Proposed Collection; 60-Day Comment Request Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director), 33270-33272 [2019-14821]
Download as PDF
<![CDATA[
33270
Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mehrdad Mohseni, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7854, Bethesda, MD 20892, 301–435–
0484, mohsenim@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–AI–
18–057: Long-acting Drug Delivery Systems
for ART Optimization in HIV–1 Infected
Children.
Date: August 9, 2019.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health
Rockledge II 6701 Rockledge Drive Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 8, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–14805 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Allogeneic Therapy
Using Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this notice to Kite Pharma,
Inc. (‘‘Kite’’) located in Santa Monica,
CA.
DATES: Only written comments and/or
complete applications for a license
which are received by the National
Cancer Institute’s Technology Transfer
Center on or before July 29, 2019 will
be considered.
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:55 Jul 11, 2019
Jkt 247001
Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: David A Lambertson, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240)-276–5530;
Facsimile: (240)-276–5504 Email:
david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
United States Provisional Patent
Application No. 62/732,263, filed 17
September 2018 and entitled
‘‘Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20 and
Their Uses’’ [HHS Reference No. E–205–
2018–0–US–01]; and U.S. and foreign
patent applications claiming priority to
the aforementioned application.
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
following:
‘‘The development, production and
commercialization of an anti-CD19 antiCD20 dual targeting chimeric antigen
receptor (CAR)-based immunotherapy
using allogeneic (where the donor and
the recipient are different) immune
cells, wherein the genome editing is
meditated only by zinc-finger nucleases,
and where the CAR has at least:
(1) A dual antigen specificity;
(2) the complementary determining
region (CDR) sequences of the anti-CD19
antibody known as Hu19;
(3) the complementary determining
region (CDR) sequences of the anti-CD20
antibody known as 2.1.2; and
(4) a T cell signaling domain;
for the treatment of B-cell derived
human cancers.’’
This technology discloses the
development of chimeric antigen
receptors that recognize both the CD19
and CD20 cell surface proteins. CD19
and CD20 are expressed on the cell
surface of several hematological
malignancies, including Non-Hodgkins
Lymphoma (NHL), acute lymphoblastic
leukemia (ALL) and chronic
lymphocytic leukemia (CLL). Although
the FDA has recently approved CARbased therapies which target only CD19
(Yescarta, Kymriah), tumors are capable
of undergoing tumor antigen escape (the
downregulation of target antigen
expression on tumor cells), which
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
results in gradual resistance to ‘‘single
target therapies.’’ As a result, patients
receiving single target CAR therapies are
susceptible to relapse. This has
prompted investigators to pursue dual
targeting CAR therapies to provide as a
means of overcoming tumor antigen
escape, thereby providing a more
comprehensive therapeutic alternative.
The development of a new therapeutic
targeting both CD19 and CD20 will
benefit public health by offering up an
improved treatment for patients that
would otherwise be subject to relapse
due to tumor antigen escape.
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
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 completed 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: July 2, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–14822 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Application and Impact of
Clinical Research Training on
Healthcare Professionals in Academia
and Clinical Research (Office of the
Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
SUMMARY:
E:\FR\FM\12JYN1.SGM
12JYN1
33271
Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
Office of Clinical Research (OCR), Office
of the Director (OD), National Institutes
of Health, will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
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. Anne Zajicek, M.D.,
Pharm.D., Deputy Director, Office of
Clinical Research, NIH Office of the
Director, Building 1, Room 208A, MSC–
0155, Bethesda, Maryland 20892 or call
non-toll-free number (301) 480–9913 or
Email your request, including your
address to: zajiceka@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
XX/XXXX, National Institutes of Health
(NIH), Office of the Director (OD).
Need and Use of Information
Collection: The purpose of this survey is
to assess the long-term impact and
outcomes of clinical research training
programs provided by the Office of
Clinical Research located in the NIH
Office of the Director (OD) over a tenyear follow-up period. The information
received from respondents will provide
insight on the following: Impact of the
courses on (a) promotion of professional
competence, (b) research productivity
and independence, and (c) future career
development within clinical,
translational and academic research
settings. These surveys will provide
preliminary data and guidance in (1)
developing recommendations for
collecting outcomes to assess the
effectiveness of the training courses, and
(2) tracking the impact of the
curriculum on participants’ ability to
perform successfully in academic, nonacademic, research, and non-research
settings.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,589.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address 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 minimizes
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.
Proposed Collection Title:
Application and Impact of Clinical
Research Training on Healthcare
Professionals in Academia and Clinical
Research, Office of Clinical Research,
(OCR), 0925–NEW, expiration date XX/
SUPPLEMENTARY INFORMATION:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Type of respondents
OCR Learning Portal Registration ....
Healthcare Professionals .................
Students ...........................................
General Public ..................................
Healthcare Professionals .................
Students ...........................................
General Public ..................................
Healthcare Professionals .................
Students ...........................................
General Public ..................................
Healthcare Professionals .................
Students ...........................................
General Public ..................................
Healthcare Professionals .................
Students ...........................................
General Public ..................................
Healthcare Professionals .................
2,000
1,000
500
750
500
250
750
500
250
750
500
250
750
500
250
20
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
333
167
83
125
83
42
125
83
42
125
83
42
125
83
42
3
Healthcare Professionals .................
20
1
10/60
3
...........................................................
........................
9,540
........................
1,589
IPPCR Lecture Evaluation ................
IPPCR Final Course Evaluation .......
PCP Lecture Evaluation ....................
PCP Final Course Evaluation ...........
NIH Summer Course in Clinical and
Translational Research Course
Evaluation.
Sabbatical in Clinical Research Management Course Evaluation.
Total ...........................................
jbell on DSK3GLQ082PROD with NOTICES
Estimated
number of
respondents
Form name
VerDate Sep<11>2014
16:55 Jul 11, 2019
Jkt 247001
PO 00000
Frm 00054
Fmt 4703
Sfmt 9990
E:\FR\FM\12JYN1.SGM
12JYN1
33272
Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices
Dated: July 3, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–14821 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Autologus Therapy
Using Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to Kite Pharma,
Inc. (‘‘Kite’’) located in Santa Monica,
CA.
SUMMARY:
Only written comments and/or
complete applications for a license
which are received by the National
Cancer Institute’s Technology Transfer
Center on or before July 29, 2019 will
be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
an Exclusive Patent License should be
directed to: David A. Lambertson, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240) 276–5530;
Facsimile: (240) 276–5504 Email:
david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION:
DATES:
jbell on DSK3GLQ082PROD with NOTICES
Intellectual Property
United States Provisional Patent
Application No. 62/732,263, filed 17
September 2018 and entitled
‘‘Bicistronic Chimeric Antigen
Receptors Targeting CD19 and CD20 and
Their Uses’’ [HHS Reference No. E–205–
2018–0–US–01]; and U.S. and foreign
patent applications claiming priority to
the aforementioned application.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
VerDate Sep<11>2014
16:55 Jul 11, 2019
Jkt 247001
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the
following:
‘‘The development, production and
commercialization of an anti-CD19 antiCD20 dual targeting chimeric antigen
receptor (CAR)-based immunotherapy
using autologous (meaning one
individual is both the donor and the
recipient) immune cells transfected with
either a viral or non-viral vector,
wherein the vector expresses a CAR
having at least:
(1) A dual antigen specificity;
(2) the complementary determining
region (CDR) sequences of the anti-CD19
antibody known as Hu19;
(3) the complementary determining
region (CDR) sequences of the anti-CD20
antibody known as 2.1.2; and
(4) a T cell signaling domain;
for the treatment of B-cell derived
human cancers.’’
This technology discloses the
development of chimeric antigen
receptors that recognize both the CD19
and CD20 cell surface proteins. CD19
and CD20 are expressed on the cell
surface of several hematological
malignancies, including Non-Hodgkins
Lymphoma (NHL), acute lymphoblastic
leukemia (ALL) and chronic
lymphocytic leukemia (CLL). Although
the FDA has recently approved CARbased therapies which target only CD19
(Yescarta, Kymriah), tumors are capable
of undergoing tumor antigen escape (the
downregulation of target antigen
expression on tumor cells), which
results in gradual resistance to ‘‘single
target therapies.’’ As a result, patients
receiving single target CAR therapies are
susceptible to relapse. This has
prompted investigators to pursue dual
targeting CAR therapies to provide as a
means of overcoming tumor antigen
escape, thereby providing a more
comprehensive therapeutic alternative.
The development of a new therapeutic
targeting both CD19 and CD20 will
benefit public health by offering up an
improved treatment for patients that
would otherwise be subject to relapse
due to tumor antigen escape.
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
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.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Comments and objections, other than
those in the form of a completed 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: July 2, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2019–14823 Filed 7–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
All of Us Research Program, Tribal
Consultation Meetings and Listening
Sessions; Correction
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice; correction.
The Department of Health and
Human Services, National Institutes of
Health published a Notice in the
Federal Register on June 3, 2019. That
Notice requires a correction in the DATES
and SUPPLEMENTARY INFORMATION
sections.
SUMMARY:
The
All of Us Tribal Engagement team by
phone at 240–515–5317, by email at
AOUTribal@nih.gov, or by mail at 6011
Executive Boulevard, Suite 214,
Rockville, MD 20852.
SUPPLEMENTARY INFORMATION: On June 3,
2019, the Department of Health and
Human Services, National Institutes of
Health published a Notice in the
Federal Register on pages 25551–25552
(84 FR 25551) that provided two dates
for the HHS Regional Consultation,
Regions 1–4 (Washington, DC) session
to take place on July 16, 2019 and
August 21, 2019. The purpose of this
Notice is to correct the date within the
Dates and Supplemental Information
sections for the Regional Washington
DC consultation session to read: July 17,
2019. A full schedule of consultations
and listening sessions will be made
available on the All of Us Tribal
Engagement web page at https://
AllofUs.nih.gov/All-Us-TribalEngagement.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\12JYN1.SGM
12JYN1
]]>Agencies
[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33270-33272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14821]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Application and
Impact of Clinical Research Training on Healthcare Professionals in
Academia and Clinical Research (Office of the Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork
[[Page 33271]]
Reduction Act of 1995 to provide opportunity for public comment on
proposed data collection projects, the Office of Clinical Research
(OCR), Office of the Director (OD), National Institutes of Health, will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 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: Dr. Anne
Zajicek, M.D., Pharm.D., Deputy Director, Office of Clinical Research,
NIH Office of the Director, Building 1, Room 208A, MSC-0155, Bethesda,
Maryland 20892 or call non-toll-free number (301) 480-9913 or Email
your request, including your address to: [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address 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 minimizes 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.
Proposed Collection Title: Application and Impact of Clinical
Research Training on Healthcare Professionals in Academia and Clinical
Research, Office of Clinical Research, (OCR), 0925-NEW, expiration date
XX/XX/XXXX, National Institutes of Health (NIH), Office of the Director
(OD).
Need and Use of Information Collection: The purpose of this survey
is to assess the long-term impact and outcomes of clinical research
training programs provided by the Office of Clinical Research located
in the NIH Office of the Director (OD) over a ten-year follow-up
period. The information received from respondents will provide insight
on the following: Impact of the courses on (a) promotion of
professional competence, (b) research productivity and independence,
and (c) future career development within clinical, translational and
academic research settings. These surveys will provide preliminary data
and guidance in (1) developing recommendations for collecting outcomes
to assess the effectiveness of the training courses, and (2) tracking
the impact of the curriculum on participants' ability to perform
successfully in academic, non-academic, research, and non-research
settings.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,589.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Number of Average time
Form name Type of number of responses per per response Total annual
respondents respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
OCR Learning Portal Healthcare 2,000 1 10/60 333
Registration. Professionals.
Students........ 1,000 1 10/60 167
General Public.. 500 1 10/60 83
IPPCR Lecture Evaluation...... Healthcare 750 1 10/60 125
Professionals.
Students........ 500 1 10/60 83
General Public.. 250 1 10/60 42
IPPCR Final Course Evaluation. Healthcare 750 1 10/60 125
Professionals.
Students........ 500 1 10/60 83
General Public.. 250 1 10/60 42
PCP Lecture Evaluation........ Healthcare 750 1 10/60 125
Professionals.
Students........ 500 1 10/60 83
General Public.. 250 1 10/60 42
PCP Final Course Evaluation... Healthcare 750 1 10/60 125
Professionals.
Students........ 500 1 10/60 83
General Public.. 250 1 10/60 42
NIH Summer Course in Clinical Healthcare 20 1 10/60 3
and Translational Research Professionals.
Course Evaluation.
Sabbatical in Clinical Healthcare 20 1 10/60 3
Research Management Course Professionals.
Evaluation.
---------------------------------------------------------------
Total..................... ................ .............. 9,540 .............. 1,589
----------------------------------------------------------------------------------------------------------------
[[Page 33272]]
Dated: July 3, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-14821 Filed 7-11-19; 8:45 am]
BILLING CODE 4140-01-P
