Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44281 

SUPPLEMENTARY INFORMATION: The BSC 

will provide input to the NTP on 

programmatic activities and issues. 

Preliminary agenda topics include 

discussions on strategic realignment of 

NTP and updates on peer reviews. 

Please see the preliminary agenda for 

information about the specific 

presentations. The preliminary agenda, 

roster of BSC members, background 

materials, public comments, and any 

additional information, when available, 

will be posted on the BSC meeting 

website (http://ntp.niehs.nih.gov/go/ 

165) or may be requested in hardcopy 

from the Designated Federal Official for 

the BSC. Following the meeting, 

summary minutes will be prepared and 

made available on the BSC meeting 

website. 

Meeting and Registration: The 

meeting is open to the public with time 

scheduled for oral public comments. 

Registration to view the webcast is by 

October 9, 2018, at http://

ntp.niehs.nih.gov/go/165. Registration is 

required to view the webcast; the URL 

for the webcast will be provided in the 

email confirming registration. TTY users 

should contact the Federal TTY Relay 

Service at 800–877–8339. Requests 

should be made at least five business 

days in advance of the event. 

Written Public Comments: NTP 

invites written and oral public 

comments on the agenda topics. 

Guidelines for public comments are 

available at https://ntp.niehs.nih.gov/ 

ntp/about_ntp/guidelines_public_

comments_508.pdf. The deadline for 

submission of written comments is 

October 1, 2018. Written public 

comments should be submitted through 

the meeting website. Persons submitting 

written comments should include name, 

affiliation, mailing address, phone, 

email, and sponsoring organization (if 

any). Written comments received in 

response to this notice will be posted on 

the NTP website, and the submitter will 

be identified by name, affiliation, and 

sponsoring organization (if any). 

Oral Public Comments: Registration 

for oral comments is on or before 

October 1, 2018, at http://

ntp.niehs.nih.gov/go/165. Oral 

comments will be received only during 

the formal public comment periods 

indicated on the preliminary agenda. 

Oral comments may be by 

teleconference line. The access number 

for the teleconference line will be 

provided to registrants by email prior to 

the meeting. Each organization is 

allowed one time slot, and five minutes 

will be allotted to each time slot. 

Meeting Materials: The preliminary 

meeting agenda is available on the 

meeting web page (http://

ntp.niehs.nih.gov/go/165) and will be 

updated one week before the meeting. 

Individuals are encouraged to access the 

meeting web page to stay abreast of the 

most current information regarding the 

meeting. 

Background Information on the BSC: 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

biochemistry, epidemiology, risk 

assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. The BSC 

usually meets biannually. The authority 

for the BSC is provided by 42 U.S.C. 

217a, section 222 of the Public Health 

Service Act (PHS), as amended. 

The BSC is governed by the 

provisions of the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

app.), which sets forth standards for the 

formation and use of advisory 

committees. 

Dated: August 20, 2018 

Brian R. Berridge, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2018–18778 Filed 8–29–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Yogikala Prabhu, Ph.D., 301–761–7789; 

prabhuyo@niaid.nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Methods of Diagnosing and Treating 

CHAPLE, a Newly Identified Orphan 

Disease Description of Technology 

This technology is directed towards a 

potential treatment for a new disease, 

CHAPLE (Complement Hyperactivation, 

Angiopathic thrombosis, and ProteinLosing Enteropathy), identified by 

NIAID researchers. CHAPLE is 

associated with GI symptoms and 

vascular thrombosis and is caused by 

loss-of-function variants in the gene 

encoding the complement regulatory 

protein CD55. The disease is caused by 

enhanced activation of the complement 

pathway and complement-mediated 

induction of intestinal lymphangiectasia 

and protein-losing enteropathy. There is 

no current therapy for the newly 

described heritable genetic disorder and 

the symptoms are poorly controlled. 

CHAPLE is similar to other complement 

activating diseases that can be fatal, 

particularly for patients who develop 

severe thrombosis. Recent off-label use 

of a complement inhibiting drug, 

eculizumab (CD55 inhibitor) was shown 

to provide a dramatic benefit in patients 

with CHAPLE disease with an 

immediate correction of gastrointestinal 

protein loss. Thus, identification of 

CD55 deficiency in CHAPLE patients, 

and the possibility to use complement 

inhibitory drugs provide opportunities 

for treatment. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Diagnostic. 

• Therapeutic. 

Competitive Advantages 

• There is no therapy currently 

approved for CHAPLE disease, and 


amozie on DSK3GDR082PROD with NOTICES1
44282 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 

patients face a debilitating and often 

time fatal course of the disease. 

• Anti-complement drugs (including 

eculizumab) has the potential to treat 

CHAPLE disease. 

Development Stage 

• Pre-clinical. 

• Clinical. 

Inventors 

Dr. Michael J. Lenardo (NIAID), Dr. 

Helen Su (NIAID), Ahmet Ozen (NIAID), 

William A. Comrie (NIAID), Mr. Rico C. 

Ardy (CeMM, Austria), and Dr. Kaan 

Boztug (CeMM, Austria). 

Intellectual Property 

HHS Reference No. E–251–2016/0, 

U.S. Provisional Patent Application 

Number 62/394,630, filed September 14, 

2016, and PCT/US2017/051413 filed 

September 13, 2017. 

Licensing Contact 

Yogikala Prabhu, Ph.D., 301–761– 

7789; prabhuyo@niaid.nih.gov. 

Collaborative Research Opportunity 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize the use of Eculizumab or 

other complement inhibitory drugs for 

the treatment of CHAPLE. For 

collaboration opportunities, please 

contact Yogikala Prabhu, Ph.D., 301– 

761–7789; prabhuyo@niaid.nih.gov. 

Dated: August 18, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–18779 Filed 8–29–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Shared and 

High-end Mass Spectrometers. 

Date: September 20–21, 2018. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Nikko San Francisco, 222 

Mason Street, San Francisco, CA 94102. 

Contact Person: Sudha Veeraraghavan, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–435–1504, 

sudha.veeraraghavan@nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Surgery, 

Anesthesiology and Trauma Study Section. 

Date: September 26–27, 2018 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Weihua Luo, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1170, luow@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Neural regulation of Cancer. 

Date: September 26, 2018. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Rolf Jakobi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6187, 

MSC 7806, Bethesda, MD 20892, 301–495– 

1718, jakobir@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 23, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–18772 Filed 8–29–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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 Center for 

Advancing Translational Sciences Special 

Emphasis Panel CTSA. 

Date: September 13–14, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, Brookside Conference 

Rooms A & B, 5701 Marinelli Road, 

Rockville, MD 20852. 

Contact Person: Victor Henriquez, Ph.D., 

Scientific Review Officer, Office of Scientific 

Director, National Center for Advancing 

Translational Sciences (NCATS), National 

Institutes of Health, 6701 Democracy Blvd., 

Democracy 1, Room 1080, Bethesda, MD 

20892–4878, 301–435–0813, henriquv@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: August 23, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–18773 Filed 8–29–18; 8:45 am] 

BILLING CODE 4140–01–P 


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