BARDA Chem and RadNuc Animal Model Development
Added: Dec 05, 2014 11:42 am
The development of animal models is a key element in the successful development of medical countermeasures (MCMs) for chemical, radiological, and nuclear (CRN) threats, particularly since efficacy of products directed against most of these threats cannot be verified using clinical studies. In 2002, the FDA amended its regulations for drugs and biologics to permit approval or licensure of MCMs based on substantial evidence of effectiveness in animals when adequate and well-controlled efficacy studies in humans cannot be conducted because it would be unethical to expose healthy human volunteers to lethal or disabling toxic CBRN substances. This change in the regulations (21 CFR 314.600 for drugs and 21 CFR 601.90 for biologics), commonly referred to as the "Animal Rule," made the design and conduct of adequate efficacy studies in appropriate animal models of paramount regulatory importance, since the inference of efficacy in humans necessary for drug approval or licensure is based solely on efficacy data derived in animals. Demonstration of the safety of the medical countermeasure (drug or biologic) is done in normal, healthy adult humans and in some cases safety in a related pathology particularly if the drug or biologic is already approved for the related pathology.The United States Government (USG) seeks appropriate Good Laboratory Practice (GLP) laboratories that are adequate and available to establish new or existing animal tests and/or models for the development of CRN MCMs. In these models, the challenge dose generally should be the same as that which produces the human disease or condition and the pathophysiological mechanism of its toxicity should be reasonably well-understood and mimic the human disease/condition as closely as possible. When these models are used to test the efficacy of potential MCMs for CRN agents, the mechanism of action of the countermeasure will need to establish the utility of the animal model as a surrogate for humans. BARDA anticipates that contracts awarded from this RFP will serve to facilitate the animal model development of medical countermeasures and/or supportive reagents and assays for regulatory acceptance in the U.S.HHS, through ASPR and BARDA, anticipates multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts. The anticipated period of performance for any resultant contracts will be for a total of up to 60 months. Additional details and requirements will be described in the solicitation. Offeror's will be required to respond to Sample Request for Task Order Response (RTOR) documents as part of their proposal.Mandatory Criteria for EligibilityOfferors must meet the following mandatory criterion for eligibility for an award: 1. Federal, State, and/or local licenses as required for the operation and control of a clinical level irradiation facility with qualified personnel for the operation, assigned safety restrictions, domestic and instrument calibration per licensed Health Physics authority. (Applies to RadNuc Only)2. Federal, State, and/or local licenses as required for the storage, use, and disposal of select agents such as chemical agents and radionuclides and training of all associated staff responsible for the use of such material. (Applies to both Chem and RadNuc)3. Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation or equivalent. (Applies to both Chem and RadNuc)4. U.S. Department of Agriculture (USDA) - licensed animal research facility, or equivalent. (Applies to both Chem and RadNuc)5. GLP Capabilities - List of all GLP studies conducted in the past three years. (Applies to both Chem and RadNuc)6. BARDA does not intend to award any contracts to offerors that do not have laboratory space within their facilities to conduct small and/or large animal model studies. Subcontracting is an available option, but only to expand capabilities. (Applies to both Chem and RadNuc)Pre-solicitation Notice ObjectiveThis Pre-solicitation Notice is issued pursuant to FAR Subpart 5.2. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This Pre-solicitation Notice does not commit the Government to contract for any supply or service whatsoever. Further, AMCG is not at this time seeking proposals, and will not accept unsolicited proposals.It is anticipated that an RFP will be available electronically through the FedBizOpps website on or about January 20, 2015, with proposals being due on or about March 4, 2015. Any responsible offeror may submit a proposal that will be considered by the Government. It is the offeror's responsibility to monitor this internet site (www.fbo.gov) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the RFP number, name of firm, size standard of the firm, name of requestor, mailing address, telephone number, fax number, and email address, and should be submitted to the Point of Contact(s) identified in this notice.Multiple awards may result from this solicitation with an estimated award date in July 2015.Furthermore, all respondents must be registered in the System for Award Management (SAM) https://www.sam.gov and have their records updated in the Central Contractor Registry (CCR).
RFP-15-100-SOL-00004 Department of Health and Human Services Immediate Office of the Secretary
12/5/14, 11:42 AM