Award Notice and Limited Source Justification.pdf

Public Award Notice of Blanket Purchase Agreement

Subject: Synopsis of the Food and Drug Administration’s Awarding a Blanket Purchase Agreement (BPA) with a Limited Source Justification to Executive Information Systems, LLC (EIS) for SAS software licenses purchase and subscription, SAS professional service support, and training needs, under Request for Quote FDA-RFQ-21- 1235685.

Pursuant to the authority of Federal Acquisition Regulation (FAR) 8.405-6(b) (items peculiar to one manufacturer), Food and Drug Administration (FDA) awarded on December 31, 2020, a BPA with estimated value of $49.9 million dollars for a five-year term (Base and four 12-months Option Years) to EIS, located at:

16901 Rockledge Drive, Suite 600

Post Office Box 34076, Bethesda, MD 20827

Main: 301-581-8594

Fax: 301-581-2573

Email: sales@execinfosys.com

FDA posted the RFQ (FDA-RFQ-2021-1238077) on GSA e-Buy with a limited source justification (see attachment). The objective was to establish a BPA for the purchase and renewal of SAS software, services and training. EIS was the only responsible source that can satisfy the agency’s requirements because they were SAS’ sole authorized reseller for Version 8 and later of the Software to government entities and institutions. Additionally, the EIS GSA Schedule is the sole GSA Schedule which offers professional services specifically performed by SAS employees.

This BPA allowed FDA to purchase provided advanced-level architectural and technical support for installing, configuring, and operating SAS and JMP systems, while ensuring minimal impact on the user community for transitions between current products, services and systems and future acquisitions. The

BPA secured significant discounts off the EIS’ GSA schedule (Contract 47QTCA18D0081) for SAS software license subscription and purchase, professional service support, and training; and reduced administrative costs for contract maintenance, inventory, tracking, accounting, and procurement actions through the life cycle of this BPA.

This notice is to fulfill the requirement of FAR 8.405-6 (a) (2) (i) to post a notice and the justification at the GPE https://beta.sam.gov/ in accordance with FAR 5.301 for a minimum of 30 days.

Please email Min Jie (Terry) Zeng at minjie.zeng@fda.hhs.gov for any question.

Last Modified: May 18, 2016 Page 1 of 8

Template

TMPLT 2016.06‐028

Limited Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Service Food and Drug Administration

b. Sponsoring organization.

Center for Drug Evaluation and Research Office of Strategic Programs

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

i. Name:

ii. E‐mail address:

iii. Telephone number:

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

This will be a Blanket Purchase Agreement (BPA) issued for a five (5)‐year term (1‐year base period with 4 option periods) under the Federal Supply Schedule (FSS) 70, Contract 47QTCA18D0081 with Executive Information Systems, LLC (EIS), for acquisition and renewal of brand name Statistical Analysis System (SAS) software, maintenance, and support services. This BPA applies to capabilities under special item numbers (SIN): SIN 511210 Software Licenses, SIN 611420 Information Technology Training, and SIN 54151S Information Technology Professional Services.

FDA has utilized the HHS Enterprise License Agreement (ELA) managed by NIH for 19 years for desktop SAS 9.x and JMP licenses. In 2018, multiple CDER offices began contracting with SAS to procure cloud‐based SAS Viya software and support for advanced analytics, natural language processing, and visualizations that are not in scope of the HHS ELA. As a result of these disparate procurements and lack of centralized oversight, CDER’s SAS expenditures have increased over in less than 5 years. Further, CDER’s strategic IT initiatives involve optimizing the broad analytics portfolio into a centralized cloud‐based enterprise data and analytics solution, CDEROne.

CDER continues to invest heavily in data analytics IT capabilities to support its regulatory informatics activities across CDER Offices, experiencing a cost increase in the past 3 years. CDER needs have greatly increased, including the capabilities of identifying and extracting data from structured and unstructured sources, easily accessing and connecting data from different data sources (internal to CDER, from other Centers, or outside FDA), and creating data visualizations to support regulatory review and surveillance activities. The suite of SAS Viya software is critical to support CDER’s expanded data analytics needs.

Attachment

Last Modified: May 18, 2016 Page 2 of 8

This BPA is to establish an agency‐wide vehicle to procure SAS Institute capacity to include technical services, training support, and software subscriptions which are included or beyond the scope of the current HHS ELA. This agreement will allow for the centralized subscription‐based procurement of software that can be catered to each Center or office needs, as well as the renewal of existing desktop and CPU licenses as needed. The BPA will also allow for the services to enable the transition from desktops and servers to a central cloud environment, maintenance and management of the new environment, and expanded training and support.

a. Acquisition purpose and objectives.

The objectives of this acquisition are to create a BPA that would allow the FDA to procure software and services that:

Centralize the procurement, infrastructure, licensing, and support of SAS and JMP software subscriptions, to include additional software and services not available under the existing HHS

ELA

Support migration of desktop and server installations ultimately to one cloud‐based environment in CDER

Provide training and user support for staff as they migrate to new software and capabilities

SAS and JMP software are mission critical applications for new and generic drug review, drug supply chain, and drug safety analyses and tracking. Thousands of FDA staff and contractors utilize SAS and JMP software for clinical trial data reviews, analysis and prioritization of drug manufacturing site inspections, and identifying adverse events pre and post market.

In early 2020, the Government performed an analysis of alternatives across multiple technologies to determine which could integrate with the CDEROne Analytical Platform, while meeting a broad range of CDER analytical needs as well as affordability and scalability requirements. The assessment objectively evaluated multiple solutions based on their data integration, simple to advanced data analytics, and visualization capabilities. This analysis evaluated functional capabilities (e.g., analytics, data ingestion and management, user experience), management considerations (time to deliver, cost) and operational components (e.g., performance, security).

Through this assessment, SAS Viya was determined to be functionally equivalent to other more costly solutions. Given the comparable functionality, the assessment further evaluated the long‐ term costs. Based on market research and current CDER software expenditures, the SAS Viya software solution is approximately one fifth the cost of similar software solutions, resulting in a clear preference for SAS Viya software. The purchase of SAS Viya software is a critical component of CDER’s technology roadmap and infrastructure over the coming years. Further, SAS Viya is currently installed in multiple siloed CDER solutions that required consolidation to achieve Government cost efficiencies, while providing scalable value‐added solutions to meet CDER's growing analytics needs.

This BPA provides a singular mechanism to continue obtaining SAS software subscriptions, maintenance, and services, while enabling enhanced oversight, consistent terms and conditions, and NIH ELA pricing. This agreement will also enable the migration of desktop users and other projects from SAS 9.X to SAS Viya and accommodate future growth with discounted software and guaranteed services rates.

This BPA will enable convergence of CDER’s siloed technical solutions into a common platform, enabling more accurate and focused analytics and improved monitoring and security though centralized role‐based security. This agreement also includes contractor support for

Last Modified: May 18, 2016 Page 3 of 8 modernization to new SAS and JMP capabilities, standardization of architecture and advisory support, and expanded training. The long‐term strategic objective of this agreement is to create one central source for SAS products and services for agency‐wide use to reduce acquisition barriers to access and to obtain the best pricing available.

This BPA shall run concurrently with the current HHS ELA through December 31, 2021 to facilitate the immediate transition of desktop licenses as well as allow for the same terms, conditions, and guaranteed discounts to be applied to this new agreement. The HHS ELA discounts consist of a reduction in software, reduction in services, and reduction in training costs from the GSA schedule. This new agreement shall also include the option to purchase all of the software and services currently available under the HHS ELA, should FDA choose to not renew the ELA after December 31, 2021.

b. Project background.

CDER has had in place for several years its Mercado Enterprise Data Warehouse, which is a data analytics and visualization platform focused on aggregated regulatory data. Over the past year, CDER has been working to complement this capability to establish a cloud‐based data lake (CDEROne) and analytic environment to deliver data integration, analytics, and data visualization capabilities. This new environment is envisioned to provide the technical framework to support different analytic tools and to bring in and connect additional data sources. One of the key solutions of this analytic suite is the SAS Viya software, which is used in the following environments:

Office of Pharmaceutical Quality (OPQ) use cases on the RAPID environment include dashboards for facility surveillance and the ability to monitor and proactively anticipate emerging drug supply chain issues

Office of Business Informatics (OBI) Enterprise Data Architecture for Regulatory Review (EDARR) program will enable reviewers to analyze, search, and tag unstructured data to streamline the drug review process.

Office of Compliance (OC) use case in the Opioid Data Warehouse (ODW) environment to proactively monitor and quickly respond to imports, recalls, shortages, and drug supply chain issues

By 2022, CDEROne will provide a centralized, intelligent data lake that will be capable of hosting CDER’s disparate data sources and environments in a single managed, governed, and secure environment, facilitating application development, data aggregation, complex analytics, and reporting. Through this agreement, CDER seeks to transition the critical aforementioned CDER SAS AWS cloud installations into CDEROne. This agreement will also enable the migration of desktop users and other projects from SAS 9.x to Viya and accommodate future growth with discounted software and guaranteed services rates.

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

a. Project title.

Food and Drug Administration Analytics Modernization Agreement ‐ SAS

b. Project Description.

The FDA Analytics Modernization Agreement BPA includes:

Licensing and renewals for SAS and JMP software, to include additional options not available under the existing HHS ELA

Services and architecture support for desktop and server installations ultimately to one

Last Modified: May 18, 2016 Page 4 of 8 cloud‐based environment Installation, configuration, and support of SAS and JMP software on the FDA environment

Installation and support of additional user capabilities on the SAS Viya platform for modernization

Change management, training, and user support for JMP and SAS users as they migrate to new software and capabilities

Project management to ensure successful coordination, tracking, reporting, transparency and implementation

Requirement type.

☐ Support services (non‐R&D)

☐ Supplies/equipment

☒ Information Technology (IT)

☐ Other:

Type of action.

☒ New requirement

☐ Follow‐on

☐ Other:

Proposed contract/order type.

☐ Firm‐fixed‐price

☐ Time and materials

☐ Indefinite delivery:

☒ Other: BPA (Includes FFP/ LH/Hybrid)

☐ Completion Form

☐ Term Form

Acquisition identification number.

Requisition number 1235685

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

The BPA will consist of one 12‐month base ordering period with four 12‐month optional ordering periods. The estimated value of the BPA is $49.9 million over all possible ordering periods.

4. The authority and supporting rationale (see FAR 8.405‐6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

☐ This acquisition is conducted under the authority of the Multiple Award Schedule Program. In

Last Modified: May 18, 2016 Page 5 of 8 accordance with Federal Acquisition Regulation (FAR) 8.405‐6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405‐1, FAR 8.405‐2, FAR 8.405‐3 (i.e., fewer than three FSS contractors). FAR 8.405‐6 (a)(1)(i), for a proposed order or BPA with an estimated value exceeding the micro‐purchase threshold not placed or established in accordance with the procedures in FAR 8.405‐1, FAR 8.405‐2, or FAR 8.405‐3, the only circumstances that may justify the actions are‐

☐ (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

☐ (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

☐ (C) In the interest of economy and efficiency, the new work is a logical follow‐on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole‐source or limited‐sources procedures.

☒ This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with FAR 8.405‐6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

• Name and address of the proposed contractor(s).

Executive Information Systems, LLC 6901 Rockledge Drive, Suite 600, Post Office Box 34076, Bethesda, Maryland, 20827‐0076

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

Based on market research, it was determined that there is no competition among vendors and EIS is the sole Government provider of SAS software, services, and training.

SAS software is proprietary in nature and is not released to any other party; only SAS or its lone authorized reseller have the required access to the source code and other proprietary software data to be able to meet the Government’s needs. No other firm has the capability to develop and issue software updates and fixes for SAS software necessary to support existing FDA solutions and statistical and analytical requirements without access to SAS proprietary software code. Renewal of SAS software maintenance will ensure that all support services are performed and properly configured to the FDA‐owned SAS software which can only be provided by those who have access to the proprietary software code.

Additionally, replacement of the SAS software and maintenance with a product other than SAS would require FDA to procure new analytical software and associated maintenance

Last Modified: May 18, 2016 Page 6 of 8 support. The time it would take to install, test, and train staff on the use of new software would cause multiple project delays. If the software is not properly maintained, the risk of failure would impact thousands of staff and numerous applications depending on its functionality. If this award is not made, it would be impossible to modify the software code as necessary for these patches and updates, degrading the Government’s ability to analyze, visualize, and share data to fulfill FDA’s mission.

SAS engineers who have successfully demonstrated they can install their software in the FDA cloud environment. This has been evidenced by the fact that multiple current vendors have claimed they could install SAS Viya software in CDER, however they were unsuccessful and then had to subcontract to SAS (through EIS) to resolve the issues. In one case, this resulted in an additional 2‐month delay to the Government until the vendors could reach a subcontractor agreement.

Given the relative newness and complexity of the SAS Viya software, CDER does require SAS’ unique expertise to efficiently and effectively install and configure the software. Further, the level of complexity and expertise required to install the software to support the multi‐tenant cloud environment for CDEROne will require SAS architects. Directly procuring SAS services is critical to the success and efficiency of the Government program by having the installation and configuration of the software done right the first time. SAS is uniquely qualified to perform services under this BPA, given the complexity of installing, configuring and maintaining their software.

SAS provides the software, maintenance, and services to the Government exclusively through EIS, as SAS does not use any other resellers. In addition, EIS holds a current contract under GSA FSS 70. Only EIS can provide the maintenance and service support that meets the Government’s requirements. Therefore, only an award to EIS will satisfy the Government’s requirement for the renewal of the maintenance support services for existing SAS software.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Consistent with 8.404(d), GSA has already determined the prices of supplies and fixed‐price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable.

Additionally, initial market research indicates that pricing from GSA Schedule IT‐70 is lower than the pricing publicly available in the commercial marketplace. Furthermore, this agreement is predicated on running concurrently with the existing HHS ELA of which FDA participates, which provides extensive discounts from the GSA Schedule IT‐70. These HHS discounts off the GSA schedule consist of a reduction in software, reduction in services, and reduction in training costs.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

Market research was conducted in June 2020, by Government technical experts by reviewing similar software maintenance plans to ascertain if these items could meet the Government’s requirements.

Specifically, the Government technical experts conducted internet search to determine if there were other software providers capable of maintaining the existing SAS software. Although there are firms that offer data visualization and simulation software and maintenance of that software, those companies do not have access to SAS’ source code. Government technical experts confirmed that as the source code required to issue the updates is proprietary, SAS, or an authorized reseller, is the only source capable of providing the required maintenance and upgrades for SAS software. No other firm has the capability of developing and issuing software updates and fixes for SAS software

Last Modified: May 18, 2016 Page 7 of 8 necessary to support existing FDA requirements.

Market research indicated only EIS has exclusive rights to sell and support all SAS software and maintenance to Government customers. Finally, Government representatives received a letter dated, July 1, 2020, directly from SAS confirming EIS as the sole authorized reseller for SAS software to Government entities.

7. Any other facts supporting the justification.

SAS issued a company letter to the Program Office proving that EIS is currently the sole authorized reseller for Version 8 and later of the SAS software to government entities and institutions, and that EIS GSA Schedule is the sole GSA Schedule which offers professional services specifically performed by SAS employees.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a) Removal of barriers to competition.

CDER will continue to monitor available industry software capabilities over the coming years to consider alternate software vendors to invite competition. Furthermore, open source analytics solutions are planned for inclusion in the overall CDER IT roadmap. Given CDER’s intention to create alternative solutions and even migrate data analytic services to a Government‐managed cloud environment, there are expected to be opportunities for other commercial services to utilize (using FDA standards) that cloud environment to conduct application development and deployment functions.

b) Listing of sources, if any, that expressed an interest, in writing, in the acquisition.

During market research, it was determined that EIS was the only reseller of SAS services and software to the Government, as validated by the letter referenced in #7 above. As a result of determining no other sources were available, the Program Office did not consider alternate sources to provide SAS software or services.

9. 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 limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:

COR/Requiring Activity POC

Signature:

COR/POC Immediate Supervisor

Last Modified: May 18, 2016 Page 8 of 8

Head of the Sponsoring Program Office

10. Contracting Officer Certification.

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

Contracting Officer

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

Division Director

Head of the Contracting Activity

12. Competition Advocate signature.