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This document is a Sources Sought Notice issued by the Department of Health and Human Services Food and Drug Administration (FDA) Center for Biologics Evaluation and Research regarding the procurement of Fel d 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA/ImmunoEnzymetric Assay (IEMA)).

The FDA is conducting market research to identify potential qualified sources, including small business vendors, that can provide 3 grams of a human monoclonal antibody specific for a first epitope on the cat allergen Fel d 1 and 1 gram of a biotinylated human monoclonal antibody specific for a second, distinct epitope on the Fel d 1 allergen. Interested parties must submit capability statements by August 20, 2024 that include business information, past performance, technical details, pricing, and information related to the Buy American Act. The government reserves the right to use the information received to determine the procurement strategy, but responses will not be considered as offers. A presolicitation synopsis and solicitation may be published in SAM.gov after the sources sought process is complete.

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SOURCES SOUGHT NOTICE:

FDASSN125149

Fel d 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA/ImmunoEnzymetric Assay (IEMA)

This is NOT a solicitation announcement. This is a Sources Sought Notice only.

The purpose of this sources sought synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled Veteran-Owned, Veteran-Owned Small Business, Women- Owned Small Business, HubZone 8(a), 8(a), HubZone, Small Business, Emerging Small Business, Small Disadvantage Business (SDB), and Large Business) relative to NAICS code 423450, Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (size standard of 200 people). Responses to this sources sought notice shall not constitute responses to solicitation, which is not currently available. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation.

The decision to solicit for a contract shall be solely the Government's discretion.

This sources sought notice is not to be construed as a commitment by the Government, nor will the Government pay for the information submitted in response. Respondents will not be notified of the results of any government assessments. The information received will be utilized to assist in formulating the strategy for competitive procurements.

DESCRIPTION

The intent of this notice is 1) to gather industry, especially small business (including 8(a), HUBZone, small disadvantaged business, service disabled veteran-owned small business and women-owned small business) input for FDA’s procurement to provide FDA personnel with the following:

Procurement of the following:

Human monoclonal antibody specific for a first epitope on the cat allergen Fel d 1.

3 grams

Biotinylated human monoclonal antibody specific for a second, distinct epitope on a cat allergen Fel d 1.

1 gram

See Statement of Work for details.

RESPONSES

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar service.

Though the target audience is small business vendors 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 services.

• 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.

• 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 2:00 pm EASTERN TIME on August 20, 2024 to Howard Yablon at email howard.yablon@fda.hhs.gov. Reference: FDASSN125149.

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 SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

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:

mailto:howard.yablon@fda.hhs.gov

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.

SOURCES SOUGHT NOTICE:
FDASSN125149
DESCRIPTION
Disclaimer and Important Notes
Confidentiality and Proprietary Information
Additional Notes:

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