83 FR 55904 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

Page Range		55904-55905
FR Document		2018-24468

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 83 Issue 217 (Thursday, November 8, 2018)

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55904-55905]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24468]


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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. Jenish Patel, Ph.D., 240-669-2894; 
[email protected]. 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to receive copies of unpublished patent applications.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.

Universal Influenza Virus Probes for Enrichment of Influenza Viral 
Sequences

    Description of Technology:
    This technology is a set of influenza virus enrichment probes 
developed to increase the sensitivity of sequence-based, universal 
detection of all influenza viruses. This universal influenza enrichment 
probe set contains a unique set of 46,953 biotin-labeled, RNA probes, 
each 120 base-pairs long, that can be used to enrich for any influenza 
sequences without prior knowledge of type or subtype. This probe set 
can capture and enrich influenza viral sequences selectively and 
effectively in a variety of samples, such as clinical samples with 
degraded nucleotides or samples containing very low amounts of 
influenza virus, thus making it a valuable tool for influenza virus 
diagnoses and surveillance.
    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:
     Influenza diagnostics; influenza surveillance
    Competitive Advantages:
     Highly sensitive detection of influenza viruses
     Detection of any influenza viruses in a variety of samples
    Development Stage:
     In vitro Testing
    Inventors: Yongli Xiao, Ph.D., (NIAID), Jeffrey Taubenberger, 
Ph.D., (NIAID), and Zong-Mei Sheng, Ph.D. (NIAID)
    Publications: Xiao Y, et al. Design and validation of a universal 
influenza virus enrichment probe set and its utility in deep sequence 
analysis of primary cloacal swab surveillance samples of wild birds. 
Virology, 2018, Nov; 524:182-191 [PMID 30212665]
    Intellectual Property: HHS Reference No. E-032-2018/0--US-01 Patent 
Application No. 62/611,734 filed December 29, 2017.
    Licensing Contact: Jenish Patel, Ph.D., 240-669-2894; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases (NIAID) is also

[[Page 55905]]

seeking statements of capability or interest from parties interested in 
collaborative research, such as from bio-analytic research groups to 
develop rapid influenza monitoring, diagnostic, and surveillance 
devices and biotechnology companies to formulate and test influenza 
next generation sequencing kits for challenging influenza infected 
samples, for example zoonotic infections of influenza A virus subtypes 
differing from currently circulating human influenza viruses or in 
mixed infections. NIAID will consider executing a Confidentiality 
Agreement with a prospective collaborator to facilitate receipt of a 
Capability Statement if requested. For collaboration opportunities, 
please contact Jenish Patel, Ph.D., 240-669-2894; [email protected].

    Dated: October 19, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-24468 Filed 11-7-18; 8:45 am]
 BILLING CODE 4140-01-P

55904 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices

least five business days in advance of and private sectors that provides Property Office, National Institute of
the event. primary scientific oversight to the NTP. Allergy and Infectious Diseases, 5601
Written Public Comments: NTP Specifically, the BSC advises the NTP Fishers Lane, Rockville, MD, 20852; tel.
invites written public comments. on matters of scientific program content, 301–496–2644. A signed Confidential
Guidelines for public comments are both present and future, and conducts Disclosure Agreement will be required
available at https://ntp.niehs.nih.gov/ periodic review of the program for the to receive copies of unpublished patent
ntp/about_ntp/guidelines_public_ purpose of determining and advising on applications.
comments_508.pdf. the scientific merit of its activities and SUPPLEMENTARY INFORMATION:
The deadline for submission of their overall scientific quality. Its Technology description follows.
written comments is December 3, 2018. members are selected from recognized
Written public comments should be authorities knowledgeable in fields such Universal Influenza Virus Probes for
submitted through the meeting website. as toxicology, pharmacology, pathology, Enrichment of Influenza Viral
Persons submitting written comments biochemistry, epidemiology, risk Sequences
should include name, affiliation, assessment, carcinogenesis, Description of Technology:
mailing address, phone, email, and mutagenesis, molecular biology, This technology is a set of influenza
sponsoring organization (if any). Written behavioral toxicology, neurotoxicology, virus enrichment probes developed to
comments received in response to this immunotoxicology, reproductive increase the sensitivity of sequence-
notice will be posted on the NTP toxicology or teratology, and based, universal detection of all
website, and the submitter will be biostatistics. Members serve overlapping influenza viruses. This universal
identified by name, affiliation, and terms of up to four years. The BSC influenza enrichment probe set contains
sponsoring organization (if any). usually meets biannually. The authority a unique set of 46,953 biotin-labeled,
Oral Public Comment Registration: for the BSC is provided by 42 U.S.C. RNA probes, each 120 base-pairs long,
The agenda allows for two public 217a, section 222 of the Public Health that can be used to enrich for any
comment periods: The first comment Service Act (PHS), as amended. influenza sequences without prior
period on the CLARITY–BPA Research The BSC is governed by the knowledge of type or subtype. This
Program: Integration Report Strategy (5 provisions of the Federal Advisory probe set can capture and enrich
commenters, up to 5 minutes per Committee Act, as amended (5 U.S.C. influenza viral sequences selectively
speaker) and the second comment app.), which sets forth standards for the and effectively in a variety of samples,
period on the peer review of the Draft formation and use of advisory such as clinical samples with degraded
Report on Carcinogens Monograph on committees. nucleotides or samples containing very
Night Shift Work and Light at Night (5 low amounts of influenza virus, thus
commenters, up to 5 minutes per Dated: October 31, 2018.
Brian R. Berridge, making it a valuable tool for influenza
speaker); oral comments may be virus diagnoses and surveillance.
presented in person at NIEHS or by Associate Director, National Toxicology
Program.
This technology is available for
teleconference line. Registration for oral licensing for commercial development
comments is on or before December 3, [FR Doc. 2018–24472 Filed 11–7–18; 8:45 am]
in accordance with 35 U.S.C. 209 and 37
2018, at http://ntp.niehs.nih.gov/go/165. BILLING CODE 4140–01–P
CFR part 404, as well as for further
Registration is on a first-come, first- development and evaluation under a
served basis, and registrants will be research collaboration.
assigned a number in their confirmation DEPARTMENT OF HEALTH AND
Potential Commercial Applications:
email. Each organization is allowed one HUMAN SERVICES
• Influenza diagnostics; influenza
time slot per comment period. After the surveillance
maximum number of speakers per National Institutes of Health
Competitive Advantages:
comment period is exceeded, Government-Owned Inventions; • Highly sensitive detection of
individuals registered to provide oral Availability for Licensing influenza viruses
comment will be placed on a wait list • Detection of any influenza viruses
and notified should an opening become AGENCY: National Institutes of Health, in a variety of samples
available. Commenters will be notified HHS. Development Stage:
after December 3, 2018, about the actual ACTION: Notice. • In vitro Testing
time allotted per speaker, and the Inventors: Yongli Xiao, Ph.D.,
teleconference number will be sent to SUMMARY: The invention listed below is (NIAID), Jeffrey Taubenberger, Ph.D.,
those registered to give oral comments owned by an agency of the U.S. (NIAID), and Zong-Mei Sheng, Ph.D.
by teleconference line. Government and is available for (NIAID)
If possible, oral public commenters licensing to achieve expeditious Publications: Xiao Y, et al. Design and
should send a copy of their slides and/ commercialization of results of validation of a universal influenza virus
or statement or talking points to NTP- federally-funded research and enrichment probe set and its utility in
Meetings@icf.com by December 3, 2018. development. Foreign patent deep sequence analysis of primary
Meeting Materials: The preliminary applications are filed on selected cloacal swab surveillance samples of
meeting agenda is available on the inventions to extend market coverage wild birds. Virology, 2018, Nov;
meeting web page (http:// for companies and may also be available 524:182–191 [PMID 30212665]
ntp.niehs.nih.gov/go/165) and will be for licensing. Intellectual Property: HHS Reference
updated one week before the meeting. FOR FURTHER INFORMATION CONTACT: Dr. No. E–032–2018/0—US–01 Patent
daltland on DSKBBV9HB2PROD with NOTICES

Individuals are encouraged to access the Jenish Patel, Ph.D., 240–669–2894; Application No. 62/611,734 filed
meeting web page to stay abreast of the jenish.patel@nih.gov. Licensing December 29, 2017.
most current information regarding the information and copies of the U.S. Licensing Contact: Jenish Patel, Ph.D.,
meeting. patent application listed below may be 240–669–2894; jenish.patel@nih.gov
Background Information on the BSC: obtained by communicating with the Collaborative Research Opportunity:
The BSC is a technical advisory body indicated licensing contact at the The National Institute of Allergy and
comprised of scientists from the public Technology Transfer and Intellectual Infectious Diseases (NIAID) is also

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Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 55905

seeking statements of capability or proposed data collection projects, the electronic, mechanical, or other
interest from parties interested in National Institutes of Health Eunice technological collection techniques or
collaborative research, such as from bio- Kennedy Shriver National Institute of other forms of information technology.
analytic research groups to develop Child Health and Human Development Proposed Collection Title: National
rapid influenza monitoring, diagnostic, will publish periodic summaries of Children’s Study (NCS) Vanguard Data
and surveillance devices and proposed projects to be submitted to the and Sample Archive and Access
biotechnology companies to formulate Office of Management and Budget System, 0925–0730 exp., date 2/28/
and test influenza next generation (OMB) for review and approval. 2019—EXTENSION Eunice Kennedy
sequencing kits for challenging DATES: Comments regarding this Shriver National Institute of Child
influenza infected samples, for example information collection are best assured Health and Human Development
zoonotic infections of influenza A virus of having their full effect if received (NICHD), National Institutes of Health
subtypes differing from currently within 60 days of the date of this (NIH).
circulating human influenza viruses or publication. Need and Use of Information
in mixed infections. NIAID will FOR FURTHER INFORMATION CONTACT: To Collection: NICHD requires institutional
consider executing a Confidentiality obtain a copy of the data collection and investigator contact information
Agreement with a prospective plans and instruments, submit from users of the NCS Data and Sample
collaborator to facilitate receipt of a comments in writing, or request more Archive and Access System (NCS
Capability Statement if requested. For information on the proposed project, Archive). This information collected
collaboration opportunities, please contact: Jack Moye, Jr., MD, Bldg. 6710B from potential data users is necessary to
contact Jenish Patel, Ph.D., 240–669– Rm. 2130 MSC 7002, 9000 Rockville fulfill the requirements of their
2894; jenish.patel@nih.gov. Pike, Bethesda, MD, 20892–7002, or call proposed research projects, ensure
Dated: October 19, 2018. non-toll-free number (301) 594–8624 or compliance with Department of Health
Suzanne M. Frisbie, Email your request, including your and Human Services regulations for the
Deputy Director, Technology Transfer and address to: NCSArchive@s-3.net. Formal protection of human subjects in research
Intellectual Property Office, National Institute requests for additional plans and (45 CFR 46) and the Common Rule (45
of Allergy and Infectious Diseases. instruments must be requested in CFR 46 Subpart A), and to document,
[FR Doc. 2018–24468 Filed 11–7–18; 8:45 am] writing. track, and monitor the use of the NCS
BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: Section Archive, which provides opportunities
3506(c)(2)(A) of the Paperwork for qualified researchers to use data and
Reduction Act of 1995 requires: Written samples collected by the NCS Vanguard
DEPARTMENT OF HEALTH AND comments and/or suggestions from the phase, for approved research projects.
HUMAN SERVICES public and affected agencies are invited The information in addition will help
to address one or more of the following NIH better understand the use of
National Institutes of Health points: (1) Whether the proposed archived data and samples by the
collection of information is necessary research community. There is no plan to
Proposed Collection; 60-Day Comment publish the data collected under this
for the proper performance of the
Request; National Children’s Study request other than to post on the NCS
function of the agency, including
(NCS) Vanguard Data and Sample Archive website the titles of approved
whether the information will have
Archive and Access System (Eunice research projects together with project
practical utility; (2) The accuracy of the
Kennedy Shriver National Institute of investigators’ institutional affiliations.
agency’s estimate of the burden of the
Child Health and Human Development) The data otherwise are for internal
proposed collection of information,
AGENCY: National Institutes of Health, including the validity of the monitoring purposes only, to assess the
HHS. methodology and assumptions used; (3) archive resource requirements and for
ACTION: Notice. Ways to enhance the quality, utility, and quality improvement.
clarity of the information to be OMB approval is requested for 3
SUMMARY: In compliance with the collected; and (4) Ways to minimize the years. There are no costs to respondents
requirement of the Paperwork burden of the collection of information other than their time. The total
Reduction Act of 1995 to provide on those who are to respond, including estimated annualized burden hours are
opportunity for public comment on the use of appropriate automated, 109.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Total annual
Type of respondent Form per response
respondents response burden hours
(hours)

Research scientists ....... NCS Vanguard Data User Agreement ................ 300 1 10/60 50
Research scientists ....... NCS Vanguard Data Request Form ................... 50 1 20/60 17
Research scientists ....... NCS Vanguard Data and Sample Request Form 50 1 30/60 25
Research scientists ....... Research Materials Distribution Agreement ........ 100 1 10/60 17

Total ........................ .............................................................................. 500 500 ........................ 109
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Document Created: 2018-11-08 06:23:43
Document Modified: 2018-11-08 06:23:43

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Dr. Jenish Patel, Ph.D., 240-669-2894; [email protected] 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.
FR Citation		83 FR 55904

83 FR 55904 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health