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) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), in order to determine if there are existing small business sources capable of providing Whole Blood and Apheresis Platelets for Research. 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.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 621991 - Blood and Organ Banks; with a Small Business Size standard $40.0 million, and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected].

Background:  

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), who requires Whole Blood and Apheresis Platelets for Research for the Pathogen Reduction Technology Program.

FDA/CBER/OBRR conducts mission-relevant research to facilitate product development, manufacture, and evaluation. As part of its strategic plan to proactively address public health challenges and emerging infectious diseases, CBER will “Develop and facilitate the application of innovative technologies toward universal pathogen reduction of the blood supply.”  The research requires blood and blood components to be available on the collection day, preferably within 4 to 8 hours of collection, to obtain accurate scientific data.

Technical Requirements:

• Units of Whole Blood (400 to 450 mL each):
  • Collected from eligible blood donors in an established, Institutional Review Board (IRB)-approved program for research collections from consenting volunteers.
  • Collected in citrate phosphate dextrose.
  • Provided on the day of collection, preferably within 4 to 8 hours of collection.

• Units of Apheresis Platelets (typically 200 to 400 mL)
  • Collected from eligible blood donors in an established, IRB-approved program for research collections from consenting volunteers
  • Stored in 100% plasma or with 65% platelet additive solution
  • Provided on the day of collection, within 4 to 8 hours of collection
  • For pathogen reduced units, provided the day following collection (to allow for full treatment process)

• Deliverables

• Units of Whole Blood (400 to 450 mL each) delivered by courier service
• Units of Apheresis platelets delivered by courier service

Place of Performance:

FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein.

FDA - CBER

10903 New Hampshire Ave.

Building 52/72, Room 4370

Silver Spring, MD 20993

Period of Performance:

8/12/2025 – 8/11/2026

Collection and delivery are subject to ongoing blood establishment and FDA IRB approval.

Deliveries shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV.

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 or small businesses capable of supplying a U.S. 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 identification (UEI) 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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 UEI number and size status) if not the respondent.

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

.

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

• 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 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 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.

• Informational pricing is desired.

• 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 due by email to the point of contact listed below on or before July 8, 2025, by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email [email protected]. Reference: FDA-SSN-130100.

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. 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:

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.