Prospective Grant of an Exclusive Option License: Immunotherapy Vaccine for Treating Lymphoma and Leukemia, 21251-21252 [2014-08387]

Download as PDF 21251 Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Notices Written comments and/or suggestions from the public and affected agencies are invited on 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443–4335 or Email your request, including your address to: kshropsh@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NIMH Database of Cognitive Training and Remediation Studies, 0925–New; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMH Database of Cognitive Training and Remediation Studies (DCTRS) is an integrated database that includes study- and subject-level data from studies of cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH staff and interested investigators to examine the ways in which various patient characteristics, intervention approaches and features, and treatment combinations affect responses to remediation. The DCTRS Study Information Form and Data Submission Agreement are necessary for the ‘‘Submitter’’ to request permission to submit study data to the NIMH DCTRS for general research purposes. The primary use of this information is to collect submitter information and study information for inclusion in the NIMH DCTRS database. The DCTRS data submission agreement includes two forms: (1) The data submission form that includes the terms, agreement, submitter information and certifications, and (2) the study information form which collects de-identified data for each study. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 60. ESTIMATED ANNUALIZED BURDEN HOURS Form Type of respondent Number of respondents Frequency of response Average time per response (in hours) Annual hour burden Data Submission Agreement ................ Principal Investigators/Physicians ........ 12 1 5 60 Dated: April 7, 2014. Keisha L Shropshire, Project Clearance Liaison, NIMH, NIH. research and development of the inventions: US Patent Application Serial No. 13/890,502, entitled, ‘‘Viral Chemokine-antigen Fusion Proteins’’ [HHS Ref. No. E–194–2000/0–US–06] and in US Patent Serial No. 8,258,278 and US Patent Application Serial No.13/ 587,515, both entitled ‘‘Methods and Compositions for the Treatment and Prevention of Cancer’’ [HHS Ref. Nos. E–271–2006/0–US–03 and E–271–2006/ 0–US–04, respectively]. The patent rights in this invention have been assigned to the Government of the United States of America. The exclusive option license may be term-limited, the prospective territory may be worldwide, and the field of use may be limited to: [FR Doc. 2014–08533 Filed 4–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Option License: Immunotherapy Vaccine for Treating Lymphoma and Leukemia AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to University of Texas MD Anderson Cancer Center, of an exclusive option license to practice the inventions embodied in the following US Patents and US Patent Applications (and all foreign counterparts) for the continued mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:06 Apr 14, 2014 Jkt 232001 Research, development, manufacture, and related non-commercial use in humans for the treatment of B-cell leukemias and B-cell lymphoma of a chemokine-tumor antigen fusion protein in which the chemokine is viral Macrophage Inflammatory Protein 3 Alpha (MIP3a) and the tumor antigen is the epitope of a malignant B-cell immunoglobulin idiotype of an antibody produced by a B-cell lymphoma. Prior to the expiration or termination of the exclusive option license, University PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 of Texas M.D. Anderson Cancer Center will have the exclusive right to amend the option license to include the right to sublicense for commercialization. Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before April 30, 2014 will be considered. DATES: Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive option license should be directed to: Yolanda Mock Hawkins, Ph.D., M.B.A., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5170; Facsimile: (301) 402–0220; Email: hawkinsy@mail.nih.gov. ADDRESSES: This invention concerns a cancer treatment for B-cell lymphoma comprising a vaccine that increases the ability of a Bcell lymphoma antigen to provoke an immune response in the body. In particular, the vaccine comprises a viral chemokine fused to a tumor antigen and SUPPLEMENTARY INFORMATION: E:\FR\FM\15APN1.SGM 15APN1 21252 Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Notices is administered as either a protein or a nucleic acid. The prospective exclusive option license, and any potential sublicense, will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive option license, may be granted unless the NIH receives within fifteen (15) days from the date of this published notice 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 field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive option 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: April 9, 2014. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–08387 Filed 4–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meeting mstockstill on DSK4VPTVN1PROD with NOTICES 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 materials, 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 Library of Medicine Special Emphasis Panel; Scholarly Works G13. Date: July 30–31, 2014. Time: July 30, 2014, 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817. VerDate Mar<15>2010 18:06 Apr 14, 2014 Jkt 232001 Time: July 31, 2014, 9:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817. Contact Person: Zoe E. Huang, MD, Scientific Review Officer, Extramural Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–594–4937, huangz@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: April 9, 2014. Michelle Trout, Program Analyst, Office of the Federal Advisory Committee Policy. [FR Doc. 2014–08386 Filed 4–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory General Medical Sciences Council. The meeting will be open to the public as indicated below, with a short public comment period at the end. Attendance is limited by the 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 also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (https:// videocast.nih.gov/). 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 Advisory General Medical Sciences Council. Date: May 22–23, 2014 Closed: May 22, 2014, 8:30 a.m. to 5:00 p.m. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Open: May 23, 2014, 8:30 a.m. to ADJOURNMENT. Agenda: For the discussion of program policies and issues, opening remarks, report of the Director, NIGMS, and other business of the Council. Place: National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 45 Center Drive, Bethesda, MD 20892. Contact Person: Ann A. Hagan, Ph.D., Associate Director for Extramural Activities, NIGMS, NIH, DHHS, 45 Center Drive, Room 2AN24H, MSC 6200, Bethesda, MD 20892, (301) 594–4499, hagana@nigms.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 taxis, 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 home page (https:// www.nigms.nih.gov/About/Council/) where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: April 9, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–08390 Filed 4–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Meeting 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 AIDS Research Advisory Committee, NIAID. 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. E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21251-21252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08387]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Option License: Immunotherapy 
Vaccine for Treating Lymphoma and Leukemia

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant to University of Texas 
MD Anderson Cancer Center, of an exclusive option license to practice 
the inventions embodied in the following US Patents and US Patent 
Applications (and all foreign counterparts) for the continued research 
and development of the inventions: US Patent Application Serial No. 13/
890,502, entitled, ``Viral Chemokine-antigen Fusion Proteins'' [HHS 
Ref. No. E-194-2000/0-US-06] and in US Patent Serial No. 8,258,278 and 
US Patent Application Serial No.13/587,515, both entitled ``Methods and 
Compositions for the Treatment and Prevention of Cancer'' [HHS Ref. 
Nos. E-271-2006/0-US-03 and E-271-2006/0-US-04, respectively]. The 
patent rights in this invention have been assigned to the Government of 
the United States of America.
    The exclusive option license may be term-limited, the prospective 
territory may be worldwide, and the field of use may be limited to:

    Research, development, manufacture, and related non-commercial 
use in humans for the treatment of B-cell leukemias and B-cell 
lymphoma of a chemokine-tumor antigen fusion protein in which the 
chemokine is viral Macrophage Inflammatory Protein 3 Alpha 
(MIP3[alpha]) and the tumor antigen is the epitope of a malignant B-
cell immunoglobulin idiotype of an antibody produced by a B-cell 
lymphoma.

Prior to the expiration or termination of the exclusive option license, 
University of Texas M.D. Anderson Cancer Center will have the exclusive 
right to amend the option license to include the right to sublicense 
for commercialization.

DATES: Only written comments or applications for a license (or both) 
which are received by the NIH Office of Technology Transfer on or 
before April 30, 2014 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
option license should be directed to: Yolanda Mock Hawkins, Ph.D., 
M.B.A., Licensing and Patenting Manager, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-5170; Facsimile: (301) 
402-0220; Email: hawkinsy@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This invention concerns a cancer treatment 
for B-cell lymphoma comprising a vaccine that increases the ability of 
a B-cell lymphoma antigen to provoke an immune response in the body. In 
particular, the vaccine comprises a viral chemokine fused to a tumor 
antigen and

[[Page 21252]]

is administered as either a protein or a nucleic acid.
    The prospective exclusive option license, and any potential 
sublicense, will comply with the terms and conditions of 35 U.S.C. 209 
and 37 CFR part 404. The prospective exclusive option license, may be 
granted unless the NIH receives within fifteen (15) days from the date 
of this published notice 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 field of use filed in 
response to this notice will be treated as objections to the grant of 
the contemplated exclusive option 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: April 9, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-08387 Filed 4-14-14; 8:45 am]
BILLING CODE 4140-01-P

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