30-day FRN

15364

Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices

sradovich on DSK3GMQ082PROD with NOTICES

arteries in a majority of humans. As a
result, pressure applied by any
prosthetic device in the coronary sinus
(such as tension on the annuloplasty
device) can compress the underlying
coronary artery and induce myocardial
ischemia or infarction. This invention
pertains to devices and methods that
avoid constricting coronary artery
branches during coronary sinus-based
annuloplasty. These devices and
methods protect coronary artery
branches from constriction during transsinus mitral annuloplasty. The device
protects a coronary vessel from
compression during mitral annuloplasty
by extending an annuloplasty element,
such as a tensioning device, at least
partially through the coronary sinus
over a coronary artery. The device is a
surgically sterile bridge configured for
placement within the coronary sinus at
a location where the coronary sinus
passes over a coronary artery, so that the
protection device provides a support for
a mitral annuloplasty element, such as
a compressive prosthesis, including a
tension element when it is placed under
tension. The protection device has an
arch of sufficient rigidity and
dimensions to support the tensioning
element over the coronary artery,
redistribute tension away from an
underlying coronary artery, and inhibit
application of pressure to the
underlying artery, for example when an
annuloplasty tension element is placed
under tension during mitral
annuloplasty. In particular, the
protective device can be a support
interposed in the coronary sinus
between the annuloplasty device and
the coronary artery. The device may be
substantially tubular so that the
tensioning element is contained within
the protective device and supported in
spaced relationship to the coronary
artery. An arch may be configured to
extend between a proximal end and a
distal end that are substantially
collinear with one another so that the
ends form stabilizing members such as
feet that retain the bridge in position
over the coronary artery.
E–249–2009/3
Another embodiment of the cerclage
protection device is a combination with
a cerclage tension element that can be
used to facilitate transcatheter mitral
valve implantation. The transcatheter
strategy includes a ‘‘valve-in-ring’’
wherein a cerclage annuloplasty is first
performed. During the same session or
during a separate procedure, a
transcatheter mitral valve implantation
could be performed that would take
advantage of the cerclage annuloplasty
system to serve as a visual and a

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mechanical ‘‘landing zone’’ for mitral
valve implantation. A cerclage
annuloplasty ring would allow outward
expansion of the mitral valve to achieve
fixation. However, without the cerclage
protection device in place, such a
strategy would cause compression of an
entrapped coronary artery. This new
embodiment of the protection device
protects coronary arteries not from
extrinsic compression but from ‘‘insideout’’ compression, thereby allowing
cerclage to be the first step for
transcatheter mitral valve implantation.
It also allows the latter to be employed
as second-stage adjunct or bailout for
inadequate cerclage mitral valve
annuoplasty.
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 404.7. The prospective
exclusive license may be granted unless,
within fifteen (15) days from the date of
this published notice, NIH receives
written evidence and 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 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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 17, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2017–06036 Filed 3–27–17; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Early Career
Reviewer Program Application and
Vetting System (EAVS) (Center for
Scientific Review)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management

SUMMARY:

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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
December 29, 2016, page 96020 (Vol. 81,
No. 250) 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.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: 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,
[email protected] or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Mary Ann
Guadagno, Project Clearance Liaison,
Center for Scientific Review, NIH, Room
3182, 6701 Rockledge Drive, Bethesda,
MD 20892 or call non-toll-free number
(301) 435–1251 or Email your request,
including your address to: guadagma@
csr.nih.gov.
SUPPLEMENTARY INFORMATION: The
Center for Scientific Review (CSR),
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.
In compliance with 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.
Proposed Collection: Early Career
Reviewer Program Application and
Vetting System (EAVS) OMB #0925–
0695, Expiration Date: 04/30/2017,
Extension, Center for Scientific Review
(CSR), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The Center for Scientific
Review (CSR) is the portal for NIH grant
applications and their review for
scientific merit. Our mission is to see
that NIH grant applications receive fair,

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15365

Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
independent, expert, and timely
reviews—free from inappropriate
influences—so NIH can fund the most
promising research. To accomplish this
goal, Scientific Review Officers (SRO)
form study sections consisting of
scientists who have the technical and
scientific expertise to evaluate the merit
of grant applications. Study section
members are generally scientists who
have established independent programs
of research as demonstrated by their
publications and their grant award
experiences.

provide their names, contact
information, a description of their areas
of expertise, their study section
preferences, professional Curriculum
Vitae and links to their professional
Web site. This Information Collection
Request (ICR) is to extend the Early
Career Reviewer Application and
Vetting System to process applications
for the Early Career Reviewer program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
450.

The CSR Early Career Reviewer
program was developed to identify and
train qualified scientists who are early
in their scientific careers and who have
not had prior CSR review experience.
The goals of the program are to expose
these early career scientists to the peer
review experience so that they become
more competitive as applicants as well
as to enrich the existing pool of NIH
reviewers. Currently, online application
software, the Early Career Reviewer
Application and Vetting System, is
accessed online by applicants to the
Early Career Reviewer Program who

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total annual
burden hour

Type of respondent

A ........................................................

Applicants .........................................

1080

1

25/60

450

Totals .........................................

...........................................................

........................

1080

........................

450

Dated: March 20, 2017.
Mary Ann Guadagno,
Project Clearance Liaison, Center for
Scientific Review (CSR), National Institutes
of Health.
[FR Doc. 2017–06116 Filed 3–27–17; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Board on Medical
Rehabilitation Research.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
sradovich on DSK3GMQ082PROD with NOTICES

Number of
respondents

Form name

Name of Committee: National Advisory
Board on Medical Rehabilitation Research.
Date: May 1–2, 2017.
Time: May 1, 2017, 9:00 a.m. to 5:00 p.m.
Agenda: NICHD Director’s report; NIH
Research Plan on Rehabilitation Annual
Report; Clinical trials; Update on the NIH
Cures Act; Training Efforts to Support
Rehabilitation Research; Breakout sessions.

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Place: Bethesda Marriott Suites, Patriot
Ball Room, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Time: May 2, 2017, 8:30 a.m. to 12:00 p.m.
Agenda: Update on Clinical Trials Policy;
Update on Cerebral Palsy Plan; Update on
StrokeNet; Scientific Presentation on
Neuroplasticity.
Place: Bethesda Marriott Suites, Patriot
Ball Room, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Ralph M. Nitkin, Ph.D.,
Deputy Director, National Center for Medical
Rehabilitation Research (NCMRR), Eunice
Kennedy Shriver National Institute, of Child
Health and Human Development, NIH,
DHHS, 6710B Rockledge Drive, Room 2116,
MSC 7002, Bethesda, MD 20892, (301) 402–
4206, [email protected].
Information is also available on the
Institute’s/Center’s home page: http://
www.nichd.nih.gov/about/advisory/nabmrr/
Pages/index.aspx where the current roster
and minutes from past meetings are posted.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: March 22, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–06044 Filed 3–27–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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 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
Child Health and Human Development
Special Emphasis Panel; Environmental
Aspects of Mexican Migration, 1995–2010.
Date: April 19, 2017.
Time: 2:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6710B
Rockledge Drive Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Minki Chatterji, 6710B
Bethesda Drive, 2221A, Bethesda, MD 20892,
301.806.2515, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;

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