Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45865 

the corresponding reference listed drugs 

or reference standards: 

a. How to effectively integrate systems 

pharmacology, PBPK, and the exposureclinical response relationship to 

evaluate product risk and assist BE 

evaluation? 

b. What will be the next generation 

methodologies in postmarket signal 

detection to evaluate product 

substitution or compare product 

performance using the Sentinel database 

or complementary toolsets? 

III. Participating in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://survey.co1.

qualtrics.com/jfe/form/SV_3eiJOCsnr

PdTZU9. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by September 25, 2017, 

midnight, Eastern Standard Time. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. 

If you need special accommodations 

due to a disability, please contact 

Lanyan (Lucy) Fang (see FOR FURTHER

INFORMATION CONTACT) no later than 7 

days before the workshop. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session, and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and to request time for a 

joint presentation, or to submit requests 

for designated representatives to 

participate in the focused sessions. 

Following the close of registration, we 

will determine the amount of time 

allotted to each presenter and the 

approximate time each oral presentation 

is to begin, and will select and notify 

participants by September 27, 2017. All 

requests to make oral presentations 

must be received by the close of 

registration on September 25, 2017. If 

selected for presentation, any 

presentation materials must be emailed 

to Lanyan (Lucy) Fang (see FOR FURTHER

INFORMATION CONTACT) no later than 

September 28, 2017. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be webcast. A live webcast of this 

workshop will be viewable at https://

collaboration.fda.gov/dqmm1017/on the 

day of the workshop. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

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

ucm554182.htm. 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21017 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Modification of Exclusive 

Patent License Potent and Selective 

Analogues of: Monamine Transporters; 

Methods of Making; and Uses Thereof 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Institute of Drug 

Abuse, an institute of the National 

Institutes of Health, Department of 

Health and Human Services is 

contemplating the modification of grant 

of an Exclusive Patent License to 

EncepHeal Therapeutics, Inc., located in 

Winston-Salem, North Carolina, to 

practice the inventions embodied in the 

patent applications listed in the 

Supplementary Information section of 

this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute on 

Drug Abuse’s Technology Transfer 

Office on or before October 17, 2017 

will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

modification of the Exclusive Patent 

License should be directed to Martha 

Lubet, Ph.D., Technology Transfer 

Manager, NCI TTC, 9609 Medical Center 

Drive, Room IE350, MSC 9702, 

Rockville, MD 20850. Telephone: 240 

276–5508. Facsimile: 240 276–5505. 

Email: lubetm@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following represents the intellectual 

property to be licensed under the 

prospective agreement: 

U.S. provisional application 61/ 

774,878, filed March 8, 2013 entitled 

‘‘Potent and Selective Inhibitors of 

Monamine Transporters; Methods of 

Making; and Uses Thereof’’ [HHS Ref. 

No. E–073–2013/0–US–01]; 

PCT application PCT/US2014/021514, 

filed March 7, 2014 entitled ‘‘Potent and 

Selective Analogues of: Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–PCT–02]; 

U.S. application 14/772,486, filed 

September 3, 2015 entitled ‘‘Potent and 

Selective Analogues of Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–US–06]; 

EPO application 14714043.8, filed 

September 1, 2015 entitled ‘‘Potent and 

Selective Analogues of Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–EP–05]; 

Australian application 2014225550, 

filed September 8, 2015 entitled ‘‘Potent 

and Selective Analogues of Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–AU–03]; 

Australian application 2017202849, 

filed April 28, 2017 entitled Potent and 

Selective Analogues of Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–AU–07]; 

Canadian application 2903746, filed 

September 2, 2015 entitled ‘‘Potent and 

Selective Analogues of Monamine 

Transporters; Methods of Making; and 

Uses Thereof’’ [HHS Ref. No. E–073– 

2013/0–CA–04]; 

The patent rights to these inventions 

have been assigned to and/or 

exclusively licensed to the Government 

of the United States of America. 

The Government previously 

announced its intention to grant an 

exclusive license to EncepHeal at FR 

80:245 (December 22, 2015), pp. 79595– 

79596. 

The Notice of Intent to Grant (NOITG) 

specified a Field of Use as ‘‘Use of 


sradovich on DSK3GMQ082PROD with NOTICES
45866 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

analogues of monamine transporters to 

treat substance use disorders and sleep 

disorders within the scope of the 

Licensed Patent Rights’’. Comments/ 

Objections were not received in 

response to the NOITG. After 

consideration, an exclusive license was 

granted to EncepHeal with a Licensed 

Field of Use of: ‘‘Use of analogues of 

monamine transporters to treat 

substance use disorders within the 

scope of the Licensed Patent Rights’’. 

This Notice advises the public that the 

NIH intends to modify the Licensed 

Field of Use originally granted to 

EncepHeal. Specifically, the National 

Institute on Drug Abuse is proposing to 

modify the Licensed Field of Use to be 

‘‘use of a lead compound to treat one or 

more of the following: Substance use 

disorders, cognitive deficits, sleep 

disorders, attention deficit hyperactivity 

disorder and depressive disorders. The 

modification to the Licensed Field of 

Use in the Exclusive Patent License 

requires EncepHeal to select a lead 

compound for each of the disorders 

listed in the Field of Use and that upon 

selection of a lead compound for a 

disorder, the other compounds of the 

technology will become available for 

licensing to other companies. 

The technology is directed to novel 

analogues of modafinil. Modafinil 

(marketed as Provisil in United States) 

is approved by FDA to treat narcolepsy 

and other sleep disorders. Modafinil has 

been studied as a possible treatment for 

cognitive dysfunction in disorders such 

as attention-deficit hyperactivity 

disorders (ADHD) as well as cocaine 

and methamphetamine addiction. 

However, it has a relatively low affinity 

for dopamine transporter (DAT) and is 

water-insoluble, thus requiring large 

doses to achieve pharmacological 

effects. Early studies indicated that 

modafinil reduced cocaine intake more 

effectively than placebo; however, 

subsequent larger studies reported only 

modest effectiveness in reducing 

cocaine intake. The library of 

compounds in the technology are 

analogs of modafinil and are designed to 

have higher affinities for DAT and 

improved water solubility. The National 

Institute on Drug Abuse has conducted 

preliminary experiments on many of the 

compounds and has identified several 

compounds that have higher affinities 

than modafinil for the DAT and lower 

affinity than modafinil for several other 

off target receptors. Preliminary studies 

at the National Institute on Drug Abuse 

indicate that some of the compounds 

have in vivo activity in rodents to 

inhibit cocaine taking behavior and are 

not selectively self-administered 

themselves (i.e. have low abuse 

liability). 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404 

and incorporates by reference: 

‘‘Prospective Grant of Exclusive Option 

License: Potent and Selective Analogues 

of: Monamine Transporters; Methods of 

Making; and Uses Thereof’’ FR 80:245 

(December 22, 2015), pp. 79595–79596. 

The prospective modification of the 

Exclusive Patent License will be royalty 

bearing and may be granted unless 

within fifteen (15) days from date of this 

published notice, the National Institute 

on Drug Abuse receives written 

evidence and argument that establishes 

that the grant of modification to 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 field of use filed in response to this 

notice will be treated as objections to 

the grant of the contemplated 

modification to 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: September 22, 2107. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2017–21048 Filed 9–29–17; 8:45 am] 

BILLING CODE 4040–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

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 

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 

Neurological Disorders and Stroke Special 

Emphasis Panel; Program Project Grant P01. 

Date: October 23, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 

(Teleconference Meeting). 

Contact Person: Ana Olariu, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3204, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–9223, ana.olariu@nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders A. 

Date: October 23–24, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Avenue NW., Washington, DC 20037. 

Contact Person: Natalia Strunnikova, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3204, MSC 9529, Bethesda, MD 20892– 

9529, (301) 402–0288, natalia.strunnikova@

nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; K99/R00 Review. 

Date: October 23, 2017. 

Time: 11:30 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Crystal City, 2399 Jefferson 

Davis Highway, Arlington, VA 22202. 

Contact Person: Elizabeth A. Webber, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3204, MSC 9529, Bethesda, MD 20892– 

9529, (301) 496–1917, webbere@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders B. 

Date: October 26–27, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Admiral Fell Inn, 888 South 

Broadway, Baltimore, MD 21231. 

Contact Person: Birgit Neuhuber, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., Suite 3204, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–9223, neuhuber@ninds.nih.gov@nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Ruth L. Kirschstein National 

Research Service Award (NRSA) Institutional 

Research Training Grant (T32) Program. 

Date: October 30–31, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco, 700 F Street NW., 

Washington, DC 20001. 

Contact Person: William Benzing, Ph.D., 

Scientific Review Officer, Scientific Review 


sradovich on DSK3GMQ082PROD with NOTICES