Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 6033 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2016–02021 Filed 2–3–16; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2016–0010] 

Cooperative Research and 

Development Agreement Opportunity 

With the Department of Homeland 

Security for the International Foot-andMouth Disease Vaccine and 

Diagnostics Field Trial 

AGENCY: Chemical and Biological 

Defense Division (CBD), Homeland 

Security Advanced Research Projects 

Agency, Science and Technology 

Directorate, Department of Homeland 

Security. 

ACTION: Notice of intent. 

SUMMARY: The Department of Homeland 

Security (DHS), Science and Technology 

Directorate (S&T), through its Homeland 

Security Advanced Research Projects 

Agency (HSARPA), Chemical Biological 

Defense Division (CBD) is implementing 

and executing an international foot-andmouth disease (FMD) vaccine and 

diagnostics field trial. The objective of 

the project is to evaluate a newly 

developed FMD vaccine(s) and 

companion diagnostic(s) in an FMDV 

endemic country. The specific goals of 

this project are to establish the efficacy 

of the newly developed replicationdeficient adenovirus-vectored FMD 

(AdFMD) vaccine; the effectiveness, 

sensitivity, specificity, and ruggedness 

of a new companion diagnostic test (‘‘3B 

ELISA’’) under field conditions, and to 

provide data on the usage of a DIVA 

vaccine and companion diagnostic in an 

endemic disease situation which may be 

used to inform the U.S. response to an 

FMD outbreak. DHS anticipates that this 

project may lead to the development 

and fostering of partnerships and 

collaborations with industry, countries 

and national and international 

organizations that will result in a solid 

foundation that will facilitate the future 

development and testing of additional 

transboundary animal disease (TAD) 

vaccines and diagnostics. 

CBD is seeking industry partners to 

enter into a Cooperative Research and 

Development Agreement (CRADA). It is 

envisioned that the primary role of the 

selected industry collaborator(s) will be 

to provide subject matter experts to 

inform the vaccine and diagnostic field 

trial design(s), country selection and 

regulatory processes, in addition to 

potentially developing, manufacturing 

and distributing or providing, the 

AdFMD experimental vaccines and 

companion ELISA diagnostic kits for the 

field trial. 

DATES: Submit comments on or before 

March 7, 2016. 

ADDRESSES: Mail comments and 

requests to participate to Dr. Roxann 

Motroni, (ATTN: Roxann Motroni, 245 

Murray Lane SW., Washington, DC 

20528–0075). Submit electronic 

comments and other data with the 

subject line ‘‘International FMD Field 

Trial Notice of Intent’’ to 

Roxann.Motroni@hq.dhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Information on DHS CRADAs: Scott 

Pugh, scott.pugh@hq.dhs.gov, (202) 

254–2288. 

SUPPLEMENTARY INFORMATION: 

Background 

Ensuring livestock resiliency across 

the United States is crucial to the 

economic success of the American 

livestock industry. Foot-and-mouth 

disease (FMD) is caused by a highly 

infectious virus that affects clovenhoofed animals and causes high 

morbidity. While the animal health 

consequences are serious, the economic 

consequences are grave, since all trade 

of animals and animal products from 

the U.S. will cease. Worldwide, FMD 

eradication and control is difficult as it 

is costly, requires significant animal 

health infrastructure, and infection or 

vaccination with a single strain of a 

serotype often does not confer 

protection against other strains of the 

virus. 

Many countries with periodic FMD 

outbreaks vaccinate with a ‘‘killed’’ 

vaccine produced by inactivating the 

FMD virus (FMDV) and adding an 

immune system stimulant called an 

adjuvant. The killed vaccine has several 

drawbacks, including the requirement 

for high biosecurity production facilities 

to reduce the risk of accidental release 

of live FMDV, and the need for costly, 

sophisticated, and consistent 

purification procedures to remove 

FMDV pieces that may cause animals 

vaccinated with the killed FMD vaccine 

to test FMD positive in 3B based 

diagnostic assays. 

Because killed FMD vaccines vary in 

their ability to consistently differentiate 

infected from vaccinated animals 

(DIVA), under current regulations, 

killed FMD vaccine usage in an 

outbreak could result unnecessarily in 

the humane euthanasia of both 

vaccinated and infected animals. 

The Department of Homeland 

Security, and United States Department 

of Agriculture (USDA) scientists at Plum 

Island Animal Disease Center, working 

with industry partners have developed 

an effective AdFMD vaccine that does 

not required live FMDV for 

manufacturing and is also DIVA 

compatible, giving the U.S. a key 

component of implementing a 

vaccinate-to-live policy. In 2012, DHS 

S&T successfully pursued licensure for 

a single FMD serotype, A24 Cruzeiro, 

however this single vaccine will not 

protect against the multitude of other 

FMD serotypes/subtypes/topotypes that 

exist, thus DHS S&T has interest in 

continued development of additional 

serotype and broader spectrum 

vaccines. Since FMD is not endemic to 

the U.S., the goals of the International 

FMD Vaccine and Diagnostic Field Trial 

are to test the efficacy of these newly 

developed vaccines, and the DIVA 

compatibility of the vaccines using one 

or more companion ELISA diagnostic 

tests under natural exposure conditions. 

Role of the Industry Collaborator 

Any selected industry collaborator 

would play a crucial role in the CRADA 

partnership to implement and execute 

the international FMD vaccine field 

trial. Each proposal must address item 

1, and may address one or more of items 

2–6: 

1. Provide subject matter expertise for 

vaccine and companion ELISA 

diagnostic trial design, data analysis, 

country selection, and import and 

export regulations for biological 

products, be they licensed or 

experimental; 

2. Manufacture, test, and release FMD 

vaccines (experimental AdFMD and/or 

currently licensed, killed vaccines) and 

companion ELISA diagnostic kits to be 

used in field trial; 

3. Acquisition, transport, export, and 

import of the experimental and killed 

conventional vaccines, and companion 

ELISA diagnostic kits into the FMD 

endemic country; 

4. Research and development 

capabilities to construct AdFMD 

vaccine candidates and/or produce premaster seed AdFMD viruses for 

additional FMD serotypes/topotypes/

lineages for which new vaccines may be 

required; 

5. Real-time data analysis for the 

AdFMD field trial as the trial is 

conducted; and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
6034 Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 

6. Final data analysis once the 

international field trial is completed. 

Any selected industry collaborator, 

depending on the terms of the CRADA, 

would likely benefit by acquiring: 

1. Better understanding of FMD 

epidemiology in the FMD endemic 

country, which may allow for increased 

sales and marketing of a company’s 

current inactivated FMD vaccine(s) and 

FMD ELISA diagnostic kit franchise 

and; 

2. Pre-published knowledge of 

AdFMD vaccine performance during the 

field trial, as compared to the current 

inactivated FMD vaccines; 

3. Pre-published knowledge of the 

ELISA diagnostic performance during 

the field trial; 

4. Understanding of how the AdFMD 

vaccine may be used with a companion 

diagnostic test to better plan and 

execute FMD control and eradication 

strategies on the local, regional and 

national levels; and 

5. Unique perspectives to better 

leverage existing public-public 

partnerships that will focus corporate 

stewardship toward more cost effective 

FMD control strategies associated with 

the United Nations Food and 

Agriculture Organization (FAO) related 

to the FMD Progressive Control 

Programme. 

Period of Performance 

The CRADA will be in effect for 5 

years or 60 months from the effective 

date of the agreement. 

Selection Criteria 

DHS S&T reserves the right to not 

issue a CRADA in response to this 

announcement or to issue CRADAs to 

one or more prospective collaborator’s 

proposals submitted in response to this 

announcement. DHS S&T will provide 

no funding for reimbursement of 

proposal development costs. Proposals 

(or any other material) submitted in 

response to this notice will not be 

returned. Proposals submitted are 

expected to be unclassified. If 

Proprietary Information is included in 

proposals, it must be properly marked 

as such. DHS S&T will select any 

CRADA collaborator(s) at its sole 

discretion on the basis of: 

1. How well the proposal 

communicates the collaborators’ 

understanding of and ability to meet the 

CRADA’s goals and proposed timeline. 

2. How well the proposal addresses 

the following criteria as they would be 

relevant to its proposal: 

a. Availability, qualifications and 

willingness of subject matter experts to 

participate in interagency meetings and 

other teleconferences; 

b. Capability of the collaborator to 

provide equipment and materials for 

FMD vaccine and diagnostic 

manufacturing; 

c. Ability of the collaborator to 

produce experimental AdFMD 

vaccine(s) and licensed highly-purified 

inactivated FMD vaccine(s) for use in 

the field trial; 

d. Ability of the collaborator to 

produce and provide companion ELISA 

diagnostic kits for use in the field trial; 

e. Ability of the collaborator to work 

with appropriate regulatory authorities 

to allow for export of experimental and 

licensed FMD vaccines and import of 

these materials into a partner country; 

f. Ability of the collaborator to work 

with appropriate regulatory authorities 

to allow for export of companion ELISA 

diagnostic kits and import of these 

materials into a partner country. 

Participation in this CRADA does not 

imply nor create any obligation on 

DHS’s part for the future purchase of 

any materials, equipment, or services 

from the collaborating entities, and nonFederal CRADA participants will not be 

excluded from any future DHS S&T 

procurements based solely on their 

participation in this CRADA. 

Authority: CRADAs are authorized by the 

Federal Technology Transfer Act of 1986, as 

amended and codified by 15 U.S.C. 3710a. 

DHS, as an executive agency under 5 U.S.C. 

105, is a Federal agency for the purposes of 

15 U.S.C. 3710a and may enter into CRADAs. 

DHS delegated the authority to conduct 

CRADAs to the Science and Technology 

Directorate and its laboratories. 

Dated: January 21, 2016. 

Kristin Wyckoff, 

Director, Office of Public Private Partnerships. 

[FR Doc. 2016–02123 Filed 2–3–16; 8:45 am] 

BILLING CODE 9110–9F–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2016–0007] 

Office of the Chief Information Officer; 

Homeland Security Information 

Network Advisory Committee Meeting 

Notice 

AGENCY: Information Sharing 

Environment (ISEO)/Office of the Chief 

Information Officer (OCIO), DHS. 

ACTION: Committee Management; Notice 

of Federal Advisory Committee Meeting. 

SUMMARY: The Homeland Security 

Information Network Advisory Council 

(HSINAC) calls a virtual meeting of its 

membership to receive all relevant 

information and facilitate development 

of recommendations to the HSIN 

Program Management Office (PMO) 

regarding the following major issue 

areas: (1) Programmatic business 

process enhancements for achieving 

enhanced requirements management 

and governance for HSIN’s users, (2) 

continuous system protection through 

advanced security testing; and (3) 

HSIN’s infrastructure and support 

model enhancements through hosting 

and application services. 

DATES: The HSINAC will meet Tuesday, 

February 16, 2016 from 1:00–2:30 p.m. 

EST via conference call and HSIN 

Connect, an online web-conferencing 

tool, both of which will be made 

available to members of the general 

public. Please note that the meeting may 

end early if the committee has 

completed its business. 

ADDRESSES: The meeting will be held 

virtually via HSIN Connect, an online 

web-conferencing tool at https://

share.dhs.gov/hsinac, and available via 

Teleconference at 1–855–852–7677 

Conference Pin: 9999–6207–5505 for all 

public audience members. To access the 

web conferencing tool, go to https://

share.dhs.gov/hsinac, click on ‘‘enter as 

a guest,’’ type in your name as a guest, 

and click ‘‘submit.’’ The teleconference 

lines will be open for the public and the 

meeting brief will be posted beforehand 

on the Federal Register site (https://

www.federalregister.gov/). If the Federal 

government is closed, the meeting will 

be rescheduled. 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact Allison Buchinski, 

allison.buchinski@associates.dhs.gov, 

202–343–4277, as soon as possible. 

To facilitate public participation, we 

are inviting public comment on the 

issues to be considered by the 

committee. Comments must be 

submitted in writing no later than 

February 10, must be identified by the 

docket number—DHS–2016–0007, and 

may be submitted by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Email: Allison Buchinski, 

allison.buchinski@

associates.hq.dhs.gov. Also include the 

docket number in the subject line of the 

message. 

• Fax: 202–343–4294 

• Mail: Allison Buchinski, 

Department of Homeland Security, OPS 

CIO–D Stop 0426, 245 Murray Lane 

SW., Bldg. 410, Washington, DC 20528– 

0426. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and the docket 


asabaliauskas on DSK5VPTVN1PROD with NOTICES