Synopsis_Presolicitation Notice of Intent to Sole Source-Final.pdf

Notice of Intent to Sole Source – Office of Ethics and Integrity (OEI) Analytics and Decision Support

The U.S. Food and Drug Administration (FDA) intends to solicit a 5-year, sole source, firm-fixed-price type contract from Strategi Consulting, LLC, 5245 Wisconsin Avenue., Suite 600, Chevy Chase, MD 20815, in accordance with the authority under Federal Acquisition Regulation (FAR) 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements, and 15.101 Contracting by Negotiation. The North American Industry Classification System (NAICS) code is 561499 - All Other Business Support Services. The anticipated period of performance consists of a 12-month base and four (4) 12-month options.

The FDA’s Office of Ethics and Integrity (OEI) provides advice and assistance to current and former employees to help ensure that decisions they make, and actions they take, are not, nor appear to be, tainted by any question of conflict of interest. The ethics laws and regulations were established to promote and strengthen the public's confidence in the integrity of the Federal government. OEI strives to maintain a positive public perception in the way FDA conducts its business activities.

When needed, OEI consults with attorneys in the Department’s Office of the General Counsel, Ethics Division (HHS/OGC) and the U.S. Office of Government Ethics (OGE), who interpret legal provisions in the government-wide Standards of Ethical Conduct for Employees in the Executive Branch, HHS Supplemental Standards of Conduct, the criminal conflict of interest statutes (18 U.S.C. §§ 201-209), and the Foreign Gifts and Decorations Act. OEI may also consult with the U.S. Office of Special Counsel regarding the political activity restrictions under the Hatch Act.

For OEI’s staff to perform their daily activities, OEI utilizes the Ethics Application within FDA’s Agency Information Management System (AIMS), which is the official system for filer designation, in addition to record depository for all ethics records related matters. In addition to the AIMS-Ethics Application, OEI also utilizes several other systems, including the HHS Electronic Financial Disclosure System (EFDS) for collection and processing of the OGE 450 forms, and the U.S. Office of Government Ethic’s (U.S. OGE) Integrity system for collection and processing of the Public Financial Disclosure reports (OGE 278 and OGE 278T). In addition, OEI also utilizes the Enterprise Administrative Management System (EASE) system for a variety of personnel data, such as employment status, position history, and pay grades, etc.

In order to provide programmatic oversight and management of these functions, OEI requires a solution that integrates data from these systems and presents information in dashboards and reports that can be consumed by a variety of stakeholders.

The purpose of this contract is to procure continuous support to provide data reconciliation, ad-hoc reporting and analytics capabilities for collecting, storing, analyzing, and presenting data related to various ethics program area, including, but not limited to, the public financial disclosure (OGE Form 278), confidential disclosure (OGE Form 450), outside activities (Form HHS 520) and all associated forms required by OEI.

The Contractor shall work closely with OEI management and other identified stakeholders, as required, in-order-to support OEI for the duration of this effort and completion of the deliverables.

The Contractor shall develop and recommend methodologies and approaches that would aid OEI in developing comprehensive dashboards, data reconciliation, and ad-hoc reporting that encompasses all applications and systems that are currently being utilized by OEI. The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, as needed to perform the task areas listed below:

Task Area 1: Project Management Task Area 2: Advisory and Analysis Services Task Area 3: Reporting and Data Analytics Services Task Area 4: Integration Services Task Area 5: Analytics Platform Services

This contract will maintain the continuity of analytics services provided to OEI under the existing Analytics as a Service (AaaS) platform provided by Strategi Consulting, LLC (Strategi). The existing AaaS platform is proprietary to Strategi. The Aaas provides an advanced, secure, and responsive platform to efficiently monitor and enforce ethics compliance. The existing AaaS platform is fully integrated into OEI’s business processes. The contractor’s platform underpinning these services is/was designed, built, and maintained by Strategi in a cloud environment authorized to host FDA’s data by the FDA’s Cybersecurity Office.

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

Strategi is the current prime contractor and is the only responsible source for the services at the level of quality required to ensure continuity of services. OEI has been utilizing Strategi’s proprietary Analytics-as-a-Service (AaaS) platform since 2017, and since then improvements were made and the platform was made available through the Microsoft Azure Government platform. Strategi was the first contractor to have a custom tailored AaaS platform built for OEI’s specific need and is also compliant with stringent FDA cybersecurity requirements, including an Authorization to Operate (ATO). Strategi has proprietary ownership rights to the fully operational AaaS platform currently in use by FDA. The AaaS platform and the supporting services “as a service” to the FDA and all aspects of the system’s design, development, and operations are proprietary to Strategi. Strategi is, therefore, the only responsible source for continuing the services under the existing AaaS platform. The FDA has already incurred the cost of Strategi building AaaS platform and customizing it to FDA’s specific needs.

Additionally, in order to receive services from any other vendor, FDA would have to authorize costs for the creation of a new platform in addition to procuring the supporting professional analytics services.

That would necessarily require substantial duplication of costs already incurred by the agency.

Moreover, attempting to procure the services from any other source will result in unacceptable delays and risks. Moving to a new vendor would delay the agency’s ability to fulfill its requirements while a new system is procured and built, resulting in significant productivity disruptions and an unacceptable level of risk to the agency’s mission.

Strategi has the specialized working knowledge, systems, and processes and is capable of continuing services critical to OEI without interruption to the office. Also, Strategi Consulting can continue performing services without requiring a startup period and/or the normal learning curve typically encountered by new incoming contractors because systems and procedures are already in place. To have a new contractor would cause substantial duplication of cost to the Government, which is not expected to be recovered through competition and/or will cause unacceptable delays in fulfilling the executive agency’s needs with the same level of expertise deemed to be available only from the original source.

Strategi has proven capabilities and unique qualifications, including a fully operational responsive AaaS platform already tailored to the FDA’s specific needs. The system is compliant with stringent FDA cybersecurity requirements, including an Authorization to Operate (ATO). The current platform is hosted and housed by Strategi. The platform passed all assessments conducted by the Information System Security Officer (ISSO) and received concurrence from the FDA’s Privacy Office for the contractor to host thousands of employees’ data in their environment. A new incoming contractor would need to recreate this proprietary system entirely, without the benefit of requirements, design of the existing system, effectively requiring the government to pay for the work twice. The complexity and cost of replicating this secure environment with another vendor would be significant, both in terms of time delays, degradation of OEI’s capability to conduct its mission, and the duplication of cost to the taxpayer, which would not be recovered through competition.

The contractor must already have the ATO from the FDA’s Cybersecurity Office in order to not delay the services being provided to FDA employees. The ATO is a stringent process that took the current contractor about a year to obtain. The ATO process included multiple rounds of assessments conducted by the ISSO. OEI does not have the expertise to build and maintain this system; it is required that the contractor is approved to house, maintain and operate the system at their site. In order to host the system in the FDA network or have a system built by a new vendor, it would require the new vendor to obtain a new ATO, which could cause a year of delay. The initial ATO obtained by Strategi took a year to be completed.

Based on the above rationale, Strategi Consulting, LLC, is the only responsible source that will satisfy agency requirements.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response which clearly supports and demonstrates its ability to perform the requirements. Any response must be received by the response date and time set forth in this notice. Any response will undergo a review to determine whether the respondent can meet the contract requirements. A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Response Date and Time: 4:00 p.m. ET on August 26, 2024. Responses must be emailed to Alice Mihill at Alice.Mihill@fda.hhs.gov, with a CC: to Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov.

mailto:Alice.Mihill@fda.hhs.gov mailto:Nicholas.Bisher@fda.hhs.gov

The U.S. Food and Drug Administration (FDA) intends to solicit a 5-year, sole source, firm-fixed-price type contract from Strategi Consulting, LLC, 5245 Wisconsin Avenue., Suite 600, Chevy Chase, MD 20815, in accordance with the authority under Feder...