SOURCES SOUGHT
66 -- Reagents Test Kits
- Notice Date
- 5/4/2010
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- FDA1071388
- Archive Date
- 6/2/2010
- Point of Contact
- George Gonzalez, Phone: (301)-827-9361
- E-Mail Address
-
George.Gonzalez@fda.hhs.gov
(George.Gonzalez@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. Statement of Objectives: The Food and Drug Administration, Division of Microbiology in the Office of Regulatory Science has a requirement for Reagents Test Kits. The kits are for use with Vidas Instrumentation (Salmonella, Listeria, ICS, E. Coli, Staphylococcal). The chemical purchasing agreement needs to include the following items and specifications during its covered purchasing agreement period: Specifications: The FDA field laboratories require various test kits for the screening of food and environmental samples for the detection of pathogens in food. The test kits must be compatible for use with the VIDAS® instrumentation existing in the field laboratories and must contain and meet the following specifications: • Ready-to-use Solid Phase Receptacle (SPR) coated with antibodies against: o Salmonella specific antigens o Listeria specific antigens o E. coli O157 (H7) specific antigens o Staphylococcal enterotoxin specific antigens • Assay strips containing 10 wells covered with a labeled foil seal o Label must contain a bar code with assay code, kit lot number and expiration date o The foil of the first well must be perforated to facilitate the introduction of the sample o Strip well 1 must be empty for the introduction of the sample, control or standard o Strip well 2 must contain 400uL of prewash solution o Strip wells 3,4,5,7,8 and 9 must contain 600uL of wash buffer o Strip well 6 must contain 400uL of conjugate o Strip well 10 must contain a cuvette with substrate in which a fluorometric reading can be performed • Assay standards and controls containing purified and inactivated organism specific antigen + preservative + protein stabilizer must be contained in the kits • Assay positive controls must be contained in the kits • Assay specific confidence interval is required with each assay kit • Assay negative control containing TRIS with buffered saline and tween, pH 7.6 is required with each kit • Kits are required for the immunomagnetic capture of Salmonella species from food and environmental samples. • Specification sheet containing the factory master calibration data required to calibrate the test on the instrument used for pathogen detection is necessary in each kit • The laboratories must be able to interpret the assay using the VIDAS® automated reader, and store all pertinent lot and reagent information within the reader. Small Businesses are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform the task described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. If qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. Interested offerors should submit their capability statement not exceeding five (5) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: george.gonzalez@fda.hhs.gov or US Food and Drug Administration George Gonzalez 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2067 Rockville, MD 20857
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1071388/listing.html)
- Record
- SN02140219-W 20100506/100504235646-dd48ac5898e3204e42f53a755ec4683a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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