pub 30 day FRN

Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
This live-attenuated RSV vaccine is
designed to be administered intranasally
by drops or spray to infants and young
children. Based on experience with
other live-attenuated RSV vaccine
candidates, the present candidates are
anticipated to be well tolerated in
humans and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
evaluating live-attenuated RSV vaccine
candidates in pediatric clinical studies,
and opportunity for collaboration exists.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Viral diagnostics
• Vaccine research
Competitive Advantages:
•
•
•
•

Ease of manufacture
B cell and T cell activation
Low-cost vaccines
Intranasal administration/needle-free
delivery
Development Stage:

• In vivo data assessment (animal)
Inventors: Cyril Le Nouen (NIAID),
Ursula Buchholz (NIAID), Peter Collins
(NIAID).
Intellectual Property: HHS Reference
No. E–104–2020–0—U.S. Provisional
Application No. 63/023,949, filed May
13, 2020.
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; [email protected].
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
[email protected].
Dated: February 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–03872 Filed 2–24–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
To Support the Safe to Sleep®
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:

Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Lorena Kaplan,
M.P.H., CHES, Office of
Communications, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A32, Bethesda, Maryland
20892, or call non-toll free number (301)
496–6670 or Email your request,
including your address to
[email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on December 11, 2020, page
80123–80124 (85 FR 80123–80124) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Eunice Kennedy Shriver National
Institute for Child Health and Human
Development, National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
ADDRESSES:

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that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Generic
Clearance to Support the Safe to Sleep®
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD), 0925–0701, exp., date 02/28/
2021, REVISION, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a
revision to a generic clearance used for
submissions specific to the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD) Safe to Sleep® (STS) public
education campaign. Submissions for
the STS campaign will be used to assess
the understanding and reach of STS
campaign materials and messages, and
to monitor and improve campaign
activities such as training workshops
and overall implementation. The
purpose of this information collection is
to monitor and modify campaign
activities, to plan future campaign
activities, to develop messages and
materials, and to develop distribution
and outreach strategies that are effective
at communicating their message to bring
about the intended response, awareness,
and/or behavioral change for the target
audiences. This generic clearance will
enable the NICHD to: (1) More
efficiently assess the implementation of
campaign activities; (2) better
understand the target audiences’
knowledge, attitudes, and beliefs toward
STS messages and materials; (3) better
understand how the campaign activities
have influenced the target audiences’
behaviors and practices; and (4) monitor
and improve activities such as trainings,
materials, and messages. Having a way
to gather feedback on the STS campaign
activities is critical to assessing the
reach and effect of campaign efforts.
Data collected for the campaign can
inform where future STS campaign
resources can produce the most
meaningful results. Data collected for
the STS campaign generic clearance will
be used by a number of audiences,
including STS campaign staff, NICHD
leadership, STS campaign collaborators,

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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices

Federal SUID/SIDS Workgroup
members, SUID/SIDS stakeholders,
clinical and maternal and child health
professionals. These audiences may use
the information collections to: (1)
Develop new campaign messages,
materials, and/or training curricula; (2)
monitor and improve campaign
activities; (3) make decisions about
campaign activities; (4) inform current
campaign activities; and (5) inform and/
or change practices and behaviors of
program participants.
Examples of the types of information
collections that could be included under
this generic clearance include: Focus
groups and key informant interviews

with parents/caregivers and/or health
professionals to get feedback on
distribution and outreach activities,
and/or campaign messages; and Surveys
with parents/caregivers and/or health
professionals to: (1) Assess the
usefulness of the new STS campaign
materials, including print and on-line
multi-media materials, (2) track
outreach experiences of program
participants, (3) assess training
participants’ changes in knowledge
related to safe infant sleep behavior and
implementation of learned outreach and
education methods, and (4) assess
program participants’ resource needs.

The sub-studies for this generic
clearance will be small in scale,
designed to obtain results frequently
and quickly to guide campaign
development and implementation,
inform campaign direction, and be used
internally for campaign management
purposes. NICHD’s current scope and
capacity for STS generic sub-studies is
non-existent and this request would fill
this gap.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
13,305.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Focus Groups ...................................
Interviews ..........................................
Pre-/Post-Tests .................................
Pre-/Post-Tests .................................
Surveys .............................................
Tracking/Feedback Form ..................

General Public ..................................
General Public ..................................
General Public ..................................
Health Professionals ........................
Health Professionals ........................
Health Educators ..............................

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

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

Dated: February 12, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
[FR Doc. 2021–03870 Filed 2–24–21; 8:45 am]

National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Engineered Tumor
Infiltrating Lymphocytes for Cancer
Therapy

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 Iovance
Biotherapeutics, Inc. (‘‘Iovance’’),
headquartered in San Carlos, CA.

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215
50
1,500
10,000
1,500
40

26,285

49,305

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

13,305

Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before March 12, 2021 will be
considered.

DATES:

E–068–2018: Tethered Interleukin-15
and Interleukin-21

Notice.

17:04 Feb 24, 2021

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15/60
30/60
1

Intellectual Property

National Institutes of Health,

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2
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2

SUPPLEMENTARY INFORMATION:

HHS.

SUMMARY:

215
50
3,000
20,000
3,000
20

Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)–276–5484; Email:
[email protected].

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

ACTION:

Average
burden
per response,
in hours

ADDRESSES:

BILLING CODE 4140–01–P

AGENCY:

Number of
responses per
respondent

Number of
respondents

Form name

1. US Provisional Patent Application
62/628,454, filed February 9, 2018 (E–
068–2018–0–US–01);
2. International Patent Application
PCT/US2019/016975, filed February 7,
2019 (E–068–2018–0–PCT–02);
3. Australian Patent Application
2019218785, filed August 7, 2020 (E–
068–2018–0–AU–03);
4. Chinese Patent Application
201980012443.3, filed August 7, 2020
(E–068–2018–0–CN–04);

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Total annual
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5. European Patent Application
19709154.9, filed August 18, 2020 (E–
068–2018–0–EP–05);
6. United States Patent Application
16/964,796, filed July 24, 2020 (E–068–
2018–0–US–06); and
7. Canadian Patent Application
3,090,512, filed August 5, 2020 (E–068–
2018–0–CA–07).
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 use of the Licensed Patent
Rights to develop, manufacture,
distribute, sell, and use unselected
whole autologous tumor infiltrating
lymphocyte (TIL) adoptive cell therapy
products for the treatment of metastatic
melanoma, lung, breast, bladder, and
HPV-positive cancers. Specifically
excluded from this Agreement are
methods of generating or using selected
subpopulations of TIL and the use of T
cell receptors isolated from TIL.’’
E–068–2018 is primarily directed to
recombinant constructs for the coexpression of Interleukins-15 and 21
(IL–15 and 21). IL–15 and IL–21 have
been reported to support the function of
anti-tumor T cells; however, their

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