Redacted_JOFOC.pdf

CVM-18-C-0142

Justification for Other than Full and Open Competition (JOFOC)

1. Agency: Food and Drug Administration (FDA), Department of Health and Human Services

A. Program Office: Center for Veterinary Medicine Office of Research (OR), Veterinary Laboratory Investigation and Response Network (Vet-LIRN), HFV-500

B. Project Officer: REDACTED

Food and Drug Administration

MOD 2

REDACTED

REDACTED

Contracting Officer’s Representative (COR):

REDACTED

Food and Drug Administration

REDACTED

C. Contracting Activity: Contract Specialist: Jennifer Mun Office of Acquisitions and Grants Services Food and Drug Administration

2. Nature of Action Being Proposed for Approval: This action is for the establishment of a new 3.25 year Indefinite Delivery Indefinite Quantity (IDIQ) contract for the purchase of Sensititre Microbial Identification Laboratory supplies. The required supplies are needed to support Veterinary Laboratory Investigation and Response Network (VET-LIRN) laboratories for characterizing clinical microbial isolates in a standardized manner.

3. Title and Description of Supplies or Services and Estimated Value:

a. Project Title: Establishment of a new 3.25 year IDIQ contract to purchase various Sensititre Microbial Identification Laboratory supplies (ref 3.c.) to be delivered to multiple locations in support of VET-LIRN network collaborating laboratories.

b. Contract/Order Number: TBD. Requisition Number: 1194169; CVM CIN:

c. Description of supplies or services: Sensititre Microbial Identification Laboratory supplies as detailed in the following table:

CLIN Catalog # Description

001 COMPAN1F

Sensititre Companion Animal MIC Plate with cephalothin (Pk of 10)

002 COMPAN2F Sensititre Companion Animal MIC Plate (Pk of 10) 003 EQUIN1F Sensititre Equine MIC Plate (Pk of 10) 004 CMV1BURF Sensititre Urinary MIC Plate (Pk of 10) 005 CMV1AMAF Sensititre Mastitis MIC Plate (Pk of 10) 005 BOPO6F Sensititre Bovine/ Porcine MIC Plate (Pk of 10) 007 AVIAN1F Sensititre Avian MIC Plate (Pk of 10) 008 JOEYE2 Sensititre JustOne Plate Format (Pk of 10) 009 COMPGN1F Companion Gram Negative Sensitivity Panel (Box of 10)

010 COMPGP1F

Sensititre Companion Animal MIC Plate Gram Positive (pk of 10)

011 GNID Gram negative ID panel GNID 012 GPID Gram positive ID panel GPID 013 R01552 MAC plate 014 R01217 CBA plate

d. Estimated Cost: This contract is a 3.25 year IDIQ. The required minimum will be met with the issuance of the first delivery order with estimated value of REDACTED with a contract ceiling estimated at REDACTED.

4. Statutory Authority: 41 U.S.C(c)(1) Only one responsible source and no other supplies or services will satisfy the agency requirements.

5. Contractor's Unique Qualifications to Provide the Services or Supplies and/or Why The Nature of the Acquisition Requires Use of the Authority Cited.

The Sensititre Microbial Identification Laboratory supplies are required to ensure consistent testing and comparability of antimicrobial resistance (AMR) data received from Vet-LIRN laboratories participating in Vet-LIRN AMR activities.

Vet-LIRN requires the Microbial Identification Laboratory supplies to be compatible with Sensititre equipment (such as ARIS, OptiRead, AIM, Vizion, and SWIM), which is currently in use at multiple Vet-LIRN laboratories. Sensititre equipment is compatible only with Sensititre supplies, and Remel Inc., a Thermo Fisher Scientific Brand, is the sole manufacturer and provider of required Sensititre supplies. A sole source letter certifying Thermo Fisher Scientific as the sole source supplier of products, services, and maintenance for the Thermo Scientific Sensititre ID/AST System and associated consumables is on file.

It is essential that the Microbial Identification Laboratory supplies are Sensititre brand as Vet-LIRN uses multiple pieces of Sensititre equipment to conduct AMR research. Using any other brand of Microbial Identification Laboratory supplies would severely limit Vet-LIRN’s ability to respond to emerging resistance problems and outbreaks. If Vet-LIRN were to acquire new equipment to replace the existing Sensititre equipment in Vet-LIRN laboratories, which have an estimated value of $204,000.00, there would be a significant duplication of cost that is not expected to be recovered through competition of the Microbial Identification Laboratory supplies. Therefore, to continue research on the existing Sensititre equipment, Vet-LIRN requires Sensititre Microbial Identification Laboratory supplies as they are the only known Microbial Identification Laboratory supplies compatible with the existing Sensititre equipment. Sensititre brand Microbial Identification Laboratory supplies is the only brand that can meet the Government’s minimum requirements due to compatibility.

6. Description of Efforts Made to Ensure Offers Are Solicited from As Many Potential Sources As Practicable.

CVM’s market research indicates that there is no other manufacturer of these supplies and equipment. See # 8

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable.

Prior to the award of the proposed contract, cost or pricing information will be obtained from the proposed contractor and price/cost analysis will be performed, reviewed, and documented to sufficiently determine that the cost to the Government is fair and reasonable.

8. Description of the Market Survey Conducted and the Results, or Statement of the Reasons a Market Survey was not conducted.

CVM has had multiple contracts for Sensititre equipment supplies. During the market research for previous IDIQ contract number HHSF223201110015I, various companies were surveyed to see if they could provide the required Microbial Identification Laboratory supplies (as PML Microbiologicals and BD Diagnostics), but it was determined that no company other than the manufacturer could provide Sensititre Microbial Identification Laboratory supplies compatible with the existing Sensititre equipment. Additionally, during the market research for more recent contract HHSF223201610042I, the GSA schedule was surveyed to ensure that the supplies could not be provided through GSA, and a Sources Sought Notice was posted on Federal Business Opportunities (FBO) on March 8, 2016. However, the Government received no capability statements from potential vendors in response to the Sources Sought Notice. In February 2018, during market research for the subject contract, the Government contacted REDACTED and REDACTED of Thermo Fisher inquiring if there were authorized resellers (especially small businesses) for the required Sensititre supplies. REDACTED provided a sole source letter certifying Thermo Fisher Scientific as the sole source supplier of products, services, and maintenance for the Thermo Scientific Sensititre ID/AST System and associated consumables. Therefore, market research concludes that Remel Inc., a Thermo Fisher Scientific brand is the sole provider of Sensititre Microbial Identification Laboratory supplies.

9. Other Relevant Facts Supporting the Proposed Noncompetitive Acquisition.

Currently, the Government owns pieces of equipment at VET-LIRN network with an estimated value of $204,000.00. It would not be fiscally prudent to replace this equipment solely to procure a different brand of Microbial Identification Laboratory supplies. Remel Inc. is the only known source that can supply Microbial Identification Laboratory supplies compatible with the existing Sensititre equipment at VET-LIRN laboratories.

10. Sources that have Expressed Interest in the Acquisition in Writing.

A combination Synopsis-Solicitation will be posted on FedBizOpps. If any other sources express interest or capability in this acquisition, they will be fully considered and a determination will be made to compete the procurement.

11. Statement of Actions, if any, to Remove or Overcome Barrier to Competition Before any Subsequent Acquisition for the Supplies or Services.

No other actions.

12. Provide a statement that indicates that the use of the Justification for procuring this supply or service is not a result of a lack of planning or the expiration of funds.

This justification for other than Full and Open Competition is necessary because there are no other qualified sources to meet this requirement. This justification is not necessary due to lack of planning or the expiration of funds.