Contracting
Office Address
Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts
Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714, UNITED
STATES
Description
Radiation Biodosimetry (RaBiD)
SOL BAA 07-29
WHITE PAPERS DUE: May 11, 2007, no later than 4:00PM ET;
FULL PROPOSALS DUE: July 9, 2007, no later than 4:00PM ET;
TECHNICAL POC: Dr. Mildred Donlon, DARPA/DSO;
Ph: (703) 696-2289, Email: BAA07-29@darpa.mil;
URL: www.darpa.mil/dso/solicitations/solicit.htm;
Website Submission: http://www.sainc.com/dsobaa
DESCRIPTION
The Defense Sciences Office
(DSO) of the Defense Advanced
Research Projects Agency
(DARPA) is seeking proposals
for new technologies for
rapid, high-throughput,
portable and low-cost biodosimeters
to determine radiation dose
to individuals after acute
radiation exposure. This
technology would provide
rapid identification of
individuals who have been
exposed to high-dose radiation
in order to accurately assess
radiation exposure levels.
The vision of the Radiation Biodosimetry (RaBiD) Program is to create a portable biodosimeter capable of rapid (less than 10 min) assessment of a biological sample with a goal of rapid high-throughput screening of a large population in order to correctly determine the exposure. This revolutionary detection system must be portable, low cost (less than 10 dollars/test), and able to detect and classify radioactive exposure levels within specific quartiles (0 - 100 cGy, 100 - 300 cGy, 300 - 600 cGy, greater than 600 cGy corresponding to less than LD5, LD30 - LD50, LD50 - LD70, and greater than LD70 for humans). In addition, this technology must be relatively non-invasive. The RaBiD Program will consider a wide range of biodosimetry technologies. In summary, the technology must be non- or minimally-invasive, rapid, accurate, inexpensive, and portable in order to realize the vision of the program.
All proposers to this BAA must provide evidence of a competent team capable of developing a new radiation biodosimetry technology meeting all program objectives and milestones. Successful proposals will address the program goals and specifications outlined in this BAA. For more details, a Proposer Information Pamphlet (PIP) is available at www.darpa.mil/dso/solicitations/solicit.htm and also on FedBizOpps and Grants.gov, and includes information on the submission process, format for white papers and full proposals, as well as dates for all deadlines. If there is any conflict, the published BAA 07-29 takes precedence over the PIP.
PROGRAM
OVERVIEW
The Radiation Biodosimetry (RaBiD)
Program is a single phase, 15-month
program with a goal of revolutionizing
radiation exposure detection.
The first 12 months consist
of scientific research and development
during which the proposer will
develop a non- or minimally-invasive
radiological biodosimeter and
demonstrate accurate radiological
detection from biological samples
into quartiles of doses for
humans (0 - 100 cGy, 100 - 300
cGy, 300 - 600 cGy, greater
than 600 cGy) with a detection
time less than 10 minutes. This
will include radiological dose/detection
curves (to validate the linearity,
standard error, and range of
the detector), as well as multipoint
data regarding decay of biological
signal as a function of time
after radiation exposure.
A successful proposal will demonstrate a clear path to these deliverables, including a timeline for technology development, experimentation, and delivery of results. In addition, data describing the onset and rate of decay of the biological signal must be provided. Performers also need to demonstrate clear extrapolation between dose measured by the technology and the absorbed dose. This is important particularly if the biological signal being tested degrades rapidly and could result in an ambiguous calculation of the original dose based on elapsed time. For example, if the signal degrades, performers need to clearly show whether a measured dose of 50 cGy corresponds to a 75 cGy dose received 24 hours earlier or a 100 cGy dose received 36 hours earlier. The technology must be validated in an animal model or in patients undergoing radiation therapy during the 12-month period of research and development.
At the end of the 12-month scientific research and development period, the technologies will undergo a down-select based upon experimental data and the ability of the technology to meet the milestones outlined in BAA 07-29. Selected technologies will have one additional month for transition and training to the Armed Forces Radiobiology Research Institute (AFFRI) of their prototype biodosimeter to be used in a coordinated test at AFRRI. Devices will be tested for their speed, accuracy, ease of use, and cost/sample. A successful proposal must demonstrate a plan to re-locate the biodosimeter to the AFRRI testing facility (Bethesda, MD) including expected cost for full time equivalents (FTEs) for consultation, travel, and materials during the two months of additional testing.
The RaBiD Program goal of a rapid, portable, inexpensive, and accurate biodosimetry detector is an aggressive effort with an aggressive timeline. A successful proposal will thoroughly cover all details for meeting the milestones set forth for the first 12 months. At the end of the 12-month period, the team's performance will be evaluated based on experimental data and the technology's ability to meet the milestones. Performers that are selected to continue will be asked to teach their procedures to AFRRI scientists, either at AFRRI or at the performer's facility, to ensure proper use and maintenance of the technology. This technology is expected to be used in a forward deployment scenario, and therefore, an important consideration during testing will be portability, accuracy, and ease of use.
PROGRAM
PHASES/MILESTONES
The RaBiD Program is aimed at
reducing cost and testing time
while increasing throughput
and portability of radiation
biodosimeters. The milestones
that will be used as the selection
criteria for the down-select
at the end of the 12 months
of scientific research and development
are as follows:
a. Ability to resolve irradiated
animal samples or samples from
patients undergoing radiation
therapy into quartiles: less
than 100 cGy; 100 - 300 cGy;
300 - 600 cGy; greater than
600 cGy (human equivalent dose)
corresponding to less than LD5,
LD5 - LD30, LD30 - LD70, and
greater than LD70 for humans.
b. 100 percent sensitivity with
95 percent confidence accuracy
for determination of original
exposed dose.
c. Once sample has been obtained,
ability to resolve radiation
exposed dosage into one of four
quartiles in 10 minutes or less.
d. Non- or minimally-invasive:
collecting blood through a finger-prick
test, and collecting urine,
breath, hair and toe and finger
nails, as well as scanning teeth,
eyes, bones, etc. are all examples
of minimally invasive protocols.
DELIVERABLES
Performers will provide:
a. A radiation biodosimetry
prototype technology that meets
the program milestones at the
end of the 12-month research
and development period.
b. Quarterly reports describing
progress, initial results, and
analysis.
c. A final report containing
all procedures, results, and
analysis, including:
1. Dose detection curves for
animals irradiated at 0, LD5,
LD30, LD50, LD70, and LD90.
Dose detection curves will be
performed out to 72 hours with
frequency of data sampling performed
at the discretion of the performer
and relevant to the rate of
decay of the signal.
2. Multi-point data curve showing
decay of biological signal as
a function of time after radiation
exposure with multiple data
points in each quartile (0 -
100, 100 - 300, 300 - 600, greater
than 600 cGy, human equivalent
dose).
3. A clear method for extrapolating
measured dose to the original
exposed dose.
TEAM
ORGANIZATION
The aggressive goals of the
RaBiD Program require that each
proposal include a team with
demonstrated (or established)
capability. At a minimum, proposers
are expected to possess expertise
or demonstrate collaboration
with professionals in the following
areas:
a. Radiation Biologist/Radiation
Oncologist--with expertise in
radiation exposure to animal
models.
b. Engineering--with developmental
expertise needed to translate
biological sampling to radiation
readout.
Strong, competent team leadership
is essential for successful
implementation of the elements
of this program. For this reason,
it is critical that the research
team be organized around an
integration partner or Systems
Integrator (SI) who has the
responsibility of overall program
management and who will maintain
a focus on the RaBiD objectives.
DARPA will evaluate proposals based on the composite expertise and experience of the teams, their understanding of the challenges, current data, access to facilities to conduct the proposed work, and most importantly, a clear plan to achieve the specific milestones of the program. It is left to the discretion of the proposer to construct their team from the private, academic, and commercial parties that will be necessary to achieve the milestones.
Proposals may include, or be led by, foreign firms and/or personnel provided all export control laws and U.S. national security requirements are adhered to in the conduct of the effort and that the work relating to the foreign firm or personnel is unclassified. The onus of understanding and complying with export control rests with the proposer, not the Government.
All responsible sources capable of satisfying the Government's needs may submit a proposal that shall be considered by DARPA. Small Disadvantaged Businesses, Historically Black Colleges and Universities (HBCUs), and Minority Institutions (MIs) are encouraged to submit proposals and join others in submitting proposals. However, no portion of BAA 07-29 will be set aside for Small Disadvantaged Businesses, HBCU, and MI participation due to the impracticality of reserving discrete or severable areas of this research for exclusive competition among these entities.
NOVEL
MITIGATION TECHNOLOGIES
In addition to radiation biodosimeter
technologies, DARPA is also
interested in pushing the envelope
of novel radiation mitigation
technologies that can be administered
12 hours or more post irradiation
and provide better than 90 percent
survivability to humans that
would receive in excess of 200
cGy. Performers are required
to demonstrate their results
in an animal model.
DARPA will accept proposals on novel radiation mitigation technologies. While still part of the overall RaBiD program, these proposals must be clearly delineated from those proposals concerning radiation biodosimetry technologies. This will be done by stating "Novel Mitigation Technologies" both at the top of the white paper and under the "Technical Area" of the full proposal as instructed in the "Submission Process" section of the PIP. White papers are encouraged and can be submitted in the area of novel radiation mitigation technologies as outlined in the "White Paper Guidelines" and "Full Proposal Process" sections of this BAA and in the "Submission Process" section of the PIP.
Full proposals should reflect a 12-month period of performance and will not participate in further testing. Therefore, proposed costs should be calculated for a 12-month period of research and development only.
WHITE
PAPER GUIDELINES
It is STRONGLY ENCOURAGED that
a white paper be submitted to
determine the acceptability
of the proposed concept to BAA
07-29. WHITE PAPERS ARE DUE
NO LATER THAN 4:00PM ET, May
11, 2007. The Government anticipates
that all white papers will be
reviewed no later than May 25,
2007, and recommendations for
full proposals will be provided
at that time. See the PIP for
further details on white paper
content and the submission process.
FULL
PROPOSAL PROCESS
Proposals may be submitted and
received at any time until the
final proposal deadline of 4:00PM
ET, July 9, 2007. See the PIP
for further details on full
proposal content and the submission
process.
COST
PROPOSAL
Proposals to this process for
radiation biodosimetry technologies
should include a cost estimate
that is divided into two sections:
1) The 12 months of scientific
testing, including all personnel,
materials, facilities, and any
other aspects of the proposed
research project should be outlined,
and 2) A one-month period of
transition and training to AFRRI
in case of selection with two
months of additional testing
at AFRRI.
To reiterate, cost proposals for the 12-month period of research and development will be calculated and submitted and costs for a one month period of transition and training to AFFRI and two months of additional testing as outlined in the PIP under the section: "Format and Content of Full Proposal, Volume 2," should be submitted.
Proposals to this process for novel mitigation technologies should include a cost estimate for 12 months of scientific testing including all personnel, materials, facilities, and any other aspects of the proposed research project. There will not be a one-month period of transition or testing associated with novel mitigation technologies.
RESEARCH
INVOLVING HUMAN USE
Proposals selected for funding
are required to comply with
provisions of the Common Rule
(32 CFR 219) on the protection
of human subjects in research
(http://www.dtic.mil/biosys/downloads/32cfr219.pdf)
and the DoD Directive 3216.2
(http://www.dtic.mil/whs/directives/corres/html2/d32162x.htm).
All proposals that involve the
use of human subjects are required
to include documentation of
their ability to follow Federal
guidelines for the protection
of human subjects. This includes,
but is not limited to, protocol
approval mechanisms, approved
Institutional Review Boards
(IRB), and Federal Wide Assurances.
These requirements are based
on expected human use issues
sometime during the entire length
of the proposed effort. For
proposals involving "greater
than minimal risk" to human
subjects within the first year
of the project, performers must
provide evidence of protocol
submission to a Federally approved
IRB at the time of final proposal
submission to DARPA. For proposals
that are forecasted to involve "greater
than minimal risk" after
the first year, a discussion
on how and when the proposer
will comply with submission
to a Federally approved IRB
needs to be provided in the
submission. More information
on applicable Federal regulations
can be found at the Department
of Health and Human Services
Office of Human Research Protections
website: (http://www.dhhs.gov/ohrp/).
PROPOSAL
EVALUATION
Proposals will not be evaluated
against each other, since they
are not submitted in accordance
with a common work statement.
For evaluation purposes, a proposal
is the document described in
Proposal Format. Other supporting
or background materials submitted
with the proposal will be considered
for the reviewer's convenience
only and not considered as part
of the proposal. DARPA reserves
the right to request an oral
presentation of proposals. If
such a request is made, it is
expected that, to the extent
possible, all key personnel
on the team will be present.
The request for an oral presentation,
or lack thereof, should not
be construed as either a positive
or negative assessment of the
proposal.
The descriptions contained in this section are to help proposers ensure that proposals have sufficiently detailed information to be evaluated. Proposals not conforming to the instructions of this section may not, at the discretion of the Government, be evaluated. Evaluation of proposals will be accomplished through a technical review of each proposal using the following criteria, in descending order of importance:
1.
SCIENTIFIC AND TECHNICAL MERIT
Proposers must demonstrate that
their proposal is scientifically
sound with feasibility for meeting
the milestones. Proposers are
encouraged to avoid obscure
language and indeterminate measures
of success as these will not
help the application.
2.
VALUE TO DEFENSE
DARPA's vision is to develop
technologies that will enable
the Department of Defense to
mount a rapid medical response
to radiation events based on
timely and accurate dose information
of potentially affected personnel.
Such a rapid, high-throughput,
portable, and low-cost capability
is in sharp contrast to current
radiation dosimetry and biodosimetry
technology that is time consuming
(2-5 days), low-throughput (less
than 100 samples/day), expensive
(greater than 500 dollars/test),
and non-portable (generally
requiring a laboratory).
3.
CAPABILITY OF THE PERSONNEL
AND FACILITIES TO PERFORM
THE PROPOSED EFFORT
Proposers must demonstrate that
their team has the necessary
background and experience to
perform this project, including
a radiation biologist or radiation
oncologist.
4.
COST REALISM AND REASONABLENESS
Costs of the proposal must be
reasonable and provide a high
value to the Government. Reasonable
accounting of consumable reagents,
facility costs, detailed budgets
from subcontractors and personnel
should be provided.
The Government reserves the right to select all, some, or none of the proposals received in response to this solicitation and to make awards without discussions with proposers; however, the Government reserves the right to conduct discussions if the Source Selection Authority later determines them to be necessary. Proposals identified for funding may result in a contract, grant, cooperative agreement, or other transaction depending upon the nature of the work proposed, the required degree of interaction between parties, and other factors. If warranted, portions of resulting awards may be segregated into pre-priced options.
GENERAL
INFORMATION
Proposals that fail to conform
to the format described in the
PIP may not be reviewed. Proposals
MUST NOT be submitted by fax;
any so sent will be disregarded.
This notice, in conjunction
with the BAA07-29 Federal Business
Opportunity Announcement and
the grants.gov posting, along
with all references, constitutes
the entire announcement. If
there is any conflict, the published
BAA 07-29 takes precedence.
No additional information is
available, nor will a formal
Request for Proposal (RFP) or
other solicitation regarding
this announcement be issued.
Requests for same will be disregarded.
Only unclassified proposals
will be accepted in response
to this BAA.
A
website http://www.sainc.com/dsobaa/
has been set up to facilitate
the submission of white papers
and full proposals electronically.
This site will allow submission
of contact information and
uploading of a white paper
or full proposal in either
Word or PDF format. Proposers
will be able to select to
submit to BAA 07-29, and must
provide all contact information,
as well as an abstract, in
order to properly submit.
Submissions may also be made
by attachment to an e-mail
sent to BAA07-29@darpa.mil.
If submitting electronically
via e-mail, the body of the
e-mail AND the attachment
must include the Proposer's
name, mailing address, phone
number, fax number, as well
as the cost of the proposed
work and duration (in months)
of proposed work. If this
information is not contained
in the body, the e-mail will
be returned for inclusion
of that information. If proposers
choose to submit by U.S. Mail,
they should submit one (1)
original and three (3) copies
of the full proposal to the
address listed under the Full
Proposal Submission and Deadlines
section in the PIP. White
papers and full proposals
will not be accepted by way
of facsimile transmissions.
In all correspondence, reference
BAA 07-29.
POINT
OF CONTACT
Dr. Mildred Donlon, DARPA Program
Manager, DSO; Phone: (703) 696-2289,
Fax: (703) 741-3896, Email:
Mildred.Donlon@darpa.mil.
Point
of Contact
Mildred Donlon, DARPA Program
Manager, Phone 703-248-1527,
Fax 703-696-3999, Email none
- Anthony Cicala, Contracting
Officer, Phone (571)218-4639,
Fax (703)248-1927, Email anthony.cicala@darpa.mil
