden are summarized in Table A.12–
1.4 Below.
Number of
respondents
Type of respondent
Number of
responses per
respondent
Participants ......................................................................................................
Non-Participants ..............................................................................................
4580
3030
1
1
Totals ........................................................................................................
7610
Average time
per response
(in hours)
Total annual
burden hour
90/60
15/60
2
7,653
729
8,382
(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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of AntiCD70 Chimeric Antigen Receptors
(CARs) for the Treatment of Chronic
Myelogenous Leukemia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Cancer Institute,
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Dedalus
Pharma, LLC (‘‘Dedalus’’) located in
Maryland, USA.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 62/088,882, filed
December 8, 2014, entitled ‘‘Anti-CD70
Chimeric Antigen Receptors’’ [HHS
Reference No. E–021–2015/0–US–01];
and PCT Application No. PCT/US2015/
025047 filed April 9, 2015 entitled
‘‘Anti-CD70 Chimeric Antigen
Receptors’’ [HHS Reference No. E–021–
2015/0–PCT–02].
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The patent rights in these inventions
have been assigned to the government of
the United States of America. The
prospective exclusive license territory
may be worldwide and the field of use
may be limited to the development and
commercialization of CD70 chimeric
antigen receptor (CAR)-based
autologous peripheral blood T cell
VerDate Sep<11>2014
20:03 Apr 21, 2016
Jkt 238001
therapy products as set forth in the
Licensed Patent Rights for the treatment
of chronic myelogenous leukemia in
humans.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
Center at the National Cancer Institute
on or before May 9, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Andrew Burke, Ph.D., Licensing and
Patenting Manager, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, MSC 9702,
Rockville, MD 20852; Telephone: (240)
276–5484; Email: andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION: The
present invention describes chimeric
antigen receptors (CARs) targeting
CD70. CARs are hybrid proteins
comprised of extracellular antigen
binding domains and intracellular
signaling domains designed to activate
the cytotoxic functions of CARtransduced T cells upon antigen
stimulation.
CD70 is a co-stimulatory molecule
that provides proliferative and survival
cues to competent cells upon binding to
its cognate receptor, CD27. Its
expression is primarily restricted to
activated lymphoid cells; however,
recent research has demonstrated that
several cancers, including renal cell
carcinoma, glioblastoma, non-Hodgkin’s
lymphoma, and chronic myelogenous
leukemia also express CD70 under
certain circumstances. Due to its limited
expression in normal tissues, CARs
targeting CD70 may be useful in
adoptive cell therapy protocols for the
treatment of select cancers.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NCI receives written evidence and
PO 00000
Frm 00064
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Sfmt 4703
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Complete applications for a license in
an appropriate field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: April 18, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2016–09324 Filed 4–21–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Diseases
Among Men and Women in Agriculture
(NIEHS)
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 November 27,
2015, Pages 74115–74116, and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute of Environmental
Health Sciences (NIEHS), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
SUMMARY:
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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, 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 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
----------------------------------------------------------------------------------------------------------------
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...................................
----------------------------------------------------------------------------------------------------------------
* 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 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).................... 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...................................
----------------------------------------------------------------------------------------------------------------
* 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 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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
(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
