FAR 13.5 Single Source or Brand Name Justification Exceeding SAT_s.pdf

United States Department of Agriculture Sole Source (Including Brand Name) Justification under

Simplified Procedures for Certain Commercial Items (FAR 13.5)

1. Identification of the agency and the contracting activity.

USDA APHIS

250 Marquette Ave., Suite 410 Minneapolis, MN 55401

2. The nature and/or description of the action being approved.

USDA proposes to enter into a firm-fixed-price Indefinite Delivery Indefinite Quantity (IDIQ) contract with Innovative Diagnostics using the simplified acquisition procedures for certain commercial items under Federal Acquisition Regulation (FAR) Part 13.5.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

Diagnostic test kits for detection of glanders required for import testing: ID Screen Glanders Double Antigen CAT#GLANDA-5P ID Screen Glanders Double Antigen ELISA.

Estimated value:

Ordering Period 1 (12 months): $180,600 Ordering Period 2 (12 months): $180,600 Ordering Period 3 (12 months): $180,600 Ordering Period 4 (12 months): $180,600 Ordering Period 5 (12 months): $180,600 Total Estimated Value: $903,000

4. The statutory authority permitting other than full and open competition.

41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR 13.500(a) and implemented by FAR 13.501(a).

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

This diagnostic kit known as the Double Antigen ELISA kit. is the only test validated at this time by the World Organization for Animal Health reference laboratory for glanders. No other known test can meet the National Veterinary Services Laboratories requirement for performing diagnostic testing which is required by 9 CFR 93.308. Evaluation of kits by the National Veterinary Service Laboratories noted the sensitivity and specificity qualities of diagnostic reports which ensure animal health is being maintained at the highest of standards. If the ID Screen Glanders Double Antigen ELISA kits are not procured, NVSL will be unable to perform the most accurate testing available to meet this mission. This kit is specifically described in VSG13407.03. Other validated testing modalities available are less sensitive and specific than the ID Screen Glanders Double Antigen ELISA, causing false positive results, which are costly to importers. Alternatively, false negative results may occur, which could result in introduction of disease to US domestic horse populations.

The Double Antigen ELISA kits are manufactured and sold exclusively by Innovative Diagnostics.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

A sources sought notice (12639523Q01090073) was posted on SAM.gov and resulted in no responses. A notice of the proposed sole source contract action and solicitation information will be posted on SAM.gov in accordance with FAR 13.104(b).

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Government will determine a fair and reasonable price based on comparison to industry pricing for similar products.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

Market research was conducted in accordance with FAR Part 10, details of which are in the market research document in the contract file. This effort did not yield any additional sources that can meet the Government’s requirement.

9. Any other facts supporting the use of other than full and open competition.

N/A

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

Innovative Diagnostics 310 rue Louis Pasteur-34790 Grabels-France

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

The Government will continue to perform market research to identify products that would meet the Government’s requirement.

Certifications & Approvals

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Juanita Grause Technical Point of Contact

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Lisa Draves Contracting Officer

Additional Reviews & Approvals

Advocate for competition for the procuring activity (if over $750,000). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief.

Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity/MASCO, I hereby approve this justification.

Larry Nelson Procuring Activity Advocate for Competition