JA LSJ CBER_OM Business Operations and Systems Support_redact_Redacted.pdf

Limited Sources Justification

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 of Biologics Evaluation and Research (CBER) Office of Management (OM)

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

i. Name: Joshua Rowe

ii. Mailing address: 10903 New Hampshire Ave., , Silver Spring, MD 20993

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 task order to Guidehouse Inc. in support of the Center of Biologics Evaluation and Research (CBER), Office of Management (OM); to be issued under GSA Multiple Award Schedule (MAS) contract number 47QTCA18D005G. The follow-on order is to provide services to support CBER OM’s highest priority workforce management systems; the Biologics Planning and Execution Reporting System (BPERS) and PathHR applications. These two key applications, which manage CBER’s financial, acquisition, travel and human resources, require continuous system development, modernization abnd enhancements (DME) as well was operations and maintenance (O&M). As part of the evolution of CBER’s administrative functions, OM requires support for business processes and operational support to improve, refine, and enhance operations for the payroll, travel, and the Inter Agency Agreement (IAA) and Oak Ridge Institute for Science and Education (ORISE) programs.

Since embarking on the Business Process Reengineering (BPR) effort that started in 2017, CBER/OM has made several substantive changes and enhancements to how it manages its financial, acquisition, travel services, and human resources management and align them to support the strategic priorities of the Center. The BPR provided process improvements and recommendations for critical CBER priorities as identified by CBER Division of Acquisition and

Budget Resources (DABR) leadership. Notably, two system tools have been implemented resulting from this BPR.

Biologics Planning and Execution Reporting System (BPERS): An IBAPS-Child Application that provides fully integrated end-to-end planning, execution and reporting solution tailored to CBER’s operating and reporting hierarchies. This application is a critical tool for Advanced Application Planning (AAP) that provides comprehensive budget planning, budget execution, payroll planning, acquisition planning and reporting analysis.

PathHR: A Human Resources (HR) tool that provides a centralized platform to CBER HR stakeholders that tracks internal recruitment and HR actions to support CBER’s workforce;

including employee and position management, recruitment and onboarding, personnel request actions, payroll cost projections, budget integration, and reporting.

With an increasingly diverse portfolio, growing workforce, and ongoing digital transformation, CBER/OM is making improvements to business process operations and administrative systems.

These changes and enhancements will strengthen OM’s capabilities and capacity to efficiently manage its increasingly complex budget and workforce management needs. Specifically, the OM Division of Acquisition and Budget Resources (DABR) and Division of Human Capital (DHC) require resources and tools to increase operational efficiencies through system enhancement and maintenance of the PathHR application and business process and operations support.

b. Project background.

The services have been procured by issuing orders against FDA’s IT Lifecycle Support for the Integrated Budget, Acquisition, and Planning System (IBAPS) blanket purchase agreement (BPA), number 75F40119A10017; order numbers 75F40120F19005 and 75F40123F19020. The requirement for this BPA came out of the FDA Office of Finance, Budget, Acquisitions and Planning (OFBAP). The BPA was competitively solicited in 2018 using GSA’s Federal Supply Schedule (FSS) Special Item Number (SIN) 132-51 for Information Technology (IT) Professional Services. The ordering period of the BPA was extended by 180 days pursuant to FAR clause 52.217-8, and has subsequently expired on March 16, 2024. The estimated ordering ceiling at award was defined at $112M; the obligated value of all orders totaled $117M.

OFBAP has plans to recompete the requirement but due to ongoing reorganization within the FDA, the recompete has been delayed in order to allow OFBAP to realign the BPA requirement with the needs based on FDA’s reorganization.

Considering the BPA’s limited ordering period and current obligated value along with scope realignment to FDA’s reorganization, in order to best support these CBER Office of Management’s key priorities, it is most efficient to procure the required services by issuing a follow-on single order addressing the technology requirements for BPERS and PathHR. It will be achieved by procuring the services on a limited source basis using the authority of Federal Acquisition Regulation (FAR) subpart 8.405-6(a)(1)(i)(C).

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

a. Project title.

FDA/CBER/OM Business Operations and Systems Support

b. Project Description.

FDA/CBER/OM leads procedural and process changes through developing and applying new strategies to emerging problems and new management initiatives, allocating dollars and staff resources to CBER’s program offices, monitoring their usage, and setting priorities to improve the level of customer service and program performance to meet CBER’s goal of protecting and promoting the public health. OM directs and monitors Human Resources (HR), budget, payroll, space issues, and provides administrative and technical support for advisory committee meetings, as well as provides laboratory and equipment support.

The purpose of this project is to procure contractor support services to assist OM/DABR in:

PathHR system enhancements to support current and future FDA and Center-level HR initiatives.

BPERS operations and analysis support to assist end users utilize the application and manage budget planning and execution activities effectively.

Business process improvement and operational support for the Travel Team and CBER’s Inter Agency Agreement (IAA) and Oak Ridge Institute for Science and Education (ORISE) programs.

Specifically, CBER/OM requires contractor support services to include the following task areas:

1. Task 1: PathHR System Enhancement and Operations & Maintenance (O&M) Support

2. Task 2: BPERS Operations and Analysis Support

3. Task 3: Business Process and System Adoption Support (Travel and IAA/ORISE Programs)

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.

CIN # CBER-OM-24-C-1428

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

The total estimated value for a base year with one (1) option year is Up to an additional six (6) months of services may be procured pursuant to FAR clause 52.217-8 Option to Extend Services.

4. The authority and supporting rationale (see 8.405-6(a)(1)(i) and (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 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.

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

Guidehouse Inc.

1676 International Dr., STE 800 Mclean, VA 22102-3600

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

Guidehouse is the current prime contractor for the services described herein. They were competitively awarded the aforementioned BPA which supports BPERS and PathHR application DME and O&M needs. Guidehouse’s institutional knowledge of the existing technology as well as the FDA’s technology and business ecosystems makes it uniquely suited to support CBER’s core business operations while OFBAP works on the realignment of FDA needs for the recompete of the BPA. Procuring the required services from Guidehouse represents the lowest risk alternative for the CBER OM during this realignment.

A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

The Contracting Officer will ensure the new order represents the best value consistent with FAR 8.404(d) by requesting discounts. The contracting officer will leverage data from the BPA and recent orders 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.

A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Informal market research was conducted locally within FDA’s portfolio of procurement instruments for the required services. The conclusion resulting from this survey indicates there exists only one solution which would best maximize return on recent FDA investments to the BPERS and PathHR applications, exhaust immediately available private sector institutional understanding of FDA Centers’ needs for IBAPS and avoid schedule delays associated with knowledge transfer and onboarding new contractor employees. It is imperative the services required not only be provided with the greatest efficiency, but they must also be performed in manner which greatest maximizes schedule in order to meet the needs of CBER OM’s key applications. To ensure continuity of services and best manage risks, awarding a follow-on task order to Guidehouse for the services discussed herein represents the most efficient and low risk solution. For that reason, performing market research to determine alternate sources of supply to meet the requirement was not conducted.

Any other facts supporting the justification.

No other facts.

A 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.

FDA OFBAP is currently completing all tasks necessary to competitively solicit and award a new ordering vehicle which will support OFBAP IT systems to include CBER’s BPERS and PathHR applications. No sources have expressed an interest, in writing, in the acquisition.

9. 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:_

COR/Requiring Activity POC

Signature

COR/POC Immediate Supervisor

10. 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:

Head of the Sponsoring Program Office

Signature:______Dacanay -S______________________Date: 2024.07.18 13:54:08 -04'00'________ Michelle Dacanay

Contracting Officer

Michelle L. Digitally signed by Michelle L.

Dacanay -S