Justification and Approval Redacted.pdf

J&A Number 23-00013

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity:

The Justification and Approval (J&A) is executed by the Naval Medical Readiness Logistics Command (NMRLC), 693 Neiman Street, Fort Detrick, MD 21702, on behalf of the requesting agency, Naval Medical Research Center (NMRC), Silver Spring, MD.

2. Description of the Action Being approved:

Approval is being sought for the award of a sole source single award indefinite delivery indefinite quantity (IDIQ) to provide supplies in support of real-time polymerase chain reaction (RT-PCR) reagent production activities to Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46256- 1025.

3. Description of the Supplies or Services Required to Meet the Agency's Needs:

The Molecular Department of the Biological Defense Research Directorate, Naval Medical Research Center produces reagents for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. NMRC requires up to 275 each of LightCycler Faststart Uracil-DNA Glycocylase (0361740810), up to 77 each of 12.5mM solution of dNTPs (Deoxynucleoside triphosphates) (05910412190) and up to 10 each of Bovine Serum Albumin (BSA) (B-14) SQ (10715859103) for Molecular Biology 20mg/1 ml (2% solution) bulk packages, to be procured on an as-needed basis (via delivery orders) during the 3-year ordering period.

The contract is anticipated to include a base 3-year ordering period. The total estimated value of this requirement is

4. Statutory Authority Permitting Other than Full and Open Competition:

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C.

§1901. (See also FAR 13.5).

5. Rationale Justifying Use of Cited Statutory Authority:

Market research was conducted using GSAadvantage.gov to determine if items were available in the commercial marketplace and if sources, other than Roche, were capable of meeting the Government’s need. Market research located two potential sources (ThermoFisher and Franklin Young) to supply Uracil-DNA Glycosylase (UNG); two potential sources (ThermoFisher and Promega) to supply dNTPs; and two potential sources (Sigma-Aldrich and Promega) to provide bovine serum albumin (BSA). As discussed later in this document, market research determined these products were not utilized in the initial optimization process (research, development, test, and evaluation efforts) that resulted in BDRD’s ability to produce the best quality reagent. The use of any other products would void the optimization efforts and standard operating procedures used in BDRD’s production of these reagents.

The BDRD development process for the production of these reagents included extensive testing of various reagent components (three of which are included in this requirement) to produce the best combination of reagent components for the detection and identification of biological warfare agents. The UNG, dNTP blend, and the BSA, all produced by Roche are three reagent components needed to enable BDRD to produce the required reagents in accordance with their standard operating procedures. To utilize another vendor’s products, which vary slightly from the components needed for this requirement, would invalidate all previous research optimization and evaluation efforts, and would require additional Government resources to perform re-optimization and re-evaluation resulting in increased Government expenditure, extensive delays in the production process, and delays in product distribution. Any reagents produced with these components from another vendor without extensive re-optimization and evaluation would result in reduced and scientifically questionable performance of the reagents. This is unacceptable to various Government agencies that depend on the current reagents which are used in ongoing operations. The BDRD reagents and kits produced are developed in tightly controlled assays designed and optimized, using these specific reagents components to maximize accuracy.

Therefore, the components of these assays cannot be substituted by components from other manufacturers. To ensure continuous production of the critical reagents, a constant supply of essential components from Roche Diagnostics custom Biotech are required, no other source can meet the needs of the Government.

Market research utilizing GSAAdvantage.gov, for each item is outlined below:

Item 1. Uracil-DNA Glycosylase (UNG): The concentration of glycerol in the ThermoFisher and Franklin Young Intl (distributor of ThermoFisher product) storage buffer is significantly higher (50% v/v ThermoFisher/Franklin Young, 5% v/v Roche) than Roche. Glycerol is a known inhibitor of PCR reactions and incorporation of ThermoFisher UNG would likely reduce the performance of the produced reagents that would be unacceptable to the end-users and have a negative impact. Detailed studies would be required to determine if substitution of ThermoFisher suppled UNG would impact performance of the reagents.

Item 2. dNTPs: The concentrations of the dNTPs carried by ThermoFisher and Promega are of a different concentration and formulation than those carried by Roche. The reagents produced by NMRC/BDRD use specific research standard operating procedures (SOP) to ensure a stable quality product. The SOP is based on using the Roche dNTP Blend concentrations and formulation. It would not be possible to substitute another vendor’s materials that would require significant re-optimization and re-evaluation efforts in order to produce the optimized reagents.

Item 3. Bovine Serum Albumin (BSA): Sigma-Aldrich provides a 2% solution, which is a resale from Roche which may compromise the integrity of the product. Promega does not provide the 2% solution in a “ready to use” form, Promega only provides a BSA in a form standardized for use in restriction digestions reactions. Also, many forms of this product are found in a modified acetylated state. Solid forms of BSA (grams) are not acceptable for they would introduce variation to the production process and cause extensive re-standardization of the BDRD produced custom products.

Based on BDRD optimization research and the market research included herein, only one source is capable of meeting the Government’s requirement.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable:

The Sources Sought Notice was published on date 20 July 2023 with a closing date 25 July 2023, via SAM.gov. The sole source vendor Roche Diagnostics Corporation summitted a capability statement on date 24 July 2023. Notice of Intent to Sole Source was published for 10 days, with a closing date 10 August 2023 via SAM.gov.

7. Determination of Fair and Reasonable Cost:

The Contracting Officer determines the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable by conducting a price analysis in accordance with FAR part 13.5 prior to award.

8. Actions to Remove Barriers to Future Competition:

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of supplies covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point of Contact:

The point of contact at NMRLC is Marchaunda L. Tiller by email at Marchaunda.l.tiller.civ@health.mil.

See Approvals on Next Page

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

TECHNICAL/REQUIREMENTS COGNIZANCE

Stephen Lizewski Naval Medical Research Center

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

OGC

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A/LSJ value is between $250,000 and $750,000, the Contracting Officer’s signature below also represents approval of the J&A/LSJ.

Contracting Officer

COMPETITION ADVOCATE REVIEW

To the extent that the J&A/LSJ value is between $750,000 and $15,000,000, the Competition Advocate’s signature below also represents approval of the J&A/LSJ.

Competition Advocate

LIZEWSKI.STEPHEN.E

UGENE.1272396309

Digitally signed by

LIZEWSKI.STEPHEN.EUGENE.1272396

Date: 2023.08.29 13:37:11 -04'00'

VAIDEN.JAMES.E.JR.

1471614838

Digitally signed by

VAIDEN.JAMES.E.JR.1471614838

Date: 2023.08.29 14:17:16 -04'00'

BROWN.SHERELL.G.1

049873782

Digitally signed by

BROWN.SHERELL.G.1049873782

Date: 2023.08.29 14:20:16 -04'00'

SWIFT.MARIA.M.1228621770

Digitally signed by

SWIFT.MARIA.M.1228621770

Date: 2023.08.30 09:18:50 -04'00'