Sources Sought 1222579.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Bioinformatics and Biostatistics (DBB) requires Next-generation sequencing analysis of microRNA expression on 200 samples from commercially available human hepatic cell lines, and bioinformatic analysis of data to identify miRNAs associated with drug-induced liver injury.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort:

The associated North American Industry Classification System (NAICS) Code is 541380

- Testing Laboratories; Small Business Size Standard is $16.5 Million.

Minimum Performance Requirements:

1. Libraries for microRNA-seq shall be prepared utilizing appropriate technology suitable for service provider’s instrument to generate barcoded sequencing data.

2. Libraries shall be sequenced utilizing a next-generation sequencing platform (an instrument that the service providers have). The depth of sequencing data should be greater than 10,000,000 reads/sample.

3. The sequencing data shall be de-multiplexed and transformed to fastq data files.

4. Data shall be collected, cleaned up and de-multiplexed.

5. Shall perform quantification of known microRNAs in the latest version of miRBase and provide raw counts and normalized counts.

6. Shall perform new microRNA discovery and quantification and provide raw counts and normalized counts.

7. Co-variant and multi regression analysis for group comparison shall be provided.

8. Shall perform differential expression analysis of both known and new microRNAs and provide log2FoldChange and p-value.

9. Dose and time dependent analysis shall be performed, if applicable.

10. Connective Map (CMAP) analysis shall be performed.

11. Shall identify microRNA biomarkers that can predict hepatotoxicity in human hepatocytes that were treated with a group of structurally similar drugs.

12. Shall provide target prediction of new discovered microRNAs.

13. Shall perform functional analysis of differentially expressed microRNAs using in silico approaches.

14. Shall provide an overall workflow and details of methods and tools being used in each step.

15. The Contractor shall provide encrypted raw data and analyzed data (including all fastq data results) on a FDA approved external hard drive of sufficient capacity to hold all data and the drive shall be shipped 2nd Day Air (UPS or FedEx) to the FDA investigator.

The human hepatocyte samples will be shipped by NCTR staff to the contractor via FedEx overnight delivery.

Period of Performance:

12 months from award date.

Place of Delivery:

3900 NCTR Rd Jefferson, AR 72079

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying services of a small business, 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 service can meet the above requirements. All descriptive material necessary for the government to determine whether the service 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.

• 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 which are due in person, by postal mail or email to the point of contact listed below on or before December 18, 2019 by 1:00 PM (Central Time in Jefferson, Arkansas) to warren.dutter@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Warren Dutter, 3900 NCTR Road, Building 50, Room 417, Jefferson, AR 72079-9502. Reference 1222579.

Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether 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 No 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).

mailto:warren.dutter@fda.hhs.gov mailto:warren.dutter@fda.hhs.gov