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

75574 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

1A Transportation Security Incident is defined in 

33 CFR 101.105 to mean ‘‘a security incident 

resulting in a significant loss of life, environmental 

damage, transportation system disruption, or 

economic disruption in a particular area.’’ 

2 33 CFR parts 104 and 105, subparts C and D. 

3An Alternative Security Program is defined in 

33 CFR 101.105 to mean ‘‘a third-party or industry 

organization developed standard that the 

Commandant [of the Coast Guard] has determined 

provides an equivalent level of security to that 

established by [33 CFR Chapter I, Subchapter H].’’ 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response 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: December 11, 2014. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2014–29572 Filed 12–17–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2014–1020] 

Guidance on Maritime Cybersecurity 

Standards 

AGENCY: Coast Guard, DHS. 

ACTION: Notice with request for 

comments. 

SUMMARY: The Coast Guard is 

developing policy to help vessel and 

facility operators identify and address 

cyber-related vulnerabilities that could 

contribute to a Transportation Security 

Incident. Coast Guard regulations 

require certain vessel and facility 

operators to conduct security 

assessments, and to develop security 

plans that address vulnerabilities 

identified by the security assessment. 

The Coast Guard is seeking public input 

from the maritime industry and other 

interested parties on how to identify 

and mitigate potential vulnerabilities to 

cyber-dependent systems. The Coast 

Guard will consider these public 

comments in developing relevant 

guidance, which may include standards, 

guidelines, and best practices to protect 

maritime critical infrastructure. 

DATES: Comments must be submitted to 

the online docket via http://

www.regulations.gov, or reach the 

Docket Management Facility, on or 

before February 17, 2015. 

ADDRESSES: Submit comments using one 

of the listed methods, and see 

SUPPLEMENTARY INFORMATION for more 

information on public comments. 

• Online—http://www.regulations.gov 

following Web site instructions. 

• Fax—202–493–2251. 

• Mail or hand deliver—Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590–0001. Hours for 

hand delivery are 9 a.m. to 5 p.m., 

Monday through Friday, except Federal 

holidays (telephone 202–366–9329). 

FOR FURTHER INFORMATION CONTACT: For 

information about this document call or 

email LT Josephine Long, Coast Guard; 

telephone 202–372–1109, email 

Josephine.A.Long@uscg.mil or LCDR 

Joshua Rose, Coast Guard; 202–372– 

1106, email Joshua.D.Rose@uscg.mil. 

For information about viewing or 

submitting material to the docket, call 

Cheryl Collins, Program Manager, 

Docket Operations, telephone 202–366– 

9826, toll free 1–800–647–5527. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Comments 

We encourage you to submit 

comments (or related material) on the 

questions listed below. We will consider 

all submissions and may adjust our final 

policy actions based on your comments. 

Comments should be marked with 

docket number USCG–2014–1020, and 

should provide a reason for each 

suggestion or recommendation. You 

should provide personal contact 

information so that we can contact you 

if we have questions regarding your 

comments; but please note that all 

comments will be posted to the online 

docket without change and that any 

personal information you include can be 

searchable online (see the Federal 

Register Privacy Act notice regarding 

our public dockets, 73 FR 3316, Jan. 17, 

2008). 

Mailed or hand-delivered comments 

should be in an unbound 81⁄2 x 11 inch 

format suitable for reproduction. The 

Docket Management Facility will 

acknowledge receipt of mailed 

comments if you enclose a stamped, 

self-addressed postcard or envelope 

with your submission. 

Documents mentioned in this notice, 

and all public comments, are in our 

online docket at http://

www.regulations.gov and can be viewed 

by following the Web site’s instructions. 

You can also view the docket at the 

Docket Management Facility (see the 

mailing address under ADDRESSES) 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

Discussion 

The Coast Guard is developing policy 

to help vessel and facility operators 

identify and address cyber-related 

vulnerabilities that could contribute to a 

Transportation Security Incident (TSI).1

Coast Guard regulations require certain 

vessel and facility operators to conduct 

security assessments, and to develop 

security plans that address 

vulnerabilities identified by the security 

assessment.2 Vessel and facility security 

plans must also address specific 

security functions, including the 

following: 

• Communications 

• Security Training Requirements 

• Procedures for vessel/facility 

interfacing 

• Declaration of Security 

• Security Systems and Equipment 

Maintenance 

• Security Measures for Access Control 

• Security Measures for Handling Cargo 

• Security Measures for Monitoring 

• Security Incident Procedures 

The Coast Guard is seeking public input 

on the following questions: 

(1) What cyber-dependent systems, 

commonly used in the maritime 

industry, could lead or contribute to a 

TSI if they failed, or were exploited by 

an adversary? 

(2) What procedures or standards do 

vessel and facility operators now 

employ to identify potential 

cybersecurity vulnerabilities to their 

operations? 

(3) Are there existing cybersecurity 

assurance programs in use by industry 

that the Coast Guard could recognize? If 

so, to what extent do these programs 

address vessel or facility systems that 

could lead to a TSI? 

(4) To what extent do current security 

training programs for vessel and facility 

personnel address cybersecurity risks 

and best practices? 

(5) What factors should determine 

when manual backups or other nontechnical approaches are sufficient to 

address cybersecurity vulnerabilities? 

(6) How can the Coast Guard leverage 

Alternative Security Programs 3 to help 

vessel and facility operators address 

cybersecurity risks? 

(7) How can vessel and facility 

operators reliably demonstrate to the 

Coast Guard that critical cyber-systems 

meet appropriate technical or 

procedural standards? 

(8) Do classification societies, 

protection and indemnity clubs, or 

insurers recognize cybersecurity best 

practices that could help the maritime 

industry and the Coast Guard address 

mstockstill on DSK4VPTVN1PROD with NOTICES