15218 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06498 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of 

Theranostic Kits for mTOR Analogbased Chemotherapy 

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 

ProVivoX, Inc., 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 Provisional 

Patent Application Serial No. 61/

144,501, filed 14 January 2009, entitled: 

‘‘Ratio-based Biomarker of Survival 

Utilizing PTEN and Phospho-AKT’’ 

[HHS Reference No. E–025–2009/0–US– 

01]; International Application No. PCT/ 

US2010/020944, filed on 13 January 

2010, entitled: ‘‘Ratio-based Biomarkers 

and Methods of Use Thereof’’ [HHS 

Reference No. E–025–2009/0–PCT–02]; 

US Patent Application Serial No. 13/

144,474, filed 13 July 2011 [HHS 

Reference No. E–025–2009/0–US–02]; 

and Canadian Patent Application No. 

2,749,601, filed on 13 January 2010 

[HHS Reference No. E–025–2009/0–CA– 

05]. 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 United 

States and Canada, and the field of use 

may be limited to: 

a. ‘‘Exclusive use of the Licensed Patent 

Rights to develop an immunohistochemistry 

(IHC)- or tissue microarray-based test kit for 

use with human tissue samples and approved 

in the United States and Canada as a Class 

III medical device, such test kit to be 

distributed in commerce for the for the 

purpose of predicting survival, response to 

therapy, or cancer recurrence in breast cancer 

patients.’’ 

b. ‘‘Non-exclusive use of the Licensed 

Patent Rights to develop an 

immunohistochemistry (IHC)- or tissue 

microarray-based test kit for use with human 

tissue samples and for which the United 

States FDA issues an order, in the form of a 

letter, which finds Licensee’s kit to be a 

medical device 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 predicting survival, 

response to therapy, or cancer recurrence in 

breast cancer patients.’’ 

Upon the expiration or termination of 

the exclusive evaluation option license, 

ProVivoX, Inc., 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 April 

7, 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. 

SUPPLEMENTARY INFORMATION: The 

technology describes a method of 

identifying cancer patients that may 

benefit from mTOR analog-based 

chemotherapy or agents directed against 

the AKT pathway. 

The prospective exclusive evaluation 

license is being considered under the 

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: March 17, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–06487 Filed 3–20–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Prevalence, 

Incidence, Epidemiology and 

Molecular Variants of HIV in Blood 

Donors in Brazil (NHLBI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the FR in 

Volume 79 on December 31, 2014 on 

page 78876 and allowed 60-days for 

public comment. One public comment 

was received that was a personal 

opinion regarding conducting research 

about the Brazil blood donation system. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Direct Comments To Omb: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: Desk Officer for NIH. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Simone Glynn, MD, Project 

Officer/ICD Contact, Two Rockledge 

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