National Heart, Lung, and Blood Institute; Notice of Meeting, 69866-69867 [2014-27671]
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69866
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
National Institutes of Health
Prospective Grant of Exclusive
License: Development of Autologous
Tumor Infiltrating Lymphocyte
Adoptive Cells for the Treatment of
Metastatic Melanoma
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1. U.S. Provisional Patent Application No.
61/237,889, filed August 26, 2009 entitled
‘‘Adoptive cell therapy with young T cells’’
(HHS Ref No. E–273–2009/0–US–01);
2. U.S. Patent No. 8,383,099 issued
February 26, 2013 entitled ‘‘Adoptive cell
therapy with young T cells’’ (HHS Ref No. E–
273–2009/0–US–02);
3. U.S. Patent Application No. 13/742,541
filed January 16, 2013 entitled ‘‘Adoptive cell
therapy with young T cells’’ (HHS Ref No. E–
273–2009/0–US–03);
4. U.S. Provisional Patent Application No.
61/466,200 filed March 22, 2011 entitled
‘‘Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers’’
(HHS Ref No. E–114–2011/0–US–01);
5. PCT Application No. PCT/US2012/
029744 filed March 20, 2012 entitled
‘‘Methods of growing tumor infiltrating
lymphocytes in gas-permeable containers’’
(HHS Ref No. E–114–2011/0–US–01);
6. U.S. Patent Application No. 13/424,646
filed May 20, 2012 entitled ‘‘Methods of
growing tumor infiltrating lymphocytes in
gas-permeable containers’’ (HHS Ref No. E–
114–2011/0–US–01);
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 use
of the Licensed Patent Rights to
develop, manufacture, distribute, sell
and use autologous tumor infiltrating
lymphocyte adoptive cell therapy
products for the treatment of metastatic
melanoma as a stand-alone therapy.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
December 24, 2014 will be considered.
20:32 Nov 21, 2014
Isolating
cells from the tumor infiltrating
lymphocytes (TIL) of a patient tumor
sample provides a suitable initial
lymphocyte culture for further in vitro
manipulations. NIH scientists have
discovered that taking the isolated cells
through one cycle of rapid expansion
(including exposure to IL–2), rather than
multiple cycles, yields lymphocyte
cultures with higher affinity and longer
persistence in patients. In addition, they
have found that through the use of gas
permeable (GP) flasks, they could obtain
large quantities of highly reactive TIL
from patient tumor samples for anticancer immunotherapy. If an adoptive T
cell transfer immunotherapy is to gain
regulatory approval and successfully
treat a wide array of patients, it will
need to be rapid, reliable, and
technically simple. One of the most
critical factors to this approach is the
generation of effective lymphocyte
cultures that will rapidly and repeatedly
attack the target cells when infused into
patients.
The prospective exclusive license
may be granted unless within thirty (30)
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 with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
Complete 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 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.
SUPPLEMENTARY INFORMATION:
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
an exclusive patent license to the
current licensee, Lion Biotechnologies,
Inc., which is located in Woodland
Hills, California to practice the
inventions embodied in the following
patent applications and applications
claiming priority to these applications:
SUMMARY:
VerDate Sep<11>2014
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Whitney A. Hastings,
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) 451–7337; Facsimile: (301) 402–
0220; Email: hastingw@mail.nih.gov.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Dated: November 17, 2014.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel
Production, Analysis, and Distribution of
Cannabis and Related Materials (7793).
Date: December 2, 2014.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Scientific
Review Officer, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.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.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: November 18, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–27669 Filed 11–21–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
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Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Heart, Lung, and Blood
Advisory Council.
The meeting will be open to the
public as indicated below, 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.
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 Heart, Lung,
and Blood Advisory Council.
Date: February 10, 2015.
Open: 8:00 a.m. to 1:00 p.m.
Agenda: To discuss program policies and
issues, including the NHLBI Advisory
Council Asthma Expert Working Group’s
report on Asthma Guidelines Needs
Assessment. The Working Group’s draft
report can be found at https://
www.nhlbi.nih.gov/health/resources/lung/
nhlbac-asthma-report.htm and comments
may be submitted to Asthma_Needs_
Assessment_Comments@nhlbi.nih.gov by
January 5, 2015.
Place: National Institutes of Health,
Building 31, 6th Floor, C Wing, 31 Center
Drive, Bethesda, MD 20892.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 6th Floor, C Wing, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, Ph.D.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260, mockrins@
nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
VerDate Sep<11>2014
20:32 Nov 21, 2014
Jkt 235001
www.nhlbi.nih.gov/meetings/nhlbac/
index.htm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 18, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–27671 Filed 11–21–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; 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 NIH
Scientific Management Review Board
(SMRB). On December 15, 2014, the
SMRB will deliberate findings and
recommendations developed by the
SMRB Working Group on Pre-college
Engagement in Biomedical Science. The
Working Group has considered
approaches to optimize NIH’s precollege programs and initiatives that
both align with the NIH mission and
ensure a continued pipeline of
biomedical science students and
professionals. SMRB members will also
discuss preliminary findings and
recommendations for streamlining
NIH’s grant review, award, and
management process while maintaining
proper oversight. Panel discussions will
be held with grantees and other
stakeholders.
The NIH Reform Act of 2006 (Pub. L.
109–482) provides organizational
authorities to HHS and NIH officials to:
(1) Establish or abolish national research
institutes; (2) reorganize the offices
within the Office of the Director, NIH
including adding, removing, or
transferring the functions of such offices
or establishing or terminating such
offices; and (3) reorganize, divisions,
centers, or other administrative units
within an NIH national research
institute or national center including
adding, removing, or transferring the
functions of such units, or establishing
or terminating such units. The purpose
of the SMRB is to advise appropriate
HHS and NIH officials on the use of
these organizational authorities and
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69867
identify the reasons underlying the
recommendations.
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. Times are
subject to change.
Name of Committee: Scientific
Management Review Board (SMRB).
Date: December 15, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: At this meeting, SMRB members
will deliberate findings and
recommendations developed by the Working
Group on Pre-college Engagement in
Biomedical Science. The Working Group on
the NIH Grant Review, Award, and
Management Process will report their
preliminary findings and recommendations
on ways to streamline the process, and
grantees and other stakeholders will share
insights regarding the effectiveness and
feasibility of the recommendations. Time will
be allotted on the agenda for public
comment. Sign up for public comments will
begin approximately at 8:00 a.m. on
December 15, 2014, and will be restricted to
one sign-in per person. In the event that time
does not allow for all those interested to
present oral comments, any interested person
may file written comments with the
committee by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name, address,
telephone number, and when applicable, the
business or professional affiliation of the
interested person.
Place: National Institutes of Health,
Building 31, 6th Floor, Conference Room 6,
31 Center Drive, Bethesda, MD 20892.
Contact Person: Juanita Marner, Office of
Science Policy, Office of the Director, NIH,
National Institutes of Health, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892, smrb@
mail.nih.gov, (301) 435–1770.
The meeting will also be webcast. The draft
meeting agenda and other information about
the SMRB, including information about
access to the webcast, will be available at
https://smrb.od.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxis, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
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Agencies
[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69866-69867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27671]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
[[Page 69867]]
National Heart, Lung, and Blood Advisory Council.
The meeting will be open to the public as indicated below, 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.
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 Heart, Lung, and Blood Advisory
Council.
Date: February 10, 2015.
Open: 8:00 a.m. to 1:00 p.m.
Agenda: To discuss program policies and issues, including the
NHLBI Advisory Council Asthma Expert Working Group's report on
Asthma Guidelines Needs Assessment. The Working Group's draft report
can be found at https://www.nhlbi.nih.gov/health/resources/lung/nhlbac-asthma-report.htm and comments may be submitted to
Asthma_Needs_Assessment_Comments@nhlbi.nih.gov by January 5, 2015.
Place: National Institutes of Health, Building 31, 6th Floor, C
Wing, 31 Center Drive, Bethesda, MD 20892.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 6th Floor, C
Wing, 31 Center Drive, Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, Ph.D., Director, Division of
Extramural Research Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701 Rockledge Drive, Room
7100, Bethesda, MD 20892, (301) 435-0260, mockrins@nhlbi.nih.gov.
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
Information is also available on the Institute's/Center's home
page: www.nhlbi.nih.gov/meetings/nhlbac/index.htm, where an agenda
and any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: November 18, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-27671 Filed 11-21-14; 8:45 am]
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