SOL_RFP_75F40126R00042_Amendment_2.pdf

COMBINED SYNOPSIS/SOLICITATION FOR FOOD APPLICATIONS REGULATORY MANAGEMENT

(FARM) & IT INTERFACTING SYSTEMS

SOLICTATION #75F40126R00042

Amendment #2

i. This is a combined synopsis/solicitation for commercial products or services prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice.. This announcement constitutes the only solicitation; a written solicitation will not be issued.

Offerors must have an active registration in SAM.gov when submitting a proposal and at time of award in order to comply with the annual representations and certifications requirements.

Proposals submitted by Offerors without an active registration in SAM.gov or without completed representations and certifications by the close date of the solicitation may not be considered.

The FDA is not responsible for any costs incurred in preparing the documents described in this RFP. Offeror employees responsible for preparing material that may be proprietary information must mark each page that the Offeror believes contains proprietary information with the legend “Proprietary Information.”

ii. The solicitation number is 75F40126R00042. The solicitation is issued as a Request For Proposal

(RFP).

iii. The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2026-01, effective March 13, 2026, and the Revolutionary Federal Acquisition Regulation Overhaul, effective April 17, 2026.

iv. This requirement is being solicited as a competitive 8(a) set-aside; only those companies certified by the U.S. Small Business Administration as an 8(a) business that have not graduated from the program are eligible for award. The associated North American Industry Classification System (NAICS) Code is 541519 Other Computer Related Services ; Small Business Size Standard is $34 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-

Price/Labor Hour single-award Indefinite-Delivery Indefinite-Quantity (IDIQ) contract that represents the best value to the Government, technical, price and other factors considered, in accordance with the evaluation criteria set forth in this solicitation. Please submit all proposals with:

a) Pricing for all line items

CLIN Description Anticipated POP

1 Ordering Period 1: Food Applications Regulatory Management (FARM) & IT Interfacing Systems

09/29/2026 – 09/28/2027

2 Ordering Period 2: Food Applications Regulatory Management (FARM) & IT Interfacing Systems

09/29/2027 – 09/28/2028

3 Ordering Period 3: Food Applications Regulatory Management (FARM) & IT Interfacing Systems

09/29/2028 – 09/28/2029

4 Ordering Period 4: Food Applications Regulatory Management (FARM) & IT Interfacing Systems

09/29/2029 – 09/28/2030

5 Ordering Period 5: Food Applications Regulatory Management (FARM) & IT 09/29/2030 –

Interfacing Systems 09/28/2031

6 52.217-8 – 6mo Extension: Food Applications Regulatory Management (FARM) & IT Interfacing Systems

09/29/2031 – 03/28/2032

*Proposals that do not price all line items may be deemed non-responsive.

vi. and vii. Description of Requirement and Attachments

a. Attachment_1_IDIQ_SOW – Description of Requirement

b. Attachment_2_TO1_SOW_OM

c. Attachment_A_Pricing Schedule and LCAT

d. Attachment_B_Appendix_I

viii. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial

Services, applies to this acquisition. Additional instructions are detailed below.

This section provides instructions for preparing proposals for the solicitation. Offeror’s are cautioned to follow the instructions carefully to assure the Government receives consistent information in a form that will facilitate proposal evaluation. For the purposes of preparing proposals, offeror’s should assume an award timeframe of September 2026.

The Government intends to conduct this procurement through a phased proposal submission process with written submissions using an evaluation process.

a. Instructions for Proposal Preparation

Offerors are instructed to read the entire RFP document, including all attachments, prior to submitting questions and/or preparing your proposal. Omission of any information from the proposal submission requirements may result in rejection of the proposal.

Offerors shall note that proposals will be evaluated, and a selection decision will be made.

Offers are expected to follow the detailed proposal preparation instructions fully and carefully.

The Government will rely on the information provided by the Offerors to evaluate the proposals.

It is therefore imperative that Offerors carefully follow the instructions set forth below and submit their proposals in the format and with the content specified below, providing all requested information.

The Offerors are responsible for the accuracy and completeness of their proposal. Please note:

this IDIQ is being solicited concurrently with the Task Order 1. By responding to the solicitation, Offerors acknowledge the proposal’s validity through December 31, 2026.

b. Page Size and Font

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e.

email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

All electronically submitted PDF document text in the proposal shall be single-spaced, and each paragraph shall be separated by at least one (1) blank line. The Offeror is encouraged to use Calibri 11-point font. However, a font of equivalent size may be used. Tables and illustrations may use a reduced font size not less than 9-point and may be landscape. The Offeror shall use the following page setup parameters: Page size – 8.5” x 11”, Margins (top, bottom, left and right) – 1”, Gutter – 0”, From edge (header and footer) – 0.5”.

It is the sole responsibility of the Offeror to ensure that the electronic media submitted is virus-free and can be opened and read by the Government. The deadline for submission of the electronic copy of the proposal is firm. As the closing date and time draws near, heavy traffic on the web server may cause delays. Offeror’s are strongly encouraged to plan and leave ample time to prepare and submit their proposal. Offeror’s bear the risk of web site inaccessibility due to heavy usage, which may occur during the final days/hours before the RFP closing time. The electronic copy of the proposal will constitute the official copy for timely receipt.

c. Proposal Content

The CS, identified in Section XIV is the main point of contact for this acquisition. The required elements of proposal submission are provided in Table 1 below. The Cover Letter and Resumes will be in PDF format and the Pricing Workbook will be in excel format.

d. Advisory Down-Selection Notification

After the Government completes the evaluation of Phase I, Offerors will receive an advisory notification via e-mail from the Government. This notification will advise the Offeror of the Government’s advisory recommendation to proceed or not to proceed with Phase II submission.

Offerors who are rated most highly in Phase I will be advised to proceed to Phase II of the proposal submission process. Offerors who were not among the most highly rated will be advised that they are unlikely to be viable competitors, along with the general basis for the Government’s advisory recommendation. The intent of this advice is to minimize proposal development costs for those Offerors with little to no chance of receiving an award.

The Government will determine the appropriate number of Offerors for Phase II that is most beneficial to the Government. However, the Government’s advice will be a recommendation only, and those Offerors who are advised not to proceed may elect to continue their participation in the procurement.

Failure to participate in Phase I of the procurement precludes further consideration of an Offeror. Phase II submissions will not be accepted from Offerors who have not submitted Phase

I proposals by the due date and time stated in this solicitation. For those Offerors that are highly rated and advised to proceed to Phase II of the proposal submission process, the CO/CS will include the date and time for submissions. The Government recommends Offerors begin preparation of Phase II proposals only after receipt of the Phase I advisory down-select notice.

Table 1.

Naming Convention Tab Title

Volume I: Relevant Experience (Phase I)

Tab A (Document) Relevant Experience Criteria (6-page limit)

Tab B (Document) Offeror Information and Confirmation

Volume II: IDIQ Technical Proposal (Phase II) (50-Page Limit)

Tab A (Document) IDIQ Overall Understanding & Approach

TAB B (Document) Approach to Task Order (TO) #1 – Operations & Maintenance (O&M)

TAB C (Document) Management Approach

Volume III: Business & Pricing

Tab A (Document) Proposal Cover/Transmittal Letter

Tab B (Document) Pricing Excel Workbook (Attachment A)

Tab C (Document) Proposal Assumptions, Exceptions, and Dependencies

• Information contained in each volume shall be complete to the extent that evaluation of each tab may be accomplished independently of, and concurrently with, evaluation of the others. Your responses must demonstrate that both your firm and personnel can successfully complete this project. Offerors shall strictly adhere to the page limits.

• NO PRICE INFORMATION IS TO BE INCLUDED IN VOLUME I or VOLUME II

e. Solicitation Questions & Comments

Questions/clarifications regarding this requirement shall be submitted via email to the Contract Specialist, Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov, and the Contracting Officer, Peter Lee at Peter.Lee@fda.hhs.gov, by 3:00pm (Eastern) on August 7th, 2026. FDA may not answer questions received after this date and time and may not answer questions submitted to individuals other than the named contacts. Questions submitted by another means may not be answered, including phone calls. It is the Offeror’s responsibility to confirm receipt of all proposals and/or questions by the closing date of this announcement by contacting the above Contract Specialist/Contracting Officer. It is the Offeror’s responsibility to exercise due diligence to discover and bring to the attention of the CS and CO at the earliest possible time, any ambiguities, discrepancies, inconsistencies, or conflicts between the statement of work (SOW) and other documents attached hereto or incorporated by reference herein.

ix. The provision at 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV

2025) is not applicable to this requirement. The specific procedures are detailed below.

mailto:Brian.Wodzisz@fda.hhs.gov, mailto:Peter.Lee@fda.hhs.gov,

a. Basis of Award

The Government intends to award an IDIQ from this solicitation to the responsible offeror whose proposal represents the best value to the Government, technical, price and other factors considered. There is one (1) Task Order (TO) Statement of Work (SOW) which the government reserves the right to award at time of the Base IDIQ award.

The Request for Proposal (RFP) shall not be considered direction to proceed with the subject effort, nor a promise of future direction to process.

The following factors shall be used to evaluate proposals:

• Factor 1: Relevant Experience Criteria (Phase I)

• Factor 2: IDIQ Overall Understanding & Approach (Phase II) o Subfactor 1: Approach to Task Order (TO) #1 (Operations & Maintenance

(O&M)) (Phase II)

• Factor 3: Management Approach (Phase II)

Non-price factors combined are significantly more important than price. As technical merit of proposals becomes equal, the evaluated price may become the determining factor.

A written notice of award or acceptance of a proposal, emailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the proposal, shall result in a binding contract without further action by either party. Before the Offeror’s specified expiration time, the Government may accept a proposal (or part of a proposal), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

b. Evaluation Factors & Criteria

VOLUME I: RELEVANT EXPERIENCE CRITERIA SUBMISSION INSTRUCTIONS & EVALUATION (6-

page limit) (PHASE I)

TAB A: Factor 1: Relevant Experience Criteria Instructions: The Offeror shall provide a written narrative describing three (3) separate Government experiences (Federal, State, and Local) that are like this effort in terms of type, scope, complexity, technology, and size that can be ongoing or have been completed within the last three (3) years. Phase I relevant experience must be experience of the Offeror. The Offeror may submit experience it performed as a prime contractor, subcontractor, or team lead. If experience is performed as a subcontractor, teaming partner, or other entity the portion of the work performed by the Offeror must be similar to the requirements in terms of type, scope, complexity, technology, and size. Experience performed solely by a proposed subcontractor, teaming partner, or other entity will not be considered as the Offeror's relevant experience for purposes of Factor 1, except as provided below:

Small Business Teaming Arrangements: In accordance with 13 CFR 125.2(g), where the Offeror is a small business prime contractor and its proposal specifically identifies first-tier small business subcontractors as part of a proposed team, the Government will consider the capabilities and relevant experience of those identified first-tier small business subcontractors as the Offeror's own capabilities and experience, to the extent the Offeror's independent experience does not demonstrate the qualifications necessary for award. To receive this consideration, the Offeror must:

• Identify each first-tier small business subcontractor by name;

• Confirm each subcontractor's small business status; and

• Provide relevant experience references for each identified subcontractor, including how that experience is similar to the solicitation requirements in terms of type, scope, complexity, technology, and size.

. If experience is performed as a subcontractor, teaming partner, or other entity the portion of the work performed by the Offeror must be similar to the requirements in terms of type, scope, complexity, technology, and size. The proposed projects that are included in the narrative should involve experience in implementations and other work related to the task areas described in the Statement of Work. One

(1) project shall demonstrate experience relevant to Operations and Maintenance (O&M) activities, and one (1) project shall demonstrate experience relevant to Development, Modernization, and Enhancement (DME) activities. One (1) project must also involve Artificial Intelligence applications to enhance the findability of relevant records or information from various IT systems or to automate regulatory review processes, document processing, or decision support capabilities.

For projects demonstrating O&M experience, the narrative should highlight:

• 24/7 system operations and monitoring for mission-critical systems

• Database administration and performance tuning

• Release management and testing support

• Multi-tier user support/helpdesk operations

• Collaboration with data center and cloud environment providers

• IT system consolidation and modernization support

For projects demonstrating DME experience, the narrative should highlight:

• AI/ML implementation in regulatory or enterprise systems

• Workflow automation and optimization using platforms such as Appian

• System integration across multiple platforms and data sources

• Development of intelligent document processing capabilities

• Implementation of information findability across disparate repositories through integration with enterprise search capabilities, enabling multi-source query federation to retrieve and surface relevant content from multiple systems simultaneously.

• Cloud-based application development and deployment

Projects listed may involve contracts with the Federal Government and Agencies of States and Local Governments.

The terms scope, complexity, and size, are defined below:

• Scope: is defined as relevant experience that are the same or similar to the Attachment_1_IDIQ_SOW requirements and task areas in Attachment_1_IDIQ_SOW.

• Complexity: Complexity is defined as the number of helpdesk ticket requests from internal or external system users and number of change requests handled by the offerors. The anticipated number of requests is at least eight hundred (800) annually.

• Technology: Please refer to the technology mix under Attachment_1_IDIQ_SOW - Table 2. Current

System technology stack

• Size: is defined as the total dollar contract value per year, at least one relevant experience is required to have a minimum dollar value $1,000,000.00 in which they were the Prime contractor.

The Offeror’s shall, for each relevant experience contract identified above, submit the following information (if a subcontract, contact information for the prime contractor, not the customer, shall be included):

1. Name of contracting activity (Federal Government agency, State/local government);

2. Name of company who performed the work;

3. Contract number;

4. Contract type;

5. Total contract value, and subcontract value (if applicable); -or-

6. If an order, the total value of just the order for which the Offeror was awarded;

7. Contracting Officer contact information (name, phone number, email);

8. Brief Description of scope and technical requirements;

9. Relevance to this requirement;

10. Period of performance of the project.

Evaluation: The government will assess its level of confidence that the Offeror’s relevant experience submissions demonstrate performance on current and/or previous contracts that are relevant to the Statement of Work in terms of type, scope, complexity, technology, and size.

The Offeror’s shall, for each relevant experience contract identified above, submit the following information (if a subcontract, contact information for the prime contractor, not the customer, shall be included):

1. Name of contracting activity (Federal Government agency, State/local government);

2. Name of company who performed the work;

3. Contract number;

4. Contract type;

5. Total contract value, and subcontract value (if applicable); -or-

6. If an order, the total value of just the order for which the Offeror was awarded;

7. Contracting Officer contact information (name, phone number, email);

8. Brief Description of scope and technical requirements;

9. Relevance to this requirement;

10. Period of performance of the project.

TAB B: Offeror Information and Confirmation Instructions: The Offeror shall provide the following information:

a. Reference to RFP #75F40126R00042

b. Company name; address; SAM UEI; Cage (if applicable); Point of Contact (POC) name, phone number, and email address.

c. 8(a) Eligibility Confirmation: The Offeror shall confirm that, as of the Phase I proposal submission deadline, it is an SBA-certified 8(a) Program Participant eligible to compete for this requirement and meets the applicable requirements of FAR 52.219-18. Submission of the Phase

I proposal constitutes the Offeror's representation regarding its eligibility consistent with FAR 52.219-18.

Evaluation: The FDA will evaluate to the extent that the Offeror provides the following information:

a. Reference to RFP #75F40126R00042

b. Company name; address; SAM UEI; Cage (if applicable); Point of Contact (POC) name, phone number, and email address.

8(a) Eligibility Confirmation: The Offeror shall confirm that, as of the Phase I proposal submission deadline, it is an SBA-certified 8(a) Program Participant eligible to compete for this requirement and meets the applicable requirements of FAR 52.219-18. Submission of the Phase I proposal constitutes the Offeror's representation regarding its eligibility consistent with FAR 52.219- 18.__________________________________________________________________________________

VOLUME II: IDIQ TECHNICAL PROPOSAL INSTRUCTIONS & EVALUATION CRITERIA (50-page limit) (PHASE II) The FDA’s Advisory notification to offerors after evaluation of Phase I RFP submissions will include the due date for Phase II written submissions.

TAB A: FACTOR 2: IDIQ OVERALL UNDERSTANDING & APPROACH

Instructions: The Offeror shall provide a detailed narrative of it’s understanding and approach to providing the requested IDIQ services. As a part of this narrative, include a “map” between the labor categories provided in the pricing spreadsheet (Attachment_A_Pricing Schedule and LCAT) and the labor categories. The map should demonstrate that labor categories proposal will encompass all of the technical expertise described in the FDA’s suggest labor categories.

Evaluation: The FDA will evaluate the extent to which the Offeror’s narrative demonstrates that it understands the requirement and has presented a logical, cohesive and technically sound approach to delivering the types of services required. FDA will evaluate whether the labor categories offered are appropriate to deliver the technical services described, and whether the resources proposed have the appropriate skills sets and certifications necessary to successfully perform.

TAB B: SUB FACTOR 1: APPROACH TO TASK ORDER #1 (Operations & Maintenance (O&M)) Instructions: The Offeror shall provide a detailed narrative of its understanding and approach to performing each of the tasks described in the Task Order 1 SOW with minimum interruption to business operations. The narrative should describe the Offeror’s understanding of the project both from a technical and compliance standpoint.

TASK ORDER #1 TECHNICAL ASSUMPTIONS

Instructions: The Offeror shall identify any assumptions associated with the services to be performed for this Task Order.

TASK ORDER #1 DRAFT PROJECT MANAGEMENT PLAN AND WORK BREAKDOWN STRUCTURE

Instructions: The Offeror shall provide a draft project management plan for managing the activities under Task Order 1. The draft project management plan shall address the following areas: Requirements Management, Change Control, Risk Management, Schedule Management, Cost Management, Quality

Management, Communications, and Project Organization. The Offeror shall also submit a Work Breakdown Structure (WBS) which identifies all the work requirements to perform the contract. Such a WBS shall be decomposed to a low enough level to permit evaluation of the Offeror’s proposal. The Technical Proposal and the Task Order #1 Pricing shall be cross-referenced to the submitted WBS to facilitate evaluation.

TASK ORDER #1 STAFFING PLAN

Instructions: The Offeror shall complete the Task Order #1 Pricing (Attachment_A_Pricing Schedule and LCAT). The Task Order #1 Pricing shall identify the resources utilized, their qualifications and how they will be utilized across tasks. The instructions for completing the Task Order #1 Pricing are in the contained within the tab of the spreadsheet. The Offeror shall provide resumes that clearly identify education and experience of all personnel presented in the Task Order #1 Pricing. The resumes shall demonstrate the experience asserted in the Task Order #1 Pricing. Resumes are limited to (3) three pages for non-key personnel. If actual personnel have not yet been identified for non-key personnel, include representative resumes.

TASK ORDER #1 KEY PERSONNEL

Instructions: This section of the technical proposal shall identify key personnel and describe their specific roles in performing the activities in this Task Order.

In an appendix to the Staffing Approach marked Key Personnel, the Offeror shall submit resumes of key personnel. Resumes of staff and consultants shall reflect not only academic qualifications, but also length and variety of experience in similar tasks and clearly demonstrate relevant training and certifications. The Offeror shall clearly indicate whether the resumes submitted are those of current staff (subcontractor or prime) or are identified to be hired. If subcontractors are proposed, information shall be provided to support the qualifications of the subcontractors. The extent to which outside consultants or specialists will be used shall be documented and evidence of their availability shall be provided.

The Offeror shall provide resumes (limit 3 pages each) for individuals identified as key personnel. The Offeror shall provide letters of commitment for everyone identified as key personnel (limit 1 page each).

Resumes and letters of commitment shall be submitted with the proposal under this section and will not count towards the page limitation. Key Personnel must be available for assignment to this task order at task order award. The Offeror shall also clearly indicate all proposed Key Personnel within its Staffing Plan. The Offeror shall indicate whether their project manager has been certified by the Project Management Institute or demonstrate clearly in narrative form that the candidate meets all the requirements of PMI certification.

TASK ORDER #1 OPERATIONS APPROACH

Instructions: The Offeror shall provide a detailed narrative describing its approach to:

• 24/7 system monitoring and incident response for the mission-critical FARM system

• Collaboration with Data Center Contractors and Cloud Environment providers to identify and resolve system outages and performance issues

• IT consolidation and modernization support, including coordination with HALO, MARS, Elsa team, and Cloud environment teams

• Security and compliance activities, including Security Scans, COOP/ISCP exercises, and EDMSS compliance

• Disaster recovery and business continuity planning and execution

• IT capacity planning and infrastructure management, including monitoring data storage growth and infrastructure upgrades

• Response time compliance as outlined in the User Production Support Matrix

TASK ORDER #1 MAINTENANCE & DATABASE SUPPORT APPROACH

Instructions: The Offeror shall provide a detailed narrative describing its approach to:

• Performance tuning and optimization (biannual performance tuning to ensure optimal server capacity, speed, and network performance)

• Workflow and application maintenance, including maintenance and support of all FARM workflow applications and reports in the Cloud environment

• Database administration and support, including recommendations for database performance improvements, monitoring Oracle backups and recoveries, and maintaining user administration and role management

• Submission processing and automation, including recommendations for fully electronic submission processes

• Support for agency-wide IT system consolidation efforts

TASK ORDER #1 RELEASE MANAGEMENT & TESTING SUPPORT APPROACH

Instructions: The Offeror shall provide a detailed narrative describing its approach to:

• Release development and management for Initial, Major, Minor, and Emergency/Patch releases

• Change Control Board (CCB) support, including preparation of level of effort estimates, root cause analysis, and technical evaluation for defects and minor enhancements

• User Acceptance Testing (UAT) planning, support, and approval processes

• Deployment coordination with data center and Cloud environment contractors, including weekend and after-hours releases

• Testing support, including development of test plans, execution of functionality, regression, integration, performance, Section 508, and load tests

• Defect tracking and resolution using FDA tracking applications

TASK ORDER #1 USER PRODUCTION SUPPORT (HELPDESK) APPROACH

Instructions: The Offeror shall provide a detailed narrative describing its approach to:

• Multi-tier user support (Tier 1, 2, and 3) for the FARM platform

• User account and access management

• Ticket management and resolution, including achieving resolution rates consistent with historical performance

• Communication and coordination with Internal (FDA) users FDA help desk, other FDA personnel and external regulatory application submitters (industry COSM users),

• Training and user guidance, including one-on-one guidance and virtual training for external regulatory application submitters (COSM users)

• Response time compliance for different urgency levels as outlined in the User Production Support Matrix (Table 4)

TASK ORDER #1 SERVICE DELIVERY QUALITY ASSURANCE PLAN

Instructions: The Offeror shall provide a Service Delivery Quality Assurance Plan that clearly documents how the specific service levels in Table 4: User Production Support (FARM Helpdesk) Matrix within Attachment_2_TO1_SOW_OM will be assured.

TASK ORDER #1 RISK AND MITIGATION STRATEGIES

Instructions: The Offeror shall provide a narrative describing any risks it foresees carrying out its approach and mitigation strategies for those risks.

Evaluation: The FDA will evaluate the extent to which the Offeror’s proposal demonstrates that it understands the requirement; has described tasks and procedures that are technically sound, logical, likely to be effective and will result in timely execution of the services; demonstrates a draft project management plan and WBS that is feasible and likely to result in the successful delivery of the services and deliverables on schedule and on budget; will provide the level of effort and labor mix of resources qualified, experienced, and capable of implementing the technical solution described; Quality Assurance Plan is technically sound, efficient, and likely to result in the successful measurement and attainment of quality services as identified in the User Support Matrix; and understands the risks associated with the services and has proposed strategies that will mitigate those risks.

TAB C: TECHNICAL FACTOR 3: MANAGEMENT APPROACH

Instructions: The Offeror shall provide a brief narrative describing how it intends to manage the IDIQ.

This shall include a discussion of order management processes; staff availability; approach to client communication and collaboration, reporting, and the rationale for its approach.

The narrative shall identify personnel who will work on managing the IDIQ, their role in the project, and their qualifications. If the Offeror plans to form Contractor Teaming Arrangement(s) to provide an integrated solution to meet the Government’s requirements, the Offeror shall submit copies of the Contractor Teaming Arrangement(s).

Evaluation: The FDA will evaluate the extent to which the Offeror’s approach demonstrates that it can effectively manage a IDIQ of this magnitude. The FDA will evaluate each Offeror’s management approach to ensure they have demonstrated the appropriate management infrastructure to manage multiple Task Orders, respond quickly and efficiently to new Task Order requests, and to attract and retain qualified personnel to staff the Task Orders.

VOLUME III: TAB B: BUSINESS/PRICE PROPOSAL

Instructions: The FDA will conduct price analysis on business proposals in accordance with actual prices and labor categories proposed for the services in the FDA Pricing Workbook (Attachment_A_Pricing Schedule & LCAT).

Offeror’s shall certify their proposal to be valid until December 31, 2026.

Offeror’s shall submit pricing including unit pricing, for each item requested and total final price.

Proposals shall clearly state the overall cost to the Government for all ordering periods.

Offeror’s shall submit a proposal for all requirements listed in this RFP. Offerors are encouraged to submit their best pricing in their initial proposal. The Government intends to evaluate proposals based on the prices submitted and may make an award without discussions. Partial proposals will not be considered. Incomplete pricing or pricing with omissions may not be considered for award.

Rates shall remain the same for a 12-month Period of Performance (POP) and shall not change midstream of the Task Orde (TO) POP.

Offerors participating in teaming/partnering arrangements for this acquisition shall submit their teaming/partnering agreements with their proposal. The agreements shall be signed by the parties and shall demonstrate the relationship between firms and identify contractual relationships and authorities to bind the firm and the team/partnership. Offerors proposing major subcontracts (subcontracts exceeding 10% of the overall prime contract value) shall submit signed letters of commitment from the subcontractors which define the contractual relationship and identify contribution to the planned arrangement in terms of the type and proportion of work to be performed. Copies of agreements and letters of commitment shall be submitted with the proposal under this section and will not count towards the page limitation. Offerors shall include a cover page with their agreements to include a list of the teaming/partnering parties and the following information for each party: company name, SAM UEI, address, point of contact, email address, phone and fax numbers. Offeror’s that fail to submit their signed teaming/partnering agreements with their proposal may be excluded from consideration.

Evaluation: The Government will evaluate the Contractor’s ability to deliver an efficient, low-risk proposal at a fair and reasonable price. As part of this evaluation, the Government will evaluate:

• Overall pricing for Task Order #1

VOLUME III: TAB C: PROPOSAL ASSUMPTIONS, EXCEPTIONS, and DEPENDENCIES Offeror’s shall submit all assumptions in their proposal.

Offeror’s must indicate, in this section only, if any pricing-related assumptions have been made, conditions have been stipulated or exceptions have been taken with this RFP or the Statement of Work as written. If assumptions are not noted in this Volume and this section of the proposal, it will be assumed that the firm’s proposal reflects no assumptions for award and the firm agrees to comply with all of the terms and conditions set forth herein. It is not the responsibility of the Government to seek out and identify assumptions, conditions, or exceptions buried within the firm’s proposal. Accordingly, any pricing related assumptions listed in any other volume or section shall be null and void. Any exceptions taken to the price-related terms and conditions of the RFP shall be stated in this Section. Any assumptions that are considered unacceptable by the Government and cannot be resolved may result in the firm being removed from consideration.

EVALUATION OF PROPOSAL:

The Government will assess its level of confidence that the Offeror will successfully perform the requirements of the contract in regard to the evaluation factors. The evaluation factors will measure the Government’s confidence that the Offeror understands the requirements and will be successful in performing the contract. The evaluation will be done holistically with a rating scale of "high confidence," "moderate confidence," and "low confidence," representing the Government’s confidence that the Offeror understands the requirement and will be successful in performing the work.

High Confidence

The Government has high confidence that the Offeror understands the requirement, has the ability to perform the scope based on the size, scope and complexity required by the Government, and will be successful in performing the contract with little or no Government intervention.

Moderate Confidence

The Government has some confidence that the Offeror understands the requirement, has the ability to perform the scope based on the size, scope and complexity required by the Government, and will be successful in performing the contract with some Government intervention.

Low Confidence

The Government has low confidence that the Offeror understands the requirement, has the ability to perform the scope based on the size, scope and complexity required by the Government, or will be successful in performing the contract even with Government intervention.

The non-price factors will be evaluated in descending order of importance as listed below.

• Factor 1: Relevant Experience Criteria (Phase I)

• Factor 2: IDIQ Overall Understanding & Approach (Phase II)

• Subfactor 1: Approach to Task Order (TO) #1 (Operations & Maintenance (O&M)) (Phase II)

• Factor 3: Management Approach (Phase II)

The non-price factors listed above will each be evaluated with a confidence rating of high, moderate or low. The non-price evaluation factor ratings will then receive an overall confidence rating of high, moderate or low.

The Government intends to award an IDIQ and one (1) task orders to the Offeror whose proposal conforms to the solicitation and represents the best value to the Government using tradeoffs, price and other factors considered. Evaluation Phase II and I are listed in descending order of importance and, when combined, are significantly more important than Volume III Cost. The evaluation will be based on the demonstrated capabilities of the Offeror in relation to the needs of the project as set forth in the RFP. The proposals will be evaluated carefully in accordance with the aforementioned confidence ratings to determine the best value to the Government. It is important the Offeror’s proposal be submitted initially with the most favorable terms and include details to support the completed pricing in the Attachment_A_Pricing Schedule & LCAT because the Government intends to award without negotiation in accordance with FAR 52.215-1. However, the Government reserves the right to hold discussions, if the Government determines discussions are necessary.

This RFP does not commit the Government to pay any cost for the preparation and submission of a proposal. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. The Government reserves the right to make administrative price/technical trade-offs that are in the best interest and to the advantage of the Government.

The Government will evaluate proposal for award purposes by adding the total price for all option periods (including the option to extend services) to the total price for the basic requirement. The total price does NOT include Transition-In and Transition-Out costs. The Government may determine that a proposal is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

x. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial

Services (APR 2026), applies to this acquisition and with an addenda for invoicing procedures which can be found under Attachment_1_IDIQ_SOW, section 4.6 Invoicing.

xi. Additional Contract Requirements and Terms and Conditions

FAR CLAUSES

52.252-2 Clauses Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at https://www.acquisition.gov/browse/index/far (End of Clause)

52.216-18 Ordering (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from September 29, 2026, through September 28, 2031.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

52.216-19 Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1,000, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of $10,000,000

(2) Any order for a combination of items in excess of $25,000,000; or

(3) A series of orders from the same ordering office within 14 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216- 21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order https://www.acquisition.gov/browse/index/far https://www.acquisition.gov/far/52.216-21#FAR_52_216_21 https://www.acquisition.gov/far/52.216-21#FAR_52_216_21

(or orders) is returned to the ordering office within three (3) days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons.

Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

52.216-22 Indefinite Quantity (NOV 2025)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the ordering period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order, which may include order options to be exercised after the ordering period of this contract but before the end of the period of performance of the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order, including options exercised, to the same extent as if the order were completed during the contract's ordering period; provided, that the Contractor shall not be required to make any deliveries under this contract after five (5) years beyond the expiration of this IDIQ.

(End of clause)

52.217-7 Option for Increased Quantity-Separately Priced Line Item (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)

52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time prior to the expiration date of the contract.

(End of clause)

52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the

Contractor any time prior to the expiration date of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of clause)

52.219-17 Section 8(a) Award (OCT 2019)

(a) By execution of a contract, the Small Business Administration (SBA) agrees to the following:

(1) To furnish the supplies or services set forth in the contract according to the specifications and the terms and conditions by subcontracting with the Offeror who has been determined an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(2) Except for novation agreements, delegates to the [Food and Drug Administration (FDA)] the responsibility for administering the contract with complete authority to take any action on behalf of the Government under the terms and conditions of the contract; provided, however that the contracting agency shall give advance notice to the SBA before it issues a final notice terminating the right of the subcontractor to proceed with further performance, either in whole or in part, under the contract.

(3) That payments to be made under the contract will be made directly to the subcontractor by the contracting activity.

(4) To notify the [Food and Drug Administration (FDA)] Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

(5) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the cognizant Contracting Officer under the "Disputes" clause of the subcontract.

(b) The offeror/subcontractor agrees and acknowledges that it will, for and on behalf of the SBA, fulfill and perform all of the requirements of the contract.

(End of clause)

52.219-18 Notification of Competition Limited to Eligible 8(a) Participants (OCT 2022)

(a) Offers are solicited only from—

(1) Small business concerns expressly certified by the Small Business Administration (SBA) for participation in SBA's 8(a) program and which meet the following criteria at the time of submission of offer—

(i) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan; and

(ii) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by SBA;

(2) A joint venture, in which at least one of the 8(a) program participants that is a party to the joint venture complies with the criteria set forth in paragraph (a)(1) of this clause, that complies with 13 CFR 124.513(c); or

(3) A joint venture—

(i) That is comprised of a mentor and an 8(a) protégé with an approved mentor-protégé agreement under the 8(a) program;

(ii) In which at least one of the 8(a) program participants that is a party to the joint venture complies with the criteria set forth in paragraph (a)(1) of this clause; and

(iii) That complies with 13 CFR 124.513(c).

(b) By submission of its offer, the Offeror represents that it meets the applicable criteria set forth in paragraph (a) of this clause.

(c) Any award resulting from this solicitation will be made to the Small Business Administration, which will subcontract performance to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation. A contracting officer may consider a joint venture for contract award. SBA does not approve joint ventures for competitive awards, but see 13 CFR 124.501(g) for SBA's determination of participant eligibility.

(d) The ____________ [insert name of SBA's contractor]shall notify the [Food and Drug Administration (FDA)] Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock.

(End of clause)

52.223-23 Sustainable Products (NOV 2025) (DEVIATION)

(a) Definitions. As used in this clause— Sustainable product means—

(1) A product that contains recovered material designated by the EPA under the Comprehensive Procurement Guidelines (42 U.S.C.