Government-Owned Inventions; Availability for Licensing, 58817-58818 [2017-26937]
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Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
FDA to develop patient-focused drug
development guidance to address a
number of areas, including how a
person seeking to develop and submit a
proposed draft guidance relating to
patient experience data for
consideration by FDA may submit such
proposed draft guidances.
In FDA’s ‘‘Plan for Issuance of
Patient-Focused Drug Development
Guidance,’’ (the Plan) available at
https://www.fda.gov/downloads/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM563618.pdf, the Agency proposed
issuing a guidance addressing this topic
described in section 3002 during the
second quarter of 2018. FDA recognizes
that, like the other patient-focused drug
development guidances described in the
Plan, developing this draft guidance
will also benefit from public input from
the wider community of patients,
patient advocates, academic researchers,
expert practitioners, drug developers,
and other stakeholders prior to FDA’s
drafting of the guidance. Accordingly,
the Agency is scheduling this public
workshop. After this public workshop,
FDA will take into consideration the
stakeholder input from the workshop
and the public docket, and publish a
draft guidance by the end of fiscal year
2018.
II. Purpose and Scope of Meeting
FDA is announcing a public
workshop to convene a discussion on
topics related to developing and
submitting proposed draft guidance
relating to patient experience data by an
external stakeholder. The purpose of
this public workshop is to obtain input
from stakeholders on considerations for
development and submission of
proposed draft guidance relating to
patient experience data submitted by an
external stakeholder, including: (1)
Defining the scope of the proposed draft
guidance, (2) developing the proposed
draft guidance, and (3) submitting the
proposed draft guidance to FDA,
including the process and format. The
Agency is seeking information and
comments from a broad range of
stakeholders, including patients, patient
advocates, academic and medical
researchers, expert practitioners, drug
developers, and other interested
persons. FDA will publish a background
document outlining the topic areas that
will be addressed in the draft guidance
approximately 2 weeks before the
workshop date at the following website:
https://www.fda.gov/Drugs/NewsEvents/
ucm582081.htm.
After this public workshop, FDA will
take into consideration the stakeholder
input from the workshop and the public
VerDate Sep<11>2014
21:28 Dec 13, 2017
Jkt 244001
docket, and publish a draft guidance by
the end of fiscal year 2018.
III. Participating in the Public
Workshop
Registration: Interested parties are
encouraged to register early. To register
electronically, please visit https://pfddproposeddraftguidance.eventbrite.com.
Persons without access to the internet
can call 240–402–6525 to register. If you
are unable to attend the public
workshop in person, you can register to
view a live webcast. You will be asked
to indicate in your registration if you
plan to attend in person or via the
webcast. Seating will be limited, so
early registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the public workshop will be based on
space availability. If you need special
accommodations because of a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days before the public workshop.
Open Public Comment: There will be
time allotted during the public
workshop for open public comment.
Sign-up for this session will be on a
first-come, first-serve basis on the day of
the public workshop. Individuals and
organizations with common interests are
urged to consolidate or coordinate, and
request time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Transcripts: As soon as a transcript is
available of the public workshop, FDA
will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm582081.htm.
Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26978 Filed 12–13–17; 8:45 am]
BILLING CODE 4164–01–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
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
58817
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: Dr.
Natalie Greco, 301–761–7898;
Natalie.Greco@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.
Monoclonal Antibody Specific for DNA/
RNA Hybrid Molecules
Description of Technology
NIAID has a hybridoma available for
non-exclusive licensing that produces a
monoclonal antibody specific for DNA/
RNA hybrids. This antibody, which has
been extensively characterized by NIH
researchers, is already a widely-used
research tool. It is currently the only
monoclonal antibody available that is
specific for DNA/RNA hybrids, making
it a unique reagent. It is used in
immuno-fluorescence (IF) microscopy,
where it can be used to detect sites of
transcriptional activity and potentially
sites of viral replication. It has also been
used in DNA/RNA immunoprecipitation
(DRIP) experiments by a variety of
researchers.
Aside from its use as a research tool,
this antibody has potential to be used in
diagnostic kits for viral/bacterial
infections, cancers, and a variety of
other human diseases. DNA/RNA
hybrids arise during normal cellular
function, but they are typically present
in cells at low levels. When DNA/RNA
hybrids are found at high levels in a
cell, it indicates that the cell is
‘‘abnormal’’. For example, the cell may
be cancerous or infected with a virus.
NIH researchers have also incorporated
the antibody into a micro-array
platform, expanding its potential for use
in diagnostic devices.
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.
E:\FR\FM\14DEN1.SGM
14DEN1
58818
Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
Potential Commercial Applications
Research tool:
• Detection and visualization of DNA/
RNA hybrids, ‘‘R-loops’’, or sites of
viral replication in cells
• DNA/RNA immunoprecipitation
(DRIP) studies
• Antibody based micro-arrays
For use in diagnostic kits that detect:
• Viral/bacterial infections
• miRNA biomarkers of disease (i.e.
certain cancers)
Competitive Advantages
• Only available monoclonal antibody
specific for DNA/RNA hybrids
• Binding properties extensively
characterized by NIH researchers
• Widely-accepted as a key research
reagent
• Antibody based micro-arrays are
inexpensive, efficient, and increase
detection of small or structured
transcripts, as well as transcripts
present at low levels
Development Stage
• in vitro data available
Inventors
S. Leppla, C. Leysath, D. Phillips, D.
Garboczi, L. Lantz (all of NIAID).
Publications
• Phillips DD, et al. (2013)—PMID:
23784994—PMCID: PMC4061737—
The sub-nanomolar binding of DNA–
RNA hybrids by the single-chain Fv
fragment of antibody S9.6
• Hu Z, et al. (2006)—PMID:
16614443—PMCID: PMC1435976—
An antibody-based microarray assay
for small RNA detection
Intellectual Property: HHS Reference
No. E–738–2013
Licensing Contact: Dr. Natalie Greco,
301–761–7898; Natalie.Greco@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 antibodies produced by
the S9.6 hybridoma. For collaboration
opportunities, please contact Dr. Natalie
Greco, 301–761–7898; Natalie.Greco@
nih.gov.
Dated: December 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–26937 Filed 12–13–17; 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; Special Volunteer
and Guest Researcher Assignment
(Office of Intramural Research, 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.
ADDRESSES: 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: Dr. Arlyn GarciaPerez, Assistant Director, Office of
Intramural Research, Office of the
Director, National Institutes of Health, 1
Center Drive MSC 0140, Building 1,
Room 160, MSC–0140, Bethesda,
Maryland 20892 or call non-toll-free
number (301) 496–1921 or (301) 496–
SUMMARY:
1381 or Email your request, including
your address to: GarciaA@od.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on September 15, 2017, page
43394 (82 FR 43394) 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 Office
of Intramural Research (OIR), Office of
the Director, 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: Special
Volunteer and Guest Researcher
Assignment—0925–0177, exp., date
08/31/2017—Reinstatement without
Change of, Office of Intramural Research
(OIR), Office of the Director (OD),
National Institutes of Health (NIH).
Need and Use of Information
Collection: Form Number: NIH–590 is a
single form completed by an NIH
official for each Guest Researcher or
Special Volunteer prior to his/her
arrival at NIH. The information on the
form is necessary for the approving
official to reach a decision on whether
to allow a Guest Researcher to use NIH
facilities, or whether to accept volunteer
services offered by a Special Volunteer.
If the original assignment is extended,
another form notating the extension is
completed to update the file. In
addition, each Special Volunteer and
Guest Researcher reads and signs an
NIH Agreement.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
527.
sradovich on DSK3GMQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Type of respondents
Special Volunteer and Guest Researcher Assignment.
NIH Special Volunteer Agreement ....
Special Volunteers and Guest researchers.
Special Volunteers ...........................
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21:28 Dec 13, 2017
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Frm 00027
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total annual
hour burden
hours
2,870
1
6/60
287
2,600
1
5/60
217
E:\FR\FM\14DEN1.SGM
14DEN1
Agencies
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58817-58818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26937]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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: Dr. Natalie Greco, 301-761-7898;
[email protected]. 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.
Monoclonal Antibody Specific for DNA/RNA Hybrid Molecules
Description of Technology
NIAID has a hybridoma available for non-exclusive licensing that
produces a monoclonal antibody specific for DNA/RNA hybrids. This
antibody, which has been extensively characterized by NIH researchers,
is already a widely-used research tool. It is currently the only
monoclonal antibody available that is specific for DNA/RNA hybrids,
making it a unique reagent. It is used in immuno-fluorescence (IF)
microscopy, where it can be used to detect sites of transcriptional
activity and potentially sites of viral replication. It has also been
used in DNA/RNA immunoprecipitation (DRIP) experiments by a variety of
researchers.
Aside from its use as a research tool, this antibody has potential
to be used in diagnostic kits for viral/bacterial infections, cancers,
and a variety of other human diseases. DNA/RNA hybrids arise during
normal cellular function, but they are typically present in cells at
low levels. When DNA/RNA hybrids are found at high levels in a cell, it
indicates that the cell is ``abnormal''. For example, the cell may be
cancerous or infected with a virus. NIH researchers have also
incorporated the antibody into a micro-array platform, expanding its
potential for use in diagnostic devices.
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.
[[Page 58818]]
Potential Commercial Applications
Research tool:
Detection and visualization of DNA/RNA hybrids, ``R-loops'',
or sites of viral replication in cells
DNA/RNA immunoprecipitation (DRIP) studies
Antibody based micro-arrays
For use in diagnostic kits that detect:
Viral/bacterial infections
miRNA biomarkers of disease (i.e. certain cancers)
Competitive Advantages
Only available monoclonal antibody specific for DNA/RNA
hybrids
Binding properties extensively characterized by NIH
researchers
Widely-accepted as a key research reagent
Antibody based micro-arrays are inexpensive, efficient, and
increase detection of small or structured transcripts, as well as
transcripts present at low levels
Development Stage
in vitro data available
Inventors
S. Leppla, C. Leysath, D. Phillips, D. Garboczi, L. Lantz (all of
NIAID).
Publications
Phillips DD, et al. (2013)--PMID: 23784994--PMCID:
PMC4061737--The sub-nanomolar binding of DNA-RNA hybrids by the single-
chain Fv fragment of antibody S9.6
Hu Z, et al. (2006)--PMID: 16614443--PMCID: PMC1435976--An
antibody-based microarray assay for small RNA detection
Intellectual Property: HHS Reference No. E-738-2013
Licensing Contact: Dr. Natalie Greco, 301-761-7898;
[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 antibodies produced by the S9.6
hybridoma. For collaboration opportunities, please contact Dr. Natalie
Greco, 301-761-7898; [email protected].
Dated: December 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-26937 Filed 12-13-17; 8:45 am]
BILLING CODE 4140-01-P