2026-10-07 Attachment L-Questions and Answers.xlsx

Sheet1

RFP; L.4 Proposal Preparation Instructions; II. Volume 1 – Technical Proposal; Technical Factor 3 – Management Approach/Organizational Structure

Attachment E: Sample Task Order SOW; 4.2 Task 2 – Program and Project (Task) Management

Attachment E: Sample Task Order SOW; 7.3 Staffing Plan 9–10

99–100

24–25 Attachment E requires the staffing plan to include resumes of proposed personnel, while Section L.4 requires resumes only for Key Personnel and Section C.8.1 identifies only the Program (Contract) Manager as Key Personnel at the IDIQ level.

Attachment E - Sample TO SOW; 7.1 Contractor Personnel; 7. Roster 17

Attachment K: Sample Task Order Pricing Sheet 37-38

RFP; G.14 Invoicing Instructions and Requirements

RFP; G.15 Contract Financial Reporting

RFP; H.14 Insurance Requirements

RFP; L.1 Special Instructions to Offeror on Supply Chain Risk Assessments

RFP; L.4 Proposal Preparation Instructions; III. Volume 2 - Business/Price Proposal 37-38

38-39

39-40

Please clarify the following:

1: If this policy is required with the proposal submission.

2. If yes, please confirm that this policy should be included in Volume 2, Business/Price Proposal.

1. Must these certifications be submitted with the proposal, or will the certification in the cover letter that all company information listed in the SAM.gov website is complete, accurate, and current suffice in lieu of completing these clauses?

L.1 Special Instructions to Offerors on Supply Chain Risk Assessment 88-90

92 HHSAR 352.204-74 SUPPLY CHAIN RISK ASSESSMENT (OCT 2024) (DEVIATION) [HHSAR CD 2025-01 (Oct. 1, 2024)] requires completion and submission by the offeror and any potential subcontractors.

1. Please clarify in which proposal volume this information should be submitted.

RFP; L.4 Proposal Preparation Instructions; Technical Factor 3 - Management Approach/Organizational Structure 97-98

100-101 Pages 96 and 97 say that cover pages, tables of contents, dividers, glossary, resumes, CPARS, and PPQs do not count against the page limitations.

Technical Factor 3 requires signed letters of commitment from all Key Personnel listed in Section C.8.1.

Attachment E: Sample TO SOW; 4.1.1 Transition-In Services 98

Attachment C: IDIQ Pricing Worksheet

Attachment K: Sample Task Order Pricing Worksheet; TO Pricing Worksheet; Allocated Facility Cost 98-99

All

All The solicitation requires the Contractor to secure and maintain a contiguous facility of at least 20,000 square feet throughout the five-year IDIQ ordering period and through completion of any resultant task orders. However, Attachment C does not include a line item for facility costs, and Attachment K provides a Government-established facility-cost plug amount applicable only to the Sample Task Order.

Attachment E - Sample Task Order Statement of Work; Section 4.1.1 Transition-In Services 98-99

2 Please clarify how FDA expects required services to continue while the successor contractor completes the facility buildout, security testing, FDA approval, equipment relocation, system implementation, and transition-in activities. The solicitation addresses transition-in and transition-out requirements in Sections C6.6.1 and C.6.6.2 of "RFP 7540126R00009 FIRF IDIQ." These provisions establish the planning, knowledge transfer, personnel onboarding, equipment relocation, and asset reconciliation requirements that govern the transition between predecessor and successor Contractors.

Regarding continuity of services during facility buildout, security testing, FDA approval, equipment relocation, and system implementation, the Government clarifies the following:

1. Transition Period: The successor Contractor will be afforded a 90-180 day transition-in period from contract award to complete facility preparation and stand-up activities before full performance is required.

2. Predecessor Obligations: The predecessor Contractor is required to continue full performance of required services during the transition-in period in accordance with their existing contract obligations and the transition-out requirements described in Section C.6.6.1. This ensures continuity of vital FDA business operations while the successor Contractor completes facility preparation.

3. Facility Approval: The FDA facility approval process is approximately 90-180 days. Offerors should account for this timeline in their Transition-In Plan and proposed transition period schedule.

Offerors should address their complete approach to facility preparation, parallel operations, and continuity of services during the transition period in their Transition-In Plan submission.

20 RFP; L.4 Proposal Preparation Instructions; II. Volume 1 – Technical Proposal; Technical Factor 1 – Contractor’s Off-Site Facility

RFP; M.2; RFO FAR 52.212-2, Evaluation—Commercial Products and Commercial Services

RFP; M.3 Basis for Award

RFP; M.4 Evaluation Criteria; Price Factor 6

Attachment C: IDIQ Pricing Worksheet

Attachment K: Sample Task Order Pricing Worksheet 98–99

103–104

All

All The solicitation provides for award using an LPTA approach and requires the Contractor to provide and maintain a secure, contiguous facility of at least 20,000 square feet. However, Attachment C does not require Offerors to propose their total facility costs, and Attachment K includes a Government-established facility-cost plug amount rather than each Offeror’s actual costs for acquiring or leasing the facility; completing necessary construction, tenant improvements, and facility build-out; installing required security and IT infrastructure; and operating and maintaining the facility.

RFP; L.4 Proposal Preparation Instructions; III. Volume 2 – Business/Price Proposal; Price Factor 6

RFP; M.2–M.4; Basis for Award and Price Factor 6

Attachment E: Sample Task Order SOW; 4.1.1 Transition-In Services

Attachment K: Sample Task Order Pricing Worksheet 99

103–108

All The solicitation requires Offerors to propose a transition-in approach addressing activities such as parallel operations, personnel onboarding, coordination with the predecessor contractor, and relocation of Government equipment. These activities may result in materially different costs depending on each Offeror’s existing facility, workforce, systems, equipment, and operational readiness. However, Attachment K does not include a separate line item for proposing transition-in costs and prohibits Offerors from modifying non-yellow-highlighted cells.

RFP; M.4 Evaluation Criteria; Technical Subfactor 2.1 - Technical understanding and Approach to Sample Task Order

Attachment E: Sample TO SOW; 7.3 Staffing Plan 99

24-25 Please confirm that an Acceptable sample task order approach must demonstrate availability of the full proposed Attachment K staffing complement on the first day of project operations, and that the 90-day transition period does not permit deferral of recruiting or staffing for required operational positions. Offerors must demonstrate a staffing plan that presents a resourcing and retention apporach that is logical and technically effective, and satisfies the rquirements of the IDIQ SOW. Their staffing plan must demonstate that they can achieve full staffing of all "Attachment K-Sample Task Order Pricing Worksheet" positions by the end of the transition period.

23 RFP; L.4 Proposal Preparation Instructions; II. Volume 1 – Technical Proposal; Technical Subfactor 2.1 – Technical Understanding and Approach to a Sample Task Order

RFP; M.4 Evaluation Criteria; Technical Subfactor 2.1

Appendix 5: FDA-CDRH Document Control Center (DCC) Tracking System Requirements 99

All Section M.4 requires an Offeror to demonstrate that it “has a tracking system” that meets all requirements in Appendix 5.

Please confirm that, to be rated Acceptable, an Offeror must demonstrate at proposal submission that its proposed tracking system is existing and operational through evidence such as a requirements traceability matrix, system architecture, screenshots, audit-log examples, interface descriptions, and applicable FedRAMP or ATO documentation. Please also confirm that an Offeror may not satisfy this requirement solely by proposing to develop or acquire a compliant tracking system after award. The solicitation defines the requirements for the proposed tracking system in "Appendix 5-FDA-CDRH Document Control Center (DCC) Tracking System Requirements." Offerors are required to propose a tracking system that meets all requirements at the time of proposal. The proposed tracking system does not have to be fully operational at the time of proposal.

24 RFP; L.4 Proposal Preparation Instructions; II. Volume 1 – Technical Proposal; Technical Subfactor 2.1 – Technical Understanding and Approach to a Sample Task Order

Attachment K: Sample Task Order Pricing Worksheet; TO Pricing Worksheet; Instructions 99

All Section L.4 instructs Offerors to propose a staffing mix and explain the rationale for their personnel choices and how those personnel will be applied. However, Attachment K prescribes nine labor categories and the corresponding hours for each performance period, and its instructions prohibit Offerors from altering any non-yellow-highlighted cells.

Please confirm that the labor categories and hours prescribed in Attachment K constitute the mandatory staffing baseline and must be used without modification in both the Sample Task Order pricing and the corresponding technical approach. If so, please confirm that the technical staffing plan should explain how the Offeror will organize, deploy, and manage the Government-prescribed workforce rather than propose different labor categories or staffing hours. The Government confirms that the nine labor categories and corresponding hours prescribed in "Attachment K-Sample Task Order Pricing Worksheet" constitute the mandatory staffing baseline for both the Sample Task Order pricing and the corresponding technical approach. Offerors may not modify the prescribed labor categories or hours in any non-yellow-highlighted cells.

The technical staffing plan required under Section L.4 of "RFP 75F40126R00009 FIRF IDIQ" should explain how the offeror will organize, deploy, and manage the Government-prescribed workforce to successfully accomplish the requirements described in the Statement of Work. Specifically, the staffing plan should address:

How the prescribed labor categories will be assigned to specific task areas and functions;

The rationale for how personnel will be deployed across the performance period;

The management structure and oversight approach for the prescribed workforce; and How the offeror will ensure the prescribed labor categories meet the qualification requirements in "Attachment F-Labor Category Descriptions."

Offerors should not propose different labor categories or staffing hours than those prescribed in "Attachment K-Sample Task Order Pricing Worksheet." Proposals that modify the prescribed labor categories or hours will be found non-compliant. Section L.4 of "RFP 75F40126R00009 FIRF IDIQ" is intended to elicit the offeror's management and deployment approach for the Government-prescribed workforce, not to invite alternative staffing proposals.

25 RFP; L.4 Proposal Preparation Instructions; II. Volume 1 – Technical Proposal; Technical Subfactor 2.1 – Technical Understanding and Approach to a Sample Task Order

RFP; M.4 Evaluation Criteria; Technical Subfactor 2.1 99

106 Section L.4 requires Offerors to describe the staffing workforce proposed for the Sample Task Order, explain the rationale for their personnel choices, and identify how and where the proposed personnel will be applied. However, the evaluation criteria for Technical Subfactor 2.1 in Section M.4 do not expressly address the evaluation of the proposed staffing workforce, personnel choices, or supporting rationale.

Please clarify whether these elements will be evaluated under Technical Subfactor 2.1. If so, please identify the objective criteria the Government will use to determine whether an Offeror’s proposed staffing workforce and rationale are Acceptable. The Government confirms that the proposed staffing workforce required by Section L.4 of "RFP 75F40126R00009 FIRF IDIQ" will be evaluated under Technical Subfactor 2.1 – Technical Understanding and Approach to a Sample Task Order. To be rated Acceptable, offerors must propose staff that have the required skills and expertise for a project of this magnitude in accordance with the requirements in "Attachment F-Labor Category Descriptions."

The staffing rationale and deployment explanation required by Section L.4 of "RFP 75F40126R00009 FIRF IDIQ" should demonstrate how the proposed workforce, organized around the nine labor categories prescribed in "Attachment K-Sample Task Order Pricing Worksheet", will be applied to the task areas and functions described in the Statement of Work. Evaluators will assess whether the proposed staffing approach demonstrates that personnel meet the "Attachment F-Labor Category Descriptions" qualification requirements for each prescribed labor category.

No additional evaluation criteria beyond "Attachment F-Labor Category Descriptions" compliance will be applied to the staffing workforce under Technical Subfactor 2.1 – Technical Understanding and Approach to a Sample Task Order. A proposal will be rated Acceptable under this subfactor if it demonstrates that proposed staff meet the skills and expertise requirements defined in "Attachment F-Labor Category Descriptions" for each of the nine prescribed labor categories.

26 RFP; L.4 Proposal Preparation Instructions; III. Volume 2 – Business/Price Proposal; Price Factor 6

RFP; M.1 Prospective Contractor Responsibility and Eligibility Standards

RFP; M.2; RFO FAR 52.212-2, Evaluation—Commercial Products and Commercial Services 101

103-104 Section L.4 requires Offerors to address their financial capacity, working capital, and other resources. Sections M.1 and M.2 require the successful Offeror to affirmatively demonstrate compliance with the broader responsibility standards in RFO FAR 9.104-1.

RFP; M.4 Evaluation Criteria; Price Factor 6

Attachment K - Sample Task Order Pricing Worksheet

101-102

All The solicitation indicates that a proposal will be deemed incomplete and rejected if the level of effort in Attachment K is changed, and that only yellow-highlighted cells may be edited. Please confirm that this restriction applies equally to all offerors, that no offeror may add, remove, or reallocate labor hours or labor categories in Attachment K, and that the Section M.4 price evaluation will include the sample task order price in addition to the IDIQ labor rates. Offerors are to complete only the yellow highlighted portions of the spreadsheet. No other cells shall be altered in any way or offers may be deemed nonresponsive. Offerors shall provide a fully loaded labor rate for all labor categories proposed. Offerors who fail to provide pricing for each labor category and each ordering period may be considered nonresponsive. The FDA will conduct price analysis on the Volume 2 Business/Price Proposal submission.

29 RFP; M.3 Basis for Award

RFP; M.4 Evaluation Criteria; Price Factor 6 105

1. Please clarify if the price analysis will be based solely on the IDIQ pricing information provided in Attachment C, or if the Sample Task Order costs in Attachment K will also be evaluated.

2. If both will be evaluated, please clarify how each will be evaluated and weighed in the price analysis. The Government clarifies that the Total Evaluated Price under Price Factor 6 will be derived solely from the Sample Task Order pricing in "Attachment K-Sample Task Order Pricing Worksheet".

The IDIQ ceiling rates proposed in "Attachment C-IDIQ Pricing Worksheet" will be reviewed for reasonableness and internal consistency with the Sample Task Order pricing in "Attachment K-Sample Task Order Pricing Worksheet" but will not be assigned a separate evaluated price or weighted separately in the price evaluation.

32 RFP; M.4 Evaluation Criteria; Price Factor 6

Attachment K: Sample Task Order Pricing Worksheet; TO Pricing Worksheet; SCA Category 108

All Attachment K identifies several labor categories - including Project Manager, Supervisor, and Subject Matter Expert - as exempt positions that are not mapped to the SCLS wage determinations. Section M.4 states that the Government will perform a price analysis but does not indicate whether proposed compensation for professional employees will be separately evaluated.

Please confirm that Offerors must use the prescribed SCLS/exempt classifications and may not revise the classification or mapping assigned to any labor category. The Government confirms that the prescribed SCLS/exempt classifications prescribed in Attachment K-Sample Task Order Pricing Worksheet" are fixed and may not be revised by offerors.

38 Section A.2, Notice of NAICS/Set-Aside 3 Please confirm whether an offeror must be certified by the SBA and designated in SAM.gov as a Service-Disabled Veteran-Owned Small Business as of the proposal submission date. Is a certified Veteran-Owned Small Business that is not service-disabled eligible to submit an offer as the prime contractor? To be eligible to submit an offer as prime contractor, an offeror must be certified by the SBA as a Service-Disabled Veteran-Owned Small Business concern in accordance with 13 CFR Part 128 and designated as such in SAM as of the proposal submission date. Offers from concerns that are not SBA-certified SDVOSBs will not be considered.

A Veteran-Owned Small Business that does not hold a separate SBA SDVOSB certification is not eligible to submit an offer as prime contractor under this solicitation. VOSB and SDVOSB are distinct certifications. Offers submitted by VOSB concerns not separately certified as SDVOSBs will not be considered regardless of technical merit or proposed price.

The prime contractor retains full contractual responsibility for the tracking system's implementation, security, integration, operations, and performance throughout the contract period The subcontractor is identified by name and all major subcontractor documentation requirements previously communicated are satisfied, including a signed teaming agreement or letter of commitment and a workshare description identifying the subcontractor's specific role and estimated percentage of total contract work The offeror demonstrates a credible and executable approach to obtaining all required security authorizations — including any applicable FedRAMP authorization or Authority to Operate — within the approximately 90-180-day transition period, regardless of whether the system is owned or operated by the prime or subcontractor The proposed subcontracting arrangement is consistent with the SDVOSB limitation requiring the prime to perform at least 50% of the cost of contract performance with its own employees Offerors proposing to satisfy the DCC Tracking System requirement through a subcontractor should address the subcontractor's system capability, the prime's oversight and management approach, and the path to ATO in their technical proposal.

47 Technical Subfactor 2.1 98-99 May a proposed subcontractor’s experience implementing and supporting comparable document-tracking systems be used to demonstrate technical acceptability under Technical Subfactor 2.1? Yes. A proposed subcontractor's experience implementing and supporting comparable document-tracking systems may be used to demonstrate technical acceptability under the applicable technical evaluation criteria, provided the following conditions are met:

- The subcontractor is identified by name and all major subcontractor documentation requirements previously communicated are satisfied, including a signed teaming agreement or letter of commitment and a workshare description identifying the subcontractor's specific role

- The prime contractor demonstrates in its technical proposal a credible management and oversight approach for the tracking system, including responsibility for implementation, security, integration, operations, and performance

- The subcontractor's experience is clearly described and attributed to the subcontractor in the technical proposal, including the specific systems implemented, the scope of work performed, and the relevancy of that experience to the DCC Tracking System requirements defined in the solicitation

- The proposed subcontracting arrangement is consistent with the SDVOSB limitation requiring the prime to perform at least 50% of the cost of contract performance with its own employees The Government will evaluate the team's collective technical capability — including subcontractor experience — in assessing whether the proposed approach demonstrates the capability to implement and support a compliant DCC Tracking System. The prime contractor's management and oversight approach will be a key element of this assessment.

48 Appendix 5, Contractor Responsibilities Appendix 5, Page 6 Must the prime contractor own the proposed DCC Tracking System, or may the system be licensed, hosted, configured, maintained, and supported by an approved subcontractor? No. The prime contractor is not required to own the proposed DCC Tracking System. Consistent with previous Government responses, the system may be licensed, hosted, configured, maintained, and supported by an approved subcontractor provided:

- The prime retains full contractual responsibility for the system's implementation, security, integration, operations, and performance throughout the contract period

- The subcontractor is identified by name and all previously communicated major subcontractor documentation requirements are satisfied

- The offeror demonstrates a credible approach to obtaining all required security authorizations including any applicable FedRAMP authorization or ATO within the approximately 90-180-day transition period

- The licensing, hosting, configuration, maintenance, and support arrangement is described in the technical proposal including how the prime will maintain management oversight and ensure system performance and security compliance

- The arrangement is consistent with the SDVOSB limitation requiring the prime to perform at least 50% of the cost of contract performance with its own employees 49 Appendix 5, DCC Tracking System Requirements Appendix 5, Pages 1-6 Please identify the required interfaces, data exchanges, security authorizations, testing activities, and FDA systems with which the proposed DCC Tracking System must integrate. The DCC Tracking System requirements are defined in Attachment A, "Appendix 5-FDA-CDRH Document Control Ceneter (DCC) Tracking System Requirements." Offerors should refer to "Appendix 5-FDA-CDRH Document Control Ceneter (DCC) Tracking System Requirements" for complete functional requirements. The following supplements "Appendix 5-FDA-CDRH Document Control Ceneter (DCC) Tracking System Requirements" in response to this question:

Interfaces and Data Exchanges The system must provide seamless automated data exchange with CDRH data systems per REQ-08. All integration interfaces must be documented, versioned, and maintained in conformance with federal interoperability standards. Specific interface specifications will be provided to the awardee during the transition period in collaboration with CDRH system integrators and FDA IT personnel.

Testing Activities The Contractor must provide User Acceptance Testing (UAT) support for the system and all integrated CDRH applications per the Contractor Responsibilities section of "Appendix 5-FDA-CDRH Document Control Ceneter (DCC) Tracking System Requirements." Disaster recovery plans must be tested at defined intervals per REQ-10. Specific UAT protocols and acceptance criteria will be established collaboratively with FDA during the transition period.

Offerors should address their approach to system integration, security authorization, UAT, and disaster recovery testing in their technical proposal, demonstrating a credible and executable plan for achieving full system compliance within the transition period.

50 Technical Factor 1, Contractor’s Off-Site Facility 98 What documentation will FDA accept as evidence that the offeror will possess the required facility by contract award? Will a contingent lease, letter of intent, purchase option, or landlord commitment satisfy this requirement? The proposal must demonstrate that the facilty meets the requirements outline in the RFP. For purposes of demonstrating that the facility will be owned or leased by the Offeror by the time of contract award, the Offeror may provide: A contingent lease agreement; A landlord commitment letter; A letter of intent (executed by both parties identifying the property and proposed lease terms; acceptable only when accompanied by a narrative explaining why a contingent lease or landlord commitment letter could not be obtained and the offeror's plan for executing a binding agreement); or Proof of facility ownership — deed or title documentation confirming the offeror owns a qualifying facility that will be available for performance.