Awards Unsolicited Proposal for the Health Communication Initiative Program, 49386-49387 [2020-17516]
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49386
Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Teaching Health Center Costing Instrument .......................
56
1
56
10
560
Total ..............................................................................
56
........................
56
........................
560
Maria G. Button,
Director, Executive Secretariat.
Authority: 42 U.S.C. 1395.
[FR Doc. 2020–17729 Filed 8–12–20; 8:45 am]
Alex M. Azar II,
Secretary.
BILLING CODE 4165–15–P
[FR Doc. 2020–17748 Filed 8–12–20; 8:45 am]
BILLING CODE 4150–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Indian Health Service
Delegation of Authority
[Assistance Listing Number 93.933]
Notice is hereby given that I have
delegated jointly to the Administrator,
Centers for Medicare & Medicaid
Services (CMS), and to the Director,
National Institutes of Health (NIH), the
authorities vested in the Secretary under
Section 1881(c)(7)(B)–(E) [42 U.S.C.
1395rr(c)(7)(B)–(E)] of the Social
Security Act (the Act), as amended, to
assemble and analyze data reported by
network organizations, transplant
centers, and other sources on all endstage renal disease (ESRD) patients.
Limitations
This delegation of authorities under
Section 1881(c)(7)(B)–(E) [42 U.S.C.
1395rr(c)(7)(B)–(E)] of the Act shall be
shared between CMS and NIH as these
authorities relate to their respective
programs. CMS and NIH will implement
proactive collaborative measures such
as ongoing status checks to discuss
progress and resolve any potential
disputes.
This delegation supersedes any prior
delegations under this section,
including the delegation dated
September 6, 1984 (49 FR 35247).
This delegation of authority may be
re-delegated.
This delegation of authority is
effective immediately.
I hereby affirm and ratify any actions
taken by the Administrator, CMS, and
the Director, NIH, or their subordinates,
which involved the exercise of authority
under Section 1881(c)(7)(B)–(E) [42
U.S.C. 1395rr(c)(7)(B)–(E)] of the Act, as
amended, delegated herein prior to the
effective date of this delegation of
authority.
VerDate Sep<11>2014
17:16 Aug 12, 2020
Jkt 250001
Awards Unsolicited Proposal for the
Health Communication Initiative
Program
Office of Clinical and
Preventive Services, Indian Health
Service, Department of Health and
Human Services.
ACTION: Notice of award of a singlesource unsolicited grant to Johns
Hopkins University in Baltimore,
Maryland.
AGENCY:
Recipient: Johns Hopkins University,
Baltimore, Maryland.
Purpose of the Award: Cooperative
agreement to collect, develop, package
and distribute information to American
Indian and Alaska Native (AI/AN)
communities to address the coronavirus
disease 2019 (COVID–19)-specific
recommendations on healthcare, in a
culturally sensitive way.
Amount of Award: $127,644 in Fiscal
Year (FY) 2020.
Period of Performance: April 24,
2020–August 24, 2020.
SUMMARY: The Office of Clinical and
Preventive Services (OCPS) announces
the award of a single-source cooperative
agreement in response to an unsolicited
proposal from Johns Hopkins
University, Baltimore, Maryland. The
proposal submitted was not solicited
either formally or informally by any
federal government official.
OCPS performed an objective review
of the unsolicited proposal from Johns
Hopkins University (JHU) to develop
information on proper actions to
mitigate the spread of COVID–19, in a
culturally sensitive way. The Johns
Hopkins Bloomberg School of Public
Health (JHSPH) Center for American
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Indian Health (CAIH) mission is to work
in partnerships with AI/AN
communities to raise their health status,
self-sufficiency, and health leadership
to the highest possible level. This
mission is accomplished through
research, training and education, and
service. The CAIH has more than nine
facilities and approximately 100 staff in
the Southwestern tribal communities to
assist the Indian Health Service (IHS) in
containing and mitigating COVID–19,
while building a response model and set
of communication materials for all IHS
regions nationwide. The CAIH can draw
on broad expertise from JHU for
additional guidance and
recommendations on best practices as
the situation evolves.
The materials will be developed from
the Centers for Disease Control and
Prevention (CDC) and the Substance
Abuse and Mental Health Services
Administration (SAMHSA) guidance.
Based on an internal review of the
proposal and the immediate response of
the IHS to address the COVID–19 public
health emergency, OCPS determined
that the proposal has merit.
The long history between the federal
government and Native American Tribes
and people has often been less than
ideal. There are still barriers to the
Native American community accepting
instruction or direction from the federal
government. There is great value in
having a third party that has a good
history with the community to gather,
package and deliver recommendations,
in a culturally sensitive way, on staying
safe from this disease, when those
recommendations may run contrary to
cultural norms. This delivery avenue
will be more acceptable to the
community, and will be more readily
recognized for implementation within
AI/AN communities.
This award is being made
noncompetitively because there is no
current, pending, or planned funding
opportunity announcement under
which this proposal could be competed.
OCPS has identified two additional key
reasons to support rationale for
awarding this unsolicited proposal:
1. The JHU CAIH is well known in the
AI/AN communities for robust
E:\FR\FM\13AUN1.SGM
13AUN1
Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices
communication/messaging networks,
research, training, and subject matter
expertise. The dissemination of critical
COVID–19 information for tribal
communities builds trust, credibility,
and integrity of promoting a culturally
sensitive public health approach around
the information.
2. The JHU CAIH is uniquely
positioned to provide culturally specific
subject matter expertise drawn from a
direct care services or ‘‘boots on the
ground’’ approach. The CAIH has nearly
40 years of collaboration with Native
American tribes and supports public
health interventions in more than 140
tribal communities in over 21 states.
The breadth of knowledge and existing
partnerships will enhance
dissemination of information nationally.
Legislative Authority: The Snyder Act,
25 U.S.C. Section 13; the Indian Health
Care Improvement Act, 25 U.S.C.
Section 1621b; and Coronavirus Aid,
Relief, and Economic Security (CARES)
Act, Public Law 116–136.
FOR FURTHER INFORMATION CONTACT:
Audrey Solimon at Audrey.Solimon@
ihs.gov or by telephone at 301–590–
5421.
Michael D. Weahkee,
RADM, Assistant Surgeon General, U.S.
Public Health Service, Director, Indian Health
Service.
[FR Doc. 2020–17516 Filed 8–12–20; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Biomedical Imaging and
Bioengineering.
The meeting will be open to the
public by videocast as indicated below.
The meeting will be closed to the public
in accordance with the provisions set
forth in sections 552b(c)(4) and
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
VerDate Sep<11>2014
17:16 Aug 12, 2020
Jkt 250001
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering.
Date: September 15, 2020.
Open: 12:00 p.m. to 3:00 p.m.
Agenda: Report from the Institute Director
and other Institute Staff.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Closed: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David T. George, Ph.D.,
Associate Director, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 920,
Bethesda, MD 20892, georged@mail.nih.gov.
Any interested person may file
written comments with the committee
by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nibib1.nih.gov/about/NACBIB/
NACBIB.htm, where an agenda and any
additional information for the meeting
will be posted when available.
49387
listed in the Supplementary Information
section of this notice. Upon expiration
of the evaluation period the granted
licenses may be converted into a fully
exclusive patent commercialization
license for the term of the last to expire
of the patent estate upon the company
providing NHLBI with a commercial
development plan supporting such a
conversion. This notice is intended to
apprise the public of a aforementioned
license and provide a fifteen (15) day
notice period for the objection.
DATES: Only written comments and/or
applications for a license which are
received by the National Heart, Lung,
and Blood Institute on or before August
28, 2020 will be considered.
ADDRESSES: Requests for copies of
patent applications (electronic only),
inquiries, and comments relating to the
contemplated an exclusive patent
license should be emailed to: Michael
Shmilovich, Esq., Senior Licensing and
Patent Manager, 31 Center Drive Room
4A29, MSC2479, Bethesda, MD 20892–
2479, phone number 301–435–5019
shmilovm@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectual Property (Patent Estate)
HHS Ref. No. E–036–2015–0 and –1,
U.S. Provisional Patent Application 62/
079,975 filed November 14, 2014
Dated: August 7, 2020.
(expired), International Patent
Miguelina Perez,
Application PCT/US2015/060646 filed
Program Analyst, Office of Federal Advisory
November 13, 2015 (nationalized), U.S.
Committee Policy.
Patent Application 15/525,921 having
[FR Doc. 2020–17678 Filed 8–12–20; 8:45 am]
an effective filing date of November 13,
2015, and U.S. Divisional Patent
BILLING CODE 4140–01–P
Application 16/985,797 filed August 5,
2020, any and all continuation or
DEPARTMENT OF HEALTH AND
divisional applications claiming priority
HUMAN SERVICES
to any of the above.
The patent rights in these inventions
National Institutes of Health
have been assigned or exclusively
licensed to the Government of the
Prospective Grant of an Exclusive
United States of America.
Start-Up Patent License for Evaluation:
The prospective exclusive license
Immunotherapy for Relapsed/
territory may be worldwide and in field
Refractory Diffuse Large B Cell
of use that may be limited to
Lymphoma
Immunotherapy against relapsed or
refractory diffuse large B cell
AGENCY: National Institutes of Health,
lymphoma, and where the ‘‘Licensed
Health and Human Services (HHS).
Products’’ may be defined to be limited
ACTION: Notice.
to transgenically modified allogeneic
SUMMARY: The National Heart, Lung, and natural killer cells within the scope of
Blood Institute, of the National
the Licensed Patent Rights that
Institutes of Health, Department of
transiently express one or more of a (1)
Health and Human Services, is
CCR7 receptor, (2) CD16a (HA–CD16),
contemplating the grant of an exclusive
(3) a DR5 specific TRAIL, or (4) CD19
start-up patent license for evaluation to
chimeric antigen receptor.
The aforementioned patent estates
ONK Therapeutics, a start-up company
spun-off from the National University of cover methods of treating a subject with
Ireland Galway, and incorporated under a tumor by administering transgenically
modified adoptive NK (natural killer
the laws of the Republic of Ireland, to
cells), methods of generating transgenic
practice, for a limited time, the
NK cells, and transgenic NK cells per se.
inventions covered by the patent estate
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
E:\FR\FM\13AUN1.SGM
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Agencies
[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49386-49387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
[Assistance Listing Number 93.933]
Awards Unsolicited Proposal for the Health Communication
Initiative Program
AGENCY: Office of Clinical and Preventive Services, Indian Health
Service, Department of Health and Human Services.
ACTION: Notice of award of a single-source unsolicited grant to Johns
Hopkins University in Baltimore, Maryland.
-----------------------------------------------------------------------
Recipient: Johns Hopkins University, Baltimore, Maryland.
Purpose of the Award: Cooperative agreement to collect, develop,
package and distribute information to American Indian and Alaska Native
(AI/AN) communities to address the coronavirus disease 2019 (COVID-19)-
specific recommendations on healthcare, in a culturally sensitive way.
Amount of Award: $127,644 in Fiscal Year (FY) 2020.
Period of Performance: April 24, 2020-August 24, 2020.
SUMMARY: The Office of Clinical and Preventive Services (OCPS)
announces the award of a single-source cooperative agreement in
response to an unsolicited proposal from Johns Hopkins University,
Baltimore, Maryland. The proposal submitted was not solicited either
formally or informally by any federal government official.
OCPS performed an objective review of the unsolicited proposal from
Johns Hopkins University (JHU) to develop information on proper actions
to mitigate the spread of COVID-19, in a culturally sensitive way. The
Johns Hopkins Bloomberg School of Public Health (JHSPH) Center for
American Indian Health (CAIH) mission is to work in partnerships with
AI/AN communities to raise their health status, self-sufficiency, and
health leadership to the highest possible level. This mission is
accomplished through research, training and education, and service. The
CAIH has more than nine facilities and approximately 100 staff in the
Southwestern tribal communities to assist the Indian Health Service
(IHS) in containing and mitigating COVID-19, while building a response
model and set of communication materials for all IHS regions
nationwide. The CAIH can draw on broad expertise from JHU for
additional guidance and recommendations on best practices as the
situation evolves.
The materials will be developed from the Centers for Disease
Control and Prevention (CDC) and the Substance Abuse and Mental Health
Services Administration (SAMHSA) guidance. Based on an internal review
of the proposal and the immediate response of the IHS to address the
COVID-19 public health emergency, OCPS determined that the proposal has
merit.
The long history between the federal government and Native American
Tribes and people has often been less than ideal. There are still
barriers to the Native American community accepting instruction or
direction from the federal government. There is great value in having a
third party that has a good history with the community to gather,
package and deliver recommendations, in a culturally sensitive way, on
staying safe from this disease, when those recommendations may run
contrary to cultural norms. This delivery avenue will be more
acceptable to the community, and will be more readily recognized for
implementation within AI/AN communities.
This award is being made noncompetitively because there is no
current, pending, or planned funding opportunity announcement under
which this proposal could be competed. OCPS has identified two
additional key reasons to support rationale for awarding this
unsolicited proposal:
1. The JHU CAIH is well known in the AI/AN communities for robust
[[Page 49387]]
communication/messaging networks, research, training, and subject
matter expertise. The dissemination of critical COVID-19 information
for tribal communities builds trust, credibility, and integrity of
promoting a culturally sensitive public health approach around the
information.
2. The JHU CAIH is uniquely positioned to provide culturally
specific subject matter expertise drawn from a direct care services or
``boots on the ground'' approach. The CAIH has nearly 40 years of
collaboration with Native American tribes and supports public health
interventions in more than 140 tribal communities in over 21 states.
The breadth of knowledge and existing partnerships will enhance
dissemination of information nationally.
Legislative Authority: The Snyder Act, 25 U.S.C. Section 13; the
Indian Health Care Improvement Act, 25 U.S.C. Section 1621b; and
Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law
116-136.
FOR FURTHER INFORMATION CONTACT: Audrey Solimon at
[email protected] or by telephone at 301-590-5421.
Michael D. Weahkee,
RADM, Assistant Surgeon General, U.S. Public Health Service, Director,
Indian Health Service.
[FR Doc. 2020-17516 Filed 8-12-20; 8:45 am]
BILLING CODE 4165-16-P