This is a RFI 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 Evaluation for the presence of unknown adventitious viruses in vaccine cells using Massive Parallel Sequencing (MPS) or deep sequencing 454-titanium chemistry using curated virus database with bioinformatics analysis.

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.

Draft Scope of Work:

The purpose of this requirement is an evaluation for the presence of unknown adventitious viruses in vaccine cells using Massive Parallel Sequencing (MPS) or deep sequencing 454-titanium chemistry using curated virus database with bioinformatics analysis. Massive parallel sequencing (MPS) also called deep sequencing uses 454-titanium chemistry to generate whole genome or transcriptome sequences. Materials (cell culture supernatant, pellets, RNA or DNA) will be provided for cDNA synthesis for Massive Parallel Sequencing (454-deep sequencing) and bioinformatics analysis using a curated virus database.

Draft Specifications:

1) The Offeror may perform 454 sequencing-starting with both RNA, DNA material provided by FDA.
2) The Offeror may provide Bioinformatics Analysis of those 454 sequencing results, using curated virus database.
3) The FDA will provide materials (cell culture supernatant, pellets, RNA or DNA) for cDNA synthesis for Massive Parallel Sequencing (454-deep sequencing).
4) The Offeror may conduct Bioinformatics Analysis by using a curated virus database furnished by the awarded contractor.

We may anticipate a firm fixed price purchase order.

Viable parties shall provide the following:

Part A. Capabilities and Technical Experience - Provide a capability statement describing how your company would provide for Evaluation for the presence of unknown adventitious viruses in vaccine cells using Massive Parallel Sequencing (MPS) or deep sequencing 454-titanium chemistry using curated virus database with bioinformatics analysis.

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 Evaluation for the presence of unknown adventitious viruses in vaccine cells using Massive Parallel Sequencing (MPS) or deep sequencing 454-titanium chemistry using curated virus database with bioinformatics analysis.

Part D. Cost Estimate - Provide a cost estimate in accordance with FAR Part 10, Market Research for Evaluation for the presence of unknown adventitious viruses in vaccine cells using Massive Parallel Sequencing (MPS) or deep sequencing 454-titanium chemistry using curated virus database with bioinformatics analysis.

Part E. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation on Subcontracting.

Responses shall be:

 identified with the RFI 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.