Office of the Director, National Institutes of Health; Notice of Closed Meeting, 8306-8307 [2020-02860]

Download as PDF 8306 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Forms Survey on SUD Placement Criteria ................................................................. Dated: February 5, 2020. Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2020–02846 Filed 2–12–20; 8:45 am] BILLING CODE 4150–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: Ebola Virus Glycoprotein-Specific Monoclonal Antibodies and Uses Thereof Description of Technology Ebola virus is a large, negative-strand RNA virus composed of 7 genes encoding viral proteins, including a single glycoprotein (GP). The virus is responsible for causing Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever (EHF), in humans. In particular, Bundibugyo (BDBV), Zaire (EBOV), and Sudan (SUDV) species VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 87 have been associated with large outbreaks of EVD in Africa and reported case fatality rates of up to 90%. Transmission of Ebola virus to humans is not yet fully understood but is likely due to incidental exposure to infected animals. EVD spreads through humanto-human transmission, with infection resulting from direct contact with blood, secretions, organs or other bodily fluids of infected people, and indirect contact with environments contaminated by such fluids. EVD has an incubation period of 2 to 21 days (7 days on average, depending on the strain) followed by a rapid onset of non-specific symptoms such as fever, extreme fatigue, gastrointestinal complaints, abdominal pain, anorexia, headache, myalgias and/or arthralgias. While prior outbreaks of EVD have been localized to regions of Africa, there is a potential threat of spread to other countries given the frequency of international travel. The 2014 outbreak in West Africa was first recognized in March 2014, and as of April 13, 2016, the number of cases far exceeded the largest prior EVD outbreak with a combined total (suspected, probable, and laboratory-confirmed) 28616 cases and 11310 deaths (case fatality rate = 39.5%). The largest previous outbreak occurred in Uganda in 2000–2001 with 425 cases and 224 deaths (case-fatality rate = 53%). Viruses in the Filoviridae family are also categorized as potential threats for use as biological weapons due to ease of dissemination and transmission, and high levels of mortality. Currently, no effective therapies or FDA-licensed vaccines exist for any member of Filoviridae family of viruses. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) developed eight high-affinity human monoclonal antibodies, specifically EboV.YD.01, EboV.YD.02, EboV.YD.03, and EboV.YD.04, EboV.YD.05, EboV.YD.06, EboV.YD.07 and EboV.YD.08 which bind with nanomolar affinity against Ebola virus glycoprotein. The human monoclonal antibodies have been assessed by functional assays, epitope mapping, affinity measurements and in vitro neutralization assays. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (hours) 1 Total annual burden (hours) 10/60 14.5 This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications: • Prevention of acquisition of Ebola Zaire virus. • Antibody therapy for people exposed to Ebola Zaire virus. • Diagnostics for Ebola Zaire virus. Competitive Advantages: • High-affinity neutralizing antibodies (mAbs), targeting Ebola virus (EBOV) glycoprotein from a human Ebolavirus vaccine. • Currently, there are no Food and Drug Administration (FDA)-approved vaccines or therapeutics available for prevention, post-exposure, or treatment for EBOV. • The EboV.YD.01–EboV.YD.08 antibodies can be combined with other biologicals and vaccines for prevention and therapy of Ebola Zaire infection/ disease. Development Stage: Preclinical Research. Inventors: Nancy J. Sullivan, Ph.D. (NIAID); John Misasi, Ph.D. (NIAID). Intellectual Property: HHS Reference Number E–061–2018 includes U.S. Provisional Patent Application Number 62/782,809, filed 12/20/2018, and PCT Application Number PCT/US2019/ 067423, filed 12/19/2019. Licensing Contact: To license this technology, please contact Dianca Finch, Ph.D., 240–669–5503; dianca.finch@nih.gov. Dated: February 4, 2020. Wade W. Green, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2020–02916 Filed 2–12–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\13FEN1.SGM 13FEN1 8307 Federal Register / Vol. 85, No. 30 / Thursday, February 13, 2020 / Notices amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Office of Research Infrastructure Programs Special Emphasis Panel; Office of Research Infrastructure Programs (ORIP) Special Emphasis Panel: Applications for Scientific Conferences. Date: March 20, 2020. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Dr., Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, (301) 435– 0229, kenneth.ryan@nih.hhs.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: February 7, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–02860 Filed 2–12–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Zhining Wang, Ph.D., Project Officer, Center for Cancer Genomics (CCG), National Cancer Institute, Building 31 Room 3A20, 31 Center Drive, Bethesda, MD 20814 or call non-toll-free number 301–402–1892 or email your request, including your address to: zhining.wang@mail.nih.gov. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on December 2, 2019 page 65990 (Vol. 84 No. 231 FR 65990 and allowed 60 days for public comment. No ADDRESSES: public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: NCI Genomic Data Commons (GDC) Data Submission Request Form, 0925–0752, Expiration Date 5/31/2020, EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the NCI Genomic Data Commons (GDC) Data Submission Request Form is to provide a vehicle for investigators to request submission of their cancer genomic data into the GDC in support of data sharing. The purpose is to also provide a mechanism for the GDC Data Submission Review Committee to review and assess the data submission request for applicability to the GDC mission. The scope of the form involves obtaining information from investigators that: (1) Would like to submit data about their study into the GDC, (2) are affiliated with studies that adhere to GDC data submission conditions. The benefits of the collection are that it provides the needed information for investigators to understand the types of studies and data that the GDC supports, and that it provides a standard mechanism for the GDC to assess incoming data submission requests. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 50 hours. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents jbell on DSKJLSW7X2PROD with NOTICES Type ofrespondent Number of responses per respondent Average time per response (in hours) Total annual burden hour Investigator ...................................................................................................... 200 1 15/60 50 Total .......................................................................................................... ........................ 200 ........................ 50 VerDate Sep<11>2014 18:34 Feb 12, 2020 Jkt 250001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8306-8307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as

[[Page 8307]]

amended, notice is hereby given of the following meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Office of Research Infrastructure Programs 
Special Emphasis Panel; Office of Research Infrastructure Programs 
(ORIP) Special Emphasis Panel: Applications for Scientific 
Conferences.
    Date: March 20, 2020.
    Time: 11:00 a.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Dr., Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, (301) 435-
0229, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.22, Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds; 
93.232, Loan Repayment Program for Research Generally; 93.39, 
Academic Research Enhancement Award; 93.936, NIH Acquired 
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, 
Undergraduate Scholarship Program for Individuals from Disadvantaged 
Backgrounds, National Institutes of Health, HHS)

    Dated: February 7, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-02860 Filed 2-12-20; 8:45 am]
 BILLING CODE 4140-01-P
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