82_FR_42998 82 FR 42823 - Government-Owned Inventions; Availability for Licensing

82 FR 42823 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 175 (September 12, 2017)

Page Range42823-42824
FR Document2017-19313

Government owned intellectual property covering imaging agents with improved renal clearance available for licensing and commercialization.

Federal Register, Volume 82 Issue 175 (Tuesday, September 12, 2017)
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42823-42824]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19313]


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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.

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

SUMMARY: Government owned intellectual property covering imaging agents 
with improved renal clearance available for licensing and 
commercialization.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the patent applications listed below may be obtained by emailing the 
indicated licensing contact at the National Heart, Lung, and Blood, 
Office of Technology Transfer and Development Office of Technology 
Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; 
telephone: 301-402-5579. A signed Confidential Disclosure Agreement may 
be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: The inventions listed below are owned by an 
agency of the U.S. Government and are available for licensing 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. A description of the technology available for 
licensing follows.

Evans Blue Dye Derivatives for Serum Albumin Labeling

     Description of Technology: The invention is an imaging agent and 
method of its use for imaging blood pools and the lymphatic system. The 
imaging agent binds with high affinity to serum albumin, the most 
abundant serum protein, and can be tagged with several isotopes making 
it suitable for magnetic resonance imaging or positron emission 
tomographic imaging. To date, only very few blood-pool tracers have 
been introduced for positron emission tomography. The existing ones 
have short half-lives (20.4 min for \11\C and 2.05 min for \15\O) and 
thus can only be used in centers with an in-house cyclotron. Compared 
with these radiometals, \18\F has the advantages of being a pure 
position emitter with ideal half-life. It is the dominant radioisotope 
used for PET imaging for both clinical applications and preclinical 
investigations. Evans blue dye has been an important tool in many 
physiological and clinical investigations because of its

[[Page 42824]]

high affinity for plasma albumin and has been used for a long time in 
clinical practice for determination of patient plasma volume. The 
current imaging agent is a truncated form of EB [NEB]) and has the 
ability to bind albumin with high affinity. The agent is also 
conjugated to NOTA to enable in vivo labeling with \18\F labeling by 
the formation of \18\F-aluminum fluoride complex. The NOTA also 
facilitates radiometal labeling of NEB with either \68\Ga or \64\Cu. 
The resulting imaging agent does not affect the in vivo behavior of 
serum albumin such as circulation, extra-vascularization, and turn-
over; thus the imaging results will reflect the distribution and 
metabolism of serum albumin accurately.
    Potential Commercial Applications:
     Blood pool imaging.
     Lymphatic system imaging.
    Development Stage:
     In vivo data available.
    Inventors: Xiaoyuan Chen, Lixin Lang, Gang Niu (all of NIBIB).
    Intellectual Property: HHS Reference No. E-099-2015/0-US-01 and/0-
US-02.
     U.S. Patent Applications 14/675,364 filed March 31, 2015 
and 15/587,948 filed May 5, 2017.
    Licensing Contact: Michael Shmilovich, Esq, CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Environmental Health Sciences seeks statements of capability or 
interest from parties interested in collaborative research to further 
develop and evaluate, please contact Cecilia Pazman, Office of 
Technology Transfer, National Heart, Lung and Blood Institute, 
[email protected], 301-594-4273.

    Dated: September 7, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2017-19313 Filed 9-11-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                    Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices                                                                          42823

                                                                                                       TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                Number of                              Average burden               Total burden
                                                                                                                                              Number of                                     Total
                                                                                  Form name                                                                   responses per                             per response                    hours
                                                                                                                                             respondents                                 responses
                                                                                                                                                                respondent                                (in hours)                (rounded up)

                                                Missing Report Form .........................................................                           29                         1              29                        .08                3
                                                Subject Statement and Dispute .........................................                              3,547                         1           3,547                        .75            2,661
                                                Request for Dispute Resolution .........................................                                99                         1              99                          8              792
                                                Electronic Transfer of Funds (EFT) Authorization .............                                         654                         1             654                        .08               53
                                                Authorized Agent Designation ...........................................                               213                         1             213                        .25               54
                                                Account Discrepancy .........................................................                           10                         1              10                        .25                3
                                                New Administrator Request ...............................................                            3,016                         1           3,016                        .08              242
                                                Query Credit Purchase ......................................................                           789                         1             789                        .08               64
                                                Educational Request ..........................................................                          10                         1              10                        .08                1
                                                Account Balance Transfer .................................................                              10                         1              10                        .08                1

                                                      Total ............................................................................        6,059,761     ........................     6,059,761   ..........................        326,120



                                                  HRSA specifically requests comments                                        Date: October 2, 2017.                                       Transfer and Development Office of
                                                on (1) the necessity and utility of the                                      Time: 8:00 a.m. to 6:00 p.m.                                 Technology Transfer, 31 Center Drive,
                                                proposed information collection for the                                      Agenda: To review and evaluate grant                         Room 4A29, MSC2479, Bethesda, MD
                                                proper performance of the agency’s                                         applications.                                                  20892–2479; telephone: 301–402–5579.
                                                                                                                             Place: Residence Inn Bethesda Downtown,
                                                functions, (2) the accuracy of the                                         7335 Wisconsin Ave., Bethesda, MD 20814.
                                                                                                                                                                                          A signed Confidential Disclosure
                                                estimated burden, (3) ways to enhance                                        Contact Person: Cathy J. Wedeen, Ph.D.,                      Agreement may be required to receive
                                                the quality, utility, and clarity of the                                   Scientific Review Officer, Division of                         copies of the patent applications.
                                                information to be collected, and (4) the                                   Scientific Review, OD, Eunice Kennedy                          SUPPLEMENTARY INFORMATION: The
                                                use of automated collection techniques                                     Shriver National Institute of Child Health                     inventions listed below are owned by an
                                                or other forms of information                                              and Human Development, NIH, DHHS, 6710                         agency of the U.S. Government and are
                                                technology to minimize the information                                     B Rockledge Drive, Bethesda, Maryland                          available for licensing in the U.S. in
                                                collection burden.                                                         20892, 301–435–6878, wedeenc@                                  accordance with 35 U.S.C. 209 and 37
                                                                                                                           mail.nih.gov.
                                                                                                                                                                                          CFR part 404 to achieve expeditious
                                                Amy McNulty,                                                               (Catalogue of Federal Domestic Assistance                      commercialization of results of
                                                Acting Director, Division of the Executive                                 Program Nos. 93.864, Population Research;                      federally-funded research and
                                                Secretariat.                                                               93.865, Research for Mothers and Children;
                                                                                                                           93.929, Center for Medical Rehabilitation
                                                                                                                                                                                          development. Foreign patent
                                                [FR Doc. 2017–19252 Filed 9–11–17; 8:45 am]
                                                                                                                           Research; 93.209, Contraception and                            applications are filed on selected
                                                BILLING CODE 4165–15–P                                                                                                                    inventions to extend market coverage
                                                                                                                           Infertility Loan Repayment Program, National
                                                                                                                           Institutes of Health, HHS)                                     for companies and may also be available
                                                                                                                                                                                          for licensing. A description of the
                                                DEPARTMENT OF HEALTH AND                                                     Dated: September 6, 2017.
                                                                                                                                                                                          technology available for licensing
                                                HUMAN SERVICES                                                             Michelle Trout,
                                                                                                                                                                                          follows.
                                                                                                                           Program Analyst, Office of Federal Advisory
                                                National Institutes of Health                                              Committee Policy.                                              Evans Blue Dye Derivatives for Serum
                                                                                                                           [FR Doc. 2017–19232 Filed 9–11–17; 8:45 am]                    Albumin Labeling
                                                Eunice Kennedy Shriver National
                                                Institute of Child Health and Human                                        BILLING CODE 4140–01–P                                           Description of Technology: The
                                                Development; Notice of Closed                                                                                                             invention is an imaging agent and
                                                Meeting                                                                                                                                   method of its use for imaging blood
                                                                                                                           DEPARTMENT OF HEALTH AND                                       pools and the lymphatic system. The
                                                  Pursuant to section 10(d) of the                                         HUMAN SERVICES                                                 imaging agent binds with high affinity
                                                Federal Advisory Committee Act, as                                                                                                        to serum albumin, the most abundant
                                                amended, notice is hereby given of the                                     National Institutes of Health                                  serum protein, and can be tagged with
                                                following meeting.                                                         Government-Owned Inventions;                                   several isotopes making it suitable for
                                                  The meeting will be closed to the                                        Availability for Licensing                                     magnetic resonance imaging or positron
                                                public in accordance with the                                                                                                             emission tomographic imaging. To date,
                                                provisions set forth in sections                                           AGENCY:         National Institutes of Health,                 only very few blood-pool tracers have
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                 HHS.                                                           been introduced for positron emission
                                                as amended. The grant applications and                                     ACTION:         Notice.                                        tomography. The existing ones have
                                                the discussions could disclose                                                                                                            short half-lives (20.4 min for 11C and
                                                confidential trade secrets or commercial                                   SUMMARY:   Government owned                                    2.05 min for 15O) and thus can only be
                                                property such as patentable material,                                      intellectual property covering imaging                         used in centers with an in-house
                                                and personal information concerning                                        agents with improved renal clearance                           cyclotron. Compared with these
pmangrum on DSK3GDR082PROD with NOTICES1




                                                individuals associated with the grant                                      available for licensing and                                    radiometals, 18F has the advantages of
                                                applications, the disclosure of which                                      commercialization.                                             being a pure position emitter with ideal
                                                would constitute a clearly unwarranted                                     FOR FURTHER INFORMATION CONTACT:                               half-life. It is the dominant radioisotope
                                                invasion of personal privacy.                                              Licensing information and copies of the                        used for PET imaging for both clinical
                                                  Name of Committee: National Institute of                                 patent applications listed below may be                        applications and preclinical
                                                Child Health and Human Development Initial                                 obtained by emailing the indicated                             investigations. Evans blue dye has been
                                                Review Group; Developmental Biology                                        licensing contact at the National Heart,                       an important tool in many physiological
                                                Subcommittee.                                                              Lung, and Blood, Office of Technology                          and clinical investigations because of its


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                                                42824                     Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices

                                                high affinity for plasma albumin and                    provisions set forth in sections                      MSC 7818, Bethesda, MD 20892, 301–435–
                                                has been used for a long time in clinical               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            1198, sahaia@csr.nih.gov.
                                                practice for determination of patient                   as amended. The grant applications and                (Catalogue of Federal Domestic Assistance
                                                plasma volume. The current imaging                      the discussions could disclose                        Program Nos. 93.306, Comparative Medicine;
                                                agent is a truncated form of EB [NEB])                  confidential trade secrets or commercial              93.333, Clinical Research, 93.306, 93.333,
                                                                                                                                                              93.337, 93.393–93.396, 93.837–93.844,
                                                and has the ability to bind albumin with                property such as patentable material,                 93.846–93.878, 93.892, 93.893, National
                                                high affinity. The agent is also                        and personal information concerning                   Institutes of Health, HHS)
                                                conjugated to NOTA to enable in vivo                    individuals associated with the grant
                                                                                                                                                                Dated: September 6, 2017.
                                                labeling with 18F labeling by the                       applications, the disclosure of which
                                                formation of 18F-aluminum fluoride                      would constitute a clearly unwarranted                Natasha M. Copeland,
                                                complex. The NOTA also facilitates                      invasion of personal privacy.                         Program Analyst, Office of Federal Advisory
                                                                                                                                                              Committee Policy.
                                                radiometal labeling of NEB with either                    Name of Committee: Center for Scientific
                                                68Ga or 64Cu. The resulting imaging                                                                           [FR Doc. 2017–19230 Filed 9–11–17; 8:45 am]
                                                                                                        Review Special Emphasis Panel; Shared
                                                agent does not affect the in vivo                       Instrumentation Grants for Flow Cytometers.           BILLING CODE 4140–01–P

                                                behavior of serum albumin such as                         Date: September 26, 2017.
                                                circulation, extra-vascularization, and                   Time: 11:00 a.m. to 5:00 p.m.
                                                turn-over; thus the imaging results will                  Agenda: To review and evaluate grant                DEPARTMENT OF HEALTH AND
                                                reflect the distribution and metabolism                 applications.                                         HUMAN SERVICES
                                                                                                          Place: National Institutes of Health, 6701
                                                of serum albumin accurately.                            Rockledge Drive, Bethesda, MD 20892                   National Institutes of Health
                                                  Potential Commercial Applications:                    (Virtual Meeting).
                                                  • Blood pool imaging.                                   Contact Person: Jonathan Arias, Ph.D.,              National Institute on Aging; Notice of
                                                  • Lymphatic system imaging.                           Scientific Review Officer, Center for                 Closed Meetings
                                                  Development Stage:                                    Scientific Review, National Institutes of
                                                  • In vivo data available.                             Health, 6701 Rockledge Drive, Room 5170,                Pursuant to section 10(d) of the
                                                  Inventors: Xiaoyuan Chen, Lixin Lang,                 MSC 7840, Bethesda, MD 20892, 301–435–                Federal Advisory Committee Act, as
                                                Gang Niu (all of NIBIB).                                2406, ariasj@csr.nih.gov.                             amended, notice is hereby given of the
                                                  Intellectual Property: HHS Reference                    Name of Committee: Center for Scientific            following meetings.
                                                No. E–099–2015/0–US–01 and/0–US–                        Review Special Emphasis Panel; Shared and               The meetings will be closed to the
                                                02.                                                     High-End Mass Spectrometers.                          public in accordance with the
                                                                                                          Date: September 28–29, 2017.                        provisions set forth in sections
                                                  • U.S. Patent Applications                              Time: 8:00 a.m. to 6:00 p.m.
                                                14/675,364 filed March 31, 2015 and                                                                           552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                          Agenda: To review and evaluate grant                as amended. The grant applications and
                                                15/587,948 filed May 5, 2017.                           applications.
                                                  Licensing Contact: Michael                                                                                  the discussions could disclose
                                                                                                          Place: National Institutes of Health, 6701
                                                Shmilovich, Esq, CLP; 301–435–5019;                     Rockledge Drive, Bethesda, MD 20892                   confidential trade secrets or commercial
                                                shmilovm@nih.gov.                                       (Virtual Meeting).                                    property such as patentable material,
                                                  Collaborative Research Opportunity:                     Contact Person: Sudha Veeraraghavan,                and personal information concerning
                                                The National Institute of Environmental                 Ph.D., Scientific Review Officer, Center for          individuals associated with the grant
                                                Health Sciences seeks statements of                     Scientific Review, National Institutes of             applications, the disclosure of which
                                                                                                        Health, 6701 Rockledge Drive, Bethesda, MD            would constitute a clearly unwarranted
                                                capability or interest from parties                     20892, 301–435–1504,
                                                interested in collaborative research to                                                                       invasion of personal privacy.
                                                                                                        sudha.veeraraghavan@nih.gov.
                                                further develop and evaluate, please                                                                            Name of Committee: National Institute on
                                                                                                          Name of Committee: Healthcare Delivery
                                                contact Cecilia Pazman, Office of                                                                             Aging Special Emphasis Panel; Resource
                                                                                                        and Methodologies Integrated Review Group;
                                                Technology Transfer, National Heart,                                                                          Centers for Minority Aging Research
                                                                                                        Nursing and Related Clinical Sciences Study
                                                                                                                                                              (RCMAR) ZAG1 ZIJ–9 J1.
                                                Lung and Blood Institute, pazmance@                     Section.
                                                                                                                                                                Date: October 31–November 1, 2017.
                                                nhlbi.nih.gov, 301–594–4273.                              Date: October 2–3, 2017.
                                                                                                                                                                Time: 5:00 p.m. to 4:00 p.m.
                                                                                                          Time: 8:00 a.m. to 5:00 p.m.                          Agenda: To review and evaluate grant
                                                  Dated: September 7, 2017.                               Agenda: To review and evaluate grant
                                                Michael Shmilovich,                                                                                           applications.
                                                                                                        applications.                                           Place: Hyatt Regency Bethesda, One
                                                Senior Licensing and Patenting Manager,                   Place: Embassy Suites at the Chevy Chase            Bethesda Metro Center, Bethesda, MD 20814.
                                                National Heart, Lung, and Blood Institute,              Pavilion, 4300 Military Road NW.,                       Contact Person: Carmen Moten, Ph.D.,
                                                Office of Technology Transfer and                       Washington, DC 20015.                                 MPH, Scientific Review Officer, National
                                                Development.                                              Contact Person: Rafael Semansky, Ph.D.,             Institute on Aging, Gateway Building, 7201
                                                [FR Doc. 2017–19313 Filed 9–11–17; 8:45 am]             Scientific Review Officer, Center for                 Wisconsin Avenue, Suite 2C212, Bethesda,
                                                                                                        Scientific Review, National Institutes of             MD 20892, 301–402–7703, cmoten@
                                                BILLING CODE 4140–01–P
                                                                                                        Health, 6701 Rockledge Drive, Room 2040M,             mail.nih.gov.
                                                                                                        Bethesda, MD 20892, 301–496–5749,
                                                                                                        semanskyrm@csr.nih.gov.                                 Name of Committee: National Institute on
                                                DEPARTMENT OF HEALTH AND                                                                                      Aging Special Emphasis Panel; Resource
                                                                                                          Name of Committee: Center for Scientific            Centers for Minority Aging Research
                                                HUMAN SERVICES                                          Review Special Emphasis Panel; Clinical               (RCMAR) ZAG1 ZIJ–9 J3.
                                                                                                        Studies in Kidney Diseases (PAR–15–161).                Date: October 31–November 1, 2017.
                                                National Institutes of Health                             Date: October 2, 2017.                                Time: 5:00 p.m. to 4:00 p.m.
                                                                                                          Time: 2:00 p.m. to 5:00 p.m.                          Agenda: To review and evaluate grant
                                                Center for Scientific Review; Notice of
pmangrum on DSK3GDR082PROD with NOTICES1




                                                                                                          Agenda: To review and evaluate grant                applications.
                                                Closed Meetings                                         applications.                                           Place: Hyatt Regency Bethesda, One
                                                                                                          Place: National Institutes of Health, 6701          Bethesda Metro Center, Bethesda, MD 20814.
                                                  Pursuant to section 10(d) of the
                                                                                                        Rockledge Drive, Bethesda, MD 20892                     Contact Person: Carmen Moten, Ph.D.,
                                                Federal Advisory Committee Act, as                      (Telephone Conference Call).                          MPH, Scientific Review Officer, National
                                                amended, notice is hereby given of the                    Contact Person: Atul Sahai, Ph.D.,                  Institute on Aging, Gateway Building, 7201
                                                following meetings.                                     Scientific Review Officer, Center for                 Wisconsin Avenue, Suite 2C212, Bethesda,
                                                  The meetings will be closed to the                    Scientific Review, National Institutes of             MD 20892, 301–402–7703, cmoten@
                                                public in accordance with the                           Health, 6701 Rockledge Drive, Room 2188,              mail.nih.gov.



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Document Created: 2018-10-24 14:13:14
Document Modified: 2018-10-24 14:13:14
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.
ContactLicensing information and copies of the patent applications listed below may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation82 FR 42823 

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