82_FR_53729 82 FR 53509 - Government-Owned Inventions; Availability for Licensing

82 FR 53509 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 220 (November 16, 2017)

Page Range53509-53510
FR Document2017-24773

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

Federal Register, Volume 82 Issue 220 (Thursday, November 16, 2017) 
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53509-53510]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S.

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: This notice is in accordance with 35 U.S.C. 
209 and 37 CFR part 404 to achieve 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 follows.

Chimeric Antibodies Against Hepatitis B e-Antigen

    Description of Technology: The invention relates to recombinant 
chimeric rabbit/human monoclonal antibody fragments (Fabs) against 
hepatitis B Virus e-antigen (HBeAg). Viral hepatitis is the seventh 
leading cause of death worldwide. Hepatitis B core antigen (HBcAg) 
forms an icosahedral structure containing the viral genome. Both the 
HBcAg and the HBeAg of interest here are expressed by two different 
start codons of the viral C gene. Unlike the related HBcAg which 
activates type 1 T helper (Th1) cells leading to immune attack, the 
HBeAg activates Th2 cells which promote immune tolerance. The long-term 
persistence of HBeAg is associated with the development of 
hepatocellular carcinoma. Conversely, HBeAg seroconversion (from HBeAg 
carrier to anti-HBeAg carrier) is a marker for successful therapy of 
chronically infected patients. The presently phage display engineered 
antibody has potential for anti-hepatitis B virus therapeutic 
interventions.
    Potential Commercial Applications:
     Hepatitis B therapy.
     Hepatocellular carcinoma prophylaxis.
    Development Stage:
     In vitro data available.
    Inventors: Paul Winfield, Norman Watts, Alasdair Steven (all of 
NIAMS).
    Intellectual Property: HHS Reference No. E-192-2017/0-US-01.
     U.S. Provisional Patent Application 62/534,603 filed July 
19, 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 nterest 
from parties interested in collaborative research to

[[Page 53510]]

further develop and evaluate, please contact Cecilia Pazman, Ph.D., 
Technology Development Specialist, Office of Technology Transfer, 
National Heart, Lung, and Blood Institute, Phone: (301) 594-4273; 
[email protected] .

    Dated: November 6, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2017-24773 Filed 11-15-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53509 Dockets Management Staff, 5630 Fishers the general nature of the evidence or Lung, and Blood, Office of Technology Lane, Rm. 1061, Rockville, MD 20852. arguments they wish to present, the Transfer and Development Office of FOR FURTHER INFORMATION CONTACT: names and addresses of proposed Technology Transfer, 31 Center Drive Kalyani Bhatt, Center for Drug participants, and an indication of the Room 4A29, MSC2479, Bethesda, MD Evaluation and Research, Food and approximate time requested to make 20892–2479; telephone: 301–402–5579. Drug Administration, 10903 New their presentation on or before A signed Confidential Disclosure Hampshire Ave., Bldg. 31, Rm. 2417, December 14, 2017. Time allotted for Agreement may be required to receive Silver Spring, MD 20993–0002, 301– each presentation may be limited. If the copies of the patent applications. 796–9001, Fax: 301–847–8533, email: number of registrants requesting to SUPPLEMENTARY INFORMATION: This BRUDAC@fda.hhs.gov, or FDA Advisory speak is greater than can be reasonably notice is in accordance with 35 U.S.C. Committee Information Line, 1–800– accommodated during the scheduled 209 and 37 CFR part 404 to achieve 741–8138 (301–443–0572 in the open public hearing session, FDA may commercialization of results of Washington, DC area). A notice in the conduct a lottery to determine the federally-funded research and Federal Register about last minute speakers for the scheduled open public development. Foreign patent modifications that impact a previously hearing session. The contact person will applications are filed on selected announced advisory committee meeting notify interested persons regarding their inventions to extend market coverage cannot always be published quickly request to speak by December 15, 2017. for companies and may also be available enough to provide timely notice. Persons attending FDA’s advisory for licensing. A description of the Therefore, you should always check the committee meetings are advised that the technology follows. Agency 02BC;s Web site at https://www. Agency is not responsible for providing access to electrical outlets. Chimeric Antibodies Against Hepatitis fda.gov/AdvisoryCommittees/default. FDA welcomes the attendance of the B e-Antigen htm and scroll down to the appropriate advisory committee meeting link, or call public at its advisory committee Description of Technology: The the advisory committee information line meetings and will make every effort to invention relates to recombinant to learn about possible modifications accommodate persons with disabilities. chimeric rabbit/human monoclonal before coming to the meeting. If you require special accommodations antibody fragments (Fabs) against due to a disability, please contact hepatitis B Virus e-antigen (HBeAg). SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss Kalyani Bhatt at least 7 days in advance Viral hepatitis is the seventh leading new drug application (NDA) 208088, of the meeting. cause of death worldwide. Hepatitis B FDA is committed to the orderly core antigen (HBcAg) forms an oral testosterone undecanoate capsules, conduct of its advisory committee icosahedral structure containing the submitted by Lipocine Inc. for the meetings. Please visit our Web site at viral genome. Both the HBcAg and the proposed indication of testosterone https://www.fda.gov/Advisory HBeAg of interest here are expressed by replacement in males for conditions Committees/AboutAdvisoryCommittees/ two different start codons of the viral C associated with a deficiency or absence ucm111462.htm for procedures on gene. Unlike the related HBcAg which of endogenous testosterone: primary public conduct during advisory activates type 1 T helper (Th1) cells hypogonadism (congenital or acquired) committee meetings. leading to immune attack, the HBeAg and hypogonadotropic hypogonadism Notice of this meeting is given under (congenital or acquired). activates Th2 cells which promote the Federal Advisory Committee Act (5 immune tolerance. The long-term FDA intends to make background U.S.C. app. 2). persistence of HBeAg is associated with material available to the public no later than 2 business days before the meeting. Dated: November 13, 2017. the development of hepatocellular If FDA is unable to post the background Anna K. Abram, carcinoma. Conversely, HBeAg material on its Web site prior to the Deputy Commissioner for Policy, Planning, seroconversion (from HBeAg carrier to meeting, the background material will Legislation, and Analysis. anti-HBeAg carrier) is a marker for be made publicly available at the [FR Doc. 2017–24832 Filed 11–15–17; 8:45 am] successful therapy of chronically location of the advisory committee BILLING CODE 4164–01–P infected patients. The presently phage meeting, and the background material display engineered antibody has will be posted on FDA 02BC;s Web site potential for anti-hepatitis B virus after the meeting. Background material DEPARTMENT OF HEALTH AND therapeutic interventions. is available at https://www.fda.gov/ HUMAN SERVICES Potential Commercial Applications: • Hepatitis B therapy. AdvisoryCommittees/Calendar/ National Institutes of Health • Hepatocellular carcinoma default.htm. Scroll down to the prophylaxis. appropriate advisory committee meeting Development Stage: Government-Owned Inventions; link. • In vitro data available. Procedure: Interested persons may Availability for Licensing Inventors: Paul Winfield, Norman present data, information, or views, AGENCY: National Institutes of Health, Watts, Alasdair Steven (all of NIAMS). orally or in writing, on issues pending HHS. Intellectual Property: HHS Reference before the committee. All electronic and ACTION: Notice. No. E–192–2017/0–US–01. written submissions submitted to the • U.S. Provisional Patent Application SUMMARY: The inventions listed below asabaliauskas on DSKBBXCHB2PROD with NOTICES Docket (see the ADDRESSES section) on 62/534,603 filed July 19, 2017. or before December 22, 2017, will be are owned by an agency of the U.S. Licensing Contact: Michael provided to the committee. Oral Government and are available for Shmilovich, Esq, CLP; 301–435–5019; presentations from the public will be licensing in the U.S. shmilovm@nih.gov. scheduled between approximately 1 FOR FURTHER INFORMATION CONTACT: Collaborative Research Opportunity: p.m. and 2 p.m. Those individuals Licensing information and copies of the The National Institute of Environmental interested in making formal oral patent applications listed below may be Health Sciences seeks statements of presentations should notify the contact obtained by emailing the indicated capability or nterest from parties person and submit a brief statement of licensing contact at the National Heart, interested in collaborative research to VerDate Sep<11>2014 16:52 Nov 15, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1

53510 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices further develop and evaluate, please Place: National Institutes of Health, 5601 your request, including your address to: contact Cecilia Pazman, Ph.D., Fishers Lane, Rockville, MD 20892 nciocpl@mail.nih.gov. Technology Development Specialist, (Telephone Conference Call). Contact Person: Dharmendar Rathore, SUPPLEMENTARY INFORMATION: This Office of Technology Transfer, National Ph.D., Senior Scientific Review Officer, proposed information collection was Heart, Lung, and Blood Institute, Phone: Scientific Review Program, Division of previously published in the Federal (301) 594–4273; pazmance@ Extramural Activities, Room 3G30, National Register on September 5, 2017 page nhlbi.nih.gov . Institutes of Health/NIAID, 5601 Fishers 41971 (82 FR 41971) and allowed 60 Dated: November 6, 2017. Lane, MSC 9823, Bethesda, MD 20892–9823, days for public comment. No public 240–669–5058, rathored@mail.nih.gov. comments were received. The purpose Michael Shmilovich, (Catalogue of Federal Domestic Assistance of this notice is to allow an additional Senior Licensing and Patenting Manager, Program Nos. 93.855, Allergy, Immunology, National Heart, Lung, and Blood Institute, 30 days for public comment. The and Transplantation Research; 93.856, Office of Technology Transfer and Microbiology and Infectious Diseases National Cancer Institute (NCI), Development. Research, National Institutes of Health, HHS) National Institutes of Health, may not [FR Doc. 2017–24773 Filed 11–15–17; 8:45 am] conduct or sponsor, and the respondent Dated: November 9, 2017. BILLING CODE 4140–01–P is not required to respond to, an Natasha M. Copeland, information collection that has been Program Analyst, Office of Federal Advisory extended, revised, or implemented on or DEPARTMENT OF HEALTH AND Committee Policy. after October 1, 1995, unless it displays HUMAN SERVICES [FR Doc. 2017–24762 Filed 11–15–17; 8:45 am] a currently valid OMB control number. BILLING CODE 4140–01–P In compliance with Section National Institutes of Health 3507(a)(1)(D) of the Paperwork National Institute of Allergy and Reduction Act of 1995, the National DEPARTMENT OF HEALTH AND Institutes of Health (NIH) has submitted Infectious Diseases; Notice of Closed HUMAN SERVICES Meetings to the Office of Management and Budget National Institutes of Health (OMB) a request for review and Pursuant to section 10(d) of the approval of the information collection Federal Advisory Committee Act, as Submission for OMB Review; 30-Day listed below. amended, notice is hereby given of the Comment Request; NCI Cancer Proposed Collection: NCI Cancer following meetings. Genetics Services Directory Web- Genetics Services Directory Web-Based The meetings will be closed to the Based Application and Update Mailer Application and Update Mailer, 0925– public in accordance with the (National Cancer Institute) 0639, Exp., date 10/31/2017, provisions set forth in sections Reinstatement without change, National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., AGENCY: National Institutes of Health, Cancer Institute (NCI), National as amended. The grant applications and HHS. Institutes of Health (NIH). the discussions could disclose ACTION: Notice. Need and Use of Information confidential trade secrets or commercial Collection: The Office of property such as patentable material, SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the Communications and Public Liaison has and personal information concerning created the NCI Cancer Genetics individuals associated with the grant National Institutes of Health (NIH) has submitted to the Office of Management Services Directory on NCI’s Web site applications, the disclosure of which Cancer.gov. This directory is a would constitute a clearly unwarranted and Budget (OMB) a request for review and approval of the information searchable collection of information invasion of personal privacy. about professionals who provide collection listed below. Name of Committee: National Institute of services related to cancer genetics. DATES: Comments regarding this Allergy and Infectious Diseases Special These services include cancer risk Emphasis Panel, Dysregulation of Immune information collection are best assured assessment, genetic counseling, and Cell Regulatory Pathways by MTB in the of having their full effect if received genetic susceptibility testing. The Context of HIV Infection (R61/R33). within 30-days of the date of this professionals have applied to be in the Date: December 11–12, 2017. publication. directory using an online application Time: 8:00 a.m. to 5:00 p.m. ADDRESSES: Written comments and/or form and have met basic criteria Agenda: To review and evaluate grant applications. suggestions regarding the item(s) outlined on the form. Place: National Institutes of Health, 5601 contained in this notice, especially There are currently 552 genetics Fishers Lane, Rockville, MD 20892 regarding the estimated public burden professionals listed in the directory. (Telephone Conference Call). and associated response time, should be Approximately 30–60 new professionals Contact Person: J. Bruce Sundstrom, Ph.D., directed to the: Office of Management are added to the directory each year. Scientific Review Officer, Scientific Review and Budget, Office of Regulatory Affairs, The applicants are nurses, physicians, Program, Division of Extramural Activities, OIRA_submission@omb.eop.gov or by Room 3G11A, National Institutes of Health/ genetic counselors, and other NIAID, 5601 Fishers Lane, MSC 9823, fax to 202–395–6974, Attention: Desk professionals who provide services Bethesda, MD 20892–9823, 240–669–5045, Officer for NIH. related to cancer genetics. The sundstromj@niaid.nih.gov. FOR FURTHER INFORMATION CONTACT: To information collected on the application asabaliauskas on DSKBBXCHB2PROD with NOTICES Name of Committee: National Institute of request more information on the form includes name, professional Allergy and Infectious Diseases Special proposed project or to obtain a copy of qualifications, practice locations, and Emphasis Panel, Global Infectious Disease the data collection plans and the area of specialization. The Research Administration Development instruments, contact: Margaret information is updated annually using a Award For Low-And Middle-Income Country Beckwith, Office of Cancer Content, Web-based update mailer that mirrors Institutions (G11). Date: December 13, 2017. Office of Communications and Public the application form. Time: 1:00 p.m. to 2:00 p.m. Liaison (OCPL), 9609 Medical Center The NCI Cancer Genetics Services Agenda: To review and evaluate grant Drive, Rockville, MD 20892 or call non- Directory is a unique resource for cancer applications. toll-free number 240–276–6600 or email patients and their families who are VerDate Sep<11>2014 16:52 Nov 15, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1


Document Created: 2017-11-16 03:53:37
Document Modified: 2017-11-16 03:53:37
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 53509 
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