81 FR 6033 - Cooperative Research and Development Agreement Opportunity With the Department of Homeland Security for the International Foot-and-Mouth Disease Vaccine and Diagnostics Field Trial

DEPARTMENT OF HOMELAND SECURITY

Federal Register Volume 81, Issue 23 (February 4, 2016)

Page Range		6033-6034
FR Document		2016-02123

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-and-mouth 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 replication-deficient 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.

Federal Register, Volume 81 Issue 23 (Thursday, February 4, 2016)

[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6033-6034]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02123]


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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-and-
Mouth 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.

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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-and-mouth 
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 
replication-deficient 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 
[email protected].

FOR FURTHER INFORMATION CONTACT: Information on DHS CRADAs: Scott Pugh, 
[email protected], (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 
cloven-hoofed 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 pre-master 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

[[Page 6034]]

    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 non-Federal 
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

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

and Households; 97.050, Presidentially Development Agreement (CRADA). It is (DIVA), under current regulations,
Declared Disaster Assistance to Individuals envisioned that the primary role of the killed FMD vaccine usage in an
and Households—Other Needs; 97.036, selected industry collaborator(s) will be outbreak could result unnecessarily in
Disaster Grants—Public Assistance to provide subject matter experts to the humane euthanasia of both
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
inform the vaccine and diagnostic field vaccinated and infected animals.
trial design(s), country selection and The Department of Homeland
W. Craig Fugate, regulatory processes, in addition to Security, and United States Department
Administrator, Federal Emergency
potentially developing, manufacturing of Agriculture (USDA) scientists at Plum
Management Agency. and distributing or providing, the Island Animal Disease Center, working
[FR Doc. 2016–02021 Filed 2–3–16; 8:45 am]
AdFMD experimental vaccines and with industry partners have developed
companion ELISA diagnostic kits for the an effective AdFMD vaccine that does
BILLING CODE 9111–23–P
field trial. not required live FMDV for
DATES: Submit comments on or before manufacturing and is also DIVA
DEPARTMENT OF HOMELAND March 7, 2016. compatible, giving the U.S. a key
SECURITY ADDRESSES: Mail comments and component of implementing a
requests to participate to Dr. Roxann vaccinate-to-live policy. In 2012, DHS
[Docket No. DHS–2016–0010] Motroni, (ATTN: Roxann Motroni, 245 S&T successfully pursued licensure for
Murray Lane SW., Washington, DC a single FMD serotype, A24 Cruzeiro,
Cooperative Research and however this single vaccine will not
Development Agreement Opportunity 20528–0075). Submit electronic
comments and other data with the protect against the multitude of other
With the Department of Homeland FMD serotypes/subtypes/topotypes that
Security for the International Foot-and- subject line ‘‘International FMD Field
Trial Notice of Intent’’ to exist, thus DHS S&T has interest in
Mouth Disease Vaccine and continued development of additional
Diagnostics Field Trial Roxann.Motroni@hq.dhs.gov.
FOR FURTHER INFORMATION CONTACT: serotype and broader spectrum
AGENCY: Chemical and Biological Information on DHS CRADAs: Scott vaccines. Since FMD is not endemic to
Defense Division (CBD), Homeland Pugh, scott.pugh@hq.dhs.gov, (202) the U.S., the goals of the International
Security Advanced Research Projects 254–2288. FMD Vaccine and Diagnostic Field Trial
Agency, Science and Technology are to test the efficacy of these newly
SUPPLEMENTARY INFORMATION:
Directorate, Department of Homeland developed vaccines, and the DIVA
Security. Background compatibility of the vaccines using one
ACTION: Notice of intent. Ensuring livestock resiliency across or more companion ELISA diagnostic
the United States is crucial to the tests under natural exposure conditions.
SUMMARY: The Department of Homeland economic success of the American Role of the Industry Collaborator
Security (DHS), Science and Technology livestock industry. Foot-and-mouth
Directorate (S&T), through its Homeland disease (FMD) is caused by a highly Any selected industry collaborator
Security Advanced Research Projects infectious virus that affects cloven- would play a crucial role in the CRADA
Agency (HSARPA), Chemical Biological hoofed animals and causes high partnership to implement and execute
Defense Division (CBD) is implementing morbidity. While the animal health the international FMD vaccine field
and executing an international foot-and- consequences are serious, the economic trial. Each proposal must address item
mouth disease (FMD) vaccine and consequences are grave, since all trade 1, and may address one or more of items
diagnostics field trial. The objective of of animals and animal products from 2–6:
the project is to evaluate a newly the U.S. will cease. Worldwide, FMD 1. Provide subject matter expertise for
developed FMD vaccine(s) and eradication and control is difficult as it vaccine and companion ELISA
companion diagnostic(s) in an FMDV is costly, requires significant animal diagnostic trial design, data analysis,
endemic country. The specific goals of health infrastructure, and infection or country selection, and import and
this project are to establish the efficacy vaccination with a single strain of a export regulations for biological
of the newly developed replication- serotype often does not confer products, be they licensed or
deficient adenovirus-vectored FMD protection against other strains of the experimental;
(AdFMD) vaccine; the effectiveness, virus. 2. Manufacture, test, and release FMD
sensitivity, specificity, and ruggedness Many countries with periodic FMD vaccines (experimental AdFMD and/or
of a new companion diagnostic test (‘‘3B outbreaks vaccinate with a ‘‘killed’’ currently licensed, killed vaccines) and
ELISA’’) under field conditions, and to vaccine produced by inactivating the companion ELISA diagnostic kits to be
provide data on the usage of a DIVA FMD virus (FMDV) and adding an used in field trial;
vaccine and companion diagnostic in an immune system stimulant called an 3. Acquisition, transport, export, and
endemic disease situation which may be adjuvant. The killed vaccine has several import of the experimental and killed
used to inform the U.S. response to an drawbacks, including the requirement conventional vaccines, and companion
FMD outbreak. DHS anticipates that this for high biosecurity production facilities ELISA diagnostic kits into the FMD
project may lead to the development to reduce the risk of accidental release endemic country;
and fostering of partnerships and of live FMDV, and the need for costly, 4. Research and development
collaborations with industry, countries sophisticated, and consistent capabilities to construct AdFMD
asabaliauskas on DSK5VPTVN1PROD with NOTICES

and national and international purification procedures to remove vaccine candidates and/or produce pre-
organizations that will result in a solid FMDV pieces that may cause animals master seed AdFMD viruses for
foundation that will facilitate the future vaccinated with the killed FMD vaccine additional FMD serotypes/topotypes/
development and testing of additional to test FMD positive in 3B based lineages for which new vaccines may be
transboundary animal disease (TAD) diagnostic assays. required;
vaccines and diagnostics. Because killed FMD vaccines vary in 5. Real-time data analysis for the
CBD is seeking industry partners to their ability to consistently differentiate AdFMD field trial as the trial is
enter into a Cooperative Research and infected from vaccinated animals conducted; and

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Document Created: 2016-02-04 00:31:38
Document Modified: 2016-02-04 00:31:38

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of intent.
Dates		Submit comments on or before March 7, 2016.
Contact		Information on DHS CRADAs: Scott Pugh, sco[email protected], (202) 254-2288.
FR Citation		81 FR 6033