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, 11547-11548 [2021-03870]
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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; peter.soukas@nih.gov.
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;
peter.soukas@nih.gov.
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]
BILLING CODE 4140–01–P
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17:04 Feb 24, 2021
Jkt 253001
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
lorena.kaplan@nih.gov.
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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11547
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,
E:\FR\FM\25FEN1.SGM
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11548
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.
Jkt 253001
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
1
1
15/60
15/60
30/60
1
Intellectual Property
National Institutes of Health,
VerDate Sep<11>2014
1
1
2
2
1
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:
andy.burke@nih.gov.
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);
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Total annual
burden hours
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
E:\FR\FM\25FEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11547-11548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03870]
-----------------------------------------------------------------------
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[supreg] Campaign at the Eunice
Kennedy Shriver National Institute for Child Health and Human
Development
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: 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
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[supreg] 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[supreg] (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,
[[Page 11548]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response, Total annual
respondents respondents respondent in hours burden hours
----------------------------------------------------------------------------------------------------------------
Focus Groups.................. General Public.. 215 1 1 215
Interviews.................... General Public.. 50 1 1 50
Pre-/Post-Tests............... General Public.. 3,000 2 15/60 1,500
Pre-/Post-Tests............... Health 20,000 2 15/60 10,000
Professionals.
Surveys....................... Health 3,000 1 30/60 1,500
Professionals.
Tracking/Feedback Form........ Health Educators 20 2 1 40
---------------------------------------------------------------
Total..................... ................ 26,285 49,305 .............. 13,305
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4140-01-P
