National Institute of Environmental Health Sciences; Notice of Closed Meeting, 8330-8331 [2015-03094]

Download as PDF 8330 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices Therefore, selection of potential facilities will be based on the coordination of CBER’s priorities for staff training as well as the limited available resources for this program. In addition to logistical and other resource factors to consider, a key element of site selection is a successful compliance record with FDA or another Agency with which we have a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract to the applicant, the other firm also needs to agree to participate in the program, as well as have a satisfactory compliance history. III. Requests for Participation Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–03117 Filed 2–13–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Start-up Evaluation License for the Development of Theranostic Kits for Taxane-based Chemotherapy 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 Taxor Diagnostics, LLC of an exclusive evaluation option license to practice the inventions embodied in the following US Patent, US Patent Application, and International Patent Application (and all foreign counterparts): US Patent No. 8,546,091, issued 01 October 2013, entitled, ‘‘Akt Phosphorylation at SER473 as an Indicator for Taxanebased Chemotherapy’’ [HHS Ref. E–191– 2009/0–US–07]; US Patent Application serial no. 14/031,699, of the same name, filed 19 September 2013 [HHS Ref. E– 191–2009/0–US–08]; and International (PCT) Patent Application no. PCT/ US2010/035816, of the same name, filed tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 21 May 2010 [HHS Ref. E–191–2009/0– PCT–02]. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to: 1. Exclusive use of the Licensed Patent Rights to develop a test kit approved by the FDA as a Class III medical device under the Premarket approval (PMA) process, such test kit to be distributed in commerce for the purpose of identifying subgroups of breast cancer, colorectal cancer, and non-small cell lung cancer patients that may benefit from treatment with a taxane therapy; and 2. Non-exclusive use of the Licensed Patent Rights to develop a test kit for which the FDA issues an order, in the form of a letter, which finds Licensee’s device to be substantially equivalent to one or more similar legally marketed devices, and states that the Licensee’s device can be marketed in the U.S. (i.e., 510(k) cleared), such test kit to be distributed in commerce for the purpose of identifying subgroups of breast cancer, colorectal cancer, and non-small cell lung cancer patients that may benefit from treatment with a taxane therapy. Upon the expiration or termination of the exclusive evaluation option license, Taxor Diagnostics, LLC will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license. DATES: Only written comments or applications for a license (or both) which are received by the NIH Office of Technology Transfer on or before March 4, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Patrick McCue, 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) 435–5560; Facsimile: (301) 402–0220; Email: mccuepat@ mail.nih.gov. The technology describes a method of identifying cancer patients that will respond favorably to and benefit from treatment with taxane-based therapy depending on the phosphorylation status of protein Akt-Serine 473 in patient’s tumor biopsy sample. The prospective exclusive evaluation license is being considered under the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 small business initiative launched on 1 October 2011, and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive evaluation option license, and a subsequent exclusive commercialization license, may be granted unless the NIH 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 within fifteen (15) days from the date of this published notice. 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 evaluation 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: February 9, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–03088 Filed 2–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; 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 of Environmental Health Sciences Special Emphasis Panel; Worker Health and Safety Training Review. Date: March 9–10, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27517. E:\FR\FM\17FEN1.SGM 17FEN1 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices Contact Person: Sally Eckert-Tilotta, Ph.D., Scientific Review Officer, National Institute of Environmental Health Sciences, Office of Program Operations, Scientific Review Branch, P.O. Box 12233, Research Triangle Park, NC 27709, (919) 541–1446, eckertt1@ niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: February 10, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–03094 Filed 2–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Aging Special Emphasis Panel, April 06, 2015, 11:00 a.m. to April 06, 2015, 1:00 p.m., National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892 which was published in the Federal Register on February 9, 2015, 80 FR 7003. The meeting notice is amended to change the date of the meeting from April 6, 2015 to March 30, 2015. The meeting is closed to the public. Dated: February 10, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–03091 Filed 2–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES tkelley on DSK3SPTVN1PROD with NOTICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings 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 meetings. VerDate Sep<11>2014 16:51 Feb 13, 2015 Jkt 235001 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 grant and/or proposal 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 Cancer Institute Special Emphasis Panel; R13 Conference Grant Review. Date: March 3, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W556, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Bratin K. Saha, Ph.D., Scientific Review Officer, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W556, Rockville, MD 20850, 240–276–6411, sahab@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Core Infrastructure & Methodological Research for Cancer Epidemiology Cohorts (U01). Date: March 12, 2015. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 6W032, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Viatcheslav A. Soldatenkov, Ph.D., M.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W254, Bethesda, MD 20892–8329, 240–276– 6378, soldatenkovv@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Vacutubes to Preserve the Viability of Circulating Tumor Cells. Date: March 19, 2015. Time: 10:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W538, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Ivan Ding, M.D., Health Scientist Administrator, Program & Review Extramural Staff Training Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W534, Bethesda, MD 20892–9750, 240–276– 6444, dingi@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Predictive Biomarkers of Adverse Reactions to Radiation Treatment. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 8331 Date: March 20, 2015. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W538, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Ivan Ding, M.D. Health Scientist Administrator, Program & Review Extramural Staff Training Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W534, Bethesda, MD 20892–9750, 240–276– 6444, dingi@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Small Grants Program for Cancer Research. Date: March 24–25, 2015. Time: 8:00 a.m. to 5:00 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: Viatcheslav A. Soldatenkov, Ph.D., M.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W254, Bethesda, MD 20892–8329, 240–276–6378, soldatenkovv@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; AIDs Malignancy Consortium (AMC). Date: March 26–27, 2015. Time: 6:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Bratin K. Saha, Ph.D., Scientific Review Officer, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W556, Rockville, MD 20850, 240– 276–6411, sahab@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Cancer Intervention and Surveillance Modeling. Date: April 1–2, 2015. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W554, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Christopher L. Hatch, Ph.D., Chief, Health Scientific Administrator, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W554, Rockville, MD 20850, 240–276–6454, ch29v@nih.gov. Information is also available on the Institute’s/Center’s home page: https:// deainfo.nci.nih.gov/advisory/sep/sep.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; E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8330-8331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; 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 of Environmental Health 
Sciences Special Emphasis Panel; Worker Health and Safety Training 
Review.
    Date: March 9-10, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel 
Hill, NC 27517.

[[Page 8331]]

    Contact Person: Sally Eckert-Tilotta, Ph.D., Scientific Review 
Officer, National Institute of Environmental Health Sciences, Office 
of Program Operations, Scientific Review Branch, P.O. Box 12233, 
Research Triangle Park, NC 27709, (919) 541-1446, 
eckertt1@niehs.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.115, 
Biometry and Risk Estimation--Health Risks from Environmental 
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety 
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic 
Research and Education; 93.894, Resources and Manpower Development 
in the Environmental Health Sciences; 93.113, Biological Response to 
Environmental Health Hazards; 93.114, Applied Toxicological Research 
and Testing, National Institutes of Health, HHS)

    Dated: February 10, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-03094 Filed 2-13-15; 8:45 am]
BILLING CODE 4140-01-P

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