09162024_JOFOC_NEF_precisionFDA_Support (002).docx

TMPLT 2016.06-011

Justification for Other than Full and Open Competition

Completion Instructions:

Identification of the agency and contracting activity:

Federal agency and contracting activity.

HHS/FDA

Sponsoring organization.

Office of Digital Transformation (ODT), Office of Data Analytics and Research (ODAR), Health Informatics Staff (HIS)

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

i. Name: Annette Vernon

ii. Mailing address: 10993 New Hampshire Ave, Bldg 32 Rm 2254, Silver Spring, MD. 20993

iii. E-mail address: Annette.vernon@fda.hhs.gov

iv. Telephone number: 301.796.7325

Nature and/or description of the action being approved.

This memorandum serves as a justification for the approval of an increase in the ceiling of the existing award, Indefinite Delivery Indefinite Quantity (IDIQ) 75F40119D10041, there is a need for a ceiling increase from $20,000,000.00 to $23,036,960.56. An overall increase of $3,036,960.56 for the IDIQ to allow for a non-competitive, short-term, 6-month task order award in conjunction with raising the ceiling of the existing IDIQ.

The objective of the task order request is to continue to provide a framework to facilitate scientific community challenges that advances NGS technologies. Health Informatics Staff (HIS) is responsible for maintaining and improving the production version of precisionFDA that meets the following characteristics, capabilities, and requirements:

· Obtained a Federal Risk and Authorization Management Program (FedRAMP) Moderate authorization for a cloud-based Platform as a Service (PaaS)

· Facilitates private collaborations related to the tools and techniques used to analyze very large data sets

· Provides the ability to analyze data and test relevant tools and provides a library of reference data and comparative tools

1. Acquisition purpose and objectives.

This memorandum serves as a justification to raise the IDIQ ceiling to allow for additional task order. The purpose of this task order acquisition is to provide support for precisionFDA, an open-source, cloud-based regulatory science research space in which community members can share data, ideas and methods that advance the use of next generation sequencing (NGS) technology. This task order is necessary due to the receipt of last-minute funding and the lack of an available contract vehicle that would allow for a competitive procurement award within reasonable time constraints.

The FDA/ODAR Informatics Staff (HIS) plays a critical role in fulfilling the FDA’s mission to protect and promote the public health in the areas of big data analytics, data standards and data harmonization in order to:

· Advance regulatory science by providing easy access to FDA health information and enabling collaboration between internal and external experts.

· Inform regulatory decision making and research by developing standards to effectively exchange health information.

· Gain new insights from the integration and analysis of large and diverse health data sets.

HIS is focused on advancing the pace of scientific research by providing solutions that enable patients, researchers, industry, and government with access to Big Data and analytical tools that improve the quality of public health information resulting in improved public health. In doing so, HIS facilitates FDA in realizing a positive effect on public health that provides better management and timely utility of information and knowledge to FDA personnel, consumers, partners, and the public collaborates with other government agencies to provide cross-cutting solutions.

Project background.

The Food and Drug Administration (FDA) plays an integral role in precision medicine initiatives, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. To this end, the FDA is developing the tools, standards, and approaches needed to ensure that multi-omics tests provide reliable and accurate genetic results. This effort is one part of the FDA's commitment to leverage external resources and expertise to advance regulatory science, the science that is essential for product development and evaluation and which underpins the FDA’s regulatory decision-making.

PrecisionFDA is a secure, collaborative, virtual lab built on a high-performance computing platform in the cloud. PrecisionFDA connects industry and other external experts to FDA regulators and scientists to advance regulatory science and provides the tools and capacity to understand, evaluate and utilize large biological datasets for the benefit of public health.

This FDA requirement is a continuation of the IDIQ effort that began in 2019, the precisionFDA system has been developed and maintained by DNAnexus. That contract was openly competed as a five-year Indefinite Delivery Indefinite Quantity contract (IDIQ) ending September 2024. While that contract was openly competed, DNAnexus was the only provider able to meet the security needs of the solicitation.

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

1. Project title.

PrecisionFDA (pFDA) Operations and Maintenance Support Services Task Order

b. Project Description.

Services provided for this contract will be garnered under the precisionFDA system, with over 7,300 community members from around the world and it is currently publicly available and operational. Open-source software for the precisionFDA portal is located at https://github.com/FDA/precisionFDA.

The PrecisionFDA system is a fit-for-FDA-purpose portal that leverages the commercially available DNAnexus Platform (“Platform”). The users of the PrecisionFDA system see only the functionality of the underlying Platform that is revealed through the PrecisionFDA portal. The service is operational and on-going, as services provided are a virtual lab environment for collaboration, interactive regulatory review, and scientific exploration. Services are performed via the DNAnexus platform.

There are no unique requirements other than the discovery that there was only one solution provider for PrecisionFDA that met the high security platform requirements (FedRAMP Moderate, FISMA Moderate), therefore the use of the current contractor (DNAnexus) licenses to operate is our viable option for our precisionFDA system, otherwise the government will incur an extraordinary amount of transition costs for a new incumbent to become FEDRAMP and FISMA Moderate compliant.

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: Cloud services 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 Indefinite Quantity ☐ Other: This is a labor hour ☐ Completion Form ☐ Term Form Acquisition identification number.

PrecisionFDA Support Services – ODT-2024-124724 and Requisition # 1282495

Total estimated dollar value and performance/delivery period.

Total task order amount is $3,036,960.56 for the performance/delivery period of 9/28/2024 – 4/1/2025.

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 or the authority of 41 U.S.C. 1903.

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

Name and address of the proposed contractor(s). DNAnexus, 1975 West El Camino Real, Suite 204, Mountain View, CA 94040 ph: (415) 215-4183

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

b. As part of HIS’s mission, HIS is responsible for maintaining and improving the production version of precisionFDA that meets the following characteristics, capabilities, and requirements:

· Obtained a Federal Risk and Authorization Management Program (FedRAMP) Moderate authorization for a cloud-based Platform as a Service (PaaS)

· Facilitates private collaborations related to the tools and techniques used to analyze very large data sets

· Provides the ability to analyze data and test relevant tools and provides a library of reference data and comparative tools

· Provides a framework to facilitate scientific community challenges that advances NGS technologies.

Extensive market research was conducted and determined that this task order should go with the current incumbent. This should be a sole source contract awarded to the current contractor, DNAnexus. Our office received unexpected funding (Non-recurring Expenses Funds – NEF) this week with strict requirements for immediate obligation. Given the limited time, it was determined that the most effective way to utilize the unanticipated funding is to fund this task order within the time constraints.

When the precisionFDA Indefinite Delivery Indefinite Quantity (IDIQ) was originally awarded, there was only one qualified vendor that met the stringent Federal Risk and Authorization Management Program (FedRAMP) and Federal Information Security Management Act (FISMA) requirements to perform the IDIQ work.

As there was only one vendor who demonstrated capabilities required to perform the work, this vendor is currently positioned to fulfill the requirements of the task order immediately. We request that the justification for this one-time task order award be approved allowing the PrecisionFDA community to proceed with the research and development system that enables researchers and developers to test, pilot, and validate existing and new bioinformatics approaches for processing NGS data.

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.

Market research indicated that there was only one viable solution for this requirement. See question 8.

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

The Health Informatics Staff has meticulously adhered to the principles of fairness and reasonableness in evaluating costs associated with this task order. Our review ensured that this task order not only meets the necessary technical and performance requirements but also provides the best value for the government. We conducted extensive market research and gathered data on comparable contracts, we looked at industry, market rates and our historical past performance costs.

A thorough cost analysis was performed to assess the reasonableness of each cost associated with the work requirements. We conducted our Independent Government Cost Estimate based on direct costs such as labor, materials and overhead and well as considered licensing, indirect costs and other direct costs.

The price reasonableness was determined by comparing the cost data that we gathered for pricing and ensuring that the price is consistent with what has already been paid for and delivered in the past and what represents a sound expenditure. Our review determined that these costs are necessary and justified for the successful execution of the task order.

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 involved a series of steps designed to gather information about the availability, capabilities and costs of FedRAMP and FISMA moderate solutions, licensing and cloud services. Using the FedRAMP Marketplace website, viable companies that provided the required platform were identified. The analysis concluded 3 viable solutions were available. After reviewing those three companies only two met the overall technical requirements. An analysis of the costs to utilize those two companies determined that only one of the companies was a viable alternative. Additionally, after reviewing small business requirements only one of the two companies was a small business.

When taking into account one viable vendor, business size, security requirements, and overall costs it was clear that there was only viable solution provider. This market research determined that this task order contract should be awarded to the current contractor, DNAnexus. As DNAnexus has successfully met the specific and unique requirements to fulfill the task order. This vendor is necessary and in the best interest of the project. A full and open competition for this task order is not feasible due to the security requirements and FedRAMP compliance and an extraordinary amount of transition costs for a new incumbent within a limited time period.

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

FAR 6.302-1(a)(2)(ii) for a follow-on acquisition. Duplication of cost not recovered by competition.

Currently, we are actively engaged in the acquisition process to establish a new IDIQ contract that will address future requirements through a competitive process. This will result in a five-year IDIQ established to cover the flexibility and long-term requirements for the work needed for the PrecisionFDA system in the future.

Moving forward, we are committed to following the established procurement and acquisition process and this exception is solely due to the extraordinary circumstances surrounding unexpected, last-minute funding (NEF) from HHS. Awarding this to another contractor would not only require sufficient time to go through the competitive process, but it would also possibly result in shutting down the project because we would not be able to meet critical deadlines. Additionally, we have determined that at this stage of the project bringing in another contractor would require a complete rebuild of the precisionFDA portal. This rebuild would cost approximately $14.7M. This is a conservative estimate of the cost based on the portal development costing 50% of the total cost of the five increments in the previous IDIQ. This $14.7M would not be recoverable with a competitive contract. Rebuilding this portal would cost even more than the estimated $14.7M at this point.

Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed 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.

The program is continually monitoring the marketplace to determine if there are vendors that will meet the requirements for future acquisitions.

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 and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________ Annette Vernon COR/Requiring Activity POC September 16, 2024

Signature:____________________________________ Tyler Peryea COR/POC Immediate Supervisor September 16, 2024

Signature:____________________________________ Kevin Coakley Head of the Sponsoring Program Office September 16, 2024

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

Competition Advocate signature.

Competition Advocate

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

Division Director

Signature:____________________________________

Head of the Contracting Activity

HHS Senior Procurement Executive signature.

HHS Senior Procurement Executive

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