82_FR_59056 82 FR 58817 - Government-Owned Inventions; Availability for Licensing

82 FR 58817 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 239 (December 14, 2017)

Page Range58817-58818
FR Document2017-26937

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.

Federal Register, Volume 82 Issue 239 (Thursday, December 14, 2017) 
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58817-58818]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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unpublished patent applications.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

Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices 58817 FDA to develop patient-focused drug docket, and publish a draft guidance by licensing to achieve expeditious development guidance to address a the end of fiscal year 2018. commercialization of results of number of areas, including how a federally-funded research and III. Participating in the Public person seeking to develop and submit a development. Foreign patent Workshop proposed draft guidance relating to applications are filed on selected patient experience data for Registration: Interested parties are inventions to extend market coverage consideration by FDA may submit such encouraged to register early. To register for companies and may also be available proposed draft guidances. electronically, please visit https://pfdd- for licensing. In FDA’s ‘‘Plan for Issuance of proposeddraftguidance.eventbrite.com. FOR FURTHER INFORMATION CONTACT: Dr. Patient-Focused Drug Development Persons without access to the internet Natalie Greco, 301–761–7898; Guidance,’’ (the Plan) available at can call 240–402–6525 to register. If you Natalie.Greco@nih.gov. Licensing https://www.fda.gov/downloads/ are unable to attend the public information and copies of the patent ForIndustry/UserFees/ workshop in person, you can register to applications listed below may be PrescriptionDrugUserFee/ view a live webcast. You will be asked obtained by communicating with the UCM563618.pdf, the Agency proposed to indicate in your registration if you indicated licensing contact at the issuing a guidance addressing this topic plan to attend in person or via the Technology Transfer and Intellectual described in section 3002 during the webcast. Seating will be limited, so Property Office, National Institute of second quarter of 2018. FDA recognizes early registration is recommended. Allergy and Infectious Diseases, 5601 that, like the other patient-focused drug Registration is free and will be on a first- Fishers Lane, Rockville, MD 20852; tel. development guidances described in the come, first-served basis. However, FDA 301–496–2644. A signed Confidential Plan, developing this draft guidance may limit the number of participants Disclosure Agreement will be required will also benefit from public input from from each organization based on space to receive copies of unpublished patent the wider community of patients, limitations. Registrants will receive applications. patient advocates, academic researchers, confirmation once they have been SUPPLEMENTARY INFORMATION: expert practitioners, drug developers, accepted. Onsite registration on the day Technology description follows. and other stakeholders prior to FDA’s of the public workshop will be based on drafting of the guidance. Accordingly, space availability. If you need special Monoclonal Antibody Specific for DNA/ the Agency is scheduling this public accommodations because of a disability, RNA Hybrid Molecules workshop. After this public workshop, please contact Meghana Chalasani (see Description of Technology FDA will take into consideration the FOR FURTHER INFORMATION CONTACT) at stakeholder input from the workshop NIAID has a hybridoma available for least 7 days before the public workshop. and the public docket, and publish a Open Public Comment: There will be non-exclusive licensing that produces a draft guidance by the end of fiscal year time allotted during the public monoclonal antibody specific for DNA/ 2018. workshop for open public comment. RNA hybrids. This antibody, which has Sign-up for this session will be on a been extensively characterized by NIH II. Purpose and Scope of Meeting researchers, is already a widely-used first-come, first-serve basis on the day of FDA is announcing a public the public workshop. Individuals and research tool. It is currently the only workshop to convene a discussion on organizations with common interests are monoclonal antibody available that is topics related to developing and urged to consolidate or coordinate, and specific for DNA/RNA hybrids, making submitting proposed draft guidance request time for a joint presentation. No it a unique reagent. It is used in relating to patient experience data by an commercial or promotional material immuno-fluorescence (IF) microscopy, external stakeholder. The purpose of will be permitted to be presented or where it can be used to detect sites of this public workshop is to obtain input distributed at the public workshop. transcriptional activity and potentially from stakeholders on considerations for Transcripts: As soon as a transcript is sites of viral replication. It has also been development and submission of available of the public workshop, FDA used in DNA/RNA immunoprecipitation proposed draft guidance relating to will post it at https://www.fda.gov/ (DRIP) experiments by a variety of patient experience data submitted by an Drugs/NewsEvents/ucm582081.htm. researchers. external stakeholder, including: (1) Aside from its use as a research tool, Defining the scope of the proposed draft Dated: December 11, 2017. this antibody has potential to be used in guidance, (2) developing the proposed Leslie Kux, diagnostic kits for viral/bacterial draft guidance, and (3) submitting the Associate Commissioner for Policy. infections, cancers, and a variety of proposed draft guidance to FDA, [FR Doc. 2017–26978 Filed 12–13–17; 8:45 am] other human diseases. DNA/RNA including the process and format. The BILLING CODE 4164–01–P hybrids arise during normal cellular Agency is seeking information and function, but they are typically present comments from a broad range of in cells at low levels. When DNA/RNA stakeholders, including patients, patient DEPARTMENT OF HEALTH AND hybrids are found at high levels in a advocates, academic and medical HUMAN SERVICES cell, it indicates that the cell is researchers, expert practitioners, drug ‘‘abnormal’’. For example, the cell may developers, and other interested National Institutes of Health be cancerous or infected with a virus. persons. FDA will publish a background NIH researchers have also incorporated document outlining the topic areas that Government-Owned Inventions; the antibody into a micro-array Availability for Licensing sradovich on DSK3GMQ082PROD with NOTICES will be addressed in the draft guidance platform, expanding its potential for use approximately 2 weeks before the AGENCY: National Institutes of Health, in diagnostic devices. workshop date at the following website: HHS. This technology is available for https://www.fda.gov/Drugs/NewsEvents/ ACTION: Notice. licensing for commercial development ucm582081.htm. in accordance with 35 U.S.C. 209 and 37 After this public workshop, FDA will SUMMARY: The invention listed below is CFR part 404, as well as for further take into consideration the stakeholder owned by an agency of the U.S. development and evaluation under a input from the workshop and the public Government and is available for research collaboration. VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1

58818 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices Potential Commercial Applications Dated: December 1, 2017. 1381 or Email your request, including Research tool: Suzanne Frisbie, your address to: GarciaA@od.nih.gov. • Detection and visualization of DNA/ Deputy Director, Technology Transfer and SUPPLEMENTARY INFORMATION: This Intellectual Property Office, National Institute proposed information collection was RNA hybrids, ‘‘R-loops’’, or sites of of Allergy and Infectious Diseases. previously published in the Federal viral replication in cells • DNA/RNA immunoprecipitation [FR Doc. 2017–26937 Filed 12–13–17; 8:45 am] Register on September 15, 2017, page (DRIP) studies BILLING CODE 4140–01–P 43394 (82 FR 43394) and allowed 60 • Antibody based micro-arrays days for public comment. No public For use in diagnostic kits that detect: comments were received. The purpose DEPARTMENT OF HEALTH AND of this notice is to allow an additional • Viral/bacterial infections HUMAN SERVICES • miRNA biomarkers of disease (i.e. 30 days for public comment. The Office certain cancers) of Intramural Research (OIR), Office of National Institutes of Health the Director, National Institutes of Competitive Advantages Health, may not conduct or sponsor, Submission for OMB Review; 30-Day • Only available monoclonal antibody Comment Request; Special Volunteer and the respondent is not required to specific for DNA/RNA hybrids and Guest Researcher Assignment respond to, an information collection • Binding properties extensively (Office of Intramural Research, Office that has been extended, revised, or characterized by NIH researchers of the Director) implemented on or after October 1, • Widely-accepted as a key research 1995, unless it displays a currently valid reagent AGENCY: National Institutes of Health, OMB control number. • Antibody based micro-arrays are HHS. In compliance with Section inexpensive, efficient, and increase ACTION: Notice. 3507(a)(1)(D) of the Paperwork detection of small or structured Reduction Act of 1995, the National transcripts, as well as transcripts SUMMARY: In compliance with the Institutes of Health (NIH) has submitted present at low levels Paperwork Reduction Act of 1995, the to the Office of Management and Budget National Institutes of Health (NIH) has (OMB) a request for review and Development Stage submitted to the Office of Management approval of the information collection • in vitro data available and Budget (OMB) a request for review listed below. and approval of the information Inventors Proposed Collection: Special collection listed below. S. Leppla, C. Leysath, D. Phillips, D. Volunteer and Guest Researcher DATES: Comments regarding this Assignment—0925–0177, exp., date Garboczi, L. Lantz (all of NIAID). information collection are best assured 08/31/2017—Reinstatement without Publications of having their full effect if received Change of, Office of Intramural Research within 30-days of the date of this • Phillips DD, et al. (2013)—PMID: publication. (OIR), Office of the Director (OD), 23784994—PMCID: PMC4061737— National Institutes of Health (NIH). The sub-nanomolar binding of DNA– ADDRESSES: Written comments and/or Need and Use of Information RNA hybrids by the single-chain Fv suggestions regarding the item(s) Collection: Form Number: NIH–590 is a fragment of antibody S9.6 contained in this notice, especially single form completed by an NIH • Hu Z, et al. (2006)—PMID: regarding the estimated public burden official for each Guest Researcher or 16614443—PMCID: PMC1435976— and associated response time, should be Special Volunteer prior to his/her An antibody-based microarray assay directed to the: Office of Management arrival at NIH. The information on the for small RNA detection and Budget, Office of Regulatory Affairs, form is necessary for the approving Intellectual Property: HHS Reference OIRA_submission@omb.eop.gov or by official to reach a decision on whether No. E–738–2013 fax to 202–395–6974, Attention: Desk to allow a Guest Researcher to use NIH Licensing Contact: Dr. Natalie Greco, Officer for NIH. facilities, or whether to accept volunteer 301–761–7898; Natalie.Greco@nih.gov FOR FURTHER INFORMATION CONTACT: To services offered by a Special Volunteer. Collaborative Research Opportunity: request more information on the If the original assignment is extended, The National Institute of Allergy and proposed project or to obtain a copy of another form notating the extension is Infectious Diseases is seeking statements the data collection plans and completed to update the file. In of capability or interest from parties instruments, contact: Dr. Arlyn Garcia- addition, each Special Volunteer and interested in collaborative research to Perez, Assistant Director, Office of Guest Researcher reads and signs an further develop, evaluate or Intramural Research, Office of the NIH Agreement. commercialize antibodies produced by Director, National Institutes of Health, 1 OMB approval is requested for 3 the S9.6 hybridoma. For collaboration Center Drive MSC 0140, Building 1, years. There are no costs to respondents opportunities, please contact Dr. Natalie Room 160, MSC–0140, Bethesda, other than their time. The total Greco, 301–761–7898; Natalie.Greco@ Maryland 20892 or call non-toll-free estimated annualized burden hours are nih.gov. number (301) 496–1921 or (301) 496– 527. ESTIMATED ANNUALIZED BURDEN HOURS sradovich on DSK3GMQ082PROD with NOTICES Number of Average Total annual Number of responses burden per Form name Type of respondents hour burden respondents per response hours respondent (in hours) Special Volunteer and Guest Re- Special Volunteers and Guest re- 2,870 1 6/60 287 searcher Assignment. searchers. NIH Special Volunteer Agreement .... Special Volunteers ........................... 2,600 1 5/60 217 VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1


Document Created: 2018-10-25 10:52:50
Document Modified: 2018-10-25 10:52:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. 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.
FR Citation82 FR 58817 
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