Proposed Collection; 60-Day Comment Request; The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), 16345-16347 [2014-06401]
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Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices
Silver Spring, MD 20993–0002, or Office
of Communication, Outreach, and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ann
Marie Trentacosti, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6485,
Silver Spring, MD 20993–0002, 301–
796–2901; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852, 301–
827–6210.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Labeling for Human Prescription Drug
and Biological Products Approved
Under the Accelerated Approval
Regulatory Pathway.’’ Labeling must
conform to the content and format
requirements delineated in §§ 201.56(d)
and 201.57 (21 CFR 201.56(d) and
201.57). Special provisions exist for
older drug labeling under §§ 201.56(e)
and 201.80. Labeling for drugs approved
under the accelerated approval process
is fundamentally the same as for drugs
approved under the traditional pathway;
however, for drugs approved under
accelerated approval there are
additional labeling requirements as
described in § 201.57(c)(2)(i)(B) and
recommended elements for
consideration.
This draft guidance discusses FDA’s
recommendations for developing the
indication and usage statements in the
prescribing information for drugs
approved under accelerated approval as
defined in 21 CFR part 314, subpart H
(for new drug applications) and 21 CFR
part 601, subpart E (for biologics license
applications) when the approval is
based on an effect on a surrogate
endpoint that is reasonably likely to
predict clinical benefit, or an effect on
a clinical endpoint that can be measured
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earlier than an effect on irreversible
morbidity or mortality, that is
reasonably likely to predict an effect on
irreversible morbidity or mortality or
other clinical benefit. The guidance also
discusses labeling considerations for
indications approved under accelerated
approval when clinical benefit has been
verified and FDA terminates the
conditions of accelerated approval
under 21 CFR 314.560 or 21 CFR 601.46,
or when FDA withdraws accelerated
approval of an indication while other
indications for the drug remain
approved.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on labeling for human prescription drug
and biologic products approved under
accelerated approval. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in §§ 201.56 and 201.57
have been approved under OMB control
number 0910–0572.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/biologicsbloodVaccines/
GuidanceComplianceRegulatory
Information/guidances/default.htm, or
https://www.regulations.gov.
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16345
Dated: March 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–06471 Filed 3–24–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; The Hispanic Community
Health Study/Study of Latinos (HCHS/
SOL)
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), 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 obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. Larissa AvilesSanta, 6701 Rockledge, Epidemiology
Branch, Program in Prevention and
Population Sciences, Division of
Cardiovascular Sciences, National
Heart, Lung, and Blood Institute,
National Institutes of Health, 6701
Rockledge Dr., MSC 7936, Bethesda, MD
20892–7936, or call non-toll-free
number 301–435–0450, or Email your
request, including your address to
avilessantal@nhlbi.nih.gov. Formal
requests for additional plans and
SUMMARY:
E:\FR\FM\25MRN1.SGM
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16346
Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices
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: The Hispanic
Community Health Study/Study of
Latinos (HCHS/SOL), Revised, National
Heart, Lung and Blood Institute
(NHLBI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose and use of the
information collection for this project is
to study the prevalence of
cardiovascular and pulmonary disease
and other chronic diseases, and their
physiological and biochemical
measurements including DNA/RNA
extraction for ancillary genetic research
studies.
2. Follow-up of the cohort, which
consists of an annual telephone
interview to assess vital status, changes
in health status and medication intake,
and new cardiovascular and pulmonary
events (including fatal and non-fatal
myocardial infarction and heart failure;
fatal and non-fatal stroke; and
exacerbation of asthma and chronic
obstructive pulmonary disease).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
30,940.
risk and protective factors, understand
their relationship to all-cause,
cardiovascular and pulmonary
morbidity and mortality, and
understand the role of sociocultural
factors (including acculturation) on the
prevalence or onset of disease among
over 16,400 Hispanics/Latinos of
diverse origins, aged 18–74 years at
enrollment, living in four U.S.
communities: San Diego, California;
Chicago, Illinois; Miami, Florida, and
the Bronx, New York. In order to
achieve these objectives, the HCHS/SOL
had two integrated components:
1. Examination of the cohort
following a standardized protocol,
which consisted of interviews and
clinical measurements to assess
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total burden
hours
Type of respondents
Survey instrument
Participants Visit 2 Examination (Appendix 15).
Pre-visit scheduling & safety screening .......
13,878
1
2/60
463
Reception, informed consent, medical releases.
Ppt. safety update and routing .....................
Change clothes, urine specimen .................
Updated personal information ......................
Anthropometry ..............................................
Determination of fasting & blood draw ........
Determination of blood glucose, OGTT .......
Seated BP ....................................................
Echocardiography ........................................
2-hour blood draw, snack ............................
Personal Medical History .............................
Reproductive Medical History ......................
Pregnancy Complications History ................
Socio-economic Status—Occupation ...........
Health Care Access and Utilization .............
Chronic Stress ..............................................
Family Cohesion ..........................................
Social Support ..............................................
Acculturation .................................................
Well Being ....................................................
Abbreviated Medication Use ........................
Tobacco Use ................................................
Alcohol Use ..................................................
Participant Feedback ...................................
13,878
1
20/60
4,626
13,878
13,878
13,878
13,878
13,878
13,878
13,878
8,000
13,878
13,878
9,000
9,000
13,878
13,878
13,878
13,878
13,878
13,878
13,878
13,878
13,878
13,878
13,878
1
1
1
1
1
1
........................
........................
........................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2/60
10/60
5/60
7/60
11/60
6/60
9/60
30/60
12/60
10/60
9/60
4/60
3/60
15/60
4/60
5/60
3/60
3/60
4/60
4/60
4/60
3/60
12/60
463
2,313
1,157
1,619
2,544
1,388
2,082
4,000
2,776
2,313
1,350
600
694
3,470
925
1,157
694
694
463
925
925
694
2,776
.......................................................................
AFU Year 3 ..................................................
........................
3,146
........................
1
197/60
15/60
41,111
787
4 ..................................................
5 ..................................................
6 ..................................................
7 ..................................................
8 ..................................................
9 ..................................................
10 ................................................
11 ................................................
9,033
14,259
16,222
16,222
16,222
16,222
16,222
16,222
1
1
1
1
1
1
1
1
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
2,258
3,565
4,055
4,055
4,055
4,055
4,055
4,055
.......................................................................
........................
........................
120/60
30,940
emcdonald on DSK67QTVN1PROD with NOTICES
Total ...............................
Participants Annual FollowUp Interview.
(Appendix 16) ........................
AFU
AFU
AFU
AFU
AFU
AFU
AFU
AFU
Total ...............................
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18:16 Mar 24, 2014
Year
Year
Year
Year
Year
Year
Year
Year
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25MRN1
Federal Register / Vol. 79, No. 57 / Tuesday, March 25, 2014 / Notices
micro-dissection of biological specimens, as
covered by the Licensed Patent Right.
Excluded from the exclusive field of use are
(1) methods, kits, and related consumables
that are used independent of the devices or
systems by individual researchers employed
at non-profit and academic institutions, if
such kits were built by the researchers
themselves from component parts and used
for their own individual research purposes,
and (2) diagnostic services performed using
devices, systems, kits and related
consumables purchased from Ventana or
Ventana’s authorized distributor(s) by those
persons employed at non-profit and
academic institutions that purchased the
devices, systems, kits and related
consumables used in the diagnostic services,
shall not infringe Ventana’s rights.
Dated: March 11, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.
Dated: March 11, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–06401 Filed 3–24–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive
License: Device and System for
Expression Microdissection (xMD)
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 Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of a
co-exclusive commercial license
agreement to practice the inventions
embodied in International PCT
Application S/N PCT/US03/23317 (HHS
Ref. No. E–113–2003/0–PCT–02) filed
July 23, 2003, which published as WO
2004/068104 on August 12, 2004, now
expired; U.S. Patent No. 7,709,047 (HHS
Ref. No. E–113–2003/0–US–03) issued
May 4, 2010; U.S. Patent Application S/
N 12/753,566 (HHS Ref. No. E–113–
2003/0–US–07) filed April 2, 2010; U.S.
Patent No. 7,695,752 (HHS Ref. No. E–
113–2003/1–US–01) issued April 13,
2010; U.S. Patent No. 8,460,744 (HHS
Ref. No. E–113–2003/1–US–02) issued
June 11, 2013; Australian Patent No.
2003256803 (HHS Ref. No. E–113–2003/
0–AU–04) issued January 21, 2010;
Australian Patent No. 2009250964 (HHS
Ref. No. E–113–2003/0–AU–06) issued
March 25, 2013; and Canadian Patent
No. 2513646 (HHS Ref. No. E–113–
2003/0–CA–05) issued September 17,
2013, all entitled; ‘‘Target Activated
Microtransfer’’; and all continuing
applications and foreign counterparts to
Ventana Medical Systems, Inc. a
company having a place of business in
Arizona. The patent rights in these
inventions have been assigned to the
Government of the United States of
America.
The prospective co-exclusive license
territory may be ‘‘worldwide,’’ and the
field of use may be limited to the
following:
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
Devices, systems, kits and related
consumables, and methods using device,
systems, kits and related consumables, for
VerDate Mar<15>2010
18:16 Mar 24, 2014
Jkt 232001
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
9, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated co-exclusive license
should be directed to: Kevin W. Chang,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5018; Facsimile: (301) 402–
0220; Email: changke@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
subject technologies are methods,
devices, and kits for target activated
transfer of a target from a biological
sample such as a tissue section,
comprising: Contacting the biological
sample with a reagent that selectively
acts on the target within the biological
sample; placing a transfer surface
adjacent the biological sample, wherein
the reagent produces a change in the
transfer surface by heating the target;
heating the target to produce a change
in the transfer surface and selectively
adhere the target to the transfer surface,
or to selectively increase permeability of
the transfer surface to the target; and
selectively removing the target from the
biological sample by removing the
transfer surface and the adhered target
from the biological sample, or by
moving the target through the transfer
surface.
The prospective co-exclusive
commercial 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 coexclusive commercial license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
DATES:
PO 00000
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Fmt 4703
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16347
with the requirements of 35 U.S.C. 209
and 37 CFR Part 404.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated co-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: March 19, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–06413 Filed 3–24–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of T Cell
Receptors for Adoptive Transfer in
Humans to Treat Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Kite
Pharma, Inc., which is located in Los
Angeles, California to practice the
inventions embodied in the following
patent applications:
1. U.S. Provisional Patent Application
No. 61/650,020 filed May 22, 2012
entitled ‘‘Murine anti-NY–ESO–1 T
cell receptors’’ (HHS Ref No. E–
105–2012/0–US–01) and
2. PCT Application No. PCT/US13/
042162 filed May 22, 2013 entitled
‘‘Murine anti-NY–ESO–1 T cell
receptors’’ (HHS Ref No. E–105–
2012/0–PCT–02)
The patent rights in these inventions
have been assigned to the United States
of America. The prospective exclusive
license territory may be worldwide and
the field of use may be limited to the
development, manufacture, distribution,
sale, and use of the compositions and
methods set forth in the Licensed Patent
Rights using genetically engineered
autologous T lymphocytes derived from
the peripheral blood of humans for the
treatment of NY–ESO–1-expressing
cancers.
SUMMARY:
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Notices]
[Pages 16345-16347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06401]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; The Hispanic
Community Health Study/Study of Latinos (HCHS/SOL)
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), 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 obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Dr.
Larissa Aviles-Santa, 6701 Rockledge, Epidemiology Branch, Program in
Prevention and Population Sciences, Division of Cardiovascular
Sciences, National Heart, Lung, and Blood Institute, National
Institutes of Health, 6701 Rockledge Dr., MSC 7936, Bethesda, MD 20892-
7936, or call non-toll-free number 301-435-0450, or Email your request,
including your address to avilessantal@nhlbi.nih.gov. Formal requests
for additional plans and
[[Page 16346]]
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: The Hispanic Community Health Study/Study of
Latinos (HCHS/SOL), Revised, National Heart, Lung and Blood Institute
(NHLBI), National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose and use of the
information collection for this project is to study the prevalence of
cardiovascular and pulmonary disease and other chronic diseases, and
their risk and protective factors, understand their relationship to
all-cause, cardiovascular and pulmonary morbidity and mortality, and
understand the role of sociocultural factors (including acculturation)
on the prevalence or onset of disease among over 16,400 Hispanics/
Latinos of diverse origins, aged 18-74 years at enrollment, living in
four U.S. communities: San Diego, California; Chicago, Illinois; Miami,
Florida, and the Bronx, New York. In order to achieve these objectives,
the HCHS/SOL had two integrated components:
1. Examination of the cohort following a standardized protocol,
which consisted of interviews and clinical measurements to assess
physiological and biochemical measurements including DNA/RNA extraction
for ancillary genetic research studies.
2. Follow-up of the cohort, which consists of an annual telephone
interview to assess vital status, changes in health status and
medication intake, and new cardiovascular and pulmonary events
(including fatal and non-fatal myocardial infarction and heart failure;
fatal and non-fatal stroke; and exacerbation of asthma and chronic
obstructive pulmonary disease).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 30,940.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Survey Number of responses per per response Total burden
instrument respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Participants Visit 2 Pre-visit 13,878 1 2/60 463
Examination (Appendix 15). scheduling &
safety
screening.
Reception, 13,878 1 20/60 4,626
informed
consent,
medical
releases.
Ppt. safety 13,878 1 2/60 463
update and
routing.
Change clothes, 13,878 1 10/60 2,313
urine specimen.
Updated personal 13,878 1 5/60 1,157
information.
Anthropometry... 13,878 1 7/60 1,619
Determination of 13,878 1 11/60 2,544
fasting & blood
draw.
Determination of 13,878 1 6/60 1,388
blood glucose,
OGTT.
Seated BP....... 13,878 .............. 9/60 2,082
Echocardiography 8,000 .............. 30/60 4,000
2-hour blood 13,878 .............. 12/60 2,776
draw, snack.
Personal Medical 13,878 1 10/60 2,313
History.
Reproductive 9,000 1 9/60 1,350
Medical History.
Pregnancy 9,000 1 4/60 600
Complications
History.
Socio-economic 13,878 1 3/60 694
Status--Occupat
ion.
Health Care 13,878 1 15/60 3,470
Access and
Utilization.
Chronic Stress.. 13,878 1 4/60 925
Family Cohesion. 13,878 1 5/60 1,157
Social Support.. 13,878 1 3/60 694
Acculturation... 13,878 1 3/60 694
Well Being...... 13,878 1 4/60 463
Abbreviated 13,878 1 4/60 925
Medication Use.
Tobacco Use..... 13,878 1 4/60 925
Alcohol Use..... 13,878 1 3/60 694
Participant 13,878 1 12/60 2,776
Feedback.
---------------------------------------------------------------
Total..................... ................ .............. .............. 197/60 41,111
Participants Annual Follow-Up AFU Year 3...... 3,146 1 15/60 787
Interview.
(Appendix 16).................
AFU Year 4...... 9,033 1 15/60 2,258
AFU Year 5...... 14,259 1 15/60 3,565
AFU Year 6...... 16,222 1 15/60 4,055
AFU Year 7...... 16,222 1 15/60 4,055
AFU Year 8...... 16,222 1 15/60 4,055
AFU Year 9...... 16,222 1 15/60 4,055
AFU Year 10..... 16,222 1 15/60 4,055
AFU Year 11..... 16,222 1 15/60 4,055
---------------------------------------------------------------
Total..................... ................ .............. .............. 120/60 30,940
----------------------------------------------------------------------------------------------------------------
[[Page 16347]]
Dated: March 11, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.
Dated: March 11, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-06401 Filed 3-24-14; 8:45 am]
BILLING CODE 4140-01-P
