Prospective Grant of an Exclusive Patent License: Small Cell Lung Cancer Subtyping Using Plasma Cell-Free Nucleosomes, 3749-3750 [2023-01019]

Download as PDF Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 that the offense warranted the imposition of a 5-year period of debarment. The proposal informed Ms. Godding of the proposed debarment and offered her an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Godding received the proposal and notice of opportunity for a hearing on August 30, 2022. Ms. Godding failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and waived any contentions concerning her debarment (21 CFR part 12). II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Ms. Linda Godding has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Ms. Godding is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Ms. Godding is a prohibited act. Any application by Ms. Godding for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2022– N–1398 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Dated: January 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–00997 Filed 1–19–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:29 Jan 19, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, January 24, 2023, 12:00 p.m. to January 24, 2023, 4:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD, 20852, which was published in the Federal Register on December 30, 2022, FR Doc 2022–28446, 87 FR 80554. This notice is being amended to change the meeting date from January 24, 2023, to February 2, 2023. Meeting location and time remain the same. The meeting is closed to the public. Dated: January 13, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–01018 Filed 1–19–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Small Cell Lung Cancer Subtyping Using Plasma CellFree Nucleosomes AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Yissum Research and Development (‘‘Yissum’’), the technology transfer company of the Hebrew University of Jerusalem, a nonprofit research institution located in Jerusalem, Israel for NCI’s rights to the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before February 6, 2023 will be considered. SUMMARY: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive patent license should be ADDRESSES: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 3749 directed to: Michaela McCrary, Ph.D., Licensing and Patenting Manager, NCI Technology Transfer Center, at: Email: michaela.mccrary@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property 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 Yissum: United States Provisional Patent Application No. 63/ 342,763, filed May 17, 2022 and entitled ‘‘SMALL CELL LUNG CANCER SUBTYPING USING PLASMA CELL– FREE NUCELOSOMES’’ [HHS Reference No. E–172–2022–0–US–01]. The patent rights in these inventions have been assigned to the Government of the United States of America and Yissum. The prospective license will be for the purpose of consolidating the patent rights to Yissum, the co-owners of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200–212. The prospective patent license territory will be worldwide, exclusive, and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by Yissum will be subject to the provisions of 37 CFR part 401 and 404. This technology discloses a noninvasive method to molecularly subtype SCLC from plasma samples using chromatin immunoprecipitation of cellfree nucleosomes carrying active chromatin modification followed by sequencing (cfChIP–seq). This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will include terms for the sharing of royalty income with NCI from commercial sublicenses of the patent rights. 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 be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license E:\FR\FM\20JAN1.SGM 20JAN1 3750 Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices 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: January 13, 2023. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2023–01019 Filed 1–19–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Evaluation of the Enhancing Diversity of the NIH-Funded Workforce Program (National Institute of General Medical Sciences) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. SUMMARY: Extension of a currently approved collection. The goal of the DPC is to address a unique and compelling need identified by NIH, namely to enhance the diversity of well-trained biomedical research scientists who can successfully compete for NIH research funding and/ or otherwise contribute to the NIHfunded scientific workforce. The DPC is a national collaborative through which awardee institutions, in partnership with NIH, aim to enhance diversity in the biomedical research workforce through the development, implementation, assessment and dissemination of innovative and effective approaches to: (a) student outreach, engagement, training, and mentoring, (b) faculty development, and (c) institutional research training infrastructure. The Coordination and Evaluation Center (CEC) will evaluate the efficacy of the training and mentoring approaches implemented across a variety of contexts and populations and will disseminate information to the broader research community. The planned consortiumwide data collection and evaluation will provide comprehensive information about the multi-dimensional factors (individual, institutional, and faculty/ mentor) that influence student and faculty success, professional development, and persistence within biomedical research career paths across a variety of contexts. The planned data collection, and the resulting findings, is projected to have a sustained, transformative effect on biomedical research training and mentoring nationwide. OMB approval is requested for an extension of 13 months beyond the currently approved collection, until June 2024. There are no costs to respondents other than their time. The total estimated annualized burden hours are 11,730. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Alison Gammie, Director, Division of Training, Workforce Development, and Diversity, NIGMS, 45 Center Drive, Room 2AS43J, Bethesda, MD 20892, or call non-toll-free number (301) 496–7301 or Email your request, including your address to: alison.gammie@nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Evaluation of the Enhancing the Diversity of the NIH-funded Workforce Program Consortium (DPC), 0925–0747, 06/30/ 2024, EXTENSION, National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Need and Use of Information Collection: This request is for an FOR FURTHER INFORMATION CONTACT: lotter on DSK11XQN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hours Form name Type of respondents Student Annual Follow-up survey (Attachment 13). BUILD Institutional Research & Program Data Requests (Attachment 19). Non-BUILD Student and BUILD student. Personnel and Administrators at BUILD Institutions. 15,000 1 45/60 11,250 10 3 16 480 .......................................................... ........................ 15,030 ........................ 11,730 Total ........................................... VerDate Sep<11>2014 17:29 Jan 19, 2023 Jkt 259001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\20JAN1.SGM 20JAN1

Agencies

[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3749-3750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Small Cell Lung 
Cancer Subtyping Using Plasma Cell-Free Nucleosomes

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute (NCI), an institute of the 
National Institutes of Health, Department of Health and Human Services, 
is contemplating the grant of an exclusive, sublicensable patent 
license to Yissum Research and Development (``Yissum''), the technology 
transfer company of the Hebrew University of Jerusalem, a non-profit 
research institution located in Jerusalem, Israel for NCI's rights to 
the patent applications listed in the Supplementary Information section 
of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before February 6, 2023 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michaela McCrary, Ph.D., Licensing and Patenting 
Manager, NCI Technology Transfer Center, at: Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    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 Yissum: United States Provisional 
Patent Application No. 63/342,763, filed May 17, 2022 and entitled 
``SMALL CELL LUNG CANCER SUBTYPING USING PLASMA CELL-FREE NUCELOSOMES'' 
[HHS Reference No. E-172-2022-0-US-01].
    The patent rights in these inventions have been assigned to the 
Government of the United States of America and Yissum. The prospective 
license will be for the purpose of consolidating the patent rights to 
Yissum, the co-owners of said rights, for commercial development and 
marketing. Consolidation of these co-owned rights is intended to 
expedite development of the invention, consistent with the goals of the 
Bayh-Dole Act codified as 35 U.S.C. 200-212.
    The prospective patent license territory will be worldwide, 
exclusive, and may be limited to those fields of use commensurate in 
scope with the patent rights. It will be sublicensable, and any 
sublicenses granted by Yissum will be subject to the provisions of 37 
CFR part 401 and 404.
    This technology discloses a non-invasive method to molecularly 
subtype SCLC from plasma samples using chromatin immunoprecipitation of 
cell-free nucleosomes carrying active chromatin modification followed 
by sequencing (cfChIP-seq).
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will include terms for the 
sharing of royalty income with NCI from commercial sublicenses of the 
patent rights. 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 be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license that are timely filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive patent license. In response to this Notice, 
the public may file comments or objections. Comments and objections, 
other than those in the form of a license

[[Page 3750]]

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: January 13, 2023.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2023-01019 Filed 1-19-23; 8:45 am]
BILLING CODE 4140-01-P

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