75572 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

establish legally enforceable 

responsibilities. See 21 CFR 10.115(d). 

II. Paperwork Reduction Act of 1995 

This guidance contains no collection 

of information. As discussed in the 

guidance, FDA intends to develop 

individual guidances to specify the 

electronic formats for certain 

submissions under section 745A(a) of 

the FD&C Act. We will discuss any 

information collection subject to 

clearance by OMB under the Paperwork 

Reduction Act in each Federal Register 

notice announcing the availability of the 

individual guidances that specify the 

required electronic formats. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: December 12, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29609 Filed 12–17–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for 

Complementary and Alternative 

Medicine. 

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 

Council for Complementary and Alternative 

Medicine 

Date: February 6, 2015. 

Closed: 8:30 a.m. to 9:45 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Open: 10:00 a.m. to 4:00 p.m. 

Agenda: Report from the Institute Director 

and other staff. 

Place: National Institutes of Health, 

Building 31, Conference Room 10, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Martin H. Goldrosen, 

Ph.D., Director, Division of Extramural 

Activities, National Center for 

Complementary and Alternative Medicine, 

NIH, 6707 Democracy Blvd., Ste. 401, 

Bethesda, MD 20892–5475, (301) 594–2014, 

goldrosm@mail.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. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

nccam.nih.gov/about/naccam/, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: December 12, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–29571 Filed 12–17–14; 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 & Human 

Development (NICHD); Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Child Health and 

Human Development Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. A 

portion of this 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 for the review and 

discussion of grant applications. 

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. 

Name of Committee: National Advisory 

Child Health and Human Development 

Council. 

Date: January 22, 2015. 

Open: January 22, 2015, 8:00 a.m. to 12:10 

p.m. 

Agenda: Report of the Director, NICHD; 

Report of the Acting Director, Division of 

Extramural Research, NICHD; Discussion of 

the Outstanding Investigator Award (R35); 

and New Business of the Council. 

Closed: January 22, 2015, 1:15 p.m. to 

Adjournment. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Center Drive, C-Wing, 

Conference Room 6, Bethesda, MD 20892. 

Contact Person: Caroline Signore, MD., 

Mp.H., Acting Director, Division of 

Extramural Research, Eunice Kenney Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 4A05, MSC 7510, Bethesda, MD 

20892, (301) 496–5577. 

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. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 75573 

onto the NIH campus. All visitor vehicles, 

including taxis, hotel, and airport shuttles, 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

In order to facilitate public attendance at 

the open session of Council in the main 

meeting room, Conference Room 6, please 

contact Ms. Lisa Kaeser, Program and Public 

Liaison Office, NICHD, at 301–496–0536 to 

make your reservation, additional seating 

will be available in the meeting overflow 

rooms, Conference Rooms 7 and 8. 

Individuals will also be able to view the 

meeting via NIH Videocast. Please go to the 

following link for Videocast access 

instructions at: http://www.nichd.nih.gov/

about/advisory/nachhd/Pages/virtualmeeting.aspx. 

(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: December 12, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–29570 Filed 12–17–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

Advisory Committee to the Deputy 

Director for Intramural Research, 

National Institutes of Health. 

The meeting will be open to the 

public, 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. 

Name of Committee: Advisory Committee 

to the Deputy Director for Intramural 

Research, National Institutes of Health. 

Date: January 9, 2015. 

Time: 1:30 p.m. to 3:00 p.m. 

Agenda: To discuss the Advisory 

Committee to the Deputy Director for 

Intramural Research Report 

recommendations on the site visit review of 

the Office of Animal Care and Use. 

Place: National Institutes of Health, 

Building 1, Room 160, Tele: 866–556–1098, 

Code 48960, 8600 Rockville Pike, Bethesda, 

MD 20892, (Telephone Conference Call). 

Contact Person: Michael M. Gottesman, 

Deputy Director, National Institutes of 

Health, Building One, Room 160, Bethesda, 

MD 20892, 301–496–1921. 

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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: December 12, 2014. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–29573 Filed 12–17–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Multivalent Vaccines for 

Rabies Virus and Ebola and Marburg 

(Filoviruses) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209 and 37 CFR 404, that 

the National Institutes of Health (NIH), 

Department of Health and Human 

Services (HHS), is contemplating the 

grant of a an exclusive license to 

practice the following invention as 

embodied in the following patent 

applications: E–032–2011/0, Blaney et 

al., ‘‘Multivalent Vaccines for Rabies 

Virus and Filoviruses’’, U.S. Patent 

Application Number 61/439,046, filed 

on February 3, 2011, PCT Application 

Number PCT/US2012/23575, filed on 

February 2, 2012, U.S. Patent 

Application Number 13/983,545, filed 

on August 2, 2013, European Patent 

Application Number 12702953.6, filed 

on February 2, 2012, and Canadian 

Patent Application Number 2826594, 

filed on February 2, 2012, to Exxell BIO, 

Inc., having a place of business in 

Shoreview, Minnesota, United States of 

America. The patent rights in these 

inventions have been assigned to the 

United States of America and Thomas 

Jefferson University. 

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

January 20, 2015 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Peter Soukas, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Email: 

ps193c@nih.gov; Telephone: (301) 435– 

4646; Facsimile: (301) 402–0220. 

SUPPLEMENTARY INFORMATION: The 

inventors have developed a new 

platform based on live or chemically 

inactivated (killed) rabies virus (RABV) 

virions containing EBOV glycoprotein 

(GP) in their envelope. In preclinical 

trials, immunization with such 

recombinant RABV virions provided 

excellent protection in mice against 

lethal challenge with the mouse adapted 

EBOV and RABV. More specifically, the 

inventors have developed a trivalent 

filovirus vaccine based on killed rabies 

virus virions for use in humans to 

confer protection from all medically 

relevant filoviruses and RABV. Two 

additional vectors containing EBOV 

Sudan GP or MARV GP are planned to 

be constructed in addition to the 

previously developed EBOV Zaire GP 

containing vaccine. Live attenuated 

vaccines have been developed for use in 

at risk nonhuman primate populations 

in Africa and inactivated vaccines have 

been developed for use in humans. One 

recent use contemplated by the 

inventors is use of the vaccine 

candidates to generate polyclonal sera 

against Filoviruses (i.e. Ebola and 

Marburg). 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404. The prospective 

exclusive license may be granted unless, 

within thirty (30) days from the date of 

this published notice, NIH 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 404. 

These patent rights are the subject of 

a previous Federal Register notice (see 

79 FR 18039, Monday, March 31, 2014). 

The fields of use may be limited to 

production of polyclonal antibodies for 

prevention/treatment of Filoviruses in 

humans and non-human animals. 

mstockstill on DSK4VPTVN1PROD with NOTICES