42686 Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices 

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 19, 2017. 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 20, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

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 Serina HunterThomas at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

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 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19129 Filed 9–8–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0809] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that KYMRIAH 

(tisagenlecleucel), manufactured by 

Novartis Pharmaceuticals Corporation, 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Gretchen Opper, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that KYMRIAH 

(tisagenlecleucel), manufactured by 

Novartis Pharmaceuticals Corporation, 

meets the criteria for a priority review 

voucher. KYMRIAH (tisagenlecleucel) is 

indicated for the treatment of patients 

up to 25 years of age with B-cell 

precursor acute lymphoblastic leukemia 

(ALL) that is refractory or in second or 

later relapse. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go tohttps://www.fda.gov/ForIndustry/

DevelopingProductsfor

RareDiseasesConditions/

RarePediatricDiseasePriorityVoucher

Program/default.htm. For further 

information about KYMRIAH 

(tisagenlecleucel), go to the Center for 

Biologics Evaluation and Research 

cellular and gene therapy products Web 

site at https://www.fda.gov/Biologics

BloodVaccines/CellularGeneTherapy

Products/ApprovedProducts/

default.htm. 

Dated: September 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19130 Filed 9–8–17; 8:45 am] 

BILLING CODE 4164–01–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: Dr. 

Vince Contreras, 240–669–2823; 

Vince.Contreras@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. 

Broadly Neutralizing Antibodies 

Against HIV–1 Directed to the CD4 

Binding Site of HIV Envelope Protein 

Description of Technology 

Inhibiting the ability of HIV–1, the 

virus that causes AIDS, to infect cells is 

one approach to both prevention and 

treatment of HIV. Scientists at the 

NIAID Vaccine Research Center have 

isolated and characterized neutralizing 

antibodies (VRC01, 02, 03, and 07) that 

bind to the CD4 binding site of HIV–1 

envelope glycoprotein gp120. These 

human monoclonal antibodies can 

potentially be used as a therapeutic to: 

(1) Treat an HIV infection, (2) decrease 

and prevent HIV-transmission from 

mother to infant, and (3) be effectively 

combined with anti-retroviral drug 

therapy. Additionally, the antibodies 

can be used for detection of HIV–1 

infection in biological samples, 

including body fluids; and tissues from 

biopsies, autopsies, and pathology 

specimens. 

VRC01 has been tested in several 

phase I clinical trials for safety and 

pharmacokinetics in infants, adults, and 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 174 / Monday, September 11, 2017 / Notices 42687 

HIV-positive adults. VRC01 is currently 

being evaluated in a phase II clinical 

trial for prevention of HIV–1 

acquisition. 

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 

• Monoclonal antibodies to treat and/or 

diagnose HIV and/or AIDS 

• Immunoassays and kits 

Competitive Advantages 

• Monoclonal neutralizing antibodies 

prevent viral entry into cells 

• Monoclonal neutralizing antibodies 

can be used for vaccine design and to 

develop diagnostics for HIV–1 

Development Stage 

• In vitro data available 

• In vivo data available (animal) 

• In vivo data available (human) 

• Clinical Phase I 

Inventors: John Mascola, Mark 

Connors, Peter Kwong, Gary Nabel, 

Mario Roederer, Xueling Wu (all from 

NIAID). 

Publications 

Nabel G et al. (2015) Broadly 

Neutralizing Human 

Immunodeficiency Virus Type 1 

Antibody Gene Transfer Protects 

Nonhuman Primates from Mucosal 

Simian-Human Immunodeficiency 

Virus Infection. J Virol. 

89(16):8334–45. [PMID26041300]. 

Nabel G et al. (2014) Enhanced potency 

of a broadly neutralizing HIV–1 

antibody in vitro improves 

protection against lentiviral 

infection in vivo. J Virol. 

88(21):12669–82. [PMID:25142607]. 

Wu X et al. (2010) Immunotypes of a 

quaternary site of HIV–1 

vulnerability and their recognition 

by antibodies. J Virol. 2011: 

85(9):4578–85. [PMID:21325411]. 

Zhou T et al. (2010) Structural basis for 

broad and potent neutralization of 

HIV–1 by antibody VRC01. Science. 

329(5993):811–7. [PMID: 

20616231]. 

Intellectual Property: HHS Reference 

No: E–300–2009 and E–051–2012. The 

E–300–2009 family includes U.S. Patent 

Application. 13/498,286, filed March 

23, 2012 (Issued); Australia Patent 

Application 2010298025, filed 

September 24, 2010 (Issued); China 

Patent Application 201080053616.5 

filed September 24, 2010 (Issued); E.U. 

Patent Application 10760878.8 filed 

September 24, 2010 (Pending); India 

Patent Application 588/KOLNP/2012 

filed March 13, 2012 (Pending); South 

Africa Patent Application 212/02116 

filed September 24, 2017 (Pending); 

Canada Patent Application. 2274636 

filed September 24, 2017 (Pending). 

The E–051–2012 family includes U.S. 

Patent Application 14–363,740, filed 

June 6, 2014 (Issued); Australia Patent 

Application. 2012347453, filed 

December 10,2010 (Issued); China 

Patent Application 201280069415.3, 

filed December 10, 2012 (Pending); E.U. 

Patent Application 1285597.6, filed 

December 10, 2012 (Pending); Indian 

Patent Application 4661/DELNP/2014, 

filed December 10, 2012 (Pending); 

South Africa Patent Application 2014/ 

04077, filed December 10, 2012 

(Pending). 

Licensing Contact: Dr. Vince 

Contreras, 240–669–2823; 

Vince.Contreras@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 Monoclonal antibodies 

to treat and/or diagnose HIV and/or 

AIDS. 

For collaboration opportunities, 

please contact Dr. Vince Contreras, 240– 

669–2823; Vince.Contreras@nih.gov. 

Dated: September 1, 2017. 

Suzanne Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2017–19088 Filed 9–8–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; 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 

Child Health and Human Development Initial 

Review Group Reproduction, Andrology, and 

Gynecology Subcommittee. 

Date: October 20, 2017. 

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: Dennis E. Leszczynski, 

Ph.D., Scientific Review Administrator 

Division of Scientific Review National 

Institute of Child Health and Human 

Development, NIH, 6710B Bethesda Drive, 

Bethesda, MD 20892, (301) 435–2717, 

leszczyd@mail.nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Point of Care 

Technologies for the Evaluation and 

Management of Obstetrics, Neonatal, and 

Pediatric Critical Care Patients, and for 

Patients With Disorders of Reproductive 

Tract and Infertility. 

Date: November 6, 2017. 

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: Sathasiva B. Kandasamy, 

Ph.D., Scientific Review Administrator 

Division of Scientific Review National 

Institute of Child Health and Human 

Development, 6710B Bethesda Drive, 

Bethesda, MD 20892, (301) 435–6680, 

skandasa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 5, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19089 Filed 9–8–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES