80 FR 8330 - National Institute of Environmental Health Sciences; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range		8330-8331
FR Document		2015-03094

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015)

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8330-8331]
From the Federal Register Online  [www.thefederalregister.org]
[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

8330 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices

Therefore, selection of potential 21 May 2010 [HHS Ref. E–191–2009/0– small business initiative launched on 1
facilities will be based on the PCT–02]. The patent rights in this October 2011, and will comply with the
coordination of CBER’s priorities for invention have been assigned to the terms and conditions of 35 U.S.C. 209
staff training as well as the limited Government of the United States of and 37 CFR part 404. The prospective
available resources for this program. In America. exclusive evaluation option license, and
addition to logistical and other resource The prospective exclusive evaluation a subsequent exclusive
factors to consider, a key element of site option license territory may be commercialization license, may be
selection is a successful compliance worldwide, and the field of use may be granted unless the NIH receives written
record with FDA or another Agency limited to: evidence and argument that establishes
with which we have a memorandum of 1. Exclusive use of the Licensed Patent that the grant of the license would not
understanding. If a site visit involves a Rights to develop a test kit approved by the be consistent with the requirements of
visit to a separate physical location of FDA as a Class III medical device under the 35 U.S.C. 209 and 37 CFR part 404
another firm under contract to the Premarket approval (PMA) process, such test within fifteen (15) days from the date of
applicant, the other firm also needs to kit to be distributed in commerce for the this published notice.
agree to participate in the program, as purpose of identifying subgroups of breast Complete applications for a license in
well as have a satisfactory compliance cancer, colorectal cancer, and non-small cell the field of use filed in response to this
lung cancer patients that may benefit from
history. notice will be treated as objections to
treatment with a taxane therapy; and
III. Requests for Participation 2. Non-exclusive use of the Licensed Patent the grant of the contemplated exclusive
Rights to develop a test kit for which the FDA evaluation option license. Comments
Identify requests for participation issues an order, in the form of a letter, which and objections submitted to this notice
with the docket number found in finds Licensee’s device to be substantially will not be made available for public
brackets in the heading of this equivalent to one or more similar legally inspection and, to the extent permitted
document. Received requests are marketed devices, and states that the by law, will not be released under the
available for public examination in the Licensee’s device can be marketed in the U.S. Freedom of Information Act, 5 U.S.C.
Division of Dockets Management (see (i.e., 510(k) cleared), such test kit to be 552.
ADDRESSES) between 9 a.m. and 4 p.m., distributed in commerce for the purpose of
identifying subgroups of breast cancer, Dated: February 9, 2015.
Monday through Friday.
colorectal cancer, and non-small cell lung Richard U. Rodriguez,
Dated: February 10, 2015. cancer patients that may benefit from Acting Director, Office of Technology
Leslie Kux, treatment with a taxane therapy. Transfer, National Institutes of Health.
Associate Commissioner for Policy. Upon the expiration or termination of [FR Doc. 2015–03088 Filed 2–13–15; 8:45 am]
[FR Doc. 2015–03117 Filed 2–13–15; 8:45 am] the exclusive evaluation option license, BILLING CODE 4140–01–P
BILLING CODE 4164–01–P Taxor Diagnostics, LLC will have the
exclusive right to execute an exclusive
commercialization license which will DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND supersede and replace the exclusive HUMAN SERVICES
HUMAN SERVICES evaluation option license with no
greater field of use and territory than National Institutes of Health
National Institutes of Health granted in the exclusive evaluation
option license. National Institute of Environmental
Prospective Grant of Exclusive Health Sciences; Notice of Closed
License: Start-up Evaluation License DATES: Only written comments or
Meeting
for the Development of Theranostic applications for a license (or both)
Kits for Taxane-based Chemotherapy which are received by the NIH Office of Pursuant to section 10(d) of the
Technology Transfer on or before March Federal Advisory Committee Act, as
AGENCY: National Institutes of Health, 4, 2015 will be considered. amended (5 U.S.C. App.), notice is
HHS. ADDRESSES: Requests for copies of the hereby given of the following meeting.
ACTION: Notice. patent application, inquiries, comments, The meeting will be closed to the
SUMMARY: This is notice, in accordance and other materials relating to the public in accordance with the
with 35 U.S.C. 209 and 37 CFR part 404, contemplated exclusive evaluation provisions set forth in sections
that the National Institutes of Health, option license should be directed to: 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Department of Health and Human Patrick McCue, Ph.D., Licensing and as amended. The grant applications and
Services, is contemplating the grant to Patenting Manager, Office of the discussions could disclose
Taxor Diagnostics, LLC of an exclusive Technology Transfer, National Institutes confidential trade secrets or commercial
evaluation option license to practice the of Health, 6011 Executive Boulevard, property such as patentable material,
inventions embodied in the following Suite 325, Rockville, MD 20852–3804; and personal information concerning
US Patent, US Patent Application, and Telephone: (301) 435–5560; Facsimile: individuals associated with the grant
International Patent Application (and all (301) 402–0220; Email: mccuepat@ applications, the disclosure of which
foreign counterparts): US Patent No. mail.nih.gov. would constitute a clearly unwarranted
8,546,091, issued 01 October 2013, SUPPLEMENTARY INFORMATION: The invasion of personal privacy.
entitled, ‘‘Akt Phosphorylation at technology describes a method of Name of Committee: National Institute of
SER473 as an Indicator for Taxane- identifying cancer patients that will Environmental Health Sciences Special
Emphasis Panel; Worker Health and Safety
tkelley on DSK3SPTVN1PROD with NOTICES

based Chemotherapy’’ [HHS Ref. E–191– respond favorably to and benefit from
2009/0–US–07]; US Patent Application Training Review.
treatment with taxane-based therapy
Date: March 9–10, 2015.
serial no. 14/031,699, of the same name, depending on the phosphorylation Time: 8:00 a.m. to 5:00 p.m.
filed 19 September 2013 [HHS Ref. E– status of protein Akt-Serine 473 in Agenda: To review and evaluate grant
191–2009/0–US–08]; and International patient’s tumor biopsy sample. applications.
(PCT) Patent Application no. PCT/ The prospective exclusive evaluation Place: Sheraton Chapel Hill Hotel, One
US2010/035816, of the same name, filed license is being considered under the Europa Drive, Chapel Hill, NC 27517.

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Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8331

Contact Person: Sally Eckert-Tilotta, Ph.D., The meetings will be closed to the Date: March 20, 2015.
Scientific Review Officer, National Institute public in accordance with the Time: 11:00 a.m. to 3:00 p.m.
of Environmental Health Sciences, Office of provisions set forth in sections Agenda: To review and evaluate grant
Program Operations, Scientific Review applications.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: National Cancer Institute Shady
Branch, P.O. Box 12233, Research Triangle
Park, NC 27709, (919) 541–1446, eckertt1@
as amended. The grant and/or proposal Grove, 9609 Medical Center Drive, Room
niehs.nih.gov. applications and the discussions could 7W538, Rockville, MD 20850, (Telephone
(Catalogue of Federal Domestic Assistance
disclose confidential trade secrets or Conference Call).
Program Nos. 93.115, Biometry and Risk commercial property such as patentable Contact Person: Ivan Ding, M.D. Health
Estimation—Health Risks from material, and personal information Scientist Administrator, Program & Review
Environmental Exposures; 93.142, NIEHS concerning individuals associated with Extramural Staff Training Branch, Division of
Hazardous Waste Worker Health and Safety the grant applications, the disclosure of Extramural Activities, National Cancer
Training; 93.143, NIEHS Superfund Institute, 9609 Medical Center Drive, Room
which would constitute a clearly
Hazardous Substances—Basic Research and 7W534, Bethesda, MD 20892–9750, 240–276–
unwarranted invasion of personal 6444, dingi@mail.nih.gov.
Education; 93.894, Resources and Manpower privacy.
Development in the Environmental Health Name of Committee: National Cancer
Sciences; 93.113, Biological Response to Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Small
Environmental Health Hazards; 93.114, Institute Special Emphasis Panel; R13 Grants Program for Cancer Research.
Applied Toxicological Research and Testing, Conference Grant Review. Date: March 24–25, 2015.
National Institutes of Health, HHS) Date: March 3, 2015. Time: 8:00 a.m. to 5:00 p.m.
Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant
Dated: February 10, 2015. Agenda: To review and evaluate contract applications.
Carolyn Baum, proposals. Place: Hyatt Regency Bethesda, One
Program Analyst, Office of Federal Advisory Place: National Cancer Institute Shady Bethesda Metro Center, 7400 Wisconsin
Committee Policy. Grove, 9609 Medical Center Drive, Room Avenue, Bethesda, MD 20814.
7W556, Rockville, MD 20850, (Telephone Contact Person: Viatcheslav A.
[FR Doc. 2015–03094 Filed 2–13–15; 8:45 am]
Conference Call). Soldatenkov, Ph.D., M.D., Scientific Review
BILLING CODE 4140–01–P Contact Person: Bratin K. Saha, Ph.D., Officer, Special Review Branch, Division of
Scientific Review Officer, Program Extramural Activities, National Cancer
Coordination and Referral Branch, Division Institute, NIH, 9609 Medical Center Drive,
DEPARTMENT OF HEALTH AND of Extramural Activities, National Cancer Room 7W254, Bethesda, MD 20892–8329,
HUMAN SERVICES Institute, 9609 Medical Center Drive, Room 240–276–6378, soldatenkovv@mail.nih.gov.
7W556, Rockville, MD 20850, 240–276–6411,
Name of Committee: National Cancer
National Institutes of Health sahab@mail.nih.gov.
Institute Special Emphasis Panel; AIDs
Name of Committee: National Cancer Malignancy Consortium (AMC).
National Institute on Aging; Amended Institute Special Emphasis Panel; Core Date: March 26–27, 2015.
Notice of Meeting Infrastructure & Methodological Research for Time: 6:30 p.m. to 4:00 p.m.
Cancer Epidemiology Cohorts (U01). Agenda: To review and evaluate grant
Notice is hereby given of a change in Date: March 12, 2015. applications.
the meeting of the National Institute on Time: 10:00 a.m. to 6:00 p.m. Place: Bethesda North Marriott Hotel &
Agenda: To review and evaluate grant Conference Center 5701 Marinelli Road,
Aging Special Emphasis Panel, April 06,
applications. Bethesda, MD 20852.
2015, 11:00 a.m. to April 06, 2015, 1:00 Place: National Cancer Institute Shady
p.m., National Institute on Aging, Contact Person: Bratin K. Saha, Ph.D.,
Grove, 9609 Medical Center Drive, Room Scientific Review Officer, Program
Gateway Building, 7201 Wisconsin 6W032, Rockville, MD 20850, (Telephone Coordination and Referral Branch, Division
Avenue, Suite 2C212, Bethesda, MD Conference Call). of Extramural Activities, National Cancer
20892 which was published in the Contact Person: Viatcheslav A. Institute, NIH, 9609 Medical Center Drive,
Federal Register on February 9, 2015, Soldatenkov, Ph.D., M.D., Scientific Review Room 7W556, Rockville, MD 20850, 240–
80 FR 7003. Officer, Special Review Branch, Division of
276–6411, sahab@mail.nih.gov.
Extramural Activities, National Cancer
The meeting notice is amended to Institute, 9609 Medical Center Drive, Room Name of Committee: National Cancer
change the date of the meeting from 7W254, Bethesda, MD 20892–8329, 240–276– Institute Special Emphasis Panel; Cancer
April 6, 2015 to March 30, 2015. The 6378, soldatenkovv@mail.nih.gov. Intervention and Surveillance Modeling.
meeting is closed to the public. Date: April 1–2, 2015.
Name of Committee: National Cancer
Time: 12:00 p.m. to 4:00 p.m.
Dated: February 10, 2015. Institute Special Emphasis Panel; Vacutubes
Agenda: To review and evaluate grant
to Preserve the Viability of Circulating Tumor
Melanie J. Gray, applications.
Cells.
Program Analyst, Office of Federal Advisory Date: March 19, 2015. Place: National Cancer Institute Shady
Committee Policy. Time: 10:30 a.m. to 2:30 p.m. Grove, 9609 Medical Center Drive, Room
Agenda: To review and evaluate grant 7W554, Rockville, MD 20850, (Telephone
[FR Doc. 2015–03091 Filed 2–13–15; 8:45 am]
applications. Conference Call).
BILLING CODE 4140–01–P Contact Person: Christopher L. Hatch,
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room Ph.D., Chief, Health Scientific Administrator,
7W538, Rockville, MD 20850, (Telephone Program Coordination and Referral Branch,
DEPARTMENT OF HEALTH AND Conference Call). Division of Extramural Activities, National
HUMAN SERVICES Contact Person: Ivan Ding, M.D., Health Cancer Institute, NIH, 9609 Medical Center
Scientist Administrator, Program & Review Drive, Room 7W554, Rockville, MD 20850,
National Institutes of Health Extramural Staff Training Branch, Division of 240–276–6454, ch29v@nih.gov.
Extramural Activities, National Cancer Information is also available on the
tkelley on DSK3SPTVN1PROD with NOTICES

National Cancer Institute; Notice of Institute, 9609 Medical Center Drive, Room Institute’s/Center’s home page: http://
Closed Meetings 7W534, Bethesda, MD 20892–9750, 240–276– deainfo.nci.nih.gov/advisory/sep/sep.htm,
6444, dingi@mail.nih.gov. where an agenda and any additional
Pursuant to section 10(d) of the Name of Committee: National Cancer information for the meeting will be posted
Federal Advisory Committee Act, as Institute Special Emphasis Panel; Predictive when available.
amended (5 U.S.C. App.), notice is Biomarkers of Adverse Reactions to (Catalogue of Federal Domestic Assistance
hereby given of the following meetings. Radiation Treatment. Program Nos. 93.392, Cancer Construction;

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Document Created: 2015-12-18 13:19:55
Document Modified: 2015-12-18 13:19:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		March 9-10, 2015.
FR Citation		80 FR 8330

80 FR 8330 - National Institute of Environmental Health Sciences; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 31 (February 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health