Submission for OMB Review; 30-Day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director), 14689-14690 [2020-05104]
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Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
Dated: March 9, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05094 Filed 3–12–20; 8:45 am]
BILLING CODE 4140–01–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:
Peter Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov. Licensing
information and copies of the patent
applications 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to receive copies of unpublished patent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.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Genomic Sequence of Avian
Paramyxovirus Type 2 and Uses
Thereof
Description of Technology
As a first step towards characterizing
the molecular genetics and pathogenesis
of avian paramyxovirus type 2 (APMV–
2), the biological activities and growth
characteristics of APMV–2 were
investigated. The present inventors
found that APMV–2 is different than
Newcastle Disease Virus (NDV, AMPV–
1) in several characteristics: (I) APMV–
2 does not require trypsin or allantoic
fluid to grow in cell culture; (II)
previous RNA–RNA hybridization
studies showed APMV–2 is genetically
different than NDV; (III) APMV–2 is the
only paramyxovirus serotype which
causes single-cell infection foci in cell
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culture, and does not induce cell fusion,
which is a hallmark of paramyxovirus
infection; (IV) APMV–2 does not kill
chicken embryos; and (V) APMV–2 does
not grow in the brain of chickens.
These results suggested that APMV–2
is significantly different biologically and
genetically from NDV. These differences
provide certain advantages over other
viruses considered for use as a vaccine,
as a virus vector, or as a therapeutic. For
example, unlike the current NDV
vaccine such as LaSota and Hitchner B1
that can cause disease due to reversion
to virulence, since AMPV–2 is not an
agricultural pathogen, it is not a concern
for the poultry industry. Unlike many
strains of NDV, APMV–2 is not a Select
Agent.
However, in order to develop a
recombinant APMV–2 virus for use as a
vector, vaccine, or cancer therapy, the
complete genome sequence was needed,
and a reverse genetic system needed to
be developed. Sequence analysis proved
to be difficult since primers based on
NDV were not useful because the two
viruses are genetically different.
Therefore, different strategies had to be
used for primer design, including the
design and testing of consensus primers
from other paramyxoviruses, primers
based on gene start and gene end
sequences of other paramyxoviruses,
and primer walking.
This invention covers the complete
genomic sequence of avian
paramyxovirus type 2, strains Yucaipa,
England, Kenya and Bangor. The
genomic sequence of strain Yucaipa was
used to develop a reverse genetic system
for AMPV–2. This produced cDNAderived AMPV–2 with the same
properties as biologically-derived
AMPV–2, confirming the authenticity of
the genomic sequence. The sequence
and reverse genetic system are useful for
production of recombinant infective
virus, a virus vector, for vaccine
development and for therapeutic
compositions. The sequences are also
useful for development of viral
diagnostics. The recombinant APMV–2
was used to express a foreign antigen,
the green fluorescent protein (GFP), and
can be used as a vaccine vector.
Recombinant APMV–2 can also be used
in cancer treatment, similar to NDV.
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 therapeutics
• Viral diagnostics
• Vaccine research
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14689
Competitive Advantages
• Ease of manufacture
• Low-cost vaccine
• Adjuvants unnecessary
Development Stage
• In vivo data assessment (animal)
Inventors: Siba Samal (EM), Peter
Collins (NIAID).
Intellectual Property: HHS Reference
No. E–019–2018–0—U.S. Provisional
Application No. 61/218,851, filed June
19, 2009, HHS Reference No. E–019–
2018–1—U.S. Patent Application No.
12/803165, filed June 21, 2010, now
U.S. Patent No. 9,937,196.
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: March 2, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–05146 Filed 3–12–20; 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; Generic Clearance
for NIH Citizen Science and
Crowdsourcing Projects (Office of the
Director)
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)
ADDRESSES:
E:\FR\FM\13MRN1.SGM
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14690
Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
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: Mikia Currie,
Chief, Project Clearance Branch (PCB),
Office of Policy and Extramural
Research Administration (OPERA),
Office of the Director (OD), Office of
Extramural Research (OER), NIH, 6705
Rockledge Drive, Bethesda, Maryland
20892, MSC 7980, or call non-toll-free
number (301) 435–0941 or Email your
request, including your address to:
ProjectClearanceBranch@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 4, 2019, page 53162
(84 FR 53162) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
clearance will allow Agency researchers
and program staff to test ideas more
quickly, respond to the project’s needs
as they evolve, and incorporate feedback
from participants for flexible, innovative
research methods. The purpose of this
information collection is to:
• Accelerate scientific research
• Increase cost-effectiveness to
maximize the return on taxpayer
dollars
• Address societal needs
• Provide hands-on learning in STEM
education
• Connect members of the public
directly to federal science missions
and each other
• Identify and disseminate resources
more broadly to the public, on the
Institutes’ and Centers’ (ICs) websites,
and/or
• Collect information for agency
internal use to improve scientific
practices and/or assist in scientific
reviews
for public comment. The Project
Clearance Branch (PCB), Office of Policy
and Extramural Research
Administration (OPERA), Office of the
Director (OD), Office of Extramural
Research (OER), 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 for NIH Citizen Science and
Crowdsourcing Projects—0925–New—
XX/XX/XXXX, Project Clearance Branch
(PCB), Office of Policy and Extramural
Research Administration (OPERA),
Office of the Director (OD), Office of
Extramural Research (OER), National
Institutes of Health (NIH).
Need and Use of Information
Collection: Projects under this generic
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
18,584.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of collection
Time per
response
(in hours)
Total hours
Call for Nominations/Resources ......................................................................
Recommendations of scientific reviewers .......................................................
Request for Population Characteristics ...........................................................
Repository of Tools and Best Practices ..........................................................
1,000
1,000
20,000
100,000
1
1
1
1
10/60
5/60
5/60
10/60
167
83
1,667
16,667
Total ..........................................................................................................
122,000
........................
........................
18,584
Dated: March 5, 2020.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2020–05104 Filed 3–12–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
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Number of
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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.,
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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: National Institute of
Mental Health Special Emphasis Panel;
NIMH Pathway to Independence Awards
(K99/R00, K22).
Date: March 24, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6001
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
PO 00000
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6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–9734,
millerda@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: March 9, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05093 Filed 3–12–20; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14689-14690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05104]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Generic
Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of
the Director)
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/or suggestions regarding the item(s)
[[Page 14690]]
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,
[email protected] 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: Mikia Currie, Chief, Project Clearance Branch
(PCB), Office of Policy and Extramural Research Administration (OPERA),
Office of the Director (OD), Office of Extramural Research (OER), NIH,
6705 Rockledge Drive, Bethesda, Maryland 20892, MSC 7980, or call non-
toll-free number (301) 435-0941 or Email your request, including your
address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on October 4, 2019, page
53162 (84 FR 53162) 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 Project Clearance Branch
(PCB), Office of Policy and Extramural Research Administration (OPERA),
Office of the Director (OD), Office of Extramural Research (OER),
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 for NIH Citizen Science and
Crowdsourcing Projects--0925-New--XX/XX/XXXX, Project Clearance Branch
(PCB), Office of Policy and Extramural Research Administration (OPERA),
Office of the Director (OD), Office of Extramural Research (OER),
National Institutes of Health (NIH).
Need and Use of Information Collection: Projects under this generic
clearance will allow Agency researchers and program staff to test ideas
more quickly, respond to the project's needs as they evolve, and
incorporate feedback from participants for flexible, innovative
research methods. The purpose of this information collection is to:
Accelerate scientific research
Increase cost-effectiveness to maximize the return on taxpayer
dollars
Address societal needs
Provide hands-on learning in STEM education
Connect members of the public directly to federal science
missions and each other
Identify and disseminate resources more broadly to the public,
on the Institutes' and Centers' (ICs) websites, and/or
Collect information for agency internal use to improve
scientific practices and/or assist in scientific reviews
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 18,584.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Time per
Type of collection Number of responses per response (in Total hours
respondents respondent hours)
----------------------------------------------------------------------------------------------------------------
Call for Nominations/Resources.................. 1,000 1 10/60 167
Recommendations of scientific reviewers......... 1,000 1 5/60 83
Request for Population Characteristics.......... 20,000 1 5/60 1,667
Repository of Tools and Best Practices.......... 100,000 1 10/60 16,667
---------------------------------------------------------------
Total....................................... 122,000 .............. .............. 18,584
----------------------------------------------------------------------------------------------------------------
Dated: March 5, 2020.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2020-05104 Filed 3-12-20; 8:45 am]
BILLING CODE 4140-01-P
