Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73601 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: December 5, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29035 Filed 12–10–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of a Start-Up 

Exclusive Patent License Agreement: 

Use of Compounds Covered by Patent 

Rights for Diagnosis of Human Thyroid 

Cancer Requiring FDA Premarket 

Approval or an Equivalent Authority 

Outside of the United States, and 

Treatment of Human Thyroid Cancer 

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 to 

Nova Therapeutics LLC, a company 

having a place of business in Delaware, 

to practice the inventions embodied in 

the following patent applications: 

(a) PCT Patent Application No. PCT/

US2008/11958, Filed: October 20, 

2008, HHS Ref. No.: E–284–2008/0– 

PCT–01 

(b) Australian Patent No. 2008–363295, 

Filed: October 20, 2008, HHS Ref No.: 

E–284–2008/0–AU–02 

(c) Canadian Patent Application No. 

2,741,030, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–CA–03 

(d) European Patent Application No. 

08876356.0, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–EP–04 

(e) Indian Patent Application No. 3684/ 

DELNP/2011, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–IN–05 

(f) Japanese Patent Application No. 

2011–532048, Filed: October 20, 2008, 

HHS Ref. No.: E–284–2008/0–JP–06 

(g) U.S. Patent No. 8,741,259 U.S. Patent 

Application No. 13/125,045, Filed: 

October 20, 2008, HHS Ref. No.: E– 

284–2008/0–US–07 

(h) U.S. Patent Application No. 13/

897,330, Filed: October 20, 2008, HHS 

Ref. No.: E–284–2008/0–US–08 

Current status: pending 

(i) U.S. Patent Application No. 14/

243,821, Filed: October 20, 2008, HHS 

Ref. No.: E–284–2008/0–US–10 

The patent rights in this invention 

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: Use of compounds 

covered by Patent Rights for diagnosis of 

human thyroid cancer requiring FDA 

premarket approval or an equivalent 

authority outside of the United States, 

and treatment of human thyroid cancer. 

DATES: Only written comments or 

applications for a license (or both) 

which are received by the NIH Office of 

Technology Transfer on or before 

December 26, 2014 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated Start-Up Exclusive Patent 

License Agreement should be directed 

to: Lauren Nguyen-Antczak, Ph.D., J.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– 

4074; Facsimile: (301) 402–0220; Email: 

Lauren.Nguyen-antczak@nih.gov. A 

signed confidentiality nondisclosure 

agreement will be required to receive 

copies of any patent application(s) that 

have not been published or issued by 

the United States Patent and Trademark 

Office of the World Intellectual Property 

Organization. 

SUPPLEMENTARY INFORMATION: This 

invention concerns small molecule 

compounds that agonize the activity of 

the thyroid stimulating hormone 

receptor (‘‘TSHR’’). These TSHR 

agonists enhance or activate the thyroid 

stimulating hormone (‘‘TSH’’) signaling 

pathway by directly binding to the 

transmembrane domain of TSHR. 

Invention compounds may be 

administered alone or in combination 

with radioactive iodine to detect thyroid 

cancer cells. Additionally, invention 

compounds may be administered in 

combination with radioactive iodine to 

treat thyroid cancer, such as to ablate 

thyroid remnants in patients after a 

thyroidectomy. 

The prospective Start-Up Exclusive 

Patent License that is being considered 

can be found at http://www.ott.nih.gov/ 

forms-model-agreements#SUMLA, 

which complies with the terms and 

conditions of 35 U.S.C. 209 and 37 CFR 

part 404. The prospective Start-Up 

Exclusive Patent License is being 

provided under the small business 

initiative launched on 1 October 2011. 

The prospective Start-Up Exclusive 

Patent License 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 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 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. 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: December 4, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–29017 Filed 12–10–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the National 

Diabetes and Digestive and Kidney 

Diseases Advisory Council. 

The meetings will be open to the 

public as indicated below, 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. 

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 applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

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