Office of the Director, National Institutes of Health; Notice of Meetings, 68467-68468 [2019-27004]

Download as PDF lotter on DSKBCFDHB2PROD with NOTICES Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices Human Monoclonal Antibodies To The Same Epitope Of An Unknown Cell Surface Antigen Expressed In B-cell Lymphocytic Leukemia (B–CLL)’’ [HHS Ref. E–163–2009–0–US–01], PCT Patent Application PCT/US2010/034491 entitled ‘‘B-cell Surface Reactive Antibodies’’ [HHS Ref. E–163–2009–0– PCT–02], and United States Patent 8,877,199, entitled ‘‘B-cell Surface Reactive Antibodies’’ [HHS Ref. E–163– 2009–0–US–03]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to The development, production, and commercialization of a Siglec-6-specific chimeric antigen receptor (CAR) based immunotherapy using autologous (meaning one individual is both the donor and recipient) T cells modified by virus-free Sleeping Beauty (SB)-based gene transposition compromising of at least: a. A single antigen specificity; and b. comprising at least: i. The complementary determining region (CDR) sequences of the Siglec-6 antibody known as JML–1, and ii. a CD3z activation module and either a CD28 or a 4–1BB co-stimulation moiety. for the treatment of acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and other forms of acute and chronic B- and T-cell leukemia and lymphoma. The licensed field of use excludes any (a) non-specified immunoconjugates, including, but not limited to, antibody drug conjugates and immunotoxins and (b) unconjugated antibodies. This technology discloses monoclonal antibodies that are specific for the cell surface domain of Siglec-6. The antibodies can potentially be used for the treatment of acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and other forms of acute and chronic B-and T-cell leukemia and lymphoma cells. In the subject situation, the antibodies can be used in a CAR, leading to the selective destruction of the cancerous cells. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: December 5, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–27002 Filed 12–13–19; 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 Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the meetings of the Council of Councils. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov). A portion of the meetings 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: Council of Councils. Open: January 24, 2020. Time: 8:15 a.m. to 12:10 p.m. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 68467 Agenda: Call to Order and Introductions; Announcements and Updates; Scientific Talks; NIH Program Updates. Place: National Institutes of Health, John E. Porter Neuroscience Research Center, Building 35A, Rooms 620/630, 35 Convent Drive, Bethesda, MD 20892. Closed: January 24, 2020. Time: 12:10 p.m. to 1:10 p.m. Agenda: Review of Grant Applications. Place: National Institutes of Health, John E. Porter Neuroscience Research Center, Building 35A, Rooms 620/630, 35 Convent Drive, Bethesda, MD 20892. Open: January 24, 2020. Time: 1:10 p.m. to 4:00 p.m. Agenda: Scientific Talks and NIH Program Updates. Place: National Institutes of Health, John E. Porter Neuroscience Research Center, Building 35A, Rooms 620/630, 35 Convent Drive, Bethesda, MD 20892. Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435– 0744. Name of Committee: Council of Councils. Open: May 15, 2020. Time: 8:15 a.m. to 12:00 p.m. Agenda: Call to Order and Introductions; Announcements and Updates; Scientific Talks; NIH Program Updates. Place: National Institutes of Health, 6001 Executive Boulevard, Neuroscience Center, Room C, E, Bethesda, MD 20892. Closed: May 15, 2020. Time: 12:00 p.m. to 1:00 p.m. Agenda: Review of Grant Applications. Place: National Institutes of Health, 6001 Executive Boulevard, Neuroscience Center, Room C, E, Bethesda, MD 20892. Open: May 15, 2020. Time: 1:00 p.m. to 4:00 p.m. Agenda: Scientific Talks and NIH Program Updates. Place: National Institutes of Health, 6001 Executive Boulevard, Neuroscience Center, Room C, E, Bethesda, MD 20892. Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435– 0744. Name of Committee: Council of Councils. Open: September 11, 2020. Time: 8:15 a.m. to 12:00 p.m. Agenda: Call to Order and Introductions; Announcements and Updates; Scientific Talks; NIH Program Updates. Place: National Institutes of Health, Natcher Building, Building 45, Room D, C1/ C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892. Closed: September 11, 2020. Time: 12:00 p.m. to 1:00 p.m. Agenda: Review of Grant Applications. Place: National Institutes of Health, Natcher Building, Building 45, Room D, C1/ E:\FR\FM\16DEN1.SGM 16DEN1 68468 Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892. Open: September 11, 2020. Time: 1:00 p.m. to 4:00 p.m. Agenda: Scientific Talks and NIH Program Updates. Place: National Institutes of Health, Natcher Building, Building 45, Room D, C1/ C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, GriederF@mail.nih.gov, 301–435– 0744. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Council of Council’s home page at https:// dpcpsi.nih.gov/council/ where an agenda will be posted before the meeting date. (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: December 10, 2019. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–27004 Filed 12–13–19; 8:45 am] BILLING CODE 4140–01–P lotter on DSKBCFDHB2PROD with NOTICES Coast Guard [Docket No. USCG–2019–0753] Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625– NEW Coast Guard, DHS. VerDate Sep<11>2014 19:21 Dec 13, 2019 Jkt 250001 In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for the following collection of information: 1625–NEW, Merchant Mariner Credentialing—Job Task Analysis. Our ICR describe the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties. DATES: Comments must reach the Coast Guard and OIRA on or before January 15, 2020. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2019–0753] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. Alternatively, you may submit comments to OIRA using one of the following means: (1) Email: OIRA-submission@ omb.eop.gov. (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention Desk Officer for the Coast Guard. (3) Fax: 202–395–6566. To ensure your comments are received in a timely manner, mark the fax, attention Desk Officer for the Coast Guard. A copy of the ICR is available through the docket on the internet at https:// www.regulations.gov. Additionally, copies are available from: Commandant (CG–612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710, Washington, DC 20593–7710. FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of Information Management, telephone 202–475–3532, or fax 202–372–8413, for questions on these documents. SUPPLEMENTARY INFORMATION: SUMMARY: Public Participation and Request for Comments DEPARTMENT OF HOMELAND SECURITY AGENCY: Thirty-Day notice requesting comments. ACTION: This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection’s purpose, the Collection’s likely burden on the affected public, an explanation of the necessity of the Collection, and PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. Consistent with the requirements of Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, the Coast Guard is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents. These comments will help OIRA determine whether to approve the ICR referred to in this Notice. We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG–2019–0753], and must be received by January 15, 2020. Submitting Comments We encourage you to submit comments through the Federal eRulemaking Portal at https:// www.regulations.gov. If your material cannot be submitted using https:// www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website’s instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted. We accept anonymous comments. All comments received will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68467-68468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27004]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the meetings of the Council of 
Councils.
    The meetings will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting. The open session will be 
videocast and can be accessed from the NIH Videocasting and Podcasting 
website (https://videocast.nih.gov).
    A portion of the meetings 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: Council of Councils.
    Open: January 24, 2020.
    Time: 8:15 a.m. to 12:10 p.m.
    Agenda: Call to Order and Introductions; Announcements and 
Updates; Scientific Talks; NIH Program Updates.
    Place: National Institutes of Health, John E. Porter 
Neuroscience Research Center, Building 35A, Rooms 620/630, 35 
Convent Drive, Bethesda, MD 20892.
    Closed: January 24, 2020.
    Time: 12:10 p.m. to 1:10 p.m.
    Agenda: Review of Grant Applications.
    Place: National Institutes of Health, John E. Porter 
Neuroscience Research Center, Building 35A, Rooms 620/630, 35 
Convent Drive, Bethesda, MD 20892.
    Open: January 24, 2020.
    Time: 1:10 p.m. to 4:00 p.m.
    Agenda: Scientific Talks and NIH Program Updates.
    Place: National Institutes of Health, John E. Porter 
Neuroscience Research Center, Building 35A, Rooms 620/630, 35 
Convent Drive, Bethesda, MD 20892.
    Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive 
Secretary, Council of Councils Director, Office of Research 
Infrastructure Programs, Division of Program Coordination, Planning, 
and Strategic Initiatives, Office of the Director, NIH, 6701 
Democracy Boulevard, Room 948, Bethesda, MD 20892, 
[email protected], 301-435-0744.

    Name of Committee: Council of Councils.
    Open: May 15, 2020.
    Time: 8:15 a.m. to 12:00 p.m.
    Agenda: Call to Order and Introductions; Announcements and 
Updates; Scientific Talks; NIH Program Updates.
    Place: National Institutes of Health, 6001 Executive Boulevard, 
Neuroscience Center, Room C, E, Bethesda, MD 20892.
    Closed: May 15, 2020.
    Time: 12:00 p.m. to 1:00 p.m.
    Agenda: Review of Grant Applications.
    Place: National Institutes of Health, 6001 Executive Boulevard, 
Neuroscience Center, Room C, E, Bethesda, MD 20892.
    Open: May 15, 2020.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: Scientific Talks and NIH Program Updates.
    Place: National Institutes of Health, 6001 Executive Boulevard, 
Neuroscience Center, Room C, E, Bethesda, MD 20892.
    Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive 
Secretary, Council of Councils Director, Office of Research 
Infrastructure Programs, Division of Program Coordination, Planning, 
and Strategic Initiatives, Office of the Director, NIH, 6701 
Democracy Boulevard, Room 948, Bethesda, MD 20892, 
[email protected], 301-435-0744.

    Name of Committee: Council of Councils.
    Open: September 11, 2020.
    Time: 8:15 a.m. to 12:00 p.m.
    Agenda: Call to Order and Introductions; Announcements and 
Updates; Scientific Talks; NIH Program Updates.
    Place: National Institutes of Health, Natcher Building, Building 
45, Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
    Closed: September 11, 2020.
    Time: 12:00 p.m. to 1:00 p.m.
    Agenda: Review of Grant Applications.
    Place: National Institutes of Health, Natcher Building, Building 
45, Room D, C1/

[[Page 68468]]

C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
    Open: September 11, 2020.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: Scientific Talks and NIH Program Updates.
    Place: National Institutes of Health, Natcher Building, Building 
45, Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892.
    Contact Person: Franziska Grieder, D.V.M., Ph.D., Executive 
Secretary, Council of Councils Director, Office of Research 
Infrastructure Programs, Division of Program Coordination, Planning, 
and Strategic Initiatives, Office of the Director, NIH, 6701 
Democracy Boulevard, Room 948, Bethesda, MD 20892, 
[email protected], 301-435-0744.

    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.
    Information is also available on the Council of Council's home 
page at https://dpcpsi.nih.gov/council/ where an agenda will be 
posted before the meeting date.

(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: December 10, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-27004 Filed 12-13-19; 8:45 am]
 BILLING CODE 4140-01-P


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