J&A N6264520P0011.docx

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

I. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD on behalf of the Department of Defense (DoD) Drng Demand Reduction Program (DDRP) to meet its requirements.

2. Description of the Action Being Approved.

The proposed action is for award of a contract on a sole source basis for a one month supply, and five option months, of immunoassay screening reagents for the detection of Fentanyl / Norfentanyl in human urine. . The Government intends on awarding a Finn Fixed Price (FFP) contract. The proposed source is Immunalysis, 9975 Summers llidge Rd, San Diego, CA 92121.

3. Description of Supplies/Services.

General Requirement for an Immunossay test reagent for the detection for Fentanyl / Norfentanyl in urine. Fentanyl SERFRIA kit, manufacture part number 6 ISUR-0500 are considered medical devices and have clearance from the Food and Drug Administration.

Fentanyl SERFRIA kit meets the following dmg cutoffs which are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively:

Drug Class

Drugs/Metabolites

(ng/mL)

1-lydromorphone

Alpha-hydroxyalprazolam

Estimated Dollar Value

Operation and Maintenance funds in the amount of$ will be used to fund line item 0001, which is the base 1 month supply. The five option periods in the total amount of $ are currently unfunded.

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 USC 2901, see also FAR 13.50l(a), Only One Responsible Source.

5. Rationale Justifying Use of Cited Statutory Authority.

DDRP has an immediate need for the fentanyl reagent. On 29 March 2019, the Office of the Under Secretary of Defense for Personnel and Readiness indicated that fentanyl and norfentanyl will be added to the DDRP drug testing panel within 90 days. In recent years, the emergence of fentanyl, a synthetic opioid which requires much lower doses to produce narcotic effects and which dramatically increases the likelihood of abuse and overdose, has been J&A

#20-00015 recognized as a serious public health issue. This is done to protect the interest and concerns of military and civilian members and our nation by providing identification and preventative action of drug abuse and potential drug overdose.

This requirement was previously competed as a small business set-aside in the fall of 2019. Multiple offers were received. However, none of the offers received from small businesses could meet the minimum requirements. limnunalysis was no longer considered a small business at the time of proposal evaluation and thus was ineligible for award, though it was found to meet the minimum requirements. Imnmnalysis was the only vendor identified capable of meeting the requirements of the Government. The solicitation, N62645-19-Q-0017, was cancelled and a notice of intent to sole source was posted to Federal Business Opp01tunities on 28 September 2019. No responses were received from the notice of intent and the requirement was sole-sourced to Immunalysis for a one time delivery.

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

This requirement will be posted to beta.sam.gov in accordance with FAR 5.202. NMLC is developing the acquisition strategy for a longer term contract that will be solicited using full and open competition. Market research was conducted in March, April, and May 2019. It included a search of the Internet using Google, Bing, GSA Advantage, and Federal Procurement Data System Next Generation (FPDS-NG) at https://www.contractdirectory.gov/conb·actdirectory/. Contact was also made with a subject matter expert, the Deputy of Navy Drug Testing Program, regarding requirement capabilities. It was determined that Immunalysis, Ark Diagnostics, and Carolina Liquid Chemistries were sources that could potentially provide reagents to meet the requirements of the Government, and at the time all were small businesses. A requirement was competed as a small business set-aside and multiple offers were received. However, none of the offers received from small businesses could meet the minimum requirements. Immunalysis was no longer considered a small business at the time of proposal evaluation and thus was ineligible for award, though it was found to meet the minimum requirements. Immunalysis was the only vendor identified capable of meeting the requirements of the Government.

A sole sourced contract was issued to Immunalysis for a five month supply of reagent. A notice of Intent to sole source to Immunalysis was posted to the Federal Business Opportunity website on 13 September 2019 with a closing date of28 September 2019. No responses were received.

A notice of intent to sole source this procurement will be posted to beta.sam.gov. All responses will be reviewed and handled accordingly.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies covered by this Justification and Approval will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

A long term, competitive contract is currently being solicited and was posted on https://beta.sam.gov/, on 13 January 2020, in accordance with FAR 5.203.

Certifications and approvals continued on next page.