JEFO SDSSM_redact.pdf

Justification for an Exception to Fair Opportunity

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Department of Health and Human Services (HHS) U.S. Food and Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS)

b. Sponsoring organization.

Center for Food Safety and Applied Nutrition (CFSAN) Office of Management (OM) Division of Information Technology Management (DITM)

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

i. COR/POC:

ii. Mailing address:

iii. E-mail address:

iv. Telephone number:

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

a. Acquisition purpose and objectives.

The purpose of this acquisition is to award a follow-on bridge order to Trigent Solutions Inc. in support of the Center for Food Safety and Applied Nutrition (CFSAN); to be issued under their National Institutes of Health Information Technology Acquisition and Assessment Center (NITAAC) Chief Information Officer-Solutions and Partners (CIO-SP3) Small Business contract number 75N98120D00098. The follow-on order is a short term bridge to ensure there is no lapse in service while the FDA conducts new market research to find another vendor in the Small Business Administration’s (SBA) 8(a) Business Development Program. It is critical that services are maintained during this time as contractor support is needed for CFSAN’s Scientific Data Workflow Systems Development and Modernization efforts. The contractor support allows CFSAN to quickly analyze and decode complex genetic sequences in response to foodborne disease outbreaks;

share research data with external collaborators; assist in the development of regulatory workflows and decision-making processes; perform complex risk analysis to predict and prepare for foodborne illness outbreaks; and enhance the efficiency of genomics and bioinformatics applications. to ensure that CFSAN continues to fulfill its mission to ensure food safety. Without support for these functions, CFSAN’s ability to fulfill its mission to ensure food safety would be significantly compromised.

b. Project background.

The services required are in the SBA 8(a) Business Development Program. The services were previously acquired under a directed 8(a) task order under NITAAC CIO-SP3 to Trigent Solutions Inc. contract no. 75N98119D00034, order no. 75F40122F80373.

The FDA understands the scope of work under this requirement is in the SBA 8(a) Business Development Program and does not intend to permanently pursue support for these services outside of the program beyond this short-term bridge order. The follow-on bridge order is a result of the circumstances below.

Early August 2024, the FDA submitted an offer letter to the SBA for a directed award to Trigent Solutions Inc. utilizing their NITAAC 8(a) contract, no. 75N98119D00034, but the offer was rejected as Trigent Solutions Inc. despite still having an active 8(a) contract on NITAAC.

As such, the FDA conducted additional market research and sent a new offer letter to the SBA for a direct award to Precise Systems Inc. This offer was also rejected; the SBA stated in their email “the information provided does not align with the regulatory requirements and parameters, thus we are unable to accept the proposed offer.” However, the SBA advised that “to avoid any interruption in service, the agency may choose to implement a bridge contract to guarantee the continuity of services while it finalizes its 8(a) follow-on requirement.”

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

a. Project title.

Scientific Data System Support and Modernization

b. Project Description.

CFSAN has a requirement for a Scientific Data Workflow Systems Development and Modernization Support Team to evaluate new and existing scientific workflows for cloud feasibility, and architect and implement cloud solutions for migration to a public cloud service such as Microsoft Azure, Amazon Web Services (AWS) or Google Cloud. The purpose of this requirement is to provide a support team that has a comprehensive knowledge of scientific data related to genomics, transcriptomics, metagenomics bioinformatics, and epigenomics.

The requirement is for complete range of scientific computing services necessary to support FDA scientists and research programs. This requirement includes:

1. IT Management Services for Biomedical Research, Health Sciences, & HealthCare

2. CIO Support

3. Operations and Maintenance

4. Independent Integration Services

5. Software Development and Cloud Services

Requirement type.

Support services (non-R&D)

Information Technology (IT) Type of action.

Follow-on Proposed contract/order type.

Firm-fixed-price Other: Labor Hour

Acquisition identification number.

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

The total estimated value for a period of performance of six (6) months is .

4. Identification of the exception to fair opportunity (see 16.505(b)(2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

(B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. IAW 16.505(a)(4)(ii) suggests placing brand-name justifications under this exception.

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

The Contracting Officer will ensure the bridge order represents the best value to the Government and that the cost will be fair and reasonable to the Government. The NITAAC CIO-SP3 labor categories and rates were previously determined to be fair and reasonable, However, the Government will conduct market research to ensure that the rates are still in line with the current market. Furthermore, the Contracting Officer will leverage historical data from the incumbent order to inform pricing strategy for the new work. Leveraging the expertise of technical evaluator(s) of the requirement and real time operational environment will support the Contracting Officer in evaluating quoted pricing. The Contracting Officer will ensure the established prices for the new order represents a fair and reasonable price.

6. Any other facts supporting the justification.

No other facts.

7. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

The FDA will be conducting new market research to solicit and award a new 8(a) contract. Directed or competitive solicitation, the FDA does not intend to remove the services from the SBA 8(a) Business Development Program without their approval. This is a short-term bridge order and the FDA will make every effort to overcome barriers that led to this procurement action.

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8. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:____________________________________ Thomas Farrell

COR/Requiring Activity POC

Signature:____________________________________ Bhabani Das

COR/POC Immediate Supervisor

Signature:____________________________________ Robyn Barringer

Head of the Sponsoring Program Office

9. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided.

(NOTE: The CO’s signed certification may serve as approval of a JEFO over $150,000 but not exceeding $700,000, FAR 16.505(b)(2)(ii)(C)(1) depending on OPDIV procedures.)

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Signature:____________________________________ Michelle Dacanay

Contracting Officer

Bhabani Das -S Digitally signed by Bhabani Das -S Date: 2024.09.06 12:17:45 -04'00'

Robyn P.

Barringer -S

Digitally signed by Robyn P. Barringer -S Date: 2024.09.06 12:21:28 -04'00'

Thomas J.

Farrell -S

Digitally signed by Thomas J. Farrell -S Date: 2024.09.06 12:32:38 -04'00'

Michelle L.

Dacanay -S

Digitally signed by Michelle L.

Dacanay -S Date: 2024.09.11 16:56:04 -04'00'