83_FR_13555 83 FR 13494 - Government-Owned Invention; Availability for Licensing

83 FR 13494 - Government-Owned Invention; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 61 (March 29, 2018)

Page Range13494-13495
FR Document2018-06364

The inventions listed below are owned by an agency of the U.S. Government.

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018) 
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13494-13495]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Invention; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government.

FOR FURTHER INFORMATION CONTACT: Licensing information 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, MSC 2479, Bethesda, 
MD 20892-2479; telephone: 301- 402-5579. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: The following inventions are available for

[[Page 13495]]

licensing 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. Technology description follows.

Lentiviral Protein Delivery System for RNA-Guided Genome Editing

    Description of Technology: This invention provides an HIV-1-based 
lentiviral vector system for gene correction strategies involving a 
homologous recombination with a variation of the CRISPR/Cas9 system. 
Such systems are being explored as potential therapies for certain 
hereditary diseases. This system comprises (a) a lentivirus vector 
particle comprising a lentiviral genome which encodes at least one 
guide RNA sequence that is complementary to a first DNA sequence in a 
host cell genome, (b) a Cas9 protein, and optionally (c) a donor 
nucleic acid molecule comprising a second DNA sequence. In addition, 
the invention provides a host cell comprising the foregoing system, as 
well as a method of altering a DNA sequence in a host cell comprising 
contacting a host cell with the foregoing system. Alternatively, the 
invention also provides a fusion protein comprising a Cas9 protein and 
a cyclophilin A (CypA) protein, wherein the fusion protein binds to the 
lentivirus vector particle, as well as a lentiviral vector particle 
comprising such a fusion protein. Other such lentivirus-based vectors 
encode a guide RNA, which contains a specific sequence that recognizes 
a target gene, and a Cas9 endonuclease, which cuts at the specific 
site. However, such systems present some problems due to constitutive 
expression of Cas9 endonuclease in lentiviral vector-transduced cells 
and the large size of the Cas9 gene. The variation of this invention 
delivers the Cas9 endonuclease directly, instead of the gene encoding 
the protein.
    Potential Commercial Applications: Clinical trials for hereditary 
diseases such as sickle-cell disease and beta-thalassemia are good 
market opportunities. Gene correction using the disclosed lentiviral 
vector system are being tested with respect to the beta-globin gene and 
the BCL11A gene to treat sickle-cell disease and will be used for 
induced pluripotent stem cell (iPS) generation.
    Development Stage: Early-stage. In vitro data in cell-line models 
available.
    Inventors: Naoya Uchida, Juan J. Haro Mora and John F. Tisdale 
(NHLBI).
    Intellectual Property: US Application No. 62/236,223, filed October 
2, 2015 and PCT/US2016/054759, filed September 30, 2016, (NIH Reference 
No. E-165-2015/0,1).
    Publications: Lentiviral protein delivery system for RNA-guided 
genome editing, PCT Publication No. WO/2017/059241, published April 6, 
2017.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
    Collaborative Research Opportunity: The National Heart, Lung and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize this technology. For collaboration 
opportunities, please contact Denise Crooks at crooksd@mail.nih.gov.

    Dated: March 22, 2018.
Cristina Thalhammer-Reyero,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2018-06364 Filed 3-28-18; 8:45 am]
 BILLING CODE 4140-01-P

13494 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices information that you do not wish to be learn about possible modifications conduct a lottery to determine the made publicly available, submit your before coming to the meeting. speakers for the scheduled open public comments only as a written/paper SUPPLEMENTARY INFORMATION: hearing session. The contact person will submission. You should submit two Agenda: The committees will be notify interested persons regarding their copies total. One copy will include the asked to discuss supplemental new drug request to speak by April 3, 2018. information you claim to be confidential application (sNDA) 20998, for Persons attending FDA’s advisory with a heading or cover note that states CELEBREX (celecoxib) capsules committee meetings are advised that ‘‘THIS DOCUMENT CONTAINS submitted by Pfizer, Inc., which FDA is not responsible for providing CONFIDENTIAL INFORMATION.’’ FDA includes the results from the access to electrical outlets. will review this copy, including the PRECISION (Prospective Randomized For press inquiries, please contact the claimed confidential information, in its Evaluation of Celecoxib Integrated Office of Media Affairs at fdaoma@ consideration of comments. The second Safety vs. Ibuprofen Or Naproxen) trial, fda.hhs.gov or 301–796–4540. copy, which will have the claimed a cardiovascular outcomes randomized FDA welcomes the attendance of the confidential information redacted/ controlled trial that compared celecoxib public at its advisory committee blacked out, will be available for public to ibuprofen and naproxen, and meetings and will make every effort to viewing and posted on https:// determine whether the findings of the accommodate persons with disabilities. www.regulations.gov. Submit both trial change FDA’s current If you require special accommodations copies to the Dockets Management Staff. understanding of the safety of these due to a disability, please contact If you do not wish your name and three NSAIDs. In order to interpret some Jennifer Shepherd (see FOR FURTHER contact information to be made publicly of the PRECISION findings, the INFORMATION CONTACT) at least 7 days in available, you can provide this committees will also consider the advance of the meeting. information on the cover sheet and not clinical implications of the drug FDA is committed to the orderly in the body of your comments and you interactions between each of these three conduct of its advisory committee must identify this information as NSAIDs and aspirin in patients taking meetings. Please visit our website at ‘‘confidential.’’ Any information marked aspirin for secondary prevention of https://www.fda.gov/Advisory as ‘‘confidential’’ will not be disclosed cardiovascular disease. Committees/AboutAdvisoryCommittees/ except in accordance with 21 CFR 10.20 FDA intends to make background ucm111462.htm for procedures on and other applicable disclosure law. For material available to the public no later public conduct during advisory more information about FDA’s posting than 2 business days before the meeting. committee meetings. of comments to public dockets, see 80 If FDA is unable to post the background Notice of this meeting is given under FR 56469, September 18, 2015, or access material on its website prior to the the Federal Advisory Committee Act the information at: https://www.gpo.gov/ meeting, the background material will (5 U.S.C. app. 2). fdsys/pkg/FR-2015-09-18/pdf/2015- be made publicly available at the Dated: March 21, 2018. 23389.pdf. location of the advisory committee Leslie Kux, Docket: For access to the docket to meeting, and the background material Associate Commissioner for Policy. will be posted on FDA’s website after read background documents or the [FR Doc. 2018–06309 Filed 3–28–18; 8:45 am] the meeting. Background material is electronic and written/paper comments BILLING CODE 4164–01–P available at https://www.fda.gov/ received, go to https:// AdvisoryCommittees/Calendar/ www.regulations.gov and insert the default.htm. Scroll down to the DEPARTMENT OF HEALTH AND docket number, found in brackets in the appropriate advisory committee meeting HUMAN SERVICES heading of this document, into the link. ‘‘Search’’ box and follow the prompts Procedure: Interested persons may National Institutes of Health and/or go to the Dockets Management present data, information, or views, Staff, 5630 Fishers Lane, Rm. 1061, Government-Owned Invention; orally or in writing, on issues pending Rockville, MD 20852. Availability for Licensing before the committees. All electronic FOR FURTHER INFORMATION CONTACT: and written submissions submitted to AGENCY: National Institutes of Health, Jennifer Shepherd, Center for Drug the Docket (see ADDRESSES) on or before HHS. Evaluation and Research, Food and April 10, 2018, will be provided to the Drug Administration, 10903 New committees. Oral presentations from the ACTION: Notice. Hampshire Ave., Bldg. 31, Rm. 2417, public will be scheduled between SUMMARY: The inventions listed below Silver Spring, MD 20993–0002, 301– approximately 8:30 a.m. and 9:30 a.m. are owned by an agency of the U.S. 796–9001, Fax: 301–847–8533, email: on April 25, 2018. Those individuals Government. AAC@fda.hhs.gov, or FDA Advisory interested in making formal oral Committee Information Line, 1–800– presentations should notify the contact FOR FURTHER INFORMATION CONTACT: 741–8138 (301–443–0572 in the person and submit a brief statement of Licensing information may be obtained Washington, DC area). A notice in the the general nature of the evidence or by emailing the indicated licensing Federal Register about last minute arguments they wish to present, the contact at the National Heart, Lung, and modifications that impact a previously names and addresses of proposed Blood, Office of Technology Transfer announced advisory committee meeting participants, and an indication of the and Development Office of Technology cannot always be published quickly approximate time requested to make Transfer, 31 Center Drive Room 4A29, sradovich on DSK3GMQ082PROD with NOTICES enough to provide timely notice. their presentation on or before April 2, MSC 2479, Bethesda, MD 20892–2479; Therefore, you should always check 2018. Time allotted for each telephone: 301- 402–5579. A signed FDA’s website at https://www.fda.gov/ presentation may be limited. If the Confidential Disclosure Agreement may AdvisoryCommittees/default.htm and number of registrants requesting to be required to receive any unpublished scroll down to the appropriate advisory speak is greater than can be reasonably information. committee meeting link, or call the accommodated during the scheduled SUPPLEMENTARY INFORMATION: The advisory committee information line to open public hearing session, FDA may following inventions are available for VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1

Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 13495 licensing in accordance with 35 U.S.C. September 30, 2016, (NIH Reference No. Name of Committee: Board of Scientific 209 and 37 CFR part 404 to achieve E–165–2015/0,1). Counselors, NICHD. expeditious commercialization of Date: June 1, 2018. Publications: Lentiviral protein Open: 8:00 a.m. to 11:45 a.m. results of federally-funded research and delivery system for RNA-guided genome Agenda: A report by the Scientific Director, development. Technology description editing, PCT Publication No. WO/2017/ NICHD, on the status of the NICHD Division follows. 059241, published April 6, 2017. of Intramural Research; talks by various Lentiviral Protein Delivery System for Licensing Contact: Cristina intramural scientists, and current Thalhammer-Reyero, Ph.D., M.B.A.; organizational structure. RNA-Guided Genome Editing Place: National Institutes of Health, 301–435–4507; thalhamc@mail.nih.gov. Description of Technology: This Building 31A, Conference Room 2A48, 31 Collaborative Research Opportunity: Center Drive, Bethesda, MD 20892. invention provides an HIV–1-based The National Heart, Lung and Blood lentiviral vector system for gene Closed: 11:45 a.m. to 4:00 p.m. Institute is seeking statements of Agenda: To review and evaluate personal correction strategies involving a capability or interest from parties qualifications and performance, and homologous recombination with a interested in collaborative research to competence of individual investigators. variation of the CRISPR/Cas9 system. further develop, evaluate or Place: National Institutes of Health, Such systems are being explored as commercialize this technology. For Building 31A, Conference Room 2A48, 31 potential therapies for certain hereditary collaboration opportunities, please Center Drive, Bethesda, MD 20892. diseases. This system comprises (a) a contact Denise Crooks at crooksd@ Contact Person: Constantine A. Stratakis, lentivirus vector particle comprising a MD, D(med)Sci, Scientific Director, Eunice mail.nih.gov. Kennedy Shriver National Institute of Child lentiviral genome which encodes at least one guide RNA sequence that is Dated: March 22, 2018. Health and Human Development, NIH, Cristina Thalhammer-Reyero, Building 31A, Room 2A46, 31 Center Drive, complementary to a first DNA sequence Bethesda, MD 20892, 301–594–5984, in a host cell genome, (b) a Cas9 protein, Senior Licensing and Patenting Manager, stratakc@mail.nih.gov. and optionally (c) a donor nucleic acid Office of Technology Transfer and Development, National Heart, Lung, and Information is also available on the molecule comprising a second DNA Institute’s/Center’s home page: https:// sequence. In addition, the invention Blood Institute. www.nichd.nih.gov/about/meetings/Pages/ provides a host cell comprising the [FR Doc. 2018–06364 Filed 3–28–18; 8:45 am] index.aspx, where an agenda and any foregoing system, as well as a method of BILLING CODE 4140–01–P additional information for the meeting will altering a DNA sequence in a host cell be posted when available. comprising contacting a host cell with (Catalogue of Federal Domestic Assistance the foregoing system. Alternatively, the DEPARTMENT OF HEALTH AND Program Nos.93.864, Population Research; invention also provides a fusion protein HUMAN SERVICES 93.865, Research for Mothers and Children; comprising a Cas9 protein and a 93.929, Center for Medical Rehabilitation National Institutes of Health Research; 93.209, Contraception and cyclophilin A (CypA) protein, wherein Infertility Loan Repayment Program, National the fusion protein binds to the lentivirus Eunice Kennedy Shriver National Institutes of Health, HHS) vector particle, as well as a lentiviral Institute of Child Health and Human vector particle comprising such a fusion Dated: March 23, 2018. Development; Notice of Meeting protein. Other such lentivirus-based Michelle Trout, vectors encode a guide RNA, which Pursuant to section 10(d) of the Program Analyst, Office of Federal Advisory contains a specific sequence that Federal Advisory Committee Act, as Committee Policy. recognizes a target gene, and a Cas9 amended, notice is hereby given of a [FR Doc. 2018–06259 Filed 3–28–18; 8:45 am] endonuclease, which cuts at the specific meeting of the Board of Scientific BILLING CODE 4140–01–P site. However, such systems present Counselors, NICHD. some problems due to constitutive The meeting will be open to the expression of Cas9 endonuclease in public as indicated below, with the DEPARTMENT OF HEALTH AND lentiviral vector-transduced cells and attendance limited to space available. HUMAN SERVICES the large size of the Cas9 gene. The Individuals who plan to attend and variation of this invention delivers the need special assistance, such as sign National Institutes of Health Cas9 endonuclease directly, instead of language interpretation or other Eunice Kennedy Shriver National the gene encoding the protein. reasonable accommodations, should Institute of Child Health and Human Potential Commercial Applications: notify the Contact Person listed below Development; Notice of Meeting Clinical trials for hereditary diseases in advance of the meeting. such as sickle-cell disease and beta- The meeting will be closed to the Pursuant to section 10(a) of the thalassemia are good market public as indicated below in accordance Federal Advisory Committee Act, as opportunities. Gene correction using the with the provisions set forth in section amended (5 U.S.C. App.), notice is disclosed lentiviral vector system are 552b(c)(6), Title 5 U.S.C., as amended hereby given of a meeting of the being tested with respect to the beta- for the review, discussion, and National Advisory Board on Medical globin gene and the BCL11A gene to evaluation of individual intramural Rehabilitation Research. The meeting treat sickle-cell disease and will be used programs and projects conducted by the will be open to the public, with for induced pluripotent stem cell (iPS) Eunice Kennedy Shriver National attendance limited to space available. generation. Institute Of Child Health And Human Individuals who plan to attend and sradovich on DSK3GMQ082PROD with NOTICES Development Stage: Early-stage. In Development, including consideration need special assistance, such as sign vitro data in cell-line models available. of personnel qualifications and language interpretation or other Inventors: Naoya Uchida, Juan J. Haro performance, and the competence of reasonable accommodations, should Mora and John F. Tisdale (NHLBI). individual investigators, the disclosure notify the Contact Person listed below Intellectual Property: US Application of which would constitute a clearly in advance of the meeting. No. 62/236,223, filed October 2, 2015 unwarranted invasion of personal Name of Committee: National Advisory and PCT/US2016/054759, filed privacy. Board on Medical Rehabilitation Research. VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1


Document Created: 2018-03-29 00:25:57
Document Modified: 2018-03-29 00:25:57
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 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, MSC 2479, Bethesda, MD 20892-2479; telephone: 301- 402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
FR Citation83 FR 13494 
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