Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38717 

hindered both its characterization and 

its use as a vaccine antigen. 

Researchers at the Vaccine Research 

Center (VRC) of the National Institute of 

Allergy and Infectious Diseases have 

overcome technical obstacles to produce 

a homogeneous, soluble RSV F 

glycoprotein vaccine which is stabilized 

in the prefusion conformation and has 

improved stability and immunogenicity 

compared to the native protein. 

Additionally, several modifications 

were introduced to remove the 

requirement for furin during 

production, resulting in an increase in 

expression levels of the immunogen. 

Stability of the immunogen was 

increased 20-fold as compared to DS– 

CAV1 (a prefusion-stabilized RSV F 

glycoprotein vaccine candidate that is 

currently being assessed in clinical 

trials) upon incubation at 60 °C. In mice, 

these immunogens elicited 

neutralization titers that were 2 to 5-fold 

higher than DS–CAV1. 

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: 

• Vaccine: RSV vaccine for human 

use. 

• Probe: B cell-sorting probe to isolate 

potent neutralizing monoclonal 

antibodies. 

• Diagnostics: To assess the titer of 

prefusion-specific antibodies in sera. 

Competitive Advantages: 

• Increased stability compared to the 

current leading RSV vaccine candidate 

(DS-Cav1). 

• Elicits increased neutralization 

titers in mice. 

Development Stage: 

• In vivo testing (mice). 

Inventors: Peter D. Kwong (NIAID), M. 

Gordon Joyce (NIAID), Baoshan Zhang 

(NIAID), Man Chen (NIAID), Barney S. 

Graham (NIAID), John R. Mascola 

(NIAID), Aliaksandr A. Druz (NIAID), 

Wing-Pui Kong (NIAID), Ivelin Georgiev 

(NIAID), Yaroslav Tsybovsky (Leidos 

Biomedical Research), Paul V. Thomas 

(NIAID), Marie L. Pancera (NIAID), 

Mallika Sastry (NIAID), Cinque Soto 

(NIAID), Guillaume B.E. Stewart-Jones 

(NIAID), Yongping Yang (NIAID), Li Ou 

(NIAID), Ulrich Baxa (NCI), Emily 

Rundlet (NIAID), Joseph Van Galen 

(NIAID). 

Publications: Joyce, M. Gordon, et al., 

Nature structural & molecular biology, 

23.9 (2016): 811; PMID: 27478931. 

Intellectual Property: HHS Reference 

Number E–064–2016: U.S. Patent 

Application No. 62/314,946 filed 03/29/ 

2016; PCT Application Number PCT/ 

US2017/024714 filed 03/29/2017 

(pending). 

Related Intellectual Property: HHS 

Reference Number E–081–2013. 

Licensing Contact: Vince Contreras, 

Ph.D., 240–669–2823; vince.contreras@

nih.gov. 

Dated: July 20, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–16835 Filed 8–6–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Interagency Coordinating Committee 

on the Validation of Alternative 

Methods Biennial Progress Report: 

2016–2017; Availability of Report 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Toxicology 

Program (NTP) Interagency Center for 

the Evaluation of Alternative 

Toxicological Methods (NICEATM) 

announces availability of the 

Interagency Coordinating Committee on 

the Validation of Alternative Methods 

(ICCVAM) Biennial Progress Report: 

2016–2017. This report, prepared in 

accordance with requirements of the 

ICCVAM Authorization Act of 2000, 

describes activities and 

accomplishments from January 2016 

through December 2017. 

ADDRESSES: The report is available at 

http://ntp.niehs.nih.gov/iccvamreport/ 

2017/index.html. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Warren Casey, Director, NICEATM; 

email: warren.casey@nih.gov; telephone: 

(984) 287–3118. 

SUPPLEMENTARY INFORMATION: 

Background: The ICCVAM 

Authorization Act of 2000 established 

ICCVAM as a permanent interagency 

committee of the National Institute of 

Environmental Health Sciences (NIEHS) 

under NICEATM. ICCVAM’s mission is 

to facilitate development, validation, 

and regulatory acceptance of new and 

revised regulatory test methods that 

reduce, refine, or replace the use of 

animals in testing while maintaining 

and promoting scientific quality and the 

protection of human health, animal 

health, and the environment. 

A provision of the ICCVAM 

Authorization Act states that ICCVAM 

shall prepare ‘‘reports to be made 

available to the public on its progress 

under this Act.’’ The eighth ICCVAM 

biennial progress report describing 

ICCVAM activities and 

accomplishments from January 2016 

through December 2017 is now 

available. 

Summary of Report Contents: Key 

ICCVAM, ICCVAM agency, and 

NICEATM accomplishments 

summarized in the report include: 

• Development of a strategic roadmap 

for incorporating new approaches into 

safety testing of chemicals and medical 

products in the United States. 

• Publication of two guidance 

documents by the U.S. Environmental 

Protection Agency (EPA) in 2016. One 

included a policy statement to waive all 

acute dermal lethality studies for 

pesticide formulations. The other 

described a transparent, stepwise 

process for evaluating and 

implementing alternative methods for 

six-pack studies, which test for acute 

systemic toxicity by the oral, dermal, 

and inhalation routes; skin and eye 

irritation; and skin sensitization. 

• Publication of notices permitting 

removal of back-titration hamsters for 

potency testing of vaccines containing 

Leptospira pomona and Leptospira 

grippotyphosa by the U.S. Department 

of Agriculture, further reducing the 

number of hamsters required for 

leptospirosis vaccine potency testing. 

• Publication by the U.S. Food and 

Drug Administration of the Predictive 

Toxicology Roadmap for integrating 

predictive toxicology methods into 

safety and risk assessments. 

• Development by NICEATM and 

EPA scientists of a defined approach 

that combines data from 11 highthroughput screening assays with a 

computational model to identify 

chemicals with the potential to interact 

with the androgen receptor pathway. 

• Development by NICEATM and 

ICCVAM scientists of a defined 

approach that uses non-animal 

approaches to predict murine local 

lymph node assay outcomes and human 

skin sensitization hazard and potency. 

• Submission of a proposal to 

develop a performance-based test 

guideline for defined approaches to skin 

sensitization testing and assessment to 

the Organisation for Economic Cooperation and Development (OECD) by 

partners in the International 

Cooperation on Alternative Test 

Methods in 2016. The proposal was 

approved as part of the OECD workplan 

in 2017. 

• Launch of the Integrated Chemical 

Environment, a publicly accessible 

online resource developed to provide 

high-quality curated data and 


daltland on DSKBBV9HB2PROD with NOTICES
38718 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

computational workflows to facilitate 

chemical safety assessment, by 

NICEATM. 

Availability of Report: The report is 

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

iccvamreport/2017/index.html. Links to 

this report and all past ICCVAM annual 

and biennial reports are available at 

http://ntp.niehs.nih.gov/go/iccvam-bien. 

Background Information on ICCVAM 

and NICEATM: ICCVAM is an 

interagency committee composed of 

representatives from 16 federal 

regulatory and research agencies that 

require, use, generate, or disseminate 

toxicological and safety testing 

information. ICCVAM conducts 

technical evaluations of new, revised, 

and alternative safety testing methods 

and integrated testing strategies with 

regulatory applicability. ICCVAM also 

promotes the scientific validation and 

regulatory acceptance of testing 

methods that more accurately assess the 

safety and hazards of chemicals and 

products and replace, reduce, or refine 

(enhance animal well-being and lessen 

or avoid pain and distress) animal use. 

The ICCVAM Authorization Act of 

2000 (42 U.S.C. 285l–3) establishes 

ICCVAM as a permanent interagency 

committee of NIEHS and provides the 

authority for ICCVAM involvement in 

activities relevant to the development of 

alternative test methods. Additional 

information about ICCVAM can be 

found at http://ntp.niehs.nih.gov/go/ 

iccvam. 

NICEATM administers ICCVAM, 

provides scientific and operational 

support for ICCVAM-related activities, 

and conducts and publishes analyses 

and evaluations of data from new, 

revised, and alternative testing 

approaches. NICEATM and ICCVAM 

work collaboratively to evaluate new 

and improved testing approaches 

applicable to the needs of U.S. federal 

agencies. NICEATM and ICCVAM 

welcome the public nomination of new, 

revised, and alternative testing 

approaches for validation studies and 

technical evaluations. Additional 

information about NICEATM can be 

found at http://ntp.niehs.nih.gov/go/ 

niceatm. 

Dated: July 24, 2018. 

Brian R. Berridge, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2018–16837 Filed 8–6–18; 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, 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 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council. 

Date: September 7, 2018. 

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

Agenda: To present the Director’s Report 

and other scientific presentations. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 10, 31 Center Drive, Bethesda, MD 

20892. 

Closed: 1:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 10, 31 Center Drive, Bethesda, MD 

20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council; Kidney, Urologic and Hematologic 

Diseases Subcommittee. 

Date: September 7, 2018. 

Open: 1:00 p.m. to 2:45 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 7, 31 Center Drive, Bethesda, MD 

20892. 

Closed: 2:45 p.m. to 3:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 7, 31 Center Drive, Bethesda, MD 

20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division Of Extramural 

Activities, National Institutes of Diabetes and 

Digestive and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council; Diabetes, Endocrinology, and 

Metabolic Diseases Subcommittee. 

Date: September 7, 2018. 

Open: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 10, 31 Center Drive, Bethesda, MD 

20892. 

Closed: 2:00 p.m. to 3:15 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 10, 31 Center Drive, Bethesda, MD 

20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division Of Extramural 

Activities, National Institutes of Diabetes and 

Digestive and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Name of Committee: National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council; Digestive Diseases and Nutrition 

Subcommittee. 

Date: September 7, 2018. 

Open: 1:00 p.m. to 2:00 p.m. 

Agenda: To review the Division’s scientific 

and planning activities. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 6, 31 Center Drive, Bethesda, MD 

20892. 

Closed: 2:15 p.m. to 3:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room 6, 31 Center Drive, Bethesda, MD 

20892. 

Contact Person: Karl F. Malik, Ph.D., 

Acting Director, Division of Extramural 

Activities, National Institutes of Diabetes and 

Digestive and Kidney Diseases, 6707 

Democracy Blvd., Room 7329, MSC 5452, 

Bethesda, MD 20892, (301) 594–4757, 

malikk@niddk.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 


daltland on DSKBBV9HB2PROD with NOTICES