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The associated North American Industry Classification System (NAICS) Code is 541380- Testing Laboratories; Small Business Size standards $15.0 MIL.
The FDA/CBER requires HLA Typing to support hemophilia genetic project at CBER. HLA typing is performed as a routing service in CBER clinical laboratories. For our research we require high resolution, gene-based HLA typing of 1,000 patient samples. There are several HLA loci on the human gene; we require HLA Class II DRB1; DRB 3, 4 & 5; DQB1 and DPB1 to be typed for all 1,000 samples
Technical Specifications: DNA samples from de-identified hemophilia A patients have been collected by MLOF under appropriate IRB approvals from consented patients. These have been provided to the FDA and we will ship them to the selected clinical laboratory for high-resolution HLA typing. It is required that the vendor perform HLA typing of the following loci:
• HLA Class II DRB1
• HLA Class II DRB 3, 4 & 5
• HLA Class II DQB1
• HLA Class II DPB1
FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation completed within 30 days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA CBER facility located at 10903 New Hampshire Ave, WO52/72 Room 4120, Silver Spring, MD 20993.
The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:
• Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
•Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.
•If a large business, identify the subcontracting opportunities that would exist for small business concerns;
•Standard commercial warranty and payment terms; and
•Though this is not a request for quote, informational pricing is encouraged.
The government is not responsible for locating or securing any information, not identified in the response.
The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.
Interested Parties shall respond with capability statements on or before June 05, 2019 by 12:00 hours (Central Time in Jefferson, Arkansas). Reference FDA_SSN_1214032.
Notice of Intent
Responses to this source sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.
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 FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
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).