SPECIAL NOTICE
A -- Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors
- Notice Date
- 6/2/2010
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- HHS-FDA-RFI-1071408
- Archive Date
- 6/22/2010
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams, Phone: 3018273366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Description: Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors This is an RFI NOTICE to determine the availability and capability of small businesses (i.e. certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) for Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. No telephone inquiries will be accepted. FDA may consider soliciting services for a two year contract. Draft Objective: The FDA is responsible for the safety of seafood harvested from federal waters and seafood that is available through interstate commerce. Paralytic shellfish poisoning (PSP) is a common human illness that is caused by the consumption of seafood contaminated with these natural neurotoxins known collectively as the saxitoxins (STXs). Immunological based assays are needed to detect when toxin levels in seafood exceed a safe threshold. However, the antibody, or suite of antibodies, that is used in such immunological based assays is of critical importance. Commercially available antibody-based kits for detecting the STXs do not demonstrate a cross reactivity with the other congeners in a way that reflects potency. The purpose of this contract is to produce a number of antibodies to the STXs to determine the best antibody or suite of antibodies for use in detection methods that would more accurately measure toxicity. The selected antibodies will then be available for use by FDA and for a commercial test kit manufacturer to develop test kits such as lateral flow devices. Draft Scope of Work: The contract must provide for development of antibodies for seafood toxin analysis methods. Part 1. Services Personnel must perform their tasks to develop the materials and required characterization of produced materials. For characterization, the antibodies selected must be shown to have a high affinity and selectivity for one or more members of the PSP toxin family. Antibodies with IC50s of greater than 20ppb will be excluded. At least four antibodies must be produced that fulfill this criterion. Affinity should be determined using surface Plasmon resonance based assays and avidity can be determined using ELISAs. Part 2. Production of toxin-protein conjugates Specific requirements: All conjugates must be assessed for their incorporation rate of PSP. Only conjugates with a greater than 1:1 molar ratio of toxin to protein must be considered suitable for the project. At least 4 toxin-protein conjugates (including STX-KLH) must be produced meeting these specifications and 0.5 mg each will be delivered to FDA. Part 3. Production of monoclonal antibodies Specific requirements: All clones selected must be shown to be inhibited by presence of one or more members of the PSP toxin family. At least 4 antibodies must be selected that fulfill this criterion. Each antibody must be characterized as described above, and 5 mg each will be delivered to FDA. We may anticipate a firm fixed price type contract for five years. Viable parties shall provide the following: Part A. Capabilities and Technical Experience - Provide a capability statement describing how your company would provide Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors as provided in the Draft Scope of Work. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm's status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors. Part D. Cost Estimate- Provide a cost estimate in accordance with FAR Part 10, Market Research for the services (i.e. hourly rates, hours/days) and the number of hours for the Field & Laboratory Immunological Phycotoxin Poison Examination by Rapid Sensors. Part E. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation on Subcontracting. Responses shall be:  RFI Sought number ;  no more than ten (10) pages in length;  not submit marketing materials;  submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-RFI-1071408/listing.html)
- Record
- SN02166007-W 20100604/100602235018-308e4b232af583374689bf3cbdc569d2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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