Prospective Grant of Start-Up Exclusive Patent License Agreement: Treatment of Breast Cancer, Prostate Cancer, Ewing Sarcoma, and Thymoma, 15136-15137 [2014-05867]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES 15136 Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices Service at (800) 877–8339. Requests should be made at least five business days in advance of the event. The preliminary agenda and draft TRs should be posted on the NTP Web site (https://ntp.niehs.nih.gov/go/36051) by April 10, 2014. Additional information will be posted when available or may be requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following the meeting, a report of the peer review will be prepared and made available on the NTP Web site. Registered attendees are encouraged to access the meeting Web page to stay abreast of the most current information. Request for Comments: The NTP invites written and oral public comments on the draft TRs. The deadline for submission of written comments is May 8, 2014, to enable review by the peer-review panel and NTP staff prior to the meeting. Registration to provide oral comments is by May 15, 2014, at https:// ntp.niehs.nih.gov/go/36051. Public comments and any other correspondence on the draft TRs should be sent to the FOR FURTHER INFORMATION CONTACT. Persons submitting written comments should include their name, affiliation, mailing address, phone, email, and sponsoring organization (if any) with the document. Written comments received in response to this notice will be posted on the NTP Web site, and the submitter will be identified by name, affiliation, and/or sponsoring organization. Public comment at this meeting is welcome, with time set aside for the presentation of oral comments on the draft TRs. In addition to in-person oral comments at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability is on a first-come, first-served basis. The lines will be open from 8:30 a.m. until approximately 5:00 p.m. EDT on May 22, 2014, although oral comments will be received only during the formal public comment periods indicated on the preliminary agenda. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Each organization is allowed one time slot per draft TR. At least 7 minutes will be allotted to each time slot, and if time permits, may be extended to 10 minutes at the discretion of the chair. Persons wishing to make an oral presentation are asked to register online at https://ntp.niehs.nih.gov/go/36051 by May 15, 2014, indicate whether they will present comments in-person or via the teleconference line, and indicate the TR(s) on which they plan to comment. VerDate Mar<15>2010 18:34 Mar 17, 2014 Jkt 232001 If possible, oral public commenters should send a copy of their slides and/ or statement or talking points at that time. Written statements can supplement and may expand the oral presentation. Registration for in-person oral comments will also be available at the meeting, although time allowed for presentation by on-site registrants may be less than that for registered speakers and will be determined by the number of speakers who register on-site. Background Information on NTP PeerReview Panels: NTP panels are technical, scientific advisory bodies established on an ‘‘as needed’’ basis to provide independent scientific peer review and advise the NTP on agents of public health concern, new/revised toxicological test methods, or other issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening. The NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide current curriculum vitae to the FOR FURTHER INFORMATION CONTACT. The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service (PHS) Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: March 10, 2014. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2014–05895 Filed 3–17–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Patent License Agreement: Treatment of Breast Cancer, Prostate Cancer, Ewing Sarcoma, and Thymoma 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 SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Services, is contemplating the grant of a Start-Up Exclusive Patent License Agreement to Paris Therapeutics, a company having a place of business in Santee, CA, to practice the inventions embodied in the following patent applications: 1. U.S. Provisional Patent Application. No. 61/474,664, filed April 12, 2011; HHS Ref. No.: E–068–2011/0– US–01; Titled: Human Monoclonal Antibodies that bind insulin-like growth factor (IGF) I and II; Inventors: Dimiter S. Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu (NCI) 2. PCT Application No. PCT/US2012/ 033128, filed April 11, 2012; HHS Ref. No.: E–068–2011/0–PCT–02; Titled: Human Monoclonal Antibodies that bind insulin-like growth factor (IGF) I and II; Inventors: Dimiter S. Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu (NCI) 3. U.S. Patent Application No. 14/ 111,507, filed October 11, 2013; HHS Ref. No.: E–068–2011/0–US– 03; Titled: Human Monoclonal Antibodies that bind insulin-like growth factor (IGF) I and II; Inventors: Dimiter S. Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu (NCI) The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License Agreement may be worldwide, and the field of use may be limited to ‘‘Antibodies against Insulin-like Growth Factors IGF–I and IGF–II for the treatment of breast cancer, prostate cancer, Ewing sarcoma, and thymoma.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 2, 2014 will be considered. ADDRESSES: Requests for copies of the patent application(s), inquiries, comments, and other materials relating to the contemplated Start-Up Exclusive Patent License Agreement should be directed to: Whitney A. Hastings, Ph.D., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 451– 7337; Facsimile: (301) 402–0220; Email: hastingw@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the E:\FR\FM\18MRN1.SGM 18MRN1 Federal Register / Vol. 79, No. 52 / Tuesday, March 18, 2014 / Notices World Intellectual Property Organization. DEPARTMENT OF HOMELAND SECURITY This technology describes fully human monoclonal antibodies that have been affinity maturated against IGF–I and IGF–II and display extremely high affinities for IGF–I and IGF–II in the picoM range. Some of these antibodies potently inhibited signal transduction mediated by the IGF–1R interaction with IGF–I and IGF–II and blocked phosphorylation of IGF–IR and the insulin receptor. In addition, they inhibited migration in the MCF–7 breast cancer cell line at the picoM range. Therefore, these antibodies could be used to prevent binding of IGF–I and/or IGF–II to its concomitant receptor IGFIR, consequently, modulating diseases such as cancer. The prospective Start-Up Exclusive Patent License Agreement is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective Start-Up Exclusive Patent License Agreement may be granted unless the NIH receives written evidence and argument, within fifteen (15) days from the date of this published notice, that establishes that the grant of the contemplated Start-Up Exclusive Patent License Agreement 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 Start-Up 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. U.S. Customs and Border Protection SUPPLEMENTARY INFORMATION: Dated: March 14, 2014. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. emcdonald on DSK67QTVN1PROD with NOTICES [FR Doc. 2014–05867 Filed 3–17–14; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 18:34 Mar 17, 2014 Jkt 232001 [1651–0058] Agency Information Collection Activities: Documents Required Aboard Private Aircraft U.S. Customs and Border Protection, Department of Homeland Security. ACTION: 30-Day notice and request for comments; extension of an existing collection of information. AGENCY: U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Documents Required Aboard Private Aircraft. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. DATES: Written comments should be received on or before April 17, 2014 to be assured of consideration. ADDRESSES: Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to oira_submission@ omb.eop.gov or faxed to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229– 1177, at 202–325–0265. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register (78 FR 77484) on December 23, 2013, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 15137 collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3507). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs burden to respondents or record keepers from the collection of information (a total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: Title: Documents Required Aboard Private Aircraft. OMB Number: 1651–0058. Form Number: None. Abstract: In accordance with 19 CFR 122.27, a commander of a private aircraft arriving in the U.S. must present several documents to CBP officers for inspection. These documents include: (1) A pilot certificate/license; (2) a medical certificate; and (3) a certificate of registration, which is also called a ‘‘pink slip’’ and is a duplicate copy of the Aircraft Registration Application (FAA Form AC 8050–1). The information on these documents is used by CBP officers as an essential part of the inspection process for private aircraft arriving from a foreign country. These requirements are authorized by 19 U.S.C. 1433, as amended by Public Law 99–570. Current Actions: CBP proposes to extend the expiration date of this information collection with no change to the burden hours. Type of Review: Extension (with change). Affected Public: Individuals. Estimated Number of Respondents: 120,000. Estimated Number of Annual Responses: 120,000. Estimated Time per Response: 1 minute. Estimated Total Annual Burden Hours: 1,992. E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15136-15137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05867]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Patent License Agreement: 
Treatment of Breast Cancer, Prostate Cancer, Ewing Sarcoma, and Thymoma

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 of a Start-Up Exclusive 
Patent License Agreement to Paris Therapeutics, a company having a 
place of business in Santee, CA, to practice the inventions embodied in 
the following patent applications:
1. U.S. Provisional Patent Application. No. 61/474,664, filed April 12, 
2011; HHS Ref. No.: E-068-2011/0-US-01; Titled: Human Monoclonal 
Antibodies that bind insulin-like growth factor (IGF) I and II; 
Inventors: Dimiter S. Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu 
(NCI)
2. PCT Application No. PCT/US2012/033128, filed April 11, 2012; HHS 
Ref. No.: E-068-2011/0-PCT-02; Titled: Human Monoclonal Antibodies that 
bind insulin-like growth factor (IGF) I and II; Inventors: Dimiter S. 
Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu (NCI)

3. U.S. Patent Application No. 14/111,507, filed October 11, 2013; HHS 
Ref. No.: E-068-2011/0-US-03; Titled: Human Monoclonal Antibodies that 
bind insulin-like growth factor (IGF) I and II; Inventors: Dimiter S. 
Dimitrov (NCI), Qi Zhao (NCI), and Zhongyu Zhu (NCI)

The patent rights in these inventions have been assigned to the 
Government of the United States of America. The territory of the 
prospective Start-Up Exclusive Patent License Agreement may be 
worldwide, and the field of use may be limited to ``Antibodies against 
Insulin-like Growth Factors IGF-I and IGF-II for the treatment of 
breast cancer, prostate cancer, Ewing sarcoma, and thymoma.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 2, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application(s), inquiries, 
comments, and other materials relating to the contemplated Start-Up 
Exclusive Patent License Agreement should be directed to: Whitney A. 
Hastings, Ph.D., Licensing and Patenting Manager, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 451-7337; 
Facsimile: (301) 402-0220; Email: hastingw@mail.nih.gov. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the

[[Page 15137]]

World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This technology describes fully human 
monoclonal antibodies that have been affinity maturated against IGF-I 
and IGF-II and display extremely high affinities for IGF-I and IGF-II 
in the picoM range. Some of these antibodies potently inhibited signal 
transduction mediated by the IGF-1R interaction with IGF-I and IGF-II 
and blocked phosphorylation of IGF-IR and the insulin receptor. In 
addition, they inhibited migration in the MCF-7 breast cancer cell line 
at the picoM range. Therefore, these antibodies could be used to 
prevent binding of IGF-I and/or IGF-II to its concomitant receptor 
IGFIR, consequently, modulating diseases such as cancer.
    The prospective Start-Up Exclusive Patent License Agreement is 
being considered under the small business initiative launched on 
October 1, 2011 and will comply with the terms and conditions of 35 
U.S.C. 209 and 37 CFR part 404. The prospective Start-Up Exclusive 
Patent License Agreement may be granted unless the NIH receives written 
evidence and argument, within fifteen (15) days from the date of this 
published notice, that establishes that the grant of the contemplated 
Start-Up Exclusive Patent License Agreement 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 Start-Up 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: March 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-05867 Filed 3-17-14; 8:45 am]
BILLING CODE 4140-01-P
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