SOLICITATION NOTICE
A -- POINT OF CARE OR HIGH-THROUGHPUT BIOLOGICAL ASSAYS FOR DETERMINING ABSORBED IONIZING RADIATION DOSE (BIODOSIMETRY) AFTER RADIOLOGIC AND NUCLEAR EVENTS
- Notice Date
- 1/16/2009
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, 330 Independence Avenue, SW, Rm G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- BAA-BARDA-09-36
- Point of Contact
- Carl A. Newman,, Phone: 202-205-1156, Schuyler T Eldridge,, Phone: 202-260-1554
- E-Mail Address
-
carl.newman@hhs.gov, schuyler.eldridge@hhs.gov
- Small Business Set-Aside
- N/A
- Description
- 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. 100 PROCUREMENT SENSITIVE 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; 101 PROCUREMENT SENSITIVE �� 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 102 PROCUREMENT SENSITIVE 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 (See Government-wide numbered note 26.)
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