Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE), 11362-11363 [2017-03402]

Download as PDF 11362 Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques of other forms of information technology, e.g., permitting electronic submission of responses. Title of Proposal: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment. Type of Information Collection Request: Three year approval of this new information collection. OMB Control Number: To be assigned. Need and Use of Information Collection: The Mashpee Wampanoag Indian Health Service (IHS) Unit seeks to conduct a health assessment of the Mashpee Wampanoag Tribe. The collection of information will be used to evaluate the health care needs of the Mashpee Wampanoag Tribal community. As a healthcare organization, the Mashpee Wampanoag Health Service Unit has questions regarding a respondent’s health status, behavior and social practices as well as environmental concerns. These answers will help the organization assess healthcare needs of the community and guide the implementation of programs. The Mashpee Wampanoag Health Service Unit will be able to assess the community’s needs and plan our Number of responses per respondent programs accordingly to improve the health and well-being of the community. Status of the Proposed Information Collection: New request. Form(s): IHS Mashpee Wampanoag Community Health Assessment Questionnaire. Agency Form Numbers: None. Members of Affected Public: The Mashpee Wampanoag Tribal community members in the Mashpee Wampanoag Tribal service area. The table below provides: Type of data collection instrument, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s). Total annual response Average burden per response (hours) Estimated burden hours Data collection instrument Type of respondents Community Health Assessment ........ Individuals ........................................ 1 469 25/60 195 Total ........................................... ........................................................... 1 469 25/60 195 received by the National Cancer Institute’s Technology Transfer Center on or before March 9, 2017 will be considered. There are no direct costs to respondents to report. Dated: February 10, 2017. Chris Buchanan, Assistant Surgeon General, USPHS, Acting Director, Indian Health Service. [FR Doc. 2017–03407 Filed 2–21–17; 8:45 am] BILLING CODE 4160–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE) AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to 3D Medicines (‘‘3DMed’’) located in Shanghai, China. DATES: Only written comments and/or applications for a license which are sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:05 Feb 21, 2017 Jkt 241001 Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Ph.D., Technology Transfer and Patent Specialist, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892– 9702 (for business mail), Rockville, MD 20850–9702; Telephone: (240) 276– 5530; Facsimile: (240) 276–5504; Email: jim.knabb@nih.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: Intellectual Property United States Provisional Patent Application No. 62/292,789, filed February 8, 2016 entitled ‘‘Gene Signature Predictive of Hepatocellular Carcinoma Response to Transcatheter Arterial Chemoembolization’’ [HHS Reference No. E–101–2016/0–US–01]; PCT Patent Application PCT/US2017/ 016851, filed February 7, 2017 and entitled ‘‘GENE SIGNATURE PREDICTIVE OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE)’’ [HHS Reference No. E–101–2016/0– PCT–02]; (and U.S. and foreign patent PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 applications claiming priority to the aforementioned applications). 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 and commercialization of the transcatheter arterial chemoembolization (TACE) gene signature as a diagnostic device predictive of TACE response in patients with hepatocellular carcinoma (HCC). The field of use may be further limited to companion diagnostic tests that are sold following Premarket Approval by the FDA or equivalent regulatory agency in foreign jurisdictions’’. This technology discloses a gene expression signature that is predictive of HCC patient response to TACE. TACE therapy is a procedure whereby the tumor is targeted with both local chemotherapy and restriction of local blood supply, and is employed in the treatment of locally advanced hepatocellular carcinoma (HCC). Patient biopsies are analyzed by NextGeneration Sequencing (NGS) and expression analysis of the gene signature can be used to stratify patients for TACE therapy. Through the commercialization of this gene signature for TACE efficacy, HCC patients can be identified as candidates for TACE E:\FR\FM\22FEN1.SGM 22FEN1 Federal Register / Vol. 82, No. 34 / Wednesday, February 22, 2017 / Notices therapy, or as needing alternative treatment strategies. 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 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 filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. 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: February 15, 2017. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2017–03402 Filed 2–21–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting sradovich on DSK3GMQ082PROD with NOTICES Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Institute Board of Scientific Advisors. The meeting will be open to the public, 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 meeting will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (http:// videocast.nih.gov/). Name of Committee: National Cancer Institute Board of Scientific Advisors. Date: March 21, 2017. Time: 8:30 a.m. to 5:00 p.m. Agenda: Acting Director’s Report: Ongoing and New Business; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, 31 Center Drive, Building 31, C-Wing, 6th Floor, Room 10, Bethesda, MD 20892. VerDate Sep<11>2014 16:05 Feb 21, 2017 Jkt 241001 Contact Person: Paulette S. Gray, Ph.D., Director, Division of Extramural Activities, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, 7th Floor, Rm. 7W444, Bethesda, MD 20892, 240–276–6340, grayp@ mail.nih.gov. Name of Committee: National Cancer Institute Board of Scientific Advisors. Date: March 22, 2017. Time: 8:30 a.m. to 12:00 p.m. Agenda: Acting Director’s Report: Ongoing and New Business; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, 31 Center Drive, Building 31, C-Wing, 6th Floor, Room 10, Bethesda, MD 20892. Contact Person: Paulette S. Gray, Ph.D., Director, Division of Extramural Activities, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, 7th Floor, Rm. 7W444, Bethesda, MD 20892, 240–276–6340, grayp@ mail.nih.gov. 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 Institute’s/Center’s home page: http:// deainfo.nci.nih.gov/advisory/bsa/bsa.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: February 15, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–03387 Filed 2–21–17; 8:45 am] BILLING CODE 4140–01–P PO 00000 11363 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Clinical Trials and Translation Research Advisory Committee, March 8, 2017, 8:00 a.m. to March 8, 2017, 3:00 p.m., National Institutes of Health, Building 31, C-Wing, 6th Floor, Rooms 9 and 10, 31 Center Drive, Bethesda, MD 20892 which was published in the Federal Register on January 11, 2017, 81 FR 3342. This meeting notice is amended to change the meeting format and start and end times. The meeting will now be held virtually from 11:00 a.m. to 1:30 p.m. due to a change in the agenda which reduced the time required for deliberation and discussion. The meeting will still be held at the National Institutes of Health, Building 31, CWing, 6th Floor, Rooms 9 and 10, 31 Center Drive, Bethesda, MD 20892 and can also be accessed via NIH Videocast at https://videocast.nih.gov. This meeting is open to the public. Dated: February 16, 2017. Melanie J. Gray-Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–03448 Filed 2–21–17; 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 (5 U.S.C. App.), 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 Institute on Aging Special Emphasis Panel; Second Stage P01 Review. Date: March 15, 2017. Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11362-11363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of a 
Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient 
Response to Transcatheter Arterial Chemoembolization (TACE)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to 3D Medicines 
(``3DMed'') located in Shanghai, China.

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 March 9, 2017 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: Jim Knabb, Ph.D., Technology Transfer and Patent 
Specialist, NCI Technology Transfer Center, 9609 Medical Center Drive, 
RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240) 276-5530; Facsimile: (240) 
276-5504; Email: jim.knabb@nih.gov.

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. 62/292,789, filed 
February 8, 2016 entitled ``Gene Signature Predictive of Hepatocellular 
Carcinoma Response to Transcatheter Arterial Chemoembolization'' [HHS 
Reference No. E-101-2016/0-US-01]; PCT Patent Application PCT/US2017/
016851, filed February 7, 2017 and entitled ``GENE SIGNATURE PREDICTIVE 
OF HEPATOCELLULAR CARCINOMA RESPONSE TO TRANSCATHETER ARTERIAL 
CHEMOEMBOLIZATION (TACE)'' [HHS Reference No. E-101-2016/0-PCT-02]; 
(and U.S. and foreign patent applications claiming priority to the 
aforementioned applications).
    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 and 
commercialization of the transcatheter arterial chemoembolization 
(TACE) gene signature as a diagnostic device predictive of TACE 
response in patients with hepatocellular carcinoma (HCC). The field of 
use may be further limited to companion diagnostic tests that are sold 
following Premarket Approval by the FDA or equivalent regulatory agency 
in foreign jurisdictions''.
    This technology discloses a gene expression signature that is 
predictive of HCC patient response to TACE. TACE therapy is a procedure 
whereby the tumor is targeted with both local chemotherapy and 
restriction of local blood supply, and is employed in the treatment of 
locally advanced hepatocellular carcinoma (HCC). Patient biopsies are 
analyzed by Next-Generation Sequencing (NGS) and expression analysis of 
the gene signature can be used to stratify patients for TACE therapy. 
Through the commercialization of this gene signature for TACE efficacy, 
HCC patients can be identified as candidates for TACE

[[Page 11363]]

therapy, or as needing alternative treatment strategies.
    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 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 filed in response to this notice will be treated as objections 
to the grant of the contemplated Exclusive Patent License Agreement. 
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: February 15, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-03402 Filed 2-21-17; 8:45 am]
 BILLING CODE 4140-01-P