Office of the Director, National Institutes of Health; Notice of Closed Meeting, 8306-8307 [2020-02860]
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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Forms
Survey on SUD Placement Criteria .................................................................
Dated: February 5, 2020.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2020–02846 Filed 2–12–20; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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:
Dianca Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at 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to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Ebola Virus Glycoprotein-Specific
Monoclonal Antibodies and Uses
Thereof Description of Technology
Ebola virus is a large, negative-strand
RNA virus composed of 7 genes
encoding viral proteins, including a
single glycoprotein (GP). The virus is
responsible for causing Ebola virus
disease (EVD), formerly known as Ebola
hemorrhagic fever (EHF), in humans. In
particular, Bundibugyo (BDBV), Zaire
(EBOV), and Sudan (SUDV) species
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have been associated with large
outbreaks of EVD in Africa and reported
case fatality rates of up to 90%.
Transmission of Ebola virus to humans
is not yet fully understood but is likely
due to incidental exposure to infected
animals. EVD spreads through humanto-human transmission, with infection
resulting from direct contact with blood,
secretions, organs or other bodily fluids
of infected people, and indirect contact
with environments contaminated by
such fluids.
EVD has an incubation period of 2 to
21 days (7 days on average, depending
on the strain) followed by a rapid onset
of non-specific symptoms such as fever,
extreme fatigue, gastrointestinal
complaints, abdominal pain, anorexia,
headache, myalgias and/or arthralgias.
While prior outbreaks of EVD have
been localized to regions of Africa, there
is a potential threat of spread to other
countries given the frequency of
international travel. The 2014 outbreak
in West Africa was first recognized in
March 2014, and as of April 13, 2016,
the number of cases far exceeded the
largest prior EVD outbreak with a
combined total (suspected, probable,
and laboratory-confirmed) 28616 cases
and 11310 deaths (case fatality rate =
39.5%). The largest previous outbreak
occurred in Uganda in 2000–2001 with
425 cases and 224 deaths (case-fatality
rate = 53%).
Viruses in the Filoviridae family are
also categorized as potential threats for
use as biological weapons due to ease of
dissemination and transmission, and
high levels of mortality. Currently, no
effective therapies or FDA-licensed
vaccines exist for any member of
Filoviridae family of viruses.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
developed eight high-affinity human
monoclonal antibodies, specifically
EboV.YD.01, EboV.YD.02, EboV.YD.03,
and EboV.YD.04, EboV.YD.05,
EboV.YD.06, EboV.YD.07 and
EboV.YD.08 which bind with
nanomolar affinity against Ebola virus
glycoprotein. The human monoclonal
antibodies have been assessed by
functional assays, epitope mapping,
affinity measurements and in vitro
neutralization assays.
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Number of
responses per
respondent
Average
burden per
response
(hours)
1
Total annual
burden
(hours)
10/60
14.5
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• Prevention of acquisition of Ebola
Zaire virus.
• Antibody therapy for people
exposed to Ebola Zaire virus.
• Diagnostics for Ebola Zaire virus.
Competitive Advantages:
• High-affinity neutralizing
antibodies (mAbs), targeting Ebola virus
(EBOV) glycoprotein from a human
Ebolavirus vaccine.
• Currently, there are no Food and
Drug Administration (FDA)-approved
vaccines or therapeutics available for
prevention, post-exposure, or treatment
for EBOV.
• The EboV.YD.01–EboV.YD.08
antibodies can be combined with other
biologicals and vaccines for prevention
and therapy of Ebola Zaire infection/
disease.
Development Stage: Preclinical
Research.
Inventors: Nancy J. Sullivan, Ph.D.
(NIAID); John Misasi, Ph.D. (NIAID).
Intellectual Property: HHS Reference
Number E–061–2018 includes U.S.
Provisional Patent Application Number
62/782,809, filed 12/20/2018, and PCT
Application Number PCT/US2019/
067423, filed 12/19/2019.
Licensing Contact: To license this
technology, please contact Dianca
Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov.
Dated: February 4, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–02916 Filed 2–12–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices
amended, notice is hereby given of the
following meeting.
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, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Office of Research
Infrastructure Programs Special Emphasis
Panel; Office of Research Infrastructure
Programs (ORIP) Special Emphasis Panel:
Applications for Scientific Conferences.
Date: March 20, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: Kenneth Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3218,
MSC 7717, Bethesda, MD 20892, (301) 435–
0229, kenneth.ryan@nih.hhs.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: February 7, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–02860 Filed 2–12–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; NCI Genomic Data
Commons (GDC) Data Submission
Request Form (National Cancer
Institute)
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/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
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: Zhining Wang,
Ph.D., Project Officer, Center for Cancer
Genomics (CCG), National Cancer
Institute, Building 31 Room 3A20, 31
Center Drive, Bethesda, MD 20814 or
call non-toll-free number 301–402–1892
or email your request, including your
address to: zhining.wang@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on December 2, 2019 page
65990 (Vol. 84 No. 231 FR 65990 and
allowed 60 days for public comment. No
ADDRESSES:
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Cancer Institute (NCI),
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: NCI Genomic
Data Commons (GDC) Data Submission
Request Form, 0925–0752, Expiration
Date 5/31/2020, EXTENSION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of the NCI
Genomic Data Commons (GDC) Data
Submission Request Form is to provide
a vehicle for investigators to request
submission of their cancer genomic data
into the GDC in support of data sharing.
The purpose is to also provide a
mechanism for the GDC Data
Submission Review Committee to
review and assess the data submission
request for applicability to the GDC
mission. The scope of the form involves
obtaining information from investigators
that: (1) Would like to submit data about
their study into the GDC, (2) are
affiliated with studies that adhere to
GDC data submission conditions. The
benefits of the collection are that it
provides the needed information for
investigators to understand the types of
studies and data that the GDC supports,
and that it provides a standard
mechanism for the GDC to assess
incoming data submission requests.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
50 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Type ofrespondent
Number of
responses
per
respondent
Average time
per response
(in hours)
Total annual
burden hour
Investigator ......................................................................................................
200
1
15/60
50
Total ..........................................................................................................
........................
200
........................
50
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]]>Agencies
[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8306-8307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, National Institutes of Health; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
[[Page 8307]]
amended, notice is hereby given of the following meeting.
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, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Office of Research Infrastructure Programs
Special Emphasis Panel; Office of Research Infrastructure Programs
(ORIP) Special Emphasis Panel: Applications for Scientific
Conferences.
Date: March 20, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Dr., Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, (301) 435-
0229, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.14,
Intramural Research Training Award; 93.22, Clinical Research Loan
Repayment Program for Individuals from Disadvantaged Backgrounds;
93.232, Loan Repayment Program for Research Generally; 93.39,
Academic Research Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187,
Undergraduate Scholarship Program for Individuals from Disadvantaged
Backgrounds, National Institutes of Health, HHS)
Dated: February 7, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-02860 Filed 2-12-20; 8:45 am]
BILLING CODE 4140-01-P
