[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48165-48166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19723]
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DEPARTMENT OF HOMELAND SECURITY
[Docket No. DHS-2012-0044]
Cooperative Research and Development Agreement (CRADA)
Opportunity With the Department of Homeland Security for the Efficacy
Testing of Vaporous Hydrogen Peroxide (VHP) and Chlorine Dioxide
(ClO2) Against Foot and Mouth Disease Virus (FMDV) and
African Swine Fever Virus (ASFV)
AGENCY: Science and Technology Directorate, Plum Island Animal Disease
Center, Department of Homeland Security.
ACTION: Notice of intent.
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SUMMARY: The Department of Homeland Security Science and Technology
Directorate (DHS S&T), through its Plum Island Animal Disease Center
(PIADC), is seeking collaborators to aid DHS S&T in conducting
validation testing on the ability of VHP and ClO2 to achieve
sufficient biological load reduction against live FMDV and ASFV. PIADC
operates a Biosafety Level 3 (BSL-3) facility working primarily with
high consequence foreign animal diseases. The nature of this work makes
it
[[Page 48166]]
paramount to ensure the effective and thorough decontamination of all
material exiting the bio containment area within the facility. Rising
health concerns and process efficiency/turn-around time with the use of
formaldehyde gas (the current fumigation method used against FMDV and
ASFV) are key driving factors in validating an alternative fumigation
method. The fumigation method(s) will ultimately be used to
decontaminate sensitive equipment and electronics, other material
within the bio containment area, sealed portions of the facility,
biological safety cabinets and perform in-place decontamination of
heating, ventilation, and cooling (HVAC) HEPA filtration systems. The
role of the collaborator(s) in this CRADA will be to provide PIADC with
the materials, equipment, and technological expertise to support
accurate and reliable efficacy testing using VHP and ClO2.
DHS S&T is seeking CRADA collaborators that own the technological
components for, have the technological expertise in, and have proven
track records of success in the fields of VHP and ClO2
decontamination validation studies. The proposed term of the CRADA can
be up to eighteen (18) months.
DATES: Submit comments on or before September 14, 2012.
ADDRESSES: Mail comments and requests to participate to Doug Ports, (PO
Box 848, Greenport, NY 11944). Submit electronic comments and other
data to [email protected].
FOR FURTHER INFORMATION CONTACT: Information on DHS CRADAs: Marlene
Owens, (202) 254-6671. Information on proposed technical effort: Doug
Ports, (631) 323-3210.
SUPPLEMENTARY INFORMATION:
Efficacy Testing Plan
The target agents (FMDV and ASFV) and test microorganisms (Bacillus
subtilis, Vaccinia Virus, Geobacillius stearothermophilus, and
potentially other commercially available spore strips) will be used to
test the efficacy of VHP and ClO2 on various surfaces
including balsa wood, stainless steel, glass, and paper. Phase I of the
testing is set to take place at a federal laboratory facility against
the test microorganisms, requiring successful results prior to moving
on to Phase II. Phase II testing will take place at PIADC (Plum Island,
NY) against both the test microorganisms and target agents. Phase I and
Phase II efficacy testing will not require the VHP or ClO2
generators to enter the bio containment area; however, components or
probes that do enter the bio containment area will need to be
decontaminated using a validated method prior to removal. Testing and
decontamination validation will take place using pre-approved methods
agreed upon between federal and non-federal personnel. Mutual benefits
to both federal and non-federal collaborators include the opportunity
to support the Homeland Security Enterprise in protecting the United
States from internal and external foreign animal disease threats and
response capabilities. Specifically, DHS S&T is interested in validated
alternatives to formaldehyde fumigation with respect to outbreak
control, infection control, and decontamination for FMDV and AFSV
releases. The collaborators will also have the opportunity to test
their decontamination methods directly against live FMDV and ASFV at
the only laboratory in the United States, and one of few in the world,
that works with live FMDV. Efficacy testing data and results may be
published in scientific journals by or under the guidance of federal
personnel.
Period of Performance
Once CRADA collaborators have been selected, finalized Phase I
testing is expected to take approximately 3 months. Contingent on Phase
I testing results, Phase II testing is expected to take an additional 6
months and data consolidation, analysis, and results finalization is
expected to take another 3 months following.
Selection Criteria
The Plum Island Animal Disease Center (PIADC) reserves the right to
select CRADA collaborators for all, some, or none of the proposals in
response to this notice. PIADC 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.
PIADC will select proposals at its sole discretion on the basis of:
i. How well the proposal communicates the collaborators'
understanding of and ability to meet the CRADAs goals and proposed
timeline
ii. How well the proposal addresses the following criteria:
a. Capability of the collaborator to provide equipment and
materials for proposed Phase I and Phase II efficacy testing.
b. Capability of the collaborator to provide on-site and remote
technological expertise, within a reasonable time period and for a
reasonable duration, for Phase I and Phase II efficacy testing.
Participation in this CRADA does not imply the future purchase of any
materials, equipment or services from the collaborating entities;
however, non-Federal CRADA participants will not be excluded from any
future PIADC 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 a CRADA. DHS
delegated the authority to conduct CRADAs to the Science and
Technology Directorate and its laboratories.
Dated: August 7, 2012
James Johnson,
Director, Office of National Laboratories.
[FR Doc. 2012-19723 Filed 8-10-12; 8:45 am]
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