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[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48165-48166]
From the Federal Register Online via the Government Printing 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 Douglas.Ports@hq.dhs.gov.

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]
BILLING CODE 9110-9F-P
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