ODT-2024-124724_Justification and Approval Brand Name_pFDA_Sep10_signed.pdf

Justification and Approval Brand Name

Exception to Fair Opportunity

September 10, 2024

1. Agency and Contracting Activity:

Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA)

a. Program Office/Center:

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

b. Contracting Officer’s Representative (COR) / Address / Telephone:

Contracting Officer’s Representative (COR) - Annette Vernon U.S. Department of Health and Human Services (HHS) U.S. Food & Drug Administration (FDA)

Address: 10993 New Hampshire Ave Rm 2254

Silver Spring, MD 20993

Telephone (301) 796-7325

c. Contracting Activity:

Food and Drug Administration (FDA) Division of Information Technology Acquisitions Office of Acquisitions and Grants Services (OAGS)

2. Nature of Action Being Proposed for Approval:

This memorandum serves as a justification for the approval of a non-competitive task order short-term award in conjunction with raising the ceiling of the existing PrecisionFDA Support Indefinite Delivery Indefinite Quantity (IDIQ). We are requesting the IDIQ (75F40119D10041) contract award, ceiling be increased from $20,000,000.00 to $22,500,000.00. An overall increase of $2.5M for the IDIQ.

The ceiling increase of the IDIQ is needed to award a task order to provide operations and maintenance 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. Additionally, this task order will provide the PrecisionFDA Global Substance Registration System (GSRS) portal enhancements that will improve data security, performance, interoperability, and standardization of the critical data

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

U.S. Food & Drug Administration elements to establish a modernized and more secure data architecture, improve data pipelines and develop key features that enhance the portal’s ability to format data.

Overall, this task order is intended to be a one-time, short-term solution to ensure a task order is in place for PrecisionFDA within the imposed timeframe.

3. Background of Action Being Proposed for Approval:

Our office received unexpected funding (NEF) of $1M 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.

Since there was only one suitable vendor who demonstrated capabilities required to perform the work, this vendor is currently positioned to fulfill the requirements of this task order immediately. We request the approval for this one-time task order award. Approval allows FDA resources to ensure that our PrecisionFDA community continues its work that enables reviewers, researchers and developers to test, pilot, and validate existing and new bioinformatics and NGS data using FDA’s PrecisionFDA system.

4. Moving Forward of Ongoing Acquisition Process:

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 PrecisionFDA 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.

5. Description of Supplies or Services and Estimated Value:

The following products and services will be acquired under this acquisition:

IGCE

Cloud Platform $ 1,020,260.00 ODC's $ 813,040.00 6 Months

Labor Category Labor Rate* Hours Allocated Total Cost

Senior Project Manager $ 185.00 400 $74,000.00 Senior Bioinformatics Expert $ 204.00 300 $61,200.00 Computer Security Specialist $ 162.00 600 $97,200.00 User Support Specialist $ 118.00 600 $70,800 .00 Cloud Engineering Specialist $ 180.00 400 $72,000.00

Applications Developer $ 162.00 750 $121,500.00 Applications Programmer $ 152.00 700 $106,400.00 Quality Assurance Specialist $ 159.00 400 $63,600.00

Estimated Total Services $666,700.00 Estimated Total of All $ 2,500,000.00

6. Statutory Authority:

This task order requisition is required by FDA and imposed by law

• Section 745 of the Federal Food, Drug and Cosmetic Act (Added by FDASIA)) – Aims to improve transparency in clinical research, ensuring electronic format – availability to the public.

• 21st Century Cures - Directs modernization of product review processes

• Federal Open Data Policy (M-13-13) - The Executive Branch must make its non-confidential data publicly available in open format, using data standards, and machine-readable, Section 351 of the Public Health Service Act (electronic listing of certain biological products and registration of the manufacturing establishments for certain biological products)

7. Contractor’s Unique Qualifications to Provide the Services or Supplies and/or Why the Nature of the Acquisition Requires Use of the Authority Cited:

The DNAnexus solution is the current contractor incumbent that is FedRAMP and FISMA compliant .

DNAnexus solution addresses specialized requirements that meet FDA needs to facilitate work supporting our PrecisionFDA system, data interchange and covering required use of health-related data, information, and knowledge.

8. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable:

This acquisition requirement is a task order under the existing contract as a task order against IDIQ 75F40119D10041.

9. Statement of Actions, If Any, to Remove or Overcome Barriers to Fair Opportunity Before any Subsequent Acquisition for the Supplies or Services:

FDA will not be able to meet its regulatory commitment to provide a regulatory tool that helps inform reviewers, researchers, and data scientists on the state of emerging science.

10. Certification and Signatures This is to certify that the data supporting this justification is the responsibility of the undersigned program office personnel (technical and/or requirements personnel), including verifying the Government's minimum needs or requirements or other rationale for an exception to fair opportunity (pursuant to FAR 16.505(b)(2)(ii)(9)), which form a basis for this justification, and that such data and rationale are accurate and complete

Contracting Officer’s Representative (COR) _________________________________

Head of the Sponsoring Program Office _________________________________

Contracting Officer, OAGS _________________________________