Proposed Collection; 60-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection National Institute of Environmental Health Science (NIEHS)

CourtNational Institutes Of Health
Citation86 FR 50897
Publication Date13 Sep 2021
Record Number2021-19693
50897
Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
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 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 from 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: September 7, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2021–19618 Filed 9–10–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Division of Extramural
Research and Training (DERT)
Extramural Grantee Data Collection
National Institute of Environmental
Health Science (NIEHS)
AGENCY
: National Institutes of Health,
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: In compliance with the
requirement of the Paperwork
Reduction Act of 1995, to provide
opportunity for public comment on
proposed data collection projects, the
National Institute of Environmental
Health Sciences (NIEHS), 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. Kristianna Pettibone,
Evaluator, Program Analysis Branch,
NIEHS, NIH, 530 Davis Dr., Room 3055,
Morrisville, NC 20560, or call non-toll-
free number (984) 287–3303 or Email
your request, including your address to:
pettibonekg@niehs.nih.gov. 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 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.
Proposed Collection Title: Division of
Extramural Research and Training
(DERT) Extramural Grantee Data
Collection, 0925–0757, Expiration Date
11/30/2021—REVISION, National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: In order to make informed
management decisions about its
research programs and to demonstrate
the outputs, outcomes and impacts of its
research programs NIEHS will collect,
analyze and report on data from
extramural grantees who are currently
receiving funding or who have received
funding in the past on topics such as: (1)
Key scientific outcomes achieved
through the research and the impact on
the field of environmental health
science; (2) Contribution of research
findings to program goals and
objectives; (3) Satisfaction with the
program support received; (4)
Challenges and benefits of the funding
mechanism used to support the science;
and (5) Emerging research areas and
gaps in the research.
Information gained from this primary
data collection will be used in
conjunction with data from grantee
progress reports and presentations at
grantee meetings to inform internal
programs and new funding initiatives.
Outcome information to be collected
includes measures of agency-funded
research resulting in dissemination of
findings, investigator career
development, grant-funded knowledge
and products, commercial products and
drugs, laws, regulations and standards,
guidelines and recommendations,
information on patents and new drug
applications and community outreach
and public awareness relevant to
extramural research funding and
emerging areas of research.
OMB approval is requested for 3
years. There are no costs to respondents,
other than their time. The total
estimated annualized burden hours are
700.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondent Number of
respondents
Number of
responses
per
respondent
Average time
per response
(in hours)
Total annual
burden hour
NICHD Grantee ............................................................................................... 200 1 30/60 100
NIDCD Grantee ............................................................................................... 200 1 30/60 100
NIMH Grantee .................................................................................................. 200 1 30/60 100
NINDS Grantee ................................................................................................ 200 1 30/60 100
NCI Grantee ..................................................................................................... 400 1 30/60 200
NIEHS Grantee ................................................................................................ 200 1 30/60 100
Total .......................................................................................................... 1,400 1,400 ........................ 700
VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1
lotter on DSK11XQN23PROD with NOTICES1
50898
Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
Jane M. Lambert,
Project Clearance Liaison, National Institute
of Environmental Health Sciences, National
Institutes of Health.
[FR Doc. 2021–19693 Filed 9–10–21; 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: Development and
Commercialization of Cell Therapies
for Cancer
AGENCY
: National Institutes of Health,
HHS.
ACTION
: Notice.
SUMMARY
: 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 Athenex, Inc.
(‘‘Athenex’’) headquartered in Buffalo,
NY.
DATES
: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before September 28, 2021 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: Suna Gulay French, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, Telephone:
(240)–276–5530; Email: suna.gulay@
nih.gov.
SUPPLEMENTARY INFORMATION
:
Intellectual Property
GROUP A:
E–237–2017–0/2: T Cell Receptors
Recognizing Mutated P53
1. US Provisional Patent Application
62/565,383, filed September 29, 2017
(E–237–2017–0–US–01);
2. International Patent Application
PCT/US2018/051285, filed September
17, 2018 (E–237–2017–2–PCT–01);
3. Australian Patent Application
2018342246, filed September 17, 2018
(E–237–2017–2–AU–02);
4. Brazilian Patent Application
BR112020006012–7, filed September 17,
2018 (E–237–2017–2–BR–03);
5. Canadian Patent Application
3977024, filed September 17, 2018 (E–
237–2017–2–CA–04);
6. Chinese Patent Application
201880074539.8, filed September 17,
2018 (E–237–2017–2–CN–05);
7. Costa Rica Patent Application
2020–0170, filed September 17, 2018
(E–237–2017–2–CR–06);
8. Eurasian Patent Application
202090757, filed September 17, 2018
(E–237–2017–2–EA–07);
9. European Patent Application
18780006.5, filed September 17, 2018
(E–237–2017–2–EP–08);
10. Israeli Patent Application 273515,
filed September 17, 2018 (E–237–2017–
2–IL–09);
11. India Patent Application
202047013911, filed September 17, 2018
(E–237–2017–2–IN–10);
12. Japanese Patent Application 2020–
517556, filed September 17, 2018 (E–
237–2017–2–JP–11);
13. Korean Patent Application 2020–
7012344, filed September 17, 2018 (E–
237–2017–2–KR–12);
14. Mexico Patent Application MX/a/
2020/003504, filed September 17, 2018
(E–237–2017–2–MX–13);
15. New Zealand Patent Application
763023, filed September 17, 2018 (E–
237–2017–2–NZ–14);
16. Singapore Patent Application
11202002636P, filed September 17,
2018 (E–237–2017–2–SG–15);
17. United States Utility Patent
Application 16/651,242, filed
September 17, 2018 (E–237–2017–2–
US–16); and
18. Hong Kong Patent Application
62020021272.3, filed November 30,
2020 (E–237–2017–2–HK–17).
E–135–2019: T Cell Receptors
Recognizing R175H or Y220C Mutation
in P53
1. US Provisional Patent Application
62/867,619, filed June 27, 2019 (E–135–
2019–0–US–01);
2. International Patent Application
PCT/US2020/039785, filed June 26,
2020 (E–135–2019–0–PCT–02); and
3. Taiwanese Patent Application
109121744, filed June 26, 2020 (E–135–
2019–0–TW–03).
E–173–2020: T Cell Receptors
Recognizing R273C or Y220C Mutation
in P53
1. US Provisional Patent Application
63/074,747, filed September 4, 2020 (E–
173–2020–0–US–01).
E–098–2018: T Cell Receptors Which
Recognize Mutated EGFR
1. US Provisional Patent Application
62/665,234, filed May 1, 2018 (E–098–
2018–0–US–01);
2. International Patent Application
PCT/US2019/030108, filed May 1, 2019
(E–098–2018–0–PCT–02);
3. Australian Patent Application
2019263233, filed May 1, 2019 (E–098–
2018–0–AU–03);
4. Canadian Patent Application
3,099,106, filed May 1, 2019 (E–098–
2018–0–CA–04);
5. European Patent Application
19723615.1, filed May 1, 2019 (E–098–
2018–0–EP–05); and
6. United States Utility Patent
Application 17/051,860, filed May 1,
2019 (E–098–2018–0–US–06).
E–165–2020: HLA Class II-Restricted
DRB T Cell Receptors Against RAS With
G12D Mutation
1. US Provisional Application 63/
050,9131, filed July 13, 2020 (E–165–
2020–0–US–01); and
2. International Patent Application
PCT/US2021/041375, filed July 13, 2021
(E–165–2020–0–PCT–02).
E–172–2020: HLA Class II-Restricted
DRB T Cell Receptors Against RAS With
G12V Mutation
1. US Provisional Application 63/
052,502, filed July 16, 2020 (E–172–
2020–0–US–01); and
2. International Patent Application
PCT/US2021/041737, filed July 15, 2021
(E–172–2020–0–PCT–02).
E–189–2020: HLA Class II-Restricted DQ
T Cell Receptors Against RAS With
G13D Mutation
1. US Provisional Application 63/
086,674, filed October 2, 2020 (E–189–
2020–0–US–01).
E–190–2020: HLA Class I-Restricted T
Cell Receptors Against RAS With G12V
Mutation
1. US Provisional Application 63/
060,340, filed August 3, 2020 (E–190–
2020–0–US–01) and U.S., PCT and
foreign patent applications claiming
priority to the aforementioned
application.
GROUP B:
E–237–2017–1: Methods of Isolating T
Cells Having Antigenic Specificity for a
P53 Cancer-Specific Mutation
1. US Provisional Patent Application
62/565,464, filed September 29, 2017
(E–237–2017–1–US–01);
2. International Patent Application
PCT/US2018/051280, filed September
17, 2018 (E–237–2017–1–PCT–02);
3. Australian Patent Application
2018342245, filed September 17, 2018
(E–237–2017–1–AU–03);
4. Canadian Patent Application
3080274, filed September 17, 2018 (E–
237–2017–1–CA–04);
VerDate Sep<11>2014 17:39 Sep 10, 2021 Jkt 253001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1
lotter on DSK11XQN23PROD with NOTICES1

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT