Cooperative Research and Development Agreement (CRADA) Opportunity With the Department of Homeland Security for the Development of a Foot-and-Mouth Disease 3ABC ELISA Diagnostic Kit, 28866-28867 [2013-11693]
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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
treatment in accordance with these
standards as a basis for CSAT
certification. These standards address
patient admission requirements,
medical and counseling services, drug
testing, and other requirements. The
final rule also established an
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required to obtain and maintain
accreditation from an accreditation
organization approved by SAMHSA
under 42 CFR part 8. Accreditation
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addition, the Guidelines provide useful
elaborations on the regulatory standards
set forth under 42 CFR part 8.
As such, the updated guidelines will
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and OTPs in complying with regulatory
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for the Accreditation of Opioid
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submitted no later than 60 calendar
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Federal Register will be considered.
Summer King,
Statistician.
[FR Doc. 2013–11637 Filed 5–15–13; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4162–20–P
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18:13 May 15, 2013
Jkt 229001
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2013–0036]
Cooperative Research and
Development Agreement (CRADA)
Opportunity With the Department of
Homeland Security for the
Development of a Foot-and-Mouth
Disease 3ABC ELISA Diagnostic Kit
Science and Technology
Directorate, Plum Island Animal Disease
Center, Department of Homeland
Security.
ACTION: Notice of intent.
AGENCY:
The Department of Homeland
Security Science and Technology
Directorate (DHS S&T), through its Plum
Island Animal Disease Center (PIADC),
is seeking industry collaborators to aid
DHS S&T in developing an ELISA
diagnostic test that it capable of
obtaining a U.S. regulatory license to
detect antibodies to at least one of the
Foot and Mouth Disease virus (FMDV)
non-structural proteins (NSP): 3A, 3B,
or 3C. This new FMDV 3ABC ELISA
may be used in the event of a real or
suspected outbreak of Foot-and-Mouth
Disease (FMD) in order to differentiate
infected from vaccinated, non-infected
animals (DIVA).
The role of the industry
collaborator(s) in this CRADA will be to
develop and validate the FMDV 3ABC
ELISA assay in collaboration with DHS
S&T and the United States Department
of Agriculture Animal and Plant Health
Inspection Service Foreign Animal
Disease Diagnostic Laboratory (USDA
APHIS FADDL) at PIADC, and with
other U.S. laboratories that are
associated with USDA, such as the
National Animal Health Laboratory
Network (NAHLN). Components of a
prototype assay, developed by USDA,
Texas Veterinary Medical Diagnostic
Laboratory, and a 3rd party fee-forservice contractor, will be made
available to the industry collaborator(s).
The goal of the CRADA is to submit a
data package to USDA APHIS Center for
Veterinary Biologics (CVB) in order to
obtain a U.S. regulatory license for use
under the direction of USDA
administrators of the FMDV 3ABC
ELISA in the U.S. (See CVB Veterinary
Services Memorandum No. 800.73 for
‘‘General Requirements for
Immunodiagnostic Test Kits for the
Detection of Antibody or Antigen.’’) The
assay must also successfully identify
and test a reference panel of sera
provided by OIE (World Organisation
for Animal Health) as tested in a U.S.
Reference Laboratory, e.g., USDA APHIS
FADDL.
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
DHS S&T is seeking CRADA
collaborators that own or have access to
the technological components for, have
the technological expertise in, and have
proven track records of success in the
fields of diagnostic test kit research,
development, and the obtaining of
USDA licensure for the detection of
antibodies to viral antigen(s). CRADA
collaborators must indicate if they are
currently or may be funded by the
Federal government, and, if yes, they
must include a discussion of how
proposed CRADA work and Federal
government-funded work would not be
duplicative.
The proposed term of the CRADA can
be up to thirty (30) months.
DATES: Submit comments on or before
June 17, 2013.
ADDRESSES: Mail comments and
requests to participate to Dr. Angela
Ervin, (ATTN: Angela Ervin, 245
Murray Lane SW., Washington, DC
20528–0075). Submit electronic
comments and other data to
Angela.Ervin@hq.dhs.gov.
FOR FURTHER INFORMATION CONTACT:
Information on DHS CRADAs:
Marlene Owens, (202) 254–6671.
SUPPLEMENTARY INFORMATION:
Assay Requirements
1. Ideally a competitive ELISA (an
assay in which a molecule in the test
sample competes against a reagent
provided in the kit for binding to the
target) for FMDV NSPs that will
differentiate FMDV infected from FMDV
vaccinated animals (DIVA) (specifically
cattle) and can be made commercially
by the CRADA partner or by another
entity and upon request by USDA
APHIS, be supplied to USDA APHIS
FADDL and accredited state laboratories
within the National Animal Health
Laboratory Network.
2. The ideal assay will have the
following characteristics:
a. Diagnostic sensitivity of at least
96% for all seven major serotypes of
FMDV, including detection of cattle
antibodies to FMDV within 7 to 10 days
post-infection.
b. Diagnostic specificity of at least
96%, ideally >99% with respect to
viruses that cause FMDV look-alike
clinical signs, such as Vesicular
Stomatitis Virus, Swine Vesicular
Disease Virus, Bovine Rhinovirus,
Seneca Valley Virus.
c. Compatibility with serum samples
from U.S. national cattle (beef and
dairy) and domestic swine herds, and
ideally with other species that are
susceptible to FMDV, e.g., sheep, goats,
feral swine, buffalo, deer, antelope, etc.
E:\FR\FM\16MYN1.SGM
16MYN1
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
d. Assay time not exceeding 4 hours
from start of incubation to beginning of
reading the plate.
e. 96 well modular format.
f. Positive control (produced from
non-FMDV infected animals, e.g.,
hyperimmunized with synthetically
made FMDV peptides/proteins) and
¨
negative control (produced from naıve
animals) for each plate.
g. Compatibility with Biosafety Level
2 (BSL–2) laboratory requirements, i.e.,
will not contain any reagents considered
to be select agents or potentially
contaminated with select agents.
3. Transportability under cold chain
(1) to USDA APHIS PIADC, (2) upon
USDA APHIS administrator request
approved laboratories within the
National Animal Health Laboratory
network, and (3) outside of the US
without special restrictions.
tkelley on DSK3SPTVN1PROD with NOTICES
DHS S&T Role (includes but not limited
to)
1. As necessary, coordination of
development and commercialization
access to critical assay components such
as the recombinant 3ABC* protein
(* indicates that the 3C protein has a
mutation in the active site) and a
FMDV-specific monoclonal antibody,
which may be negotiated through
intellectual property licenses with 3rd
parties who control rights to these assay
components. DHS will supply data from
testing a prototype assay, but DHS will
not supply historical background or any
proprietary information.
2. Coordination of testing and
evaluation of samples from U.S. cattle
and swine vaccinated with FMD
molecular vaccines.
3. Coordination of testing and
evaluation of true positive samples from
U.S. cattle and swine that were
experimentally infected. A maximum of
500 samples can be tested.
4. If requested, coordination of testing
and evaluation of true positive and true
negative samples from other FMDV
susceptible U.S. domestic species.
5. If requested, coordination of testing
and evaluation of serum samples from
FMDV susceptible U.S. wildlife species.
6. The actual testing of samples listed
above mainly by scientists in USDA
APHIS FADDL or by partners in
laboratories that USDA APHIS FADDL
and DHS S&T will identify, e.g., the
NAHLN.
Period of Performance
If CRADA collaborator(s) is (are)
selected, a comprehensive data package
to obtain a USDA license for the FMDV
3ABC ELISA for use in cattle should be
submitted to USDA APHIS CVB within
30 months of the CRADA award date.
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18:13 May 15, 2013
Jkt 229001
The submission must adhere to the
requirements in USDA APHIS CVB
Veterinary Services Memo No. 800.73
and other applicable CVB 9CFR
requirements for diagnostic kits and
reagents. The assay must also
successfully identify samples in a
reference panel of sera provided by OIE
(World Organisation for Animal Health)
as tested in a U.S. reference laboratory,
e.g., USDA APHIS FADDL. Because
these reference panels are provided on
a yearly basis to FMD world reference
laboratories, the testing and analysis of
results may extend beyond the 30
month Period of Performance.
Nevertheless, results should be made
available within 2 months of the
availability of reference panels.
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:
1. How well the proposal
communicates the collaborators’
understanding of and ability to meet the
CRADAs goals and proposed timeline.
2. How well the proposal addresses
the following criteria:
a. Capability of the collaborator to
provide equipment and materials for
proposed testing.
b. Capability of the collaborator to
meet the requirements for development,
validation testing and analysis, and
submission of supporting data and
documents fulfilling the CVB
requirements for licensure in the U.S.
c. Preliminary data or results which
support the assay requirements outlined
above.
Participation in this CRADA does not
imply the future purchase of any
materials, equipment, or services from
the collaborating entities, and nonFederal 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.
PO 00000
Frm 00072
Fmt 4703
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28867
Dated: May 9, 2013.
James Johnson,
Director, Office of National Laboratories.
[FR Doc. 2013–11693 Filed 5–15–13; 8:45 am]
BILLING CODE 9110–9F–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2013–0078]
Privacy Act of 1974; Department of
Homeland Security/U.S. Immigration
and Customs Enforcement—014
Homeland Security Investigations
Forensic Laboratory System of
Records
Privacy Office, Department of
Homeland Security.
ACTION: Notice of Privacy Act System of
Records.
AGENCY:
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security proposes to
establish a new Department of
Homeland Security system of records
titled, ‘‘Department of Homeland
Security/U.S. Immigration and Customs
Enforcement—014 Homeland Security
Investigations Forensic Laboratory
System of Records.’’ This system of
records allows the Department of
Homeland Security/U.S. Immigration
and Customs Enforcement to collect and
maintain records by the Homeland
Security Investigations Forensic
Laboratory (HSI–FL). The HSI–FL is a
U.S. crime laboratory specializing in
scientific authentication; forensic
examination; research, analysis, and
training related to travel and identity
documents; latent and patent finger and
palm prints; and audio and video files
in support of law enforcement
investigations and activities by DHS and
other agencies. To facilitate forensic
examinations and for use in forensic
document training, research, and
analysis, the HSI–FL maintains case
files, a case management system, an
electronic library of travel and identity
documents (Imaged Documents and
Exemplars Library), and a hard copy
library referred to as the HSI–FL
Library. Additionally, the Department of
Homeland Security is issuing a Notice
of Proposed Rulemaking elsewhere in
the Federal Register to exempt this
system of records from certain
provisions of the Privacy Act. This
newly established system will be
included in the Department of
Homeland Security’s inventory of
record systems.
SUMMARY:
E:\FR\FM\16MYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28866-28867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11693]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
[Docket No. DHS-2013-0036]
Cooperative Research and Development Agreement (CRADA)
Opportunity With the Department of Homeland Security for the
Development of a Foot-and-Mouth Disease 3ABC ELISA Diagnostic Kit
AGENCY: Science and Technology Directorate, Plum Island Animal Disease
Center, Department of Homeland Security.
ACTION: Notice of intent.
-----------------------------------------------------------------------
SUMMARY: The Department of Homeland Security Science and Technology
Directorate (DHS S&T), through its Plum Island Animal Disease Center
(PIADC), is seeking industry collaborators to aid DHS S&T in developing
an ELISA diagnostic test that it capable of obtaining a U.S. regulatory
license to detect antibodies to at least one of the Foot and Mouth
Disease virus (FMDV) non-structural proteins (NSP): 3A, 3B, or 3C. This
new FMDV 3ABC ELISA may be used in the event of a real or suspected
outbreak of Foot-and-Mouth Disease (FMD) in order to differentiate
infected from vaccinated, non-infected animals (DIVA).
The role of the industry collaborator(s) in this CRADA will be to
develop and validate the FMDV 3ABC ELISA assay in collaboration with
DHS S&T and the United States Department of Agriculture Animal and
Plant Health Inspection Service Foreign Animal Disease Diagnostic
Laboratory (USDA APHIS FADDL) at PIADC, and with other U.S.
laboratories that are associated with USDA, such as the National Animal
Health Laboratory Network (NAHLN). Components of a prototype assay,
developed by USDA, Texas Veterinary Medical Diagnostic Laboratory, and
a 3rd party fee-for-service contractor, will be made available to the
industry collaborator(s). The goal of the CRADA is to submit a data
package to USDA APHIS Center for Veterinary Biologics (CVB) in order to
obtain a U.S. regulatory license for use under the direction of USDA
administrators of the FMDV 3ABC ELISA in the U.S. (See CVB Veterinary
Services Memorandum No. 800.73 for ``General Requirements for
Immunodiagnostic Test Kits for the Detection of Antibody or Antigen.'')
The assay must also successfully identify and test a reference panel of
sera provided by OIE (World Organisation for Animal Health) as tested
in a U.S. Reference Laboratory, e.g., USDA APHIS FADDL.
DHS S&T is seeking CRADA collaborators that own or have access to
the technological components for, have the technological expertise in,
and have proven track records of success in the fields of diagnostic
test kit research, development, and the obtaining of USDA licensure for
the detection of antibodies to viral antigen(s). CRADA collaborators
must indicate if they are currently or may be funded by the Federal
government, and, if yes, they must include a discussion of how proposed
CRADA work and Federal government-funded work would not be duplicative.
The proposed term of the CRADA can be up to thirty (30) months.
DATES: Submit comments on or before June 17, 2013.
ADDRESSES: Mail comments and requests to participate to Dr. Angela
Ervin, (ATTN: Angela Ervin, 245 Murray Lane SW., Washington, DC 20528-
0075). Submit electronic comments and other data to
Angela.Ervin@hq.dhs.gov.
FOR FURTHER INFORMATION CONTACT:
Information on DHS CRADAs: Marlene Owens, (202) 254-6671.
SUPPLEMENTARY INFORMATION:
Assay Requirements
1. Ideally a competitive ELISA (an assay in which a molecule in the
test sample competes against a reagent provided in the kit for binding
to the target) for FMDV NSPs that will differentiate FMDV infected from
FMDV vaccinated animals (DIVA) (specifically cattle) and can be made
commercially by the CRADA partner or by another entity and upon request
by USDA APHIS, be supplied to USDA APHIS FADDL and accredited state
laboratories within the National Animal Health Laboratory Network.
2. The ideal assay will have the following characteristics:
a. Diagnostic sensitivity of at least 96% for all seven major
serotypes of FMDV, including detection of cattle antibodies to FMDV
within 7 to 10 days post-infection.
b. Diagnostic specificity of at least 96%, ideally >99% with
respect to viruses that cause FMDV look-alike clinical signs, such as
Vesicular Stomatitis Virus, Swine Vesicular Disease Virus, Bovine
Rhinovirus, Seneca Valley Virus.
c. Compatibility with serum samples from U.S. national cattle (beef
and dairy) and domestic swine herds, and ideally with other species
that are susceptible to FMDV, e.g., sheep, goats, feral swine, buffalo,
deer, antelope, etc.
[[Page 28867]]
d. Assay time not exceeding 4 hours from start of incubation to
beginning of reading the plate.
e. 96 well modular format.
f. Positive control (produced from non-FMDV infected animals, e.g.,
hyperimmunized with synthetically made FMDV peptides/proteins) and
negative control (produced from na[iuml]ve animals) for each plate.
g. Compatibility with Biosafety Level 2 (BSL-2) laboratory
requirements, i.e., will not contain any reagents considered to be
select agents or potentially contaminated with select agents.
3. Transportability under cold chain (1) to USDA APHIS PIADC, (2)
upon USDA APHIS administrator request approved laboratories within the
National Animal Health Laboratory network, and (3) outside of the US
without special restrictions.
DHS S&T Role (includes but not limited to)
1. As necessary, coordination of development and commercialization
access to critical assay components such as the recombinant 3ABC*
protein (* indicates that the 3C protein has a mutation in the active
site) and a FMDV-specific monoclonal antibody, which may be negotiated
through intellectual property licenses with 3rd parties who control
rights to these assay components. DHS will supply data from testing a
prototype assay, but DHS will not supply historical background or any
proprietary information.
2. Coordination of testing and evaluation of samples from U.S.
cattle and swine vaccinated with FMD molecular vaccines.
3. Coordination of testing and evaluation of true positive samples
from U.S. cattle and swine that were experimentally infected. A maximum
of 500 samples can be tested.
4. If requested, coordination of testing and evaluation of true
positive and true negative samples from other FMDV susceptible U.S.
domestic species.
5. If requested, coordination of testing and evaluation of serum
samples from FMDV susceptible U.S. wildlife species.
6. The actual testing of samples listed above mainly by scientists
in USDA APHIS FADDL or by partners in laboratories that USDA APHIS
FADDL and DHS S&T will identify, e.g., the NAHLN.
Period of Performance
If CRADA collaborator(s) is (are) selected, a comprehensive data
package to obtain a USDA license for the FMDV 3ABC ELISA for use in
cattle should be submitted to USDA APHIS CVB within 30 months of the
CRADA award date. The submission must adhere to the requirements in
USDA APHIS CVB Veterinary Services Memo No. 800.73 and other applicable
CVB 9CFR requirements for diagnostic kits and reagents. The assay must
also successfully identify samples in a reference panel of sera
provided by OIE (World Organisation for Animal Health) as tested in a
U.S. reference laboratory, e.g., USDA APHIS FADDL. Because these
reference panels are provided on a yearly basis to FMD world reference
laboratories, the testing and analysis of results may extend beyond the
30 month Period of Performance. Nevertheless, results should be made
available within 2 months of the availability of reference panels.
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:
1. How well the proposal communicates the collaborators'
understanding of and ability to meet the CRADAs goals and proposed
timeline.
2. How well the proposal addresses the following criteria:
a. Capability of the collaborator to provide equipment and
materials for proposed testing.
b. Capability of the collaborator to meet the requirements for
development, validation testing and analysis, and submission of
supporting data and documents fulfilling the CVB requirements for
licensure in the U.S.
c. Preliminary data or results which support the assay requirements
outlined above.
Participation in this CRADA does not imply 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
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: May 9, 2013.
James Johnson,
Director, Office of National Laboratories.
[FR Doc. 2013-11693 Filed 5-15-13; 8:45 am]
BILLING CODE 9110-9F-P
