75F40124R120978.pdf

U.S. FDA SOURCES SOUGHT NOTICE (SSN)

Reagent bundle and kits for Chromium Next GEM Single Cell Multiome ATAC instrument

Sources Sought #: 75F40124R120978 Posted Date: December 11, 2023 Response Date: December 21, 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing, Small Business

Size Standard of 1,000 employees.

MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a Sources Sought notice to determine the availability of SAM.gov-registered small businesses capable of supplying the reagent bundle and kits described herein. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible.

The appropriate NAICS code for the acquisition is 334516 - Analytical Laboratory Instrument Manufacturing, Small Business Size Standard of 1,000 employees.

Requirement The U.S. Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS) presents this Sources Sought Notice (SSN) on behalf of the Center for Biologics Evaluation and Research (CBER), Moos Laboratory in the Division of Cellular Gene Therapies and Human Tissues (DCTHT) to identify existing small businesses capable of providing certain consumables, to include reagent bundles and kits, for ongoing research. The required consumables shall integrate seamlessly with an existing 10x Genomics Chromium Next GEM Single Cell Multiome ATAC instrument system.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing, Small Business Size Standard of 1,000 employees., and believe that your firm is capable of providing these services, please submit a capability statement by e-mail to timothy.walbert@fda.hhs.gov. by the date and time specified above, providing all information as required below.

Background The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Moos Laboratory in the Division of Cellular Gene Therapies and Human Tissues (DCTHT), is currently conducting experiments to identify Quality Attributes for cellular/regenerative mailto:timothy.walbert@fda.hhs.gov.

medicine products using single cell transcriptomic analysis to further identify specific cell subpopulations that may be responsible for beneficial therapeutic or, conversely, harmful effects, so that these sub-populations can be controlled to produce improved products.

The consumables described herein comprise an integrated system of preformulated reagents and patented, proprietary microfluidic emulsion partition technology that seamlessly integrates with an existing 10x Chromium Next GEM Single Cell Multiome ATAC instrument system purchased in 2018. These consumables have also been qualified to perform sequential biochemical reactions culminating in bar-coded single-cell RNA sequencing (scRNAseq) and chromatin accessibility (ATACseq) libraries suitable for sequencing by Illumina instrumentation maintained and operated by the CBER Core Facility. This new procedure allows analysis of both types of information (scRNAseq and scATACseq) from the same cell.

Minimum Technical Requirements are as follows for the required consumables and shall include:

• Chromium Next GEM Single Cell Multiome ATAC + Gene Expression Reagent Bundle, 16 rxns;

• Dual Index Kit TT Set A 96 rxns;

• Chromium Next GEM Chip J Single Cell Kit, 48 rxns

• Single Index Kit N Set A, 96 rxn.

Delivery Address:

U.S. Food and Drug Administration

CBER-OTP-OCTHT

Attn: Dr. Malcolm Moos Bldg. 52/72, Room 3228 Silver Spring, MD 20993-0002

Delivery Terms: 90 days ARO a signed purchase order

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the required consumables Although the target audience for this Notice is small businesses or small businesses capable of providing these items from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following:

1. Business name and bio, SAM Unique Entity Identifier (UEI), 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;

2. Descriptive literature, brochures, marketing material, etc. detailing the extent to which the responding firm is regularly engaged in providing the reagent bundles and cell kits necessary to the processes required;

3. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met;

4. If applicable, standard commercial warranty and payment terms;

5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and

SIN’s that are applicable to this potential requirement are also requested;

6. If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns;

7. Though this is not a request for quote, informational pricing is encouraged;

8. The Government is not responsible for locating or securing any information, not identified in the response;

9. Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract.

10. Respondent shall provide country (or countries) of origin for the products and/or services offered in response to this solicitation, and shall include any other applicable information to enable review and analysis pursuant to the requirements under the Buy American Act and requirements relating to Executive Order 14005 - Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request (submitted through the Made in America Office (MIAO) Digital Waiver Portal) is required.

Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on December 21, 2023, to Tim Walbert, Contract Specialist, at the following address:

timothy.walbert@fda.hhs.gov.

Notice of Intent Responses to this Sources 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/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information mailto:timothy.walbert@fda.hhs.gov https://sam.gov/content/opportunities

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).