This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Please note that to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks laboratories capable of controlled exposures of various animal species to chemical agents, and capable of establishing models to evaluate the efficacy of potential MCMs. Task Orders derived from this IDIQ contract will be assigned to one of two groups: Group A covers pulmonary agents, cyanide, opioids, toxic industrial chemicals (TICs), and other potential chemical agents of concern by inhalation, ingestion, and topical routes. Performers in this group must have performed at least one GLP study in the past three (3) years. Group B covers nerve agents and vesicants (including sulfur mustard) by inhalation, ingestion, and topical routes. Performers in this group must be capable of working with chemical threat agents (i.e. OPCW Schedule 1 compounds). Please note that laboratories must be capable of performing tasks from at least one of the above groups (i.e., meeting the capabilities/requirements to belong to one group would suffice) Laboratories may belong to of either group so long as they meet the requirements for that group. In these models, the challenge dose should typically be similar to 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 chemical threat agents, the mechanism of action of the countermeasure in the animals will need to match the expected mechanism of action in human victims. The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and Development Authority (BARDA) to support development and acquisition of medical countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures. The development of animal models is a key element in the successful development of MCMs for chemical, 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. Project Requirements Written capability statements should demonstrate your organization’s in-house ability and related experience in all of the following technical requirements for the animal models to be developed under this requirement as listed below: - a reasonable well-understood pathophysiological mechanism of the toxicity of the substance (agent) and its prevention/reduction by the test product; - the effect is demonstrated in one or more animal species expected to react with a response predictive of humans; - an animal study outcome that is clearly related to the desired benefit in humans; - data on pharmacokinetics/dynamics of the product in animals and humans that allows selection of effective doses in humans; - allow for the testing and evaluation of candidate medical countermeasures; - use optimized/validated assays to monitor response and bridge data to humans; - [Only required for respondents to Group A] Respondent has conducted a laboratory study in accordance with preexisting requirements under the Good Laboratory Practices (GLP) (21 CFR 58) and adherence to Animal Welfare Act (7 U.S.C. 2131) in the last 3 years. GLP is expected for the definitive/pivotal animal studies but not necessary for the pilot studies. - [Only required for respondents to Group B] For laboratories approved to work with chemical warfare agents (OPCW Schedule 1), it is expected that the Respondent, or its affiliate/subcontractor, has ready access to chemical threat agents and maintains qualified laboratories with the requisite experience, facilities, capabilities and personnel to handle Schedule 1 agents under all applicable laws. The Respondent shall provide a detailed narrative demonstrating this capability. Additional Information Specify whether your organization uses any proprietary technology for any of the activities described for the technical requirements. In addition, your organization’s capability statement should: (1) Indicate how many staff members the small business would be able to dedicate to the program, and which of those would be available in-house; (2) Identify which requirements would be performed in-house versus those that would be performed outside your organization; and (3) Describe your organization’s ability to rapidly scale staff capacity up or down to support the anticipated workload. Contract Type and Anticipated Period of Performance The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under the future solicitation—with the eventual contract being administered and funded via Task Orders (TO). The Government anticipates awards will be made in the fourth quarter of FY2020. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 12:00 PM. EASTERN STANDARD TIME (EST), MONDAY, FEBRUARY 3, 2020, to Jeffrey Brown, Contracting Officer at
[email protected]. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Points of Contact Point of Contact: Jeffrey Brown Contracting Officer
[email protected] Phone: 202-730-8662