SSN 75F40124SSN123012.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR)’s Division of Genetic and Molecular Toxicology (DGMT) to determine if there are existing small business sources capable of providing Biopredic International, or equal, NoSpin HepaRG cells to conduct research described in NCTR protocols S000904 & E07737.01. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

The NoSpin HepaRG cells will be used to assess the cytotoxicity and genotoxicity of a total of over 30 small-molecule nitrosamines and nitrosamine drug substances-related impurities (NDSRIs).

Nitrosamines have been known to be carcinogenic in rodent models. Recently, nitrosamines have drawn increased attention to the FDA due to the identification of unacceptable levels of nitrosamines as impurities in several common medicines used for the treatment of hypertension, heartburn, and diabetes. HepaRG cells are human-derived, metabolically competent cells. The DGMT lab has successfully adapted HepaRG cells cultured in both 2D and 3D formats for performing three genotoxicity assays: the comet assay, micronucleus assay, and an error-corrected Next Generation Sequencing mutagenesis assay. Data generated from this cell model are considered more relevant to human exposure for supporting regulatory decision-making.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 541714 – Research and Development in Biotechnology; with a Small Business Size Standard of 1,000 employees, and you believe that your firm would be able to provide the FDA with the product described herein, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements below.

mailto:suzanne.martella@fda.hhs.gov

Minimum Requirements:

• The supplied cells shall be compatible with NoSpin HepaRG cells manufactured by Biopredic International in order to ensure for the reproducibility of protocol results.

• Cells shall be fully differentiated HepaRG cells supplied in a format that does not require centrifugation and counting following thaw.

• Each ampule/vial shall remain cryopreserved during shipment and shall contain ≥8.0million cells, with a cell viability of >90%.

• The metabolic capacity of the cells shall be pre-tested.

Delivery: Delivery of the cells is expected within 30 days of contract award.

Place of Delivery

The cells shall be delivered to the National Center for Toxicological Research (NCTR) at:

US FDA/NCTR

14-1036, 3900 NCTR Rd.

Jefferson, AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors and/or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) 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 again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• The offeror’s capability to initiate service within 3 days of original notification.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

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

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 3:00pm (Central Time in Jefferson AR) on April 24, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN123012.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

mailto:suzanne.martella@fda.hhs.gov

Confidentiality and Proprietary Information

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.