Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47537 

ANNUALIZED BURDEN HOUR TABLE

Forms Respondents Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden 

hours 

Advocate Form ................................. Site Coordinator .............................. 10 1 20/60 3 

Advocate Annual Follow-Up Survey Site Coordinator .............................. 10 1 20/60 3 

End of Wave 1 Interview Script ....... Site Coordinator .............................. 10 1 1 10 

End of Wave 1 Feedback Survey .... Site Coordinator .............................. 10 1 45/60 8 

End of Wave 2 Interview ................. Site Coordinator .............................. 10 1 1 10 

End of Wave 2 Feedback Survey .... Site Coordinator .............................. 10 1 20/60 3 

Technical Assistance Assessment .. Site Coordinator .............................. 10 1 25/60 4 

Mentee Pre-Assessment .................. Mentee/Program Participant ............ 700 1 20/60 233 

Mentee Post-Assessment ................ Mentee/Program Participant ............ 700 1 20/60 233 

Mentor Feedback Survey ................. Mentor ............................................. 700 1 15/60 175 

Weekly Goal-Setting Guide ............. Mentor ............................................. 700 10 10/60 1166 

Mentee Focus Group Script ............. Mentee/Program Participant ............ 60 1 1 60 

Parent/Guardian Focus Group 

Script.

Mentee’s Parent/Guardian .............. 60 1 1 60 

Total .......................................... .......................................................... ........................ 22 ........................ 1968 

Terry S. Clark, 

Office of the Secretary, Asst Paperwork 

Reduction Act Reports Clearance Officer. 

[FR Doc. 2017–21983 Filed 10–11–17; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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 on 

Alcohol Abuse and Alcoholism, Special 

Emphasis Panel; NIAAA Fellowship Review. 

Date: November 2, 2017. 

Time: 8:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, Terrace Conference Room, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Richard A. Rippe, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, National Institutes of 

Health, 5635 Fishers Lane, Room 2109, 

Rockville, MD 20852 301–443–8599, 

rippera@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel, SEP Review Member 

Conflict Applications. 

Date: November 14, 2017. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 5635 Fishers Lane, Rockville, 

MD 20892 (Telephone Conference Call). 

Contact Person: Anna Ghambaryan, M.D., 

Scientific Review Officer, Office of 

Extramural Activities, National Institute on 

Alcohol Abuse and Alcoholism, National 

Institutes of Health, 5635 Fishers Lane, 

Rockville, MD 20852, 301–443–4032, 

anna.ghambaryan@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards., National 

Institutes of Health, HHS). 

Dated: October 5, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21989 Filed 10–11–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: DNA-Based Vaccine for 

Prevention of Zika Virus Infection 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases (NIAID), 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Commercialization 

Patent License to PaxVax, Inc., located 

in Redwood City, California, 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 of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before November 

13, 2017 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive Commercialization Patent 

License should be directed to: Dr. Amy 

Petrik, Technology Transfer and Patent 

Specialist, Technology Transfer and 

Intellectual Property Office, National 

Institute of Allergy and Infectious 

Diseases, 5601 Fishers Lane, Suite 2G, 

MSC9804, Rockville, MD 20852–9804, 

phone number 301–496–2644, or 

petrika@mail.nih.gov. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47538 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

SUPPLEMENTARY INFORMATION: The 

following represents the intellectual 

property is to be licensed under the 

prospective agreement: HHS Ref. No. E– 

181–2016/0, including provisional 

patent applications 62/396,613 filed 

September 19, 2016 entitled ‘‘Zika Virus 

Vaccines’’, and all continuing U.S. and 

foreign patents/patent applications for 

the technology family, to PaxVax Inc. 

All rights in these inventions have 

been assigned to the Government of the 

United States of America. 

The prospective Exclusive Patent 

License territory may be worldwide and 

the field of use may be limited to: 

‘‘Development and use of DNA-based 

vaccines expressing virus-like particle 

antigens comprising Zika virus 

membrane and/or envelope proteins for 

prevention of Zika virus infection in 

humans.’’ 

Since 2015, Zika virus (ZIKV) 

outbreaks have had a significant effect 

on global public health. The mosquitoborne disease, which causes several 

congenital abnormalities in the 

developing fetus, as well as other 

neurological disorders in infected 

individuals has no approved vaccine to 

treat or prevent infection. To address 

this critical need, several approaches are 

being explored for a vaccine against 

ZIKV infection in priority populations 

including women of child-bearing age 

and their partners. 

Many entities, governmental, 

academic, and commercial, are actively 

pursuing development of ZIKV vaccines 

each using a different approach to 

address this public health need. The 

U.S. Government is coordinating its 

vaccine development response to ZIKV 

and has published this plan at https:// 

www.phe.gov/Preparedness/planning/ 

Pages/zika-white-paper.aspx. 

Vaccine development approaches for 

ZIKV include but are not limited to 

inactivated virus (dead virus), live 

attenuated virus (weakened virus), 

recombinant viral vectors (weakened 

virus with target genes added), and 

subunit (portion of a virus) as well as 

mRNA- and DNA-based (gene-targeted). 

These various strategies provide 

multiple redundancies, expanded 

choice, and ensure short and long term 

maximal benefits to the public. 

The subject invention relates to the 

use of nucleic acid molecules encoding 

Zika virus (ZIKV) proteins that when 

introduced in a cell produces 

noninfectious virus-like particles (VLPs) 

capable of eliciting a protective immune 

response against viral infection. More 

specifically, the subject vaccine is a 

DNA-based candidate encoding a 

polypeptide of a ZIKV membrane and 

envelope proteins that when expressed 

results in production of noninfectious 

VLPs that generate protective 

neutralizing antibodies against ZIKA 

infection. The vaccine, which is based 

on a similar vaccine developed for the 

related West Nile virus, is currently 

undergoing clinical trial evaluation. The 

subject invention has been advertised in 

the Federal Register and published on 

12 December 2016. 

This notice is made in accordance 

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

The prospective Exclusive Patent 

License will be royalty bearing and may 

be granted unless within thirty (30) days 

from the date of this published notice, 

the NIAID 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. 

Complete applications for a license in 

the prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated 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: October 5, 2017. 

Suzanne Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2017–21986 Filed 10–11–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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 

General Medical Sciences Special Emphasis 

Panel; Review of Support of Competitive 

Research (SCORE) Award Applications. 

Date: November 8, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott Chevy Chase, 

5520 Wisconsin Avenue, Chevy Chase, MD 

20815. 

Contact Person: Manas Chattopadhyay, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review, National Institute of 

General Medical Sciences, National Institutes 

of Health, Building 45, Room 3An12N, 45 

Center Drive, Bethesda, MD 20892, 301–827– 

5320, manasc@mail.nih.gov. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of NIH Pathway to 

Independence Award K99/R00 Applications. 

Date: November 16, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn Bethesda, 7301 

Waverly Street, Bethesda, MD 20814. 

Contact Person: Robert Horowits, Ph.D., 

Scientific Review Officer, National Institute 

of General Medical Sciences, National 

Institutes of Health, 45 Center Drive, Room 

3An.18, Bethesda, MD 20892–6200, 301– 

594–6904, horowitr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.859, 

Biomedical Research and Research Training, 

National Institutes of Health, HHS) 

Dated: October 5, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–21990 Filed 10–11–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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 Board of Scientific 

Counselors, NIDCD. 

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 


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