JA Urgent and Compelling.pdf

JUSTIFICATION & APPROVAL FOR OTHER THAN FULL AND OPEN

COMPETITION FOR SIMPLIFIED ACQUISITIONS

FAR Part 13.106-1

1. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Food and Drug Administration (FDA) urgently needs a high-temperature short-time (HTST) pilot-scale pasteurizer to process small volumes (approximately 5 liters) of milk with continuous flow at a nominal flow rate of 0.5L/min and 30 second max residence time (15 secs bulk mean residence time) at laminar flow. The unit should have two (2) independent product heaters (preheater and final heater) for rapid product heating seen in commercial pasteurization units. The unit must allow for interchangeability of hold tube designs. The pasteurizer must have dual product inlet ports, customized sample ports located at the hold tube inlet and at the hold tube outlet with sample port coolers, and a sterile product outlet after the product cooler. The system must have automated controls and data question for pressure, pump speed and temperature of the product at the beginning and end of the hold tube, and after the product cooler. The system must have stainless-steel product lines. The estimated dollar value is $216,000.

2. An Identification of the statutory authority permitting other than full and open competition.

No Synopsis is required IAW FAR 5.202(a)2: The proposed contract action is made under the conditions described in 6.302-2 (or, for purchases conducted using simplified acquisition procedures, if unusual and compelling urgency precludes competition to the maximum extent practicable) and the Government would be seriously injured if the agency complies with the time periods specified in 5.203.

3. Contractor’s Unique Qualifications to Provide the Equipment.

In accordance with the market research conducted by the program office and Contracting Officer and described in Section 6 below, MicroThermics is determined to be the only provider of the required high-temperature short-time (HTST) pilot-scale pasteurizer in the short timeframe to meet the public health emergency. MicroThermics has 30+ years of industry experience manufacturing small-scale HTST pasteurizer. By accurately reproducing production processes, MicroThermics equipment eliminates the need to test on full-scale processing equipment and will enable researchers to run many test conditions in just a few days.

a. Name and address of the contractor:

MicroThermics, Inc.

3216-B Wellington Ct.

Raleigh, NC 27615

4. Nature of the acquisition and rationale supporting the justification.

The FDA’s primary mission is to promote and protect the public health and the need to acquire a HTST pilot-scale pasteurizer to conduct pasteurization studies to ensure continued consumer confidence in the safety of the milk supply. Over the past several weeks, HPAI has caused illness in milking cattle herds across states. This virus, previously not known to infect cattle, has shown through preliminary testing to be in the milk. FDA is currently working rapidly stand-up research activities in support of responding to an emerging virus in cattle with the potential for public health consequences related to this important category of human foods.

The primary preventive control for biological hazards in milk is pasteurization. Since the virus has only recently emerged in cattle, there are no previous studies on the efficacy of pasteurization on this virus in milk. The risk to human health related to consuming food contaminated with this virus is largely unknown. Therefore, it is critically important to conduct these pasteurization studies as quickly as possible to ensure continued consumer confidence in the safety of the milk supply. The pasteurization process will need to be verified and validated using a pilot-scale continuous flow pasteurization system that closely approximates the conditions of large commercial-scale dairy processing operations. A customized pilot-scale continuous flow pasteurization unit is therefore urgently needed for the study.

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

The anticipated price will be determined fair and reasonable using the price analysis techniques described in FAR Part 13.106-3(a).

6. Description of the Market Survey Conducted and the Results, or Statement of the Reason a Market Survey was Not Conducted.

In depth market analysis, through internet searches, a search of SAM.gov, review of scientific literature, and personal knowledge of food process engineering and equipment design, indicated that there is only one manufacturer of pilot-scale HTST pasteurizers in the United States. MicroThermics, has 30+ years of industry experience manufacturing small-scale HTST pasteurizer. MicroThermics is a small business and search results on SAM.gov, (formerly FBO.gov), indicate that MicroThermics has previously been awarded a sole source contract for a UHT/HTST pasteurizer by the USDA in 2009.

One other manufacturer, OMVE, was identified through an internet search as having a pilot-scale HTST pasteurizer. The company is based in the Netherlands. FDA was unable to determine if customized sample ports and coolers at the inlet and outlet of the custom length hold tube were available on the HTST pasteurizer. The product lead time is unknown, but given that the manufacturer is in the Netherlands, rapid turnaround to meet FDA’s urgent need is unlikely as typical “door-to-door” freight delivery from the Netherlands to the USA would be 24-40 days.

Certification and Signatures:

Program Office Certification:

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the

Government's minimum needs, schedule requirements or other rationale for other than full and open competition, are accurate and complete.

Nathan Anderson Date Requiring Activity POC

Contracting Officer Certification:

I certify that this submission is accurate and contains complete data necessary to support the recommendations for approval. The contracting officer further certifies that an award of this contract action from this requirement will be made only if the price or cost to the Government is determined to be fair and reasonable.

Regina Williams Date Contracting Officer