81_FR_41708 81 FR 41585 - Government-Owned Inventions; Availability for Licensing

81 FR 41585 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 123 (June 27, 2016)

Page Range41585-41586
FR Document2016-15059

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

Federal Register, Volume 81 Issue 123 (Monday, June 27, 2016)
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41585-41586]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15059]


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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.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing and/or co-development in the 
U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention: Biomarker signature development: microRNAs as 
biodosimetry markers.
    Description of Technology:
    Alterations in microRNAs (miRNAs), a type of small non-coding RNAs, 
have been reported in cells/tumors subjected to radiation exposure, 
implying that miRNAs play an important role in cellular stress response 
to radiation.
    Researchers at the National Cancer Institute evaluated small non-
coding RNAs, long non-coding RNAs (lncRNA), and mRNA as potential non-
invasive biomarkers for radiation biodosimetry. While the use of miRNAs 
as radiation biomarkers has been reported, the integrated use of 
miRNAs, mRNAs and lncRNAs to accurately determine radiation doses is 
novel and has not been published. The researchers characterized a 
unique method of examining miRNA levels along with levels of its target 
mRNA and lncRNA to determine radiation exposure using whole blood 
samples from mice exposed to 2, 4, 8, 12 and 15 Gy irradiation. In 
doing so, they discovered distinct miRNA, mRNA and lncRNA biomarker 
signatures that inform degree of radiation exposure.

[[Page 41586]]

    Integrated analysis of miRNA, mRNAs, and lncRNAs to assess 
radiation exposure after mass-casualty incidents could provide a 
valuable tool in identifying biomarkers, and in the development and 
appropriate implementation of effective medical countermeasures. This 
application could potentially also be used to immediately detect, and 
therefore circumvent or mitigate non-specific injury from cancer 
radiotherapy treatments.
    Potential Commercial Applications:
     Diagnostic for radiation exposure, including for 
therapeutic procedures.
    Value Proposition:
     Blood-based biomarker assay for circulating miRNAs.
     Could be developed as part of point-of-care and high-
throughput screening platforms.
     Immediate medical care based on amount of radiation 
exposure is critical for giving appropriate care to affected 
individuals.
    Development Stage:
    In-vivo testing.
    Inventor(s):
    Molykutty Aryankalayil (NCI), Norman Coleman (NCI), Adeola Makinde 
(NCI).
    Intellectual Property:
    HHS Reference No. E-066-2015/0-US-01 US Provisional Application 62/
244,044 (HHS Reference No. E-066-2016/0-US-01) filed October 20, 2015 
entitled ``Biomarker signature development: microRNAs as biodosimetry 
markers''
    Collaboration Opportunity: Researchers at the NCI seek parties 
interested in licensing or co-development for microRNA biomarker 
signatures as biodosimetry markers.
    Contact Information:
    Requests for copies of the patent application or inquiries about 
licensing, research collaborations, and co-development opportunities 
should be sent to John D. Hewes, Ph.D., email: [email protected] or 
phone: 240-276-5515.

    Dated: June 20, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-15059 Filed 6-24-16; 8:45 am]
BILLING CODE 4140-01-P



                                                                                 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices                                             41585

                                                    Dated: June 21, 2016.                                 limitations imposed by the review and                  ACTION:   Notice.
                                                  Michelle Trout,                                         funding cycle.
                                                  Program Analyst, Office of Federal Advisory               Name of Committee: AIDS and Related                  SUMMARY:     The invention listed below is
                                                  Committee Policy.                                       Research Integrated Review Group;                      owned by an agency of the U.S.
                                                  [FR Doc. 2016–15064 Filed 6–24–16; 8:45 am]
                                                                                                          Behavioral and Social Consequences of HIV/             Government and is available for
                                                                                                          AIDS Study Section.                                    licensing and/or co-development in the
                                                  BILLING CODE 4140–01–P                                    Date: July 18–19, 2016.                              U.S. in accordance with 35 U.S.C. 209
                                                                                                            Time: 8:00 a.m. to 5:00 p.m.                         and 37 CFR part 404 to achieve
                                                                                                            Agenda: To review and evaluate grant
                                                  DEPARTMENT OF HEALTH AND                                applications.                                          expeditious commercialization of
                                                  HUMAN SERVICES                                            Place: Westin Grand, 2350 M Street NW.,              results of federally-funded research and
                                                                                                          Washington, DC 20037.                                  development. Foreign patent
                                                  National Institutes of Health                             Contact Person: Mark P. Rubert, Ph.D.,               applications are filed on selected
                                                                                                          Scientific Review Officer, Center for                  inventions to extend market coverage
                                                  Center for Scientific Review; Notice of                 Scientific Review, National Institutes of              for companies and may also be available
                                                  Closed Meetings                                         Health, 6701 Rockledge Drive, Room 5218,               for licensing and/or co-development.
                                                                                                          MSC 7852, Bethesda, MD 20892; 301–806–
                                                    Pursuant to section 10(d) of the                      6596; rubertm@csr.nih.gov.                             ADDRESSES: Invention Development and
                                                  Federal Advisory Committee Act, as                        Name of Committee: Center for Scientific
                                                                                                                                                                 Marketing Unit, Technology Transfer
                                                  amended (5 U.S.C. App.), notice is                      Review Special Emphasis Panel; Member                  Center, National Cancer Institute, 9609
                                                  hereby given of the following meetings.                 Conflict: Topics in Bacterial Pathogenesis             Medical Center Drive, Mail Stop 9702,
                                                    The meetings will be closed to the                    and Host Interactions.                                 Rockville, MD 20850–9702.
                                                  public in accordance with the                             Date: July 18, 2016.                                 FOR FURTHER INFORMATION CONTACT:
                                                  provisions set forth in sections                          Time: 10:00 a.m. to 6:00 p.m.                        Information on licensing and co-
                                                                                                            Agenda: To review and evaluate grant
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                                                     development research collaborations,
                                                                                                          applications.
                                                  as amended. The grant applications and                    Place: National Institutes of Health, 6701           and copies of the U.S. patent
                                                  the discussions could disclose                          Rockledge Drive, Bethesda, MD 20892.                   applications listed below may be
                                                  confidential trade secrets or commercial                  Contact Person:Soheyla Saadi, Ph.D.,                 obtained by contacting: Attn. Invention
                                                  property such as patentable material,                   Scientific Review Officer, Center for                  Development and Marketing Unit,
                                                  and personal information concerning                     Scientific Review, National Institutes of              Technology Transfer Center, National
                                                  individuals associated with the grant                   Health, 6701 Rockledge Drive, Room 3211,               Cancer Institute, 9609 Medical Center
                                                  applications, the disclosure of which                   MSC 7808, Bethesda, MD 20892; 301–435–                 Drive, Mail Stop 9702, Rockville, MD
                                                                                                          0903; saadisoh@csr.nih.gov.
                                                  would constitute a clearly unwarranted                                                                         20850–9702, Tel. 240–276–5515 or
                                                  invasion of personal privacy.                             Name of Committee: Center for Scientific             email ncitechtransfer@mail.nih.gov. A
                                                                                                          Review Special Emphasis Panel; Member
                                                    Name of Committee: Center for Scientific                                                                     signed Confidential Disclosure
                                                                                                          Conflict: Gastrointestinal and Liver
                                                  Review Special Emphasis Panel;                          Pathophysiology and Toxicology.                        Agreement may be required to receive
                                                  Implementation and Dissemination Science                  Date: July 20–21, 2016.                              copies of the patent applications.
                                                  for HIV/AIDS.                                             Time: 9:00 a.m. to 6:00 p.m.                         SUPPLEMENTARY INFORMATION:
                                                    Date: July 8, 2016.                                     Agenda: To review and evaluate grant                 Technology description follows.
                                                    Time: 10:00 a.m. to 6:30 p.m.                         applications.                                             Title of invention: Biomarker
                                                    Agenda: To review and evaluate grant                    Place: National Institutes of Health, 6701           signature development: microRNAs as
                                                  applications.                                           Rockledge Drive, Bethesda, MD 20892
                                                    Place: National Institutes of Health, 6701            (Virtual Meeting).
                                                                                                                                                                 biodosimetry markers.
                                                  Rockledge Drive, Bethesda, MD 20892                       Contact Person: Atul Sahai, Ph.D.,                      Description of Technology:
                                                  (Virtual Meeting).                                      Scientific Review Officer, Center for                     Alterations in microRNAs (miRNAs),
                                                    Contact Person: Shalanda A Bynum, Ph.D.,              Scientific Review, National Institutes of              a type of small non-coding RNAs, have
                                                  MPH, Scientific Review Officer, Center for              Health, 6701 Rockledge Drive, Room 2188,               been reported in cells/tumors subjected
                                                  Scientific Review, National Institutes of               MSC 7818, Bethesda, MD 20892; 301–435–                 to radiation exposure, implying that
                                                  Health, 6701 Rockledge Drive, Room 3206,                1198; sahaia@csr.nih.gov.                              miRNAs play an important role in
                                                  Bethesda, MD 20892; 301–755–4355;                       (Catalogue of Federal Domestic Assistance              cellular stress response to radiation.
                                                  bynumsa@csr.nih.gov.                                    Program Nos. 93.306, Comparative Medicine;                Researchers at the National Cancer
                                                    This notice is being published less than 15           93.333, Clinical Research, 93.306, 93.333,             Institute evaluated small non-coding
                                                  days prior to the meeting due to the timing             93.337, 93.393–93.396, 93.837–93.844,                  RNAs, long non-coding RNAs (lncRNA),
                                                  limitations imposed by the review and                   93.846–93.878, 93.892, 93.893, National
                                                  funding cycle.                                          Institutes of Health, HHS)
                                                                                                                                                                 and mRNA as potential non-invasive
                                                                                                                                                                 biomarkers for radiation biodosimetry.
                                                    Name of Committee: Center for Scientific                Dated: June 21, 2016.
                                                  Review Special Emphasis Panel; Member
                                                                                                                                                                 While the use of miRNAs as radiation
                                                                                                          Sylvia L. Neal,                                        biomarkers has been reported, the
                                                  Conflict: Cardiovascular Sciences.
                                                    Date: July 13–14, 2016.                               Program Analyst, Office of Federal Advisory            integrated use of miRNAs, mRNAs and
                                                    Time: 9:00 a.m. to 5:00 p.m.                          Committee Policy.                                      lncRNAs to accurately determine
                                                    Agenda: To review and evaluate grant                  [FR Doc. 2016–15054 Filed 6–24–16; 8:45 am]            radiation doses is novel and has not
                                                  applications.                                           BILLING CODE 4140–01–P                                 been published. The researchers
                                                    Place: National Institutes of Health, 6701                                                                   characterized a unique method of
                                                  Rockledge Drive, Bethesda, MD 20892                                                                            examining miRNA levels along with
                                                  (Virtual Meeting).                                      DEPARTMENT OF HEALTH AND                               levels of its target mRNA and lncRNA
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                                                    Contact Person: Kimm Hamann, Ph.D.,                   HUMAN SERVICES
                                                  Scientific Review Officer, Center for
                                                                                                                                                                 to determine radiation exposure using
                                                  Scientific Review, National Institutes of                                                                      whole blood samples from mice
                                                                                                          National Institutes of Health                          exposed to 2, 4, 8, 12 and 15 Gy
                                                  Health, 6701 Rockledge Drive, Room 4118A,
                                                  MSC 7814, Bethesda, MD 20892; 301–435–                                                                         irradiation. In doing so, they discovered
                                                                                                          Government-Owned Inventions;
                                                  5575; hamannkj@csr.nih.gov.                                                                                    distinct miRNA, mRNA and lncRNA
                                                                                                          Availability for Licensing
                                                    This notice is being published less than 15                                                                  biomarker signatures that inform degree
                                                  days prior to the meeting due to the timing             AGENCY:    National Institutes of Health.              of radiation exposure.


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                                                  41586                          Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices

                                                     Integrated analysis of miRNA,                        DEPARTMENT OF HEALTH AND                                  Contact Person: Robert Finkelstein, Ph.D.,
                                                  mRNAs, and lncRNAs to assess                            HUMAN SERVICES                                         Director of Extramural Research, National
                                                                                                                                                                 Institute of Neurological Disorders and
                                                  radiation exposure after mass-casualty
                                                                                                          National Institutes of Health                          Stroke, NIH, 6001 Executive Blvd., Suite
                                                  incidents could provide a valuable tool                                                                        3309, MSC 9531, Bethesda, MD 20892, (301)
                                                  in identifying biomarkers, and in the                                                                          496–9248.
                                                                                                          National Institute of Neurological
                                                  development and appropriate                                                                                       Any interested person may file written
                                                                                                          Disorders and Stroke; Notice of
                                                  implementation of effective medical                                                                            comments with the committee by forwarding
                                                                                                          Meeting
                                                  countermeasures. This application                                                                              the statement to the Contact Person listed on
                                                  could potentially also be used to                          Pursuant to section 10(d) of the                    this notice. The statement should include the
                                                  immediately detect, and therefore                       Federal Advisory Committee Act, as                     name, address, telephone number and when
                                                                                                                                                                 applicable, the business or professional
                                                  circumvent or mitigate non-specific                     amended (5 U.S.C. App.), notice is
                                                                                                                                                                 affiliation of the interested person.
                                                  injury from cancer radiotherapy                         hereby given of a meeting of the                          In the interest of security, NIH has
                                                  treatments.                                             National Advisory Neurological                         instituted stringent procedures for entrance
                                                                                                          Disorders and Stroke Council.                          onto the NIH campus. All visitor vehicles,
                                                     Potential Commercial Applications:
                                                                                                             The meeting will be open to the                     including taxicabs, hotel, and airport shuttles
                                                     • Diagnostic for radiation exposure,                 public as indicated below, with                        will be inspected before being allowed on
                                                  including for therapeutic procedures.                   attendance limited to space available.                 campus. Visitors will be asked to show one
                                                                                                          Individuals who plan to attend and                     form of identification (for example, a
                                                     Value Proposition:                                                                                          government-issued photo ID, driver’s license,
                                                                                                          need special assistance, such as sign
                                                     • Blood-based biomarker assay for                                                                           or passport) and to state the purpose of their
                                                                                                          language interpretation or other                       visit.
                                                  circulating miRNAs.
                                                                                                          reasonable accommodations, should                         Information is also available on the
                                                     • Could be developed as part of                      notify the Contact Person listed below                 Institute’s/Center’s home page: http://
                                                  point-of-care and high-throughput                       in advance of the meeting.                             www.ninds.nih.gov, where an agenda and
                                                  screening platforms.                                       The meeting will be closed to the                   any additional information for the meeting
                                                     • Immediate medical care based on                    public in accordance with the                          will be posted when available.
                                                  amount of radiation exposure is critical                provisions set forth in sections                       (Catalogue of Federal Domestic Assistance
                                                  for giving appropriate care to affected                 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,             Program Nos. 93.853, Clinical Research
                                                                                                          as amended. The grant applications and                 Related to Neurological Disorders; 93.854,
                                                  individuals.                                                                                                   Biological Basis Research in the
                                                                                                          the discussions could disclose
                                                     Development Stage:                                   confidential trade secrets or commercial               Neurosciences, National Institutes of Health,
                                                                                                                                                                 HHS).
                                                     In-vivo testing.                                     property such as patentable materials,
                                                                                                          and personal information concerning                      Dated: June 21, 2016.
                                                     Inventor(s):
                                                                                                          individuals associated with the grant                  Sylvia L. Neal,
                                                     Molykutty Aryankalayil (NCI),                        applications, the disclosure of which                  Program Analyst, Office of Federal Advisory
                                                  Norman Coleman (NCI), Adeola                            would constitute a clearly unwarranted                 Committee Policy.
                                                  Makinde (NCI).                                          invasion of personal privacy.                          [FR Doc. 2016–15068 Filed 6–24–16; 8:45 am]
                                                     Intellectual Property:                                 Name of Committee: National Advisory                 BILLING CODE 4140–01–P

                                                     HHS Reference No. E–066–2015/0–                      Neurological Disorders and Stroke Council.
                                                  US–01 US Provisional Application 62/                      Date: September 15–16, 2016.
                                                                                                            Open: September 15, 2016, 8:00 a.m. to               DEPARTMENT OF HEALTH AND
                                                  244,044 (HHS Reference No. E–066–                       2:30 p.m.                                              HUMAN SERVICES
                                                  2016/0–US–01) filed October 20, 2015                      Agenda: Report by the Director, NINDS;
                                                  entitled ‘‘Biomarker signature                          Report by the Associate Director for                   National Institutes of Health
                                                  development: microRNAs as                               Extramural Research; Administrative and
                                                  biodosimetry markers’’                                  Program Developments; and an Overview of               Center for Scientific Review; Notice of
                                                                                                          the NINDS Intramural Program.                          Closed Meetings
                                                     Collaboration Opportunity:                             Place: National Institutes of Health,
                                                  Researchers at the NCI seek parties                     Building 31, 31 Center Drive, 6th Floor,                 Pursuant to section 10(d) of the
                                                  interested in licensing or co-                          Conference Room 10, Bethesda, MD 20892.                Federal Advisory Committee Act, as
                                                  development for microRNA biomarker                        Closed: September 15, 2016, 2:30 p.m. to             amended (5 U.S.C. App.), notice is
                                                  signatures as biodosimetry markers.                     4:45 p.m.                                              hereby given of the following meetings.
                                                                                                            Agenda: To review and evaluate grant                   The meetings will be closed to the
                                                     Contact Information:                                 applications.                                          public in accordance with the
                                                     Requests for copies of the patent                      Place: National Institutes of Health,                provisions set forth in sections
                                                  application or inquiries about licensing,               Building 31, 31 Center Drive, 6th Floor,
                                                                                                          Conference Room 10, Bethesda, MD 20892.
                                                                                                                                                                 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
                                                  research collaborations, and co-                                                                               as amended. The grant applications and
                                                                                                            Closed: September 15, 2016, 4:45 p.m. to
                                                  development opportunities should be                     5:15 p.m.                                              the discussions could disclose
                                                  sent to John D. Hewes, Ph.D., email:                      Agenda: To review and evaluate the                   confidential trade secrets or commercial
                                                  john.hewes@nih.gov or phone: 240–276–                   Division of Intramural Research Board of               property such as patentable material,
                                                  5515.                                                   Scientific Counselors’ Reports.                        and personal information concerning
                                                                                                            Place: National Institutes of Health,                individuals associated with the grant
                                                    Dated: June 20, 2016.                                 Building 31, 31 Center Drive, 6th Floor,
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                                                                 applications, the disclosure of which
                                                  John D. Hewes,                                          Conference Room 10, Bethesda, MD 20892.                would constitute a clearly unwarranted
                                                  Technology Transfer Specialist, Technology                Closed: September 16, 2016, 8:00 a.m. to
                                                                                                          11:00 a.m.
                                                                                                                                                                 invasion of personal privacy.
                                                  Transfer Center, National Cancer Institute.
                                                                                                            Agenda: To review and evaluate grant                   Name of Committee: AIDS and Related
                                                  [FR Doc. 2016–15059 Filed 6–24–16; 8:45 am]
                                                                                                          applications.                                          Research Integrated Review Group; AIDS
                                                  BILLING CODE 4140–01–P                                    Place: National Institutes of Health,                Molecular and Cellular Biology Study
                                                                                                          Building 31, 31 Center Drive, 6th Floor,               Section.
                                                                                                          Conference Room 10, Bethesda, MD 20892.                  Date: July 18, 2016.



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Document Created: 2016-06-25 02:07:09
Document Modified: 2016-06-25 02:07:09
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.
ContactInformation on licensing and co- development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation81 FR 41585 

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