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POINT OF CARE OR HIGH-THROUGHPUT BIOLOGICAL ASSAYS FOR DETERMINING ABSORBED IONIZING RADIATION DOSE (BIODOSIMETRY) AFTER RADIOLOGIC AND NUCLEAR EVENTS

Solicitation Number: BAA-BARDA-09-36
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
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BAA-BARDA-09-36
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Award
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Added: Jan 16, 2009 3:26 pm Modified: Jan 21, 2009 4:37 pmTrack Changes
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of
the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of
Health and Human Services (HHS), provides an integrated, systematic approach to the
development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for
public health medical emergencies.
BARDA’s mission includes managing the advanced research and development of medical
countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN). As
part of its CBRN development and preparedness mission, BARDA announces a program to
encourage research and development aimed at physical and biological dosimetry technologies
useful in initial triage or definitive medical management after radiological and nuclear events. A
large-scale radiological incident would result in an immediate critical need to assess the
radiation doses potentially received by thousands of individuals. This will require a system
architecture or a system of platforms that contains diverse, integrated diagnostic and dosimetric
tools that are accurate and precise. For large-scale events, rapidity and ease of screening are
essential in enabling appropriate triage and treatment decisions.
The purpose of this Broad Agency Announcement (BAA) entitled, “POINT OF CARE OR HIGHTHROUGHPUT
BIOLOGICAL ASSAYS FOR DETERMINING ABSORBED IONIZING
RADIATION DOSE (BIODOSIMETRY) AFTER RADIOLOGIC AND NUCLEAR EVENTS” is to
fund advanced development of innovative physical and biological dosimetry tools and devices,
biomarkers, and bioassays including the development of new indications for already licensed or
cleared products. These tools and devices, biomarkers, bioassays will be used following a
nuclear detonation, use of a radiologic dispersive device (RDD, “dirty bomb”), or other
radiological incident for the assessment of an individual’s absorbed dose of ionizing radiation.
In a mass casualty setting, medical resources will likely be overextended, and comprehensive
clinical and laboratory evaluations to ascertain the subject’s absorbed dose will be critical to
assess medical management needs and appropriate medical countermeasure dosing. In such
circumstances, rapid radiation dosimetry tools will be critically important, particularly in cases
where the demand for approved medical radiation countermeasures and medical attention
exceeds their supply. Rational allocation of such scarce resources will be virtually impossible in
the absence of rapid, reliable diagnostics.

It is the intention of this BAA to award contracts to provide funding for Offerors to advance lead
candidate products in the development pipeline. Each lead candidate product must be
developed to serve as a tool or device, biomarker, or bioassay useful for accurate determination
of a subject’s absorbed dose of ionizing radiation. Advanced development funding from BARDA
shall assist selected candidate products through the Pre-Market Approval (PMA) process with
the Food and Drug Administration’s (FDA) Center for Devices and Radiologic Health (CDRH)
and any commensurate studies using the Animal Rule as directed with the Agency’s Centers for
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research
(CBER).
Offerors are invited to submit proposals that request funding to advance the development of a
promising diagnostic product that addresses this specific research and development area.
Offerors shall propose a well-defined product development path that must include completion
and validation, and potentially approval/clearance, of a prototype instrument or bioassay prior to
or within the five (5) years of the contract period. Performance of studies using vertebrate
animals will be done under the Animal Rule, i.e. 21 CFR §601) and potential clinical studies
must be consistent with all applicable Federal regulations and BARDA/NIH policies and
guidelines for the conduct and oversight of research in vertebrate animals and human subjects.
This announcement will also support product development activities that are enabling for FDA
approval or license of tools, devices, and bioassays, including:
1) Prototype development and manufacturing scale-up of the tool, device, or bioassay.
2) Animal studies required to support the PMA under the U.S. Food and Drug
Administration (FDA) “Animal Rule” (21 CFR §601; New Drug and Biological Drug
Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human
Efficacy Studies Are Not Ethical or Feasible: http://www.fda.gov/cber/rules/humeffic.pdf .
Offerors may submit one proposal per designated product entity that addresses the intent of the
BAA and focuses on the development of a single product. However, Offerors may submit more
than one proposal.
Once a novel radiation-responsive biomarker is qualified, the development of a diagnostic test
and the validation of a biomarker(s) assay will usually fall under OIVD (Office of In Vitro
Diagnostic Device Evaluation and Safety) (http://www.fda.gov/cdrh/oivd) / for clearance or
approval of diagnostic tests that measure biomarkers in a clinical setting. The web site “Device
Advice” is available from the FDA at http://www.fda.gov/cdrh/devadvice, for useful information
about the regulation and review of medical devices, including in vitro diagnostic devices.
It is anticipated that studies in this contract will involve novel radiation-responsive biomarkers
and bioassays which will involve animal studies under the FDA’s “Animal Rule” (21 CFR §601)
for the generation of radiation-responsive biomarkers to known doses of ionizing radiation.
These studies are expected to be supported using Institutional Animal Care and Use
Committees (IACUC) as endorsed by the US Food and Drug Administration
(http://www.iacuc.org/index.htm), the Office of Laboratory Animal Welfare (OLAW)
(http://grants.nih.gov/grants/olaw/olaw.htm), and overseen by the US Department of Agriculture
(USDA) (http://www.aphis.usda.gov/animal_welfare/index.shtml ).
The following types of proposals are not responsive to this initiative:
The development of tools, devices and bioassays intended solely for occupational
radiation exposures (<100 mSv),
The development of devices or bioassays with high levels of inter-individual variability;
The development of devices or bioassays using biomarkers with highly unstable signal
(i.e. appear and diminish in < 24 hours post-exposure to ionizing radiation),
The development of devices or bioassays that cannot be utilized in order to estimate
whole-body absorbed dose, and
Proposals involving the development of animal models for bioassay discovery unless the
models are directly relevant to the dosimetric product development.
Although the above mentioned research and development areas are not responsive to this
announcement, they may be relevant to other BARDA or NIAID Biodefense research and
development programs. A listing of such programs can be found on the BARDA web site
http://www.hhs.gov/aspr/barda or the NIAID Biodefense funding website:
http://www3.niaid.nih.gov/
The class to which your device is assigned determines, among other things, the type of
premarketing submission/application required for FDA clearance to market
(http://www.fda.gov/CDRH/DEVADVICE/3122.html). Device product classifications can be
found by searching the Product Classification Database,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. The database
search provides the name of the device, classification, and a link to the Code of Federal
Regulations (CFR), if any. The CFR provides the device type name, identification of the device,
and classification information.
For each of the devices classified by the FDA, the CFR gives a general description including
the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information
about marketing requirements. Each device should meet the definition in a classification
regulation contained in 21 CFR 862-892(see FDA web site:
http://www.fda.gov/cdrh/devadvice/313.html). If a Premarket Approval (PMA) is not required, the
Offeror’s must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of
the Federal Food, Drug, and Cosmetic Act (the Act) and the device does not exceed the
limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR
862.9, 21 CFR 864.9). Before marketing a device, each submitter must receive an order, in the
form of a letter, from FDA which finds the device to be Substantially Equivalent, and states that
the device can be marketed in the U.S. This order "clears" the device for commercial
distribution.
In Vitro Diagnostic (IVD)
IVDs are medical devices that analyze human body fluids, such as blood or urine, to provide
information for the diagnosis, prevention, or treatment of a disease. The device classification for
these devices can be found under 21 CFR 862, 21 CFR 864, and 21 CFR 866.
Clinical Laboratory Improvement Act (CLIA) of 1988
In addition to FDA regulation under the Food, Drug, and Cosmetic Act, IVD devices are also
subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This law
established quality standards for laboratory testing and an accreditation program for clinical
laboratories.
The requirements that apply vary according to the technical complexity in the testing process
and risk of harm in reporting erroneous results. The regulations established three categories of

testing on the basis of the complexity of the testing methodology: a) waived tests, b) tests of
moderate complexity, and c) tests of high complexity. Laboratories performing moderate- or
high-complexity testing or both must meet requirements for proficiency testing, patient test
management, quality control, quality assurance, and personnel. These specific requirements do
not apply to tests in the waived category.
Product Complexity Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
Labeling
Specific labeling requirements for IVDs can be found under 21 CFR 809. Additional guidance
can be found under "Device Advice - Labeling Requirements for In Vitro Diagnostic Devices."
(http://www.fda.gov/CDRH/DEVADVICE/332.html).
Other Useful Links:
FDA General information for Centers for Devices and Radiologic Health
http://www.fda.gov/cdrh/consumer/geninfo.html
FDA Center for Devices and Radiological Health (CDRH) “Device Advice”
http://www.fda.gov/cdrh/devadvice/
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
http://www.fda.gov/cdrh/oivd
FDA's CLIA homepage
http://www.fda.gov/cdrh/clia/index.html
CLIA Waivers: List of Tests Waived by FDA
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm
Product Complexity Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded for
a period of up to five 5 years beginning on or about September 16, 2009. BAA-BARDA 09-36
will be available electronically on or about January 30, 2009 and may be accessed through the
Federal Business Opportunities web site.
Responses to this BAA will be due on or about April 6, 2009. Any responsible Offeror may
submit a proposal for consideration by the Government. This advertisement does not commit
the Government to award a contract. No collect calls will be accepted. No facsimile
transmissions will be accepted.
Please consult the list of document viewers if you cannot open a file.

Solicitation 1

Type:
Solicitation
Posted Date:
February 27, 2009
BAA-Final-2-27.pdf (413.72 Kb)
Description: Point of Care Or High-Throughput Biological Assays For Determining Absorbed Ionizing Radiation Dose (Biodosimetry) After Radiologic and Nuclear Events

Amendment 1

Type:
Mod/Amendment
Posted Date:
March 5, 2009
AMENDMENT 1.doc (45.50 Kb)
Description: Amendment #1: Preproposal conference is scheduled for March 26, 2009.

Amendment 2

Type:
Mod/Amendment
Posted Date:
March 26, 2009
Description: Amendment 2-Questions and Answers and revisions of the evaluation criteria and Proposal Intent Response Sheet.

Amendment 3

Type:
Mod/Amendment
Posted Date:
April 10, 2009
Amendment 3.doc (81.00 Kb)
Description: This amendment answers a number of inquiries received subsequent to the March 26, 2009 pre-proposal conference.

Modification 1

Type:
Mod/Amendment
Posted Date:
December 30, 2009
Description: Award notice update for Duke University to amend the contract award dollar amount posted on 12/23/09 at 10:44am (EST).

Modification 2

Type:
Mod/Amendment
Posted Date:
December 30, 2009
Description: Award notice update for The Board of Trustees of the Leland Stanford Junior University to amend the contract award dollar amount posted on 12/22/09 at 4:37 pm (EST).
:
Biomedical Advanced Research and Development Authority
330 Independence Avenue, SW, Rm G640
Washington, District of Columbia 20201
United States
:
Carl A. Newman,
Contracting Officer
Phone: 202-205-1156
Fax: 202-205-4520
:
Schuyler T Eldridge,
Contracting Officer
Phone: 202-260-1554
Fax: 202-205-4520