Sol_JA_75F40124Q00128.pdf

Justification for Other than Full and Open Competition

BRAND-NAME ONLY

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Contracting activity – U.S. Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS)

b. Sponsoring organization.

FDA/Center for Veterinary Medicine (CVM)/OAGS/Division of Emerging Technologies

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

i. Name:

ii. Mailing address: Building MOD2; 8401 Muirkirk Rd; Laurel, MD 20708

iii. E-mail address:

iv. Telephone number:

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

The FDA intends to make a purchase on a brand-name only basis for an Illumina NextSeq 2000 High Throughput Next-Generation Sequencing System.

a. Acquisition purpose and objectives.

The goal is to acquire the most advanced next generation sequencer on the market, brand name only to the Illumina NextSeq 2000, to contribute to CVM research.

b. Project background.

The Office of Applied Science conducts applied research in support of current and evolving FDA regulatory issues and work to provide research solutions that ensure the safety of animal derived food and animal health products. The Division of Emerging Technologies (DET) in the Office of Applied Science (CVM/OAS), investigate antimicrobial resistance and genetic mechanisms that confer multidrug resistance in foodborne pathogens. In order to advance these efforts, DET conduct routine whole-genome, shotgun metagenomics, and total RNA sequencing, and require an advanced, efficient, cost-effective, and high-throughput next-generation sequencer, brand-name only to the Illumina NextSeq 2000, to contribute to DET research.

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

Illumina NextSeq 2000 next generation sequencing System; FY23 estimated cost is approximately including shipping, installation, and training after a discount for a trade-in of a NextSeq 500 instrument. Overall value inclusive of option years for maintenance is estimated to be of approximately .

a. Project title.

Acquisition of an Illumina NextSeq 2000 next generation sequencing System.

b. Project Description.

This requirement is for the purchase of a modernized next generation sequencing system, brand name only to the Illumina NextSeq 2000. This system shall be capable of automated generation of DNA clonal clusters, nucleic acid sequencing by synthesis, and automated analysis of DNA sequences. The acquisition is for a complete system to include, but not limited to a touchscreen monitor, integrated computer, control software, and secondary analysis pipelines.

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:

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:

Other:

Completion Form

Term Form

Acquisition identification number.

CVM-OAS-24-C-1825; Requisition TBD

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

Estimated FY24 cost (after anticipated trade-in discount); overall contract value inclusive of options is approximately . The planned award date is 6/30/24 with delivery and installation to occur 60 days from award. The base year warranty is expected to cover one year from date of acceptance and option year 1 will begin at the end of the warranty period, if exercised.

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

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.

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).

Illumina Inc.

5200 Illumina Way San Diego, CA 92122-4616

OR,

GOVERNMENT SCIENTIFIC SOURCE INC

12355 Sunrise Valley DR STE 400 Reston, Virginia 20191-3497

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

Additional details of why only the Illumina NextSeq 2000 Sequencing system can meet the requirements of FDA are discussed in more detail in section 9 below.

6. 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.

A full and open competitive solicitation will be posted to the Governmentwide point of entry (Contract Opportunities) to allow all responsible sources to submit a quotation.

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

In accordance with FAR Part 13.106-3(a)(1), price will be determined fair and reasonable based on comparison of competitive quotations received. If only one response is received, pricing will be determined fair and reasonable utilizing one or more of the price analysis techniques described at FAR Part 13.106-3(a)(2).

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

Market research was conducted by the TPOC including the availability of products available on the market. The following is a short review of each vendor/technology and model of machine capable of producing nucleic acid data for DET’s mission critical research assignments.

11. 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.

No subsequent acquisitions of this instrument system are currently anticipated, however this contract will include option years for a maintenance agreement. At the end of the period of performance of this contract, market research will be conducted to determine if any other sources can offer the maintenance required for this instrument.

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:__________________________________

Benjamin Dorgan Contracting Officer

14. Competition Advocate signature.

Signature:_______Not Applicable____________________

Competition Advocate

15. Division Director and Head of the Contracting Activity signature(s).

Division Director

Head of the Contracting Activity

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement Executive

Benjamin J.

Dorgan -S

Digitally signed by Benjamin J.

Dorgan -S Date: 2024.01.30 15:44:39 -07'00'