Animal_Whole_Blood_Combined_Synopsis.pdf

COMBINED SYNOPSIS/SOLICITATION

Animal Whole Blood for Blood Compatibility Testing and Medical Device Research FDA CDRH | Supplies

NOTICE TYPE / TIMING: This notice documents Solicitation No. 75F40126Q00362 for public record and transparency purposes under RFO 5.101(b). The RFQ was issued directly to potential small business sources on 08/19/2026 and closed on 08/26/2026; quotations were received and evaluated prior to posting of this notice.

This posting does not solicit additional quotations and does not extend or reopen the response period for this requirement.

1. GENERAL INFORMATION

This is a synopsis of a procurement for commercial products prepared in accordance with the commercial acquisition procedures of RFO Part 12.

Solicitation No. 75F40126Q00362 was issued as a Request for Quotation (RFQ) for donor animal whole blood (bovine, ovine, and porcine) for the FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Cardiovascular Program, Division of Applied Mechanics (DAM). The blood products support blood compatibility (hemocompatibility) testing and medical device research, including hemolysis- and thrombosis-related projects, as further described in Attachment 1 – Requirements Document.

All supplies shall meet the minimum requirements in Attachment 1 – Requirements Document, including species availability, minimum draw frequency, blood quality, minimum delivery volumes, anticoagulant type, labeling, quarantine protocol, veterinary oversight, AAALAC accreditation, and ISO 13485:2016 certification.

Set-Aside: Total Small Business Set-Aside

NAICS Code: 325414 – Biological Product (except Diagnostic) Manufacturing

Small Business Size Standard: 1,250 employees

This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance: U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Attn: Megan Jamiolkowski, Building 62, Room 2103, 10903 New Hampshire Avenue, Silver Spring, MD 20993

FOB Point: Destination

Inspection and Acceptance: The Government will inspect and evaluate deliverables upon receipt and provide notification of acceptance or identified deficiencies within three (3) business days of receipt, in accordance with the Requirements Document.

Period of Performance (recurring-delivery commodity acquisition; estimated quantities are the Government's best estimate for evaluation purposes only and are not guaranteed):

Base Period: October 1, 2026 – September 30, 2027

Option Period 1: October 1, 2027 – September 30, 2028

Option Period 2: October 1, 2028 – September 30, 2029

Option Period 3: October 1, 2029 – September 30, 2030

Option Period 4: October 1, 2030 – September 30, 2031

3. CONTRACT LINE ITEMS (CLINs) – BASE PERIOD

CLIN Description Est. Qty (Base Yr)

Unit of Issue

CLIN 0001 Donor, Sheep (Ovine) Whole Blood, ACD-A or Na Heparin, bleed and ship same day

15 Liter

CLIN 0002 Donor, Porcine Whole Blood, ACD-A or Na Heparin, 500 mL, bleed and ship same day

15 500 mL

CLIN 0003 Donor, Bovine Whole Blood, ACD-A or Na Heparin (different donor per liter upon request), bleed and ship same day

110 Liter

CLIN 0004 Box/Ice Charges per shipment (500 mL – Liter) 30 Each CLIN 0005 Box/Ice Charges per shipment (2 x 1 Liter) 55 Each

An identical CLIN structure (blood by species, plus per-shipment box/ice packaging charges) repeats for Option Periods 1–4, with unit prices escalating per the awarded pricing schedule. See the Requirements Document (Attachment 1), Section 5, for full quantity and delivery detail.

4. POINTS OF CONTACT

Contract Specialist: Erika Crawford — Erika.Crawford@fda.hhs.gov

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

Appl. Clause No. Title Date X 52.212-4 Terms and Conditions—Commercial Products and

Commercial Services Nov 2025

X 52.219-6 Notice of Total Small Business Set-Aside Nov 2025 X 52.219-14 Limitations on Subcontracting Nov 2025 X 52.222-19 Child Labor—Cooperation with Authorities and Remedies Nov 2025 X 52.222-50 Combating Trafficking in Persons Nov 2025 X 52.222-54 Employment Eligibility Verification Nov 2025 X 52.222-90 Addressing DEI Discrimination by Federal Contractors Apr 2026 X 52.240-91 w/Alt I Security Prohibitions and Exclusions, with Alternate I Nov 2025 X HHSAR 352.232-71 Electronic Submission of Payment Requests Apr 2026

5B. Clauses Incorporated by Full Text 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if given in full text. Full text is available at https://acquisition.gov | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar.

52.217-9, Option to Extend the Term of the Contract (Mar 2000). The Government may extend the term of this contract by written notice to the Contractor prior to expiration, provided preliminary written notice of intent to extend is given before expiration. Total duration, including exercised options, shall not exceed 5 years.

FDA Electronic Invoicing and Payment Requirements – Invoice Processing Platform (IPP) (Jan 2022). All invoice submissions must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform (IPP), https://www.ipp.gov. Questions may be directed to the FDA ERIC Helpdesk at 301-827-3742 or ERIC@fda.hhs.gov.

6. SPECIFICATIONS

The Contractor shall furnish donor animal whole blood in accordance with Attachment 1 – Requirements Document: Animal Whole Blood Supply (dated 08/18/2026). All supplies shall meet the minimum technical, quality, quarantine, veterinary oversight, accreditation, delivery, packaging, and labeling requirements stated therein.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Appl. Clause No. Title Date X 52.204-7 System for Award Management—Registration Nov 2025 X 52.212-1 Instructions to Offerors—Commercial Products and

Commercial Services Nov 2025

X 52.212-2 Evaluation—Commercial Products and Commercial Services

Nov 2025

X 52.219-1 Small Business Program Representations Nov 2025 X 52.225-2 Buy American Certificate Oct 2022

Basis for Award

Best Value Tradeoff: Award will be made to the responsible offeror whose quotation represents the best value to the Government, considering Technical/Capability and Past Performance as the non-price evaluation factors (the baseline commercial evaluation factors under RFO 12.203(a)), weighed against price. Technical/Capability and Past Performance, when combined, are approximately equal to price.

B. OFFER SUBMISSION (HISTORICAL – FOR RECORD)

RFQ Issued: August 19, 2026

Quotations Due: August 26, 2026

Submission Method: Email to the Contract Specialist, Erika Crawford, Erika.Crawford@fda.hhs.gov

This section reflects the actual solicitation and response dates for the record. As noted above, this notice does not reopen or extend the response period.

C. ADDITIONAL INFORMATION

Amendments: None issued.