JandA-JA-21-10-00217_Redacted.pdf

Justification Review Document for Other Than Full and Open Competition

(Required for actions $650,000 and up)

Control No: JA-21-10-00217

Program/Equipment: USAISR - Research Swine

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Research Swine for U.S. Army Institute of Surgical Research

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Signature:

Legal Counsel:

Acquisition Law Attorney U.S. Army Medical Research and Development Command

Signature:

FAR Part 6 Justification and Approval for Other than

Full and Open Competition

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland in support of the U.S. Army Institute of Surgical Research (USAISR), Fort Sam Houston, TX.

2. Description of Action: This approval is being requested for a new, Blanket Purchase Agreement (BPA) for repetitive orders of research swine.

3. Description of Supplies/Services: Under the contemplated award, Midwest Research Swine, LLC, 3413 11th Street E., Glencoe, MN 55336-3400, will provide research swine to the USAISR under a Blanket Purchase Agreement (BPA). The estimated total price of this request is $ for a five (5) year ordering period.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(A), Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: Under the contemplated award, Midwest Research Swine, LLC will provide research swine to USAISR under a Blanket Purchase Agreement (BPA). The ability to compare current experimental data with historical data is imperative to the scientific process. This is a follow-on award to W81XWH-15-A-0015 which was performed by Midwest Research Swine, LLC. Both W81XWH-15-A-0015 and the contemplated award support the same research protocols. Direct comparison of all experimental data across each study is essential for maintaining the scientific integrity and design of the research. Comparison of data can only be reliably performed if genetic variability among the research animals is controlled. Vendors of commonly used laboratory animals produce genetically distinct animals. Their behavioral characteristics and physical traits are different due to genetic variability that has occurred over decades of selective breeding. Therefore, substituting one vendor’s strain for another has the potential to confound the scientific results and validity of previous research. The only way to control the effects of genetic variability and ensure valid experimental data is to procure animals from the same vendor as the animals used on previous experiments supplied under W81XWH-15-A-0015 by Midwest Research Swine.

Midwest Research Swine also carries the “High Health Status Herd” designation. “High Health” was a requirement for W81XWH-15-A-0015. Past research at USAISR has shown that pigs originating from a “High Health” herd have a much higher survival rate when undergoing survival surgical procedures than animals from sources without this designation. The data required for the various research protocols are dictated by experimental design and statistical power analysis. When animals expire before established experimental end-points, data collection is incomplete and experiments must be repeated. As such, experience has shown that awarding the contemplated action to a vendor without the “High Health” designation will result in substantial duplication of cost to the Government that is not expected to be recovered through competition.

6. Efforts to Obtain Competition: Efforts to obtain competition consisted of the following pre-solicitation notices:

Sources Sought Notice number W81XWH-21-I-3223 was posted on beta.SAM.gov from 07 October 2020 to 15 October 2020 with no responses received.

Sole Source Notice of Intent number W81XWH-21-0-3223 was posted on beta.SAM.gov from 16 October 2020 to 02 November 2020 with no responses received.

a. Effective competition: Because this is a sole source action, effective competition is not applicable.

b. Subcontracting opportunities: All items must be provided by the prime contractor and no subcontracting opportunities are expected from this effort.

7. Actions to Increase Competition: Prior to the posting of the required pre-solicitation notices, efforts were made to determine if circumstances have changed since the last swine acquisition (W81XWH-15-A- 0015) that would now permit full and open competition. The customer indicated that current research protocols requiring direct comparison of results with historical data are ongoing. This precludes competition for this effort for the reasons previously discussed in Section 5 (above). As the research protocols with this requirement are closed, it is anticipated that future swine acquisitions may be competed.

8. Market Research: USAISR performed thorough market research before determining that Midwest Research Swine would provide the Army’s research swine. Market research conducted on the web sites include www.google.com www.guidelabanimals.com and www.laboratoryanimalsciencebuyersguide.com.

Previously, swine have been obtained from a local swine farm, which was USDA registered and had a close herd. This farmer has retired and swine are no longer available. Other sources providing research swine to the USAISR had endemic disease in the herds that resulted in skewed experimental results and the collection unusable data. The government is required to purchase from USDA registered vendors which further limits the potential sources of quality research swine. Sources Sought Notice number W81XWH-21-I-3223 was posted on beta.SAM.gov from 07 October 2020 to 15 October 2020 with no responses received.

9. Interested Sources: Sources Sought Notice number W81XWH-21-I-3223 was posted on beta.SAM.gov from 07 October 2020 to 15 October 2020 with no responses received.

http://www.google.com/ http://www.guidelabanimals.com/ http://www.laboratoryanimalsciencebuyersguide.com/

Sole Source Notice of Intent number W81XWH-21-0-3223 was posted on beta.SAM.gov from 16 October 2020 to 11 November 2020 with no responses received. To date, no other sources have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements.

a. W81XWH-10-D-0008, 5 MAY 10 – 5 MAY 15

b. W81XWH-15-A-0015, 1 JULY 15 – 30 JUNE 20

(2) The competitive status of these actions.

a. W81XWH-10-D-0008 was awarded through full and open competition as an unrestricted procurement with two offers received.

b. W81XWH-15-A-0015 – sole source BPA

(3) Authority previously cited if less than full and open competition was used.

The statutory authority permitting other than full and open competition is 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302- 1(a)(2)(iii)(A), Only one responsible source and no other supplies or services will satisfy agency requirements.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

Request for Information (RFI) W81XWH15-0-RSB1 was posted on FedBizOpps.gov from 16 February 2015 to 24 February 2015 with no responses received. With no other responsible sources capable of meeting the requirement identified, the decision was made by the contracting officer to proceed with Justification and Approval No.

JA15172.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The ability to compare current experimental data with historical data is imperative to the scientific process. This is a follow-on award to W81XWH-15-A-0015 which was performed by Midwest Research Swine, Inc. Both W81XWH-15-A-0015 and the contemplated award support the same research protocols. Direct comparison of all experimental data across each study is essential for maintaining the scientific integrity and design of the research. Comparison of data can only be reliably performed if genetic variability among the research animals is controlled. Vendors of commonly used laboratory animals produce genetically distinct animals. Their behavioral characteristics and physical traits are different due to genetic variability that has occurred over decades of selective breeding. Therefore, substituting one vendors' strain for another has the potential to confound the scientific results and validity of previous research. The only way to control the effects of genetic variability and ensure valid experimental data is to procure animals from the same vendor as the animals used on previous experiments supplied under W81XWH-15-A-0015 by Midwest Research Swine.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

Justification and Approval No. JA15172 was prepared to support Blanket Purchase Agreement W81XWH-15-A-0015, which was awarded prior to the currently contemplated effort. J&A JA15172 provided the following justification for limiting competition:

The ability to compare current experimental data with historical data is imperative to the scientific process. This is a follow-on award to W81XWH- 10-D-0008 which was performed by Midwest Research Swine, Inc. Both W81XWH-10-D-0008 and the contemplated award support the same research protocols. Direct comparison of all experimental data across each study is essential for maintaining the scientific integrity and design of the research. Comparison of data can only be reliably performed if genetic variability among the research animals is controlled. Vendors of commonly used laboratory animals produce genetically distinct animals. Their behavioral characteristics and physical traits are different due to genetic variability that has occurred over decades of selective breeding. Therefore, substituting one vendors' strain for another has the potential to confound the scientific results and validity of previous research. The only way to control the effects of genetic variability and ensure valid experimental data is to procure animals from the same vendor as the animals used on previous experiments supplied under W81XWH-10-D-0008 by Midwest Research Swine.

The Government’s requirement has not changed since the awarding of Blanket Purchase Agreement W81XWH-15-A-0015 and the justification for limiting competition remains valid for the currently contemplated award.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Deputy Director of Research Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: ☐ cost analysis ☒ price analysis ☐ should cost ☐ IGCE ☐ audit: ☐ other:

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☒ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Title: Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Officer Signature:

Approval Based on the foregoing justification, I hereby approve the procurement of Research Swine for the estimated amount of $ on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1), as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(A), Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Special Advocate for Competition Signature: