Office of the Director, National Institutes of Health; Notice of Meetings, 68467-68468 [2019-27004]
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Human Monoclonal Antibodies To The
Same Epitope Of An Unknown Cell
Surface Antigen Expressed In B-cell
Lymphocytic Leukemia (B–CLL)’’ [HHS
Ref. E–163–2009–0–US–01], PCT Patent
Application PCT/US2010/034491
entitled ‘‘B-cell Surface Reactive
Antibodies’’ [HHS Ref. E–163–2009–0–
PCT–02], and United States Patent
8,877,199, entitled ‘‘B-cell Surface
Reactive Antibodies’’ [HHS Ref. E–163–
2009–0–US–03].
The patent rights in these inventions
have been assigned and/or exclusively
licensed 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, production, and
commercialization of a Siglec-6-specific
chimeric antigen receptor (CAR) based
immunotherapy using autologous
(meaning one individual is both the
donor and recipient) T cells modified by
virus-free Sleeping Beauty (SB)-based
gene transposition compromising of at
least:
a. A single antigen specificity; and
b. comprising at least:
i. The complementary determining
region (CDR) sequences of the Siglec-6
antibody known as JML–1, and
ii. a CD3z activation module and
either a CD28 or a 4–1BB co-stimulation
moiety.
for the treatment of acute myeloid
leukemia (AML), chronic lymphocytic
leukemia (CLL), and other forms of
acute and chronic B- and T-cell
leukemia and lymphoma.
The licensed field of use excludes any
(a) non-specified immunoconjugates,
including, but not limited to, antibody
drug conjugates and immunotoxins and
(b) unconjugated antibodies.
This technology discloses monoclonal
antibodies that are specific for the cell
surface domain of Siglec-6. The
antibodies can potentially be used for
the treatment of acute myeloid leukemia
(AML), chronic lymphocytic leukemia
(CLL), and other forms of acute and
chronic B-and T-cell leukemia and
lymphoma cells. In the subject situation,
the antibodies can be used in a CAR,
leading to the selective destruction of
the cancerous cells.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute receives written
evidence and argument that establishes
that the grant of the license would not
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be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: December 5, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–27002 Filed 12–13–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
meetings of the Council of Councils.
The meetings 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 open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov).
A portion of the meetings 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: Council of Councils.
Open: January 24, 2020.
Time: 8:15 a.m. to 12:10 p.m.
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Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Closed: January 24, 2020.
Time: 12:10 p.m. to 1:10 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Open: January 24, 2020.
Time: 1:10 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program
Updates.
Place: National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35 Convent
Drive, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov, 301–435–
0744.
Name of Committee: Council of Councils.
Open: May 15, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Closed: May 15, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Open: May 15, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program
Updates.
Place: National Institutes of Health, 6001
Executive Boulevard, Neuroscience Center,
Room C, E, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov, 301–435–
0744.
Name of Committee: Council of Councils.
Open: September 11, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks; NIH Program Updates.
Place: National Institutes of Health,
Natcher Building, Building 45, Room D, C1/
C2 and G1/G2, 45 Center Drive, Bethesda,
MD 20892.
Closed: September 11, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health,
Natcher Building, Building 45, Room D, C1/
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
C2 and G1/G2, 45 Center Drive, Bethesda,
MD 20892.
Open: September 11, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program
Updates.
Place: National Institutes of Health,
Natcher Building, Building 45, Room D, C1/
C2 and G1/G2, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov, 301–435–
0744.
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
Council of Council’s home page at https://
dpcpsi.nih.gov/council/ where an agenda
will be posted before the meeting date.
(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
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: December 10, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–27004 Filed 12–13–19; 8:45 am]
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Coast Guard
[Docket No. USCG–2019–0753]
Collection of Information Under
Review by Office of Management and
Budget; OMB Control Number: 1625–
NEW
Coast Guard, DHS.
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In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting approval for the
following collection of information:
1625–NEW, Merchant Mariner
Credentialing—Job Task Analysis. Our
ICR describe the information we seek to
collect from the public. Review and
comments by OIRA ensure we only
impose paperwork burdens
commensurate with our performance of
duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before January
15, 2020.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2019–0753] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
Alternatively, you may submit
comments to OIRA using one of the
following means:
(1) Email: OIRA-submission@
omb.eop.gov.
(2) Mail: OIRA, 725 17th Street NW,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
(3) Fax: 202–395–6566. To ensure
your comments are received in a timely
manner, mark the fax, attention Desk
Officer for the Coast Guard.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–612), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, Stop
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: Mr.
Anthony Smith, Office of Information
Management, telephone 202–475–3532,
or fax 202–372–8413, for questions on
these documents.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Public Participation and Request for
Comments
DEPARTMENT OF HOMELAND
SECURITY
AGENCY:
Thirty-Day notice requesting
comments.
ACTION:
This Notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. chapter 35, as amended. An
ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
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other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology. Consistent with
the requirements of Executive Order
13771, Reducing Regulation and
Controlling Regulatory Costs, and
Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast
Guard is also requesting comments on
the extent to which this request for
information could be modified to reduce
the burden on respondents. These
comments will help OIRA determine
whether to approve the ICR referred to
in this Notice.
We encourage you to respond to this
request by submitting comments and
related materials. Comments to Coast
Guard or OIRA must contain the OMB
Control Number of the ICR. They must
also contain the docket number of this
request, [USCG–2019–0753], and must
be received by January 15, 2020.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
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[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68467-68468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27004]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, National Institutes of Health; Notice of
Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the meetings of the Council of
Councils.
The meetings 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 open session will be
videocast and can be accessed from the NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
A portion of the meetings 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: Council of Councils.
Open: January 24, 2020.
Time: 8:15 a.m. to 12:10 p.m.
Agenda: Call to Order and Introductions; Announcements and
Updates; Scientific Talks; NIH Program Updates.
Place: National Institutes of Health, John E. Porter
Neuroscience Research Center, Building 35A, Rooms 620/630, 35
Convent Drive, Bethesda, MD 20892.
Closed: January 24, 2020.
Time: 12:10 p.m. to 1:10 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, John E. Porter
Neuroscience Research Center, Building 35A, Rooms 620/630, 35
Convent Drive, Bethesda, MD 20892.
Open: January 24, 2020.
Time: 1:10 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program Updates.
Place: National Institutes of Health, John E. Porter
Neuroscience Research Center, Building 35A, Rooms 620/630, 35
Convent Drive, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive
Secretary, Council of Councils Director, Office of Research
Infrastructure Programs, Division of Program Coordination, Planning,
and Strategic Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda, MD 20892,
[email protected], 301-435-0744.
Name of Committee: Council of Councils.
Open: May 15, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions; Announcements and
Updates; Scientific Talks; NIH Program Updates.
Place: National Institutes of Health, 6001 Executive Boulevard,
Neuroscience Center, Room C, E, Bethesda, MD 20892.
Closed: May 15, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, 6001 Executive Boulevard,
Neuroscience Center, Room C, E, Bethesda, MD 20892.
Open: May 15, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program Updates.
Place: National Institutes of Health, 6001 Executive Boulevard,
Neuroscience Center, Room C, E, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive
Secretary, Council of Councils Director, Office of Research
Infrastructure Programs, Division of Program Coordination, Planning,
and Strategic Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda, MD 20892,
[email protected], 301-435-0744.
Name of Committee: Council of Councils.
Open: September 11, 2020.
Time: 8:15 a.m. to 12:00 p.m.
Agenda: Call to Order and Introductions; Announcements and
Updates; Scientific Talks; NIH Program Updates.
Place: National Institutes of Health, Natcher Building, Building
45, Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
Closed: September 11, 2020.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health, Natcher Building, Building
45, Room D, C1/
[[Page 68468]]
C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
Open: September 11, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: Scientific Talks and NIH Program Updates.
Place: National Institutes of Health, Natcher Building, Building
45, Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive
Secretary, Council of Councils Director, Office of Research
Infrastructure Programs, Division of Program Coordination, Planning,
and Strategic Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda, MD 20892,
[email protected], 301-435-0744.
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 Council of Council's home
page at https://dpcpsi.nih.gov/council/ where an agenda will be
posted before the meeting date.
(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 Scholarship Program for Individuals from Disadvantaged
Backgrounds, National Institutes of Health, HHS)
Dated: December 10, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-27004 Filed 12-13-19; 8:45 am]
BILLING CODE 4140-01-P