JOFOC FE.pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration

b. Sponsoring organization.

CFSAN/ORS/DBC/CHCB

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Chung Cho

ii. Mailing address: 5001 Campus Drive College Park, MD 20740

iii. E-mail address: chung.cho@fda.hhs.gov

iv. Telephone number: 240-402-2044

2. Nature and/or description of the action being approved.

Purchase of xMAP Buffered Detergent Food Allergen Detection Assay kits

a. Acquisition purpose and objectives.

In late 2013 the FDA issued a contract (HHSF223201310201C) to Radix BioSolutions (Georgetown, TX) for the development of a multiplex assay to support enforcement of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation 2013. The xMAP Food Allergen Detection Assay developed by Radix BioSolutions was single-laboratory validated and its performance with various foods characterized as prelude to conducting MLV. This acquisition is to purchase xMAP Buffered Detergent Food Detection Assay kits for use in studying its performance with dietary supplements.

b. Project background.

Before the FDA can adopt an analytical method for use in the analysis of regulatory samples it is required that the method’s reliability & performance characteristics be fully characterized with the various food products it will be used with. One complex product line is dietary supplements.

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

$150,000 48-well xMAP Buffered Detergent Food Allergen Detection Assays

ALL test kits should be of a single lot of production and the same as any other test kits purchased UNLESS the deviation from this requirement is expressly agreed to by the FDA. Such test kits are expected to have an expiration date no earlier than June 2021.

The kits should be packaged such that enough beads for 5 kits are in the various vials, except two which will contain the equivalence of two kits. Any deviation from this requirement must be agreed to by the FDA.

It is understood that the production of bead sets / test kits may take several months and such is acceptable with the stipulation that the anticipated date of delivery is communicated to the FDA at least 2 weeks prior to shipping.

Radix BioSolutions Ltd. is authorized to hold-back, in-reserve from shipping to the FDA from this custom production run, 10% of the xMAP FADA test kits (1 kit = enough reagents for the analysis of 48 wells, including calibration standards), for Radix BioSolutions Ltd. to use as it deems appropriate to further the role of the xMAP FADA in regards to its role for the analysis of regulatory samples. Such uses include, but are not limited to, any QA/QC testing, disposition (including selling at the prices normally charged for xMAP FADA test kits) to various end users including third parties associated with any regulatory actions undertaken by the U.S. Government (e.g., FD and USDA-FSIS); USDA-FSIS laboratories, ORA-FDA laboratories for the analysis of regulatory samples, among others as Radix BioSolutions deems supportive of the establishment and recognition of the xMAP FADA as an analytical regulatory tool.

a. Project title.

xMAP Buffered Detergent Food Allergen Detection Assay

b. Project Description.

In late 2013 the FDA issued a contract (HHSF223201310201C) to Radix BioSolutions (Georgetown, TX) for the development of a multiplex assay to support enforcement of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation 2013. The xMAP Food Allergen Detection Assay developed by Radix BioSolutions was single-laboratory validated and its performance with various foods characterized as prelude to conducting MLV. This acquisition is to purchase xMAP Buffered Detergent Food Detection Assay kits for use in studying its performance with dietary supplements.

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Requirement type.

Research & Development (R&D)

R&D support services

Support services (non-R&D)

Supplies/equipment

Information Technology (IT)

Construction

Architect-Engineer (A&E) services

Design-build

Other: [Specify]

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Other fixed-price:

Cost-plus-fixed-fee

Other cost reimbursement:

Time and materials

Indefinite delivery: Definite quantity

Other:

Completion Form

Term Form

Acquisition identification number.

Purchase of xMAP Buffered Detergent Food Allergen Assay Kits

c. Total estimated dollar value and performance/delivery period.

$150,000/ before January 1, 2021

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

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Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Radix BioSolutions

111 Cooperative Way, Suite 120

Georgetown, Texas 78626

Phone: 512.869.8000

Fax: 512.868.9040

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This project specifically requires xMAP Buffered Detergent Food Allergen Detection Assay test kits. These kits are a unique product developed by Radix BioSolutions under FDA Contract # HHSF223201310201C and single laboratory validated per FDA Contract # HHSF223201510071A. The unique properties of these test kits were also extensively characterized in studies conducted by the FDA as published in the scientific

Last Modified: April 5, 2017 Page 5 of literature (Anal Bioanal Chem. 2015, 407:4195-206; J Agric Food Chem. 2016, 64:1202-1211) and in multiple international presentations. Substitution of the test kits is not acceptable.

Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

This project specifically requires xMAP Buffered Detergent Food Allergen Detection Assay test kits. These kits are a unique product developed by Radix BioSolutions under FDA Contract # HHSF223201310201C and single laboratory validated per FDA Contract # HHSF223201510071A. The unique properties of these test kits were also extensively characterized in studies conducted by the FDA as published in the scientific literature (Anal Bioanal Chem. 2015, 407:4195-206; J Agric Food Chem. 2016, 64:1202-1211) and in multiple international presentations. Substitution of the test kits is not acceptable.

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

N/A

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

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

Last Modified: April 5, 2017 Page 6 of minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Shaun MacMahon, Ph.D.

COR/Requiring Activity POC

4/1/2020

Signature:____________________________________

COR/POC Immediate Supervisor

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________

Contracting Officer

Shaun A.

Macmahon -S

Digitally signed by Shaun A.

Macmahon -S Date: 2020.04.06 10:04:45 -04'00'

Jennifer L. Gibson -S Digitally signed by Jennifer L. Gibson -S Date: 2020.05.29 09:33:54 -04'00'

Digitally signed by John H.

Callahan -S

Signature:____________________________Date: 2020.05.29 09:51:22 -04'00'________

Head of the Sponsoring Program Office