National Institutes of Health, 39001-39002 [2019-16965]

Download as PDF 39001 Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices Dated: August 2, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16923 Filed 8–7–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as 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. jbell on DSK3GLQ082PROD with NOTICES Name of Committee: National Institute on Aging Special Emphasis Panel; T32 and T35 Review, January 2020 Council ZAG1 ZIJ–U (J4). Date: October 18, 2019. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Anita H. Undale, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–827– 7428, anita.undale@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 2, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16955 Filed 8–7–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Lutetium-177 Radiotherapeutics Against Glioblastoma Multiforme and SmallCell Lung Carcinoma AGENCY: National Institutes of Health, HHS. ACTION: Notice. NIH Ref No. Patent No. or patent application No. Filing date E–150–2016–0–US–01 ............. 62/333,427 .................. May 9, 2016 ............... E–150–2016–0–PCT–02 ........... PCT/US2017/031696 May 9, 2017 ............... E–150–2016–0–CN–03 ............. 201780029003X ......... November 9, 2018 ...... E–150–2016–0–EP–04 .............. 17796666.0 ................. November 12, 2018 .... E–150–2016–0–JP–05 .............. 2018–558662 .............. November 8, 2018 ...... E–150–2016–0–US–06 ............. 16/099,488 .................. November 7, 2018 ...... E–150–2016–0–SG–07 ............. 11201809982R ........... November 9, 2018 ...... E–150–2016–1–PCT–01 ........... PCT/US2017/054863 October 3, 2017 ......... The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective patent license will be granted worldwide and in a field of use not broader than Lutetium-177 radiotherapeutics containing RGDpeptide moieties targeting integrin avb3-expressing glioblastoma multiforme and small cell lung cancers. The invention pertains to a radiotherapeutic against cancers that overexpress integrin avb3. RGD peptide- VerDate Sep<11>2014 16:51 Aug 07, 2019 Jkt 247001 Frm 00075 Fmt 4703 Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development August 23, 2019 will be considered. DATES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Michael Shmilovich, Esq., Senior Licensing and Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892–2479, phone number 301–435–5019, or shmilovm@ mail.nih.gov. ADDRESSES: The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to MTTI: SUPPLEMENTARY INFORMATION: Title Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives and and Imaging Agents. Chemical Conjugates of Evans Blue Derivatives And And Imaging Agents. targeted radionuclide therapy directed against tumors that express integrin avb3 has proven effective for the treatment of advanced, low- to intermediate-grade tumors. The subject radiotherapeutic covered by the patent estate includes an RGD peptide (arginylglycylaspartic acid [Arg-GlyAsp], linear or cyclical), conjugated to an Evans Blue (EB) analog, and further chelated via DOTA to therapeutic radionuclide 177Lu, a beta emitter. The EB analog reversibly binds to circulating PO 00000 The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the patent application listed in the Supplementary Information section of this notice. SUMMARY: Sfmt 4703 Their Use as Radiotherapy Their Use as Radiotherapy Their Use as Radiotherapy Their Use as Radiotherapy Their Use as Radiotherapy Their Use as Radiotherapy Their Use as Radiotherapy Their Use As Radiotherapy serum albumin and improves the pharmacokinetics of RGD peptide DOTA conjugated radiotherapeutics and potentially toxicity. The EB analog conjugated has been shown by the inventors to provide reversible albumin binding in vivo and extended half-life in circulation. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this E:\FR\FM\08AUN1.SGM 08AUN1 39002 Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices published notice, the NHLBI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: August 1, 2019. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. Name of Committee: National Institute of Allergy and Infectious Diseases, Special Emphasis Panel; NIAID Clinical Trial Planning Grants (R34). Date: September 19, 2019. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Priti Mehrotra, Ph.D., Chief, Immunology Review Branch, Scientific Review Program, Division of Extramural Activities, Room #3G40, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–7616, 240–669– 5066, pmehrotra@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: August 2, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16965 Filed 8–7–19; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2019–16924 Filed 8–7–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings jbell on DSK3GLQ082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases, Special Emphasis Panel; Clinical Research Products Management Center (CRPMC). Date: September 3, 2019. Time: 9:30 a.m. to 12:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Audrey O. Lau, MPH, Ph.D., Acting Senior Scientific Review Officer, Aids Review Branch SRP, RM 3E70, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9834, Rockville, MD 20852–9834, 240–669–2081, audrey.lau@ nih.gov. VerDate Sep<11>2014 16:51 Aug 07, 2019 Jkt 247001 National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as 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: National Center for Advancing Translational Sciences Special Emphasis Panel; CTSA. Date: September 11–12, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Bethesda North Marriott Hotel & Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Victor Henriquez, Ph.D., Scientific Review Officer, Office of Scientific Director, National Center for Advancing Translational Sciences (NCATS), National PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1080, Bethesda, MD 20892–4878, 301–435–0813, henriquv@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: August 2, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–16925 Filed 8–7–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: SAMHSA Application for Peer Grant Reviewers (OMB No. 0930– 0255)—Revision Section 501(h) of the Public Health Service (PHS) Act (42 U.S.C. 290aa) directs the Assistant Secretary of the Substance Abuse and Mental Health Services Administration (SAMHSA) to establish such peer review groups as are needed to carry out the requirements of Title V of the PHS Act. SAMHSA administers a large discretionary grants program under authorization of Title V, and, for many years, SAMHSA has funded grants to provide prevention and treatment services related to substance abuse and mental health. In support of its grant peer review efforts, SAMHSA desires to continue to expand the number and types of reviewers it uses on these grant review committees. To accomplish that end, SAMHSA has determined that it is important to proactively seek the inclusion of new and qualified representatives on its peer review groups. Accordingly, SAMHSA has developed an application form for use by individuals who wish to apply to serve as peer reviewers. E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 39001-39002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16965]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health

Prospective Grant of Exclusive Patent License: Lutetium-177 
Radiotherapeutics Against Glioblastoma Multiforme and Small-Cell Lung 
Carcinoma

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive patent license to Molecular 
Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its 
principle place of business in West Chester, Pennsylvania, to practice 
the inventions embodied in the patent application listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
August 23, 2019 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to MTTI:

----------------------------------------------------------------------------------------------------------------
                                        Patent No. or patent
            NIH Ref No.                   application No.              Filing date                 Title
----------------------------------------------------------------------------------------------------------------
E-150-2016-0-US-01.................  62/333,427...............  May 9, 2016..............  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-PCT-02................  PCT/US2017/031696........  May 9, 2017..............  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-CN-03.................  201780029003X............  November 9, 2018.........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-EP-04.................  17796666.0...............  November 12, 2018........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-JP-05.................  2018-558662..............  November 8, 2018.........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-US-06.................  16/099,488...............  November 7, 2018.........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-0-SG-07.................  11201809982R.............  November 9, 2018.........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives and
                                                                                            Their Use as
                                                                                            Radiotherapy and
                                                                                            Imaging Agents.
E-150-2016-1-PCT-01................  PCT/US2017/054863........  October 3, 2017..........  Chemical Conjugates
                                                                                            of Evans Blue
                                                                                            Derivatives And
                                                                                            Their Use As
                                                                                            Radiotherapy And
                                                                                            Imaging Agents.
----------------------------------------------------------------------------------------------------------------

    The patent rights in these inventions have been assigned to the 
Government of the United States of America. The prospective patent 
license will be granted worldwide and in a field of use not broader 
than Lutetium-177 radiotherapeutics containing RGD-peptide moieties 
targeting integrin [alpha]v[beta]3-expressing glioblastoma multiforme 
and small cell lung cancers.
    The invention pertains to a radiotherapeutic against cancers that 
overexpress integrin [alpha]v[beta]3. RGD peptide-targeted radionuclide 
therapy directed against tumors that express integrin [alpha]v[beta]3 
has proven effective for the treatment of advanced, low- to 
intermediate-grade tumors. The subject radiotherapeutic covered by the 
patent estate includes an RGD peptide (arginylglycylaspartic acid [Arg-
Gly-Asp], linear or cyclical), conjugated to an Evans Blue (EB) analog, 
and further chelated via DOTA to therapeutic radionuclide \177\Lu, a 
beta emitter. The EB analog reversibly binds to circulating serum 
albumin and improves the pharmacokinetics of RGD peptide DOTA 
conjugated radiotherapeutics and potentially toxicity. The EB analog 
conjugated has been shown by the inventors to provide reversible 
albumin binding in vivo and extended half-life in circulation. This 
notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. 
The prospective exclusive patent license will be royalty bearing and 
may be granted unless within fifteen (15) days from the date of this

[[Page 39002]]

published notice, the NHLBI receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent license. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: August 1, 2019.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2019-16965 Filed 8-7-19; 8:45 am]
 BILLING CODE 4140-01-P


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