30-day FRN

43147

Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS:—Continued
Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(in min)

Total burden
(in hr)

Type of respondent

Form name

Prize competition non-awardees ......
Other Stakeholders ...........................
Prize competition applicants .............
Prize competition awardees and
non-awardees.

Non-awardee Interview Guide .........
Other Stakeholder Interview Guide ..
Pre-award Survey Instrument ..........
Post-award Survey Instrument .........

6
6
300
300

1
1
1
1

50/60
50/60
30/60
30/60

5
5
150
150

Total ...........................................

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

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

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

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

325

Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.

please include the document identifier
0990–New–30D and project title for
reference.

[FR Doc. 2019–17887 Filed 8–19–19; 8:45 am]

SUPPLEMENTARY INFORMATION:

BILLING CODE 4150–04–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]

Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

SUMMARY: In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 19,
2019.

Submit your comments to
[email protected] or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, [email protected]
or (202) 795–7714. When submitting
comments or requesting information,
ADDRESSES:

Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Youth
Engagement in Sports (YES)
Performance Measures.
Type of Collection: New.
OMB No. 0990–NEW—Youth
Engagement in Sports (YES)
Performance Measures
Abstract: The Office of Minority
Health (OMH) and Office of Women’s
Health (OWH) are seeking an approval
by OMB on a new information
collection, Youth Engagement in Sports
(YES Initiative) Performance Measures
(hereafter YES Initiative Performance
Measures). The purpose of this data

collection is to gather quantitative data
from YES grant recipients to monitor
project performance in achieving
process and outcome measures over the
course of the three-year project.
Grantees will collect a small set of
process and outcome measures from
program participants to assess the
degree to which YES Initiative projects
increase sports participation and
physical activity and improve nutrition
in adolescents.
Need and Proposed Use of the
Information: The clearance is needed to
collect performance data to enable OMH
and OWH to comply with Federal
reporting requirements, monitor, and
evaluate performance by enabling the
efficient collection of performanceoriented data tied to OMH- and OWHwide performance reporting needs. The
ability to monitor and evaluate
performance in this manner, and to
work towards continuous program
improvement are basic functions that
OMH and OWH must be able to
accomplish in order to carry out their
respective mandates with the most
effective and appropriate use of
resources.
Likely Respondents: Project Directors,
Youth Participants, Data Entry Persons
Affected public includes non-profit
institutions, State, Local, or Tribal
Governments.

jbell on DSK3GLQ082PROD with NOTICES

ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response

Respondents
(if necessary)

Physical Activity & Nutrition Survey ..
Sports Inventory ................................
Sports Literacy Form .........................

Youth ................................................
Youth ................................................
Youth (Staff observe youth) .............

2800
2800
2800

3
2
3

20/60
5/60
20/60

2800
467
2800

Program Participation Record ...........
Total ...........................................

Staff ..................................................
..........................................................

14
........................

2
........................

4.17
........................

117
6184

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Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

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Total burden
hours

43148

Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices

Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–17886 Filed 8–19–19; 8:45 am]
BILLING CODE 4150–29–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Potential Commercial Applications
• Target identification in B and T cell
deficiency, macrophage defects and
hematopoiesis.
• A tool for investigating IRF8
mediated issues associated with
inflammation and autoimmunity.
• Investigative tool for development
of potential therapeutics for lymphoma
and Human Chronic Myeloid Leukemia.

National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

SUMMARY: The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Chris Kornak at 240–627–3705 or
[email protected]. Licensing
information may be obtained by
communicating with the Technology
Transfer and Intellectual Property
Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Rockville, MD 20852; tel. 301–496–
2644. A signed Confidential Disclosure
Agreement will be required to receive
copies of unpublished information
related to the invention.
SUPPLEMENTARY INFORMATION:
Technology description follows:

jbell on DSK3GLQ082PROD with NOTICES

Floxed Targeted Mouse Strain for Use
in Conditional Deletion of the Irf8 Gene
Description of Technology
IRF8, a member of interferon
regulatory factor (IRF) family of
transcription factors is a novel intrinsic
transcriptional inhibitor of TH17-cell
differentiation. TH17-cells are believed
to be involved in the pathogenesis of
various autoimmune/inflammatory
diseases. The Irf8f floxed targeted
mutated mouse strain can be used to
selectively ablate expression of IRF8 in
any cell type in which a Cre
recombinase gene is activated. This will
permit the identification of IRF8regulated genes and their effects in
specific types of developing and mature
cells. These materials could be used to
help define patterns of gene expression
important for the development and
function of cells including possible
contributions to understanding: Normal

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20:49 Aug 19, 2019

Jkt 247001

immune responses, inflammatory
conditions, autoimmunity and anti-viral
responses.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.

Competitive Advantages
• Mice with established germ line
transmission for use in conditional
deletion of the IRF8 gene in any cell
type.
Development Stage
• Research Use.
Inventors: Herbert Carpenter Morse III
(NIAID).
Publications: Ouyang, Xinshou, et al.
‘‘Transcription factor IRF8 directs a
silencing programme for TH17 cell
differentiation.’’ Nature
Communications 2, Article number: 314
(2011).
Licensing Contact: To license this
technology, please contact Chris Kornak
at 240–627–3705 or Chris.Kornak@
nih.gov, and reference E–062–2012–0.
Dated: August 6, 2019.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2019–17868 Filed 8–19–19; 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: Development and
Commercialization of CD19/CD22
Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell
Malignancies
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

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Fmt 4703

Sfmt 4703

Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Lyell
Immunopharma, Inc. (‘‘Lyell’’), located
in South San Francisco, CA.
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 19, 2019 will be
considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Jim Knabb, 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)–276–7856;
Facsimile: (240)–276–5504; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
E–016–2015: Chimeric Antigen Receptor
Targeting both CD19 and CD22
1. U.S. Provisional Patent Application
62/135,442, filed March 19, 2015 (E–
106–2015–0–US–01);
2. International Patent Application
PCT/US2016/023055, filed March 18,
2016 (E–106–2015/0–PCT–02)
3. U.S. Patent Application No.: 15/
559,485, filed September 19, 2017 (E–
E–106–2015/0–US–03)
E–017–2017: CD19/CD22 Bicistronic
CAR Targeting Human B-Cell
Malignancies
1. U.S. Provisional Patent Application
62/506,268, filed May 15, 2017 (E–017–
2017–0–US–01);
2. International Patent Application
PCT/US2018/032,809, filed May 15,
2018 (E–017–2017/0–PCT–02)
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
fields of use may be limited to the
following:
An exclusive license to: ‘‘Treatment of B
cell malignancies using autologously-derived
T cell expressing chimeric antigen receptor(s)
(CAR) specific for both CD19 and CD22
utilizing the anti-CD19 antigen binding
domain of the FM63 antibody and the antiCD22 antigen binding domain of the M971
antibody.’’ The proposed territory is
worldwide.

This technology discloses CAR
therapies that target both CD19 and
CD22 by utilizing the anti-CD19 binder

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