CUI

Control Number: FY26-0608

Controlled by: Defense Health Agency (DHA) Controlled by: DHACA R&D CUI Category(ies): Source Selection Limited Dissemination Control: FED Only POC: Tonya Kreps (301) 619-2519

Justification and Approval (J&A) for Other than Full and Open Competition

Revolutionary Federal Acquisition Regulation (FAR) and Overhaul (RFO) Parts 6 and 12 Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity: The Contracting Activity responsible for this action is the Defense Health Agency Contracting Activity (DHACA) Research & Development (R&D) Contracting Division 1, 808 Chandler Street, Fort Detrick, MD 21702- 5014. The requiring activity requesting this action is the Defense Health Agency (DHA).

2. Nature and/or Description of Action being Approved: This is a follow-on contract to W81XWH21A0005 with Sinclair Bio Resources, LLC. DHA requires a Firm Fixed Price, Blanket Purchase Agreement (BPA) with an Ordering Period of 17 June 2026 through 16 June 2031. Due to ongoing research requirements, there is a continued need for this effort.

3. Description of Supplies/Services and Estimated Value: Sinclair Bio Resources, LLC, SAM.gov UEI: NANLUILGCHJF1 and CAGE: 5K6W9, shall provide the transport and delivery of Sinclair™ miniature swine (minipigs) lineages. If research necessitates, Contractor may be required to provide incidental services to include device implants, tattoos, castration, sling training, and diagnostic services including but not limited to routine surveillance and disease diagnosis on the delivered minipigs before arrival of these animals.

Period Period of Performance or Required Delivery Date

Estimated Value Type of Funding

Base Period June 17, 2026 – June 16, 2027 RDT&E Option Period 1 June 17, 2027 – June 16, 2028 RDT&E Option Period 2 June 17, 2028 – June 16, 2029 RDT&E Option Period 3 June 17, 2029 – June 16, 2030 RDT&E Option Period 4 June 17, 2030 – June 16, 2031 RDT&E

Total

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

4. Statutory Authority Permitting Other Than Full and Open Competition: "RFO 6.103- 1(c)(2)(i), Substantial duplication of cost to the Government that is not expected to be recovered through competition."

5. Rationale Justifying Use of Authority Cited: This action is a follow-on BPA to contract W81XWH21A0005, J&A number JA-21-04-00288, and W81XWH16A0005, J&A number JA16018. W81XWH21A0005 used statutory authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR 13.5. W81XWH16A0005 used authority 6.301-1(a) (2). Only one responsible source and no other supplies or services will satisfy agency requirements. Sinclair Bio Resources, LLC remains the only source reasonably available that can provide Sinclair™ miniature swine lineages, as they are the only supplier of these minipigs.

The ability to compare current experimental data with historical data is imperative to the scientific process. In order to maintain the merit and validity of scientific research, the Sinclair minipig is required. Changing the Sinclair minipig model by introducing swine from another source and herd will compromise current and previous research results obtained from the Sinclair-bred minipig. Adding these research variables would necessitate repeating research, costing the U.S. Government in labor and supplies, as current and future research results could not be scientifically compared with the long history of historical data based on the Sinclair™ minipigs. Therefore, no substitutions are allowed due to species-specific characteristics of data being collected to maintain data and research integrity. The only way to control genetic variability effects and ensure valid experimental data is procuring minipigs supplied by Sinclair Bio Resources, LLC that were previously and are currently used on research protocols at multiple DHA laboratories.

6. Efforts to Obtain Competition: Sinclair Bio Resources, LLC is the only available manufacturer and seller of the Sinclair™ miniature swine. Therefore, in accordance with RFO

5.101 a Notice of Intent to Sole Source will be posted to System of Award Management (SAM).

In accordance with RFO 6.103-1 a Request for Information (RFI) has been posted to SAM for 15 days and no responses were received.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: Future acquisitions of laboratory animals not characteristically specific to Sinclair may be procured through full and open competition. Additionally, researchers will be encouraged to find ways to increase competition with similar animal requirements without compromising science. The Government does not anticipate any action the agency could take to remove or overcome any barriers that led to the restrictive acquisition of the supplies or services made.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

8. Market Research: The DHA performed market research in 2025-2026 including all mandatory sources of supply: Excess Personal Property, Federal Prison Industries, The Procurement List maintained by the Committee for Purchase from People Who Are Blind or Severely Disabled, DLA, VA, and GSA; industry search sites: AAAALAC and AALAS; U.S. Government contract sites: FPDS-NG, U.S. Small Business Administration, and USASpending.gov; and other potential swine vendor websites. An RFI was posted to SAM as an effort to find additional contracts that could meet this requirement. The acquisition history for this requirement shows that Sinclair Bio Resource LLC, has been the only vendor that could meet the requirement,

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed?

(1) W81XWH21A0005 was awarded to Sinclair Bio Resources, LLC, Sole Source, BPA, J&A Number JA-21-04-00288 in accordance with FAR 13.5; Period of Performance (PoP): 17 Jun 2021 – 16 Jun 2026.

(2) DO HT009025FG1210006 under VA 36C24620D0104 on 13 Dec 2024 for

USAISR.

(3) W81XWH16A0005 was awarded to Sinclair Bio Resources INC (previously LLC), Sole Source, BPA, J&A Number JA16018 in accordance with FAR 13.5;

Period of Performance (PoP): 14 Mar 2016 – 14 Mar 2021.

(4) W81XWH13A0002 was awarded to Sinclair Bio Resources INC. Period of Performance (PoP): 26 Aug 2013 – 25 Aug 2015.

b. Additional Information: Sinclair Bio Resources, LLC remains the only available manufacturer and seller of the Sinclair™ miniature swine.

10. Interested Sources: To date, no other sources have written to express interest. Also, notices required by RFO 6.103-1 shall be or have been published, and any bids or proposals received shall be considered.