Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45947 

Agenda: The committee will be asked 

to discuss new drug application (NDA) 

209128, sufentanil sublingual tablets, 

submitted by AcelRx Pharmaceuticals, 

Inc., for the management of moderate-tosevere acute pain severe enough to 

require an opioid analgesic and for 

which alternative treatments are 

inadequate, in adult patients in a 

medically supervised setting. The 

committee will also be asked to discuss 

risk-benefit considerations and whether 

this product should be approved. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

October 4, 2018, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 26, 2018. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 27, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Moon Hee V. 

Choi (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19668 Filed 9–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Photoactivatable 

Liposomal Nanoparticle for the 

Delivery of an Immunotherapeutic or 

Immunotherapeutic-Enabling Agent 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

Patents and Patent Applications listed 

in the Supplementary Information 

section of this notice to Nano Red LLC 

(‘‘Nano Red’’) located in Milwaukee, 

Wisconsin. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before September 26, 2018 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: Jasmine Yang, Sr. Licensing 

and Patenting Manager, NCI Technology 

Transfer Center, 9609 Medical Center 

Drive, RM 1E530 MSC 9702, Bethesda, 

MD 20892–9702 (for business mail), 

Rockville, MD 20850–9702 Telephone: 

(240) 276–5530; Facsimile: (240) 276– 

5504 Email: jasmine.yang@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

1. U.S. Provisional Patent Application 

(Application No. 61/845,861) filed July 

12, 2013, HHS Reference No.: E–482– 

2013/0–US–01 

2. PCT Application (Application No. PCT/ 

US2014/045922) filed July 09, 2014, 

HHS Reference No.: E–482–2013/0–PCT– 

02 

3. Canada Patent Application (Application 

No. 2917545) filed 09 July 2014, HHS 

Reference No.: E–482–2013/0–CA–03 

4. European Patent Application (Application 

No. 14745037.3) filed 09 July 2014, HHS 

Reference No.: E–482–2013/0–EP–04 

5. U.S. Patent Application (Allowed 

Application No. 14/904,385) filed 

January 11, 2016, HHS Reference No.: E– 

482–2013/0–US–05 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The prospective exclusive license 

territory may be where patent 

applications are filed and the field of 

use may be limited to ‘‘Photoactivatable 

liposomal nanoparticle for the delivery 

of an immunotherapeutic or 

immunotherapeutic-enabling agent’’. 

Additional licensable fields of use are 

available (e.g. encapsulating imaging 

agent). 

This technology discloses a 

photoactivatable, lipid-based 

nanoparticles containing at least one 

hydrophilic agent, wherein the agent 

could be an anti-cancer agent, an 

imaging agent, or an anti-inflammatory 

agent and the lipid bilayer wall of the 

nanoparticle is comprised of (i) a lipid 

bilayer comprising (a) 1,2-bis(tricosa10,12-diynoyl)-sn-glycero-3- 

phosphocholine (DC8,9PC), (b) 1,2- 

distearoyl-sn-glycero-3- 

phosphoethanolamine-Nmethoxy(polyethylene glycol) (DSPE– 

PEG) and (c) 

dipalmitoylphosphatidylcholine 

(DPPC), and (ii) a tetrapyrollic 

photosensitizer, 2-[1-hexyloxyethyl]-2- 

devinyl pyropheophorbide-a (HPPH), 

and wherein the encapsulated agent is 

released by exposure to near-infrared 

light. 

This notice is made in accordance 

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

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published notice, the National 

Cancer Institute 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. 


daltland on DSKBBV9HB2PROD with NOTICES
45948 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 

confidentially, and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: August 31, 2018. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2018–19604 Filed 9–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory Eye 

Council. 

The meeting 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 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 Advisory 

Eye Council. 

Date: October 12, 2018. 

Open: 8:30 a.m. to 12:00 p.m. 

Agenda: Following opening remarks by the 

Director, NEI, there will be presentations by 

the staff of the Institute and discussions 

concerning Institute programs. 

Place: NIH, National Eye Institute, 6700B 

Rockledge Drive, First Floor Conference 

Rooms, Bethesda, MD 20817. 

Closed: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIH, National Eye Institute, 6700B 

Rockledge Drive, First Floor Conference 

Rooms, Bethesda, MD 20817. 

Contact Person: Paul A. Sheehy, Ph.D., 

Director, Division of Extramural Affairs, 

National Eye Institute, National Institutes of 

Health, 5635 Fishers Lane, Suite 12300, 

Bethesda, MD 20892, 301–451–2020, ps32h@

nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nei.nih.gov, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: September 5, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19606 Filed 9–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Peer Review Meeting. 

Date: October 10, 2018. 

Time: 10:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Chelsea D. Boyd, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, MSC–9823, Rockville, MD 

20852–9834, 240–669–2081, chelsea.boyd@

nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Implementation Cooperative Agreement (U01 

Clinical Trial Required) and NIAID SBIR 

Phase II Clinical Trial Implementation 

Cooperative Agreement (U44 Clinical Trial 

Required). 

Date: October 10, 2018. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Brenda Lange-Gustafson, 

Ph.D., Scientific Review Officer, NIAID/NIH/ 

DHHS, Scientific Review Program,5601 

Fishers Lane, Room 3G13, Rockville, MD 

20852, 240–669–5047, bgustafson@

niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 5, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19607 Filed 9–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse 

Amended; Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute on 

Drug Abuse Special Emphasis Panel, 

September 25, 2018, 10:00 a.m. to 

September 25, 2018, 12:00 p.m., 

National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 which 

was published in the Federal Register 

on August 15, 2018, 83 159 FR 2018– 

17674. 

The meeting date was changed to 

October 9, 2018. The meeting time did 

not change. The meeting is closed to the 

public. 

Dated: September 5, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–19608 Filed 9–10–18; 8:45 am] 

BILLING CODE 4140–01–P 


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