SOURCES SOUGHT
A -- TITLE: Verification, Validation, and Manufacturing of a Natural Product Mosquito Toxicant/Repellent
- Notice Date
- 8/26/2016
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- HHS-ASPR-AMCG-16-SSN-100
- Archive Date
- 9/21/2016
- Point of Contact
- Linda I Luczak, Phone: 202-260-0271
- E-Mail Address
-
linda.luczak@hhs.gov
(linda.luczak@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- TITLE: Verification, Validation, and Manufacturing of a Natural Product Mosquito Toxicant/Repellent THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. This notice does not constitute a commitment by the Government. The Office of Acquisition Management Contracts and Grants (AMCG) and 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) is seeking sources from industry by gathering information on current capabilities within the market. The findings from this Market Research effort may impact any future solicitations related to this requirement. We are especially seeking sources from small businesses. PURPOSE AND OBJECTIVES: The ongoing Zika virus epidemic is severely impacting the public health in Latin America and the Caribbean. In addition, Zika virus is an imminent threat to the southern part of the continental U.S., where the primary mosquito vectors, Aedes aegypti and Aedes albopictus, are widespread and abundant. While the virus produces a range of outcomes in infected individuals, the most dire and long lasting effects of infection are seen with fetuses exposed to the virus in early to mid-stages of a pregnancy. In the absence of a Zika virus vaccine or treatment, preventing infected mosquitoes from biting is the main method of controlling the disease. However, public perceptions about the health and environmental risks of synthetic chemical pesticides and chemical repellents, as well as increasing insecticide resistance among mosquito vectors, severely hinder these disease prevention and control efforts. New toxicants (insecticides) with modes of action that allow them to kill mosquitoes that are resistant to pyrethroids and other commonly used toxicant active ingredients are urgently needed to ensure effective emergency control of adult mosquitoes in the short term and improved management of insecticide resistance through toxicant rotations or mosaics in the long term. The objective of this request for information/sources sought notice is to obtain the capabilities of industry parties 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. As part of delivering the EPA registered repellent/toxicant, the requirement may include the following efforts: 1. Formulation of products containing the active ingredient for use in studies to support EPA registration as both a mosquito repellent and killing agent (toxicant). 2. Provide services that support the EPA filing and subsequent registration of the active ingredient as both a mosquito repellent and killing agent (toxicant). 3. Support large-scale manufacturing of the active ingredient to support both governmental and commercial interests during a pandemic response. PROJECT REQUIREMENTS: The Office of Acquisition Management Contracts and Grants (AMCG) and 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) is seeking capability statements from businesses having 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). The narrative (including figures, schematics, diagrams, photographs, etc.) should describe the capabilities of the Offeror and demonstrate their ability to meet the below 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. 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: 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. CAPABILITY STATEMENT/INFORMATION SOUGHT: Respondents must provide, as part of their responses, a capability statement (limit 20 pages) that fully describes their currently available product and the level of analytical verification/validation that they have attained. The description shall include an estimation of the Technical Readiness Level of the product for both the repellent and killing agent (toxicant) uses by way of showing how mature the product is with regard to human safety testing, efficacy testing and toxicology studies (see: https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx). Respondents must provide, as part of their responses, a capability statement (inclusive of the capability statement and its 20 page limit) that specifically addresses the items under PROJECT REQUIREMENTS. Repeating the items listed under PROJECT REQUIERMNTS will not be considered as an adequate response to this SSN. Respondents' opinions about the difficulty and/or feasibility of the potential requirements or proposed acquisitions, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts relative to this proposed solicitation will be gratefully received. Respondents must provide, as part of their responses, a scientific literature reference list (limit two pages) exclusive of the capability statement page limit, of peer-reviewed journals for studies conducted on the toxicant or repellent properties of your product. 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. All responses to this source sought notice must provide the following: 1) Company name and address 2) Point of contact 3) Phone/fax/email 4) One (1) capability statement (limit 20 pages) addressing information in response to the project requirements and qualifications identified in this notice and 5) Business size, status/type of business your organization classifies itself as (i.e., HUBZONE, Service Disabled, Disadvantaged Small Business, etc.). Written responses (as requested above) must be emailed to the Contracting Officer listed below NO LATER THAN close of business September 6, 2016. Only an electronic Microsoft Word capability statement (limit 20 pages) and scientific literature reference list (limit two pages, exclusive of the capability statement) will be accepted by the Government using a standard Arial or Time New Roman 12pt font. Marketing brochures and/or generic company literature will not be considered as an adequate response to this SSN. Not addressing all the requested information may result in the Government determining the respondent is not capable of performing the scope of work required. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. 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 shall 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 for a potential FY 2017 award (subject to the availability of funds). However, responses to this notice will not be considered adequate responses to a solicitation. 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. CONFIDENTIALITY: To the maximum extent possible, please submit non-proprietary information. Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. AMCG will presume that any unmarked information, data, and materials were furnished with an "unlimited rights" license, as FAR subpart 27 defines that term, and AMCG assumes no liability for the disclosure, use, or reproduction of the information, data, and materials Primary Point of Contact: Name: Kim Morris Title: Contracting Officer Phone: 770-488-2621 Email: ycy1@cdc.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/HHS-ASPR-AMCG-16-SSN-100/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN04242773-W 20160828/160826234626-b5a3a7a040e5317c4faa27e83b2dc43d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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