Novel Toxicant and Repellent for Arthropod-borne Virus Vectors (NTRAVV)

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) and Acquisition Contracts Management and Grants (AMCG) intend to use other than full and open competition to award a sole source contract to Evolva for an acquisition to develop an EPA-registered naturally-occurring active ingredient as both a repellent and killing agent (toxicant) against mosquitoes of public health importance, including Aedes aegypti and Aedes albopictus, and preferably also Culex quinquefasciatus and Culex pipiens. This notice of intent to award a sole source contract will be posted for 15 calendar days to verify that no other sources can meet this requirement given only one responsible source and no other supplies or services will satisfy the Government's requirement. This 15 calendar day notice shall expire on February 15, 2017, 2:00 PM Eastern Standard Time. If no credible responses to the intent to sole source are received by the Government, a request for proposal will be forwarded to Evolva and the Government will amend the intent to sole source by posting the redacted Justification and Approval (J&A) for 30 days. The proposed contract action will support services for which the Government intends to solicit and negotiate with only one source under the authority of the Federal Acquisition Regulation (FAR) 6.302-1. This notice of intent is not a request for competitive proposals. Any other interested parties may identify their interest and capability to respond to the requirement by submitting in writing their name, address, telephone number, email, and a statement regarding capability to provide the specified EPA-registered naturally-occurring active ingredient as both a repellent and killing agent (toxicant) against mosquitoes of public health importance, including Aedes aegypti and Aedes albopictus, and preferably also Culex quinquefasciatus and Culex pipiens. Responses shall be limited to twenty (20) pages or less, including all attachments. Interested parties will be considered only if they respond to this notice with clear and convincing evidence that competition would be advantageous to the Government, would not be cost or time prohibitive, and has the ability to provide verification, validation, EPA registration, and large-scale manufacturing services for a naturally-occurring active ingredient, including, but not limited to, those that are or could be approved as a food product or fragrance, with efficacy as both a mosquito repellent and a killing agent (toxicant). In addition, potential Offerors shall demonstrate their capability to meet the following criteria: 1. Documentation that the Active Ingredient/Product: a. Utilizes an active ingredient classified as a biochemical pesticide by the EPA. b. Utilizes an active ingredient that is generally regarded as safe for topical application on multiple populations. c. Exhibits a distinct mode of action from currently used pesticides. d. Is an effective repellent of mosquitoes of public health concern, including both Aedes aegypti and Aedes albopictus, and preferably also Culex quinquefasciatus and Culex pipiens. e. Is an effective biopesticide against mosquitoes of public health concern, including both Aedes aegypti and Aedes albopictus, and preferably also Culex quinquefasciatus and Culex pipiens. f. Due to the urgency of Zika public health threat, active ingredient has sufficient laboratory data to support beginning an EPA application process for an Experimental Use Permit within the next 12 months. 2. Capability to provide the following formulation and manufacturing capabilities: a. Documentation to support the ability to produce large-scale quantities of the active ingredient using cost-effective processes. b. b. Generalized plan for GMP compliant pilot manufacturing of the initial lots of mosquito-specific formulations needed for pre-submission activities, including, but not limited to (1) personal repellent spray; (2) surface repellent spray; (3) multi-use space spray, flying insect aerosol; (4) multi-use space spray, crawling insect aerosol; peridomestic residual spray for backyard/perimeter control. 3. Documentation/evidence of a potential workable plan/strategy for obtaining EPA registration of the active ingredient as both a repellent and killing agent (toxicant) against mosquito species of public health importance, including both Aedes aegypti and Aedes albopictus, and preferably Culex quinquefasciatus and Culex pipiens. a. Provide a brief table of contents for the submission package and workable timeline. b. Provide evidence of expertise in generating the submission package. 4. Evidence/documentation of interested parties quality documentation and capabilities: a. Provide evidence of an established quality assurance system with sufficient content to support the planned filing, staff to update and maintain the files, and adherence to the EPA GLP and GMP Guidelines. 5. Documentation of the interested parties' risk management system by briefly describing the activities required to document preliminary hazard analyses, FMEA plans, and risk control plans. 6. Documentation of a potential plan for producing EPA-registered commercially available repellent and toxicant products containing the active ingredient. This plan may involve partnering with another manufacturer who will produce the final commercially available repellent and toxicant products; if so, the plan must include evidence that the partnership strategy is viable. All capability statements or information received prior to February 15, 2017, 2:00 PM Eastern Standard Time will be considered by the Government. Any organization responding to this notice shall ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. The Government will not be responsible for any costs incurred by responding to this notice. The Government will notify parties of the outcome of any capability statement, or information submitted in response to this Notice of Intent. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Anticipated Award Date and Period of Performance: The Government anticipates an award date of approximately April 2017. The estimated period of performance is a 24-month base period from date of award. Any organization responding to this notice shall ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Please note: All contractors interested in doing business with the Federal Government must be registered in the System for Award Management (SAM) database. The website for registration is www.sam.gov.