R5_OSIST_QA_Master.xlsx
XLSX spreadsheet 33 KB Posted
- Attached to
- FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) IDIQ
- Solicitation number
- 75F40126R00020
About this file
This is a Master Question and Answer (Q&A) document for FDA Solicitation 75F40126R00020, the Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) indefinite-delivery/indefinite-quantity (IDIQ) contract. The document compiles 65 Government responses to contractor inquiries regarding solicitation requirements, evaluation criteria, and contract performance expectations across seven task areas: Program and Order Management, Transition Services, Occupational Safety and Policy Support, Primary Barrier Equipment Maintenance, Industrial Hygiene Services, Information and Data Systems Support, and Training Development and Management. Key contractual clarifications include confirmation that the single-award IDIQ structure will not be revised; offerors must propose to the full scope across all task areas with teaming and subcontracting permitted; subcontractors' experience will be evaluated at the team level; and the Subcontracting Plan is mandatory for non-small business offerors based on total IDIQ value exceeding $900,000, not individual subcontract thresholds. The Contracting Officer removed the PMP certification requirement for the Project Manager position and clarified that personnel security clearance requirements have been revised to Tier 2 for all contractor personnel, with no task-area-specific suitability tiers.
Technical clarifications address specific performance requirements across task orders: decontamination of ten BSL-3 suites will occur in parallel with contractor-provided VHP equipment and capacity for minimum two suites daily; historical decontamination averaged 8,960 square feet annually; the Information and Data Systems work will generally be bundled with occupational-safety and industrial-hygiene task orders rather than issued discretely; the Government will provide eLearning authoring tool licenses and LMS administrative access; approximately 35 active OOSH eLearning courses may require annual review and updates; Isoflurane exposure assessments will be conducted at White Oak campus only; and the contractor will receive access to existing FDA SharePoint environments and on-site workspace with Government-furnished IT equipment, office furnishings, and network connectivity for personnel performing at White Oak and other NCR locations as specified in individual task orders.
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Other files
| File | Type | Posted |
|---|---|---|
| 75F40126R00020_RFP_06.29.2026_clean.pdf | ||
| 75F40126R00020_RFP_06.29.2026_redline.docx | DOCX document | |
| C1_OSIST_PWS_06.29.2026_clean.pdf | ||
| C1_OSIST_PWS_06.29.2026_redline.docx | DOCX document | |
| R1_CBER BSL3 PWS 06292026_clean.pdf | ||
| R1_CBER BSL3 PWS 06292026_redline.docx | DOCX document | |
| R7_OSIST_NCR Inventory_DRAFT.xlsx | XLSX spreadsheet | |
| 75F40126R00020_Amend 01.pdf | ||
| R3_OOSH Workstream PWS 061126.pdf | ||
| 75F40126R00020_RFP.pdf | ||
| C2_OSIST Facility Inventory 061126.pdf | ||
| R2_CBER BSL3 Decontamination Spaces.pdf | ||
| R6_HHS Subkt Plan Template.pdf | ||
| C1_OSIST_PWS 061126.pdf | ||
| C3_OSIST_Price_Workbook.xlsx | XLSX spreadsheet | |
| C5_FDA CTR Personnel Security Clearance.pdf | ||
| R1_CBER BSL3 PWS 061126.pdf | ||
| R5_OSIST RFP Q_A Template.xlsx | XLSX spreadsheet | |
| C4_FDA_Form 3398_ Non Public Agreement.pdf | ||
| R4 - Past Performance Questionnaire 061126.pdf |
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Master Q&A
| Question # | Solicitation Section | Attachment Reference | Page # | Question | Response Type (Technical/Contractual) | Government Response | |
| 1 | Section K | OSIST_RFP | p. 38 | Given that Training Development and Management is identified as a distinct task area, has FDA considered whether a single-award IDIQ structure may limit competition from highly qualified firms with specialized expertise in individual task areas? | Contractual | The requirement is solicited as a single-award indefinite-delivery contract. The acquisition strategy is established and supported by the contract file. The solicitation is not being revised in response to this question. | |
| 2 | Section L | OSIST_RFP | p. 39 | If so, what factors led FDA to conclude that a single-award approach provides greater value than a multiple-award or functional-area approach? | Contractual | See response to Question 1. | |
| 3 | Section M | OSIST_RFP | p. 53-54 | The solicitation requires offerors to demonstrate capability across all Task Areas 3–7. Would FDA consider allowing offerors to propose against discrete task areas or workstreams, particularly where specialized expertise exists (e.g., Training Development and Management, Information and Data Systems Support, Industrial Hygiene Support Services)? | Contractual | No. Offerors shall propose to the full scope, including Task Areas 3 through 7. Subcontractors and teaming partners are permitted; proposals limited to discrete task areas will not be considered. | |
| 4 | Section L | OSIST_RFP | p. 46-47 | For offerors whose primary expertise aligns with one or more specific task areas rather than the entire OSIST portfolio, does FDA anticipate that meaningful participation through teaming arrangements or subcontracting relationships will be sufficient to satisfy evaluation requirements under Factors 1 and 2? | Contractual | Yes. The Government evaluates corporate experience and past performance at the team level. The team must collectively demonstrate capability across the full scope, including Task Areas 3 through 7. | |
| 5 | Section M | OSIST_RFP | p. 56-57 | Does FDA anticipate future task orders being issued as integrated requirements spanning multiple task areas, or will task orders commonly align to individual workstreams such as Training Development and Management, Information Systems Support, or Industrial Hygiene Services? | Contractual | Task orders may cover any combination of task areas or focus on specific ones, depending on Agency needs. Offerors should propose to the full scope of services contemplated under the IDIQ. | |
| 6 | Section K | OSIST_RFP | p. 38 | Has FDA assessed whether the current single-award structure could reduce participation opportunities for small businesses possessing specialized capabilities within individual task areas? | Contractual | See response to Question 1. Subcontracting and teaming are permitted, allowing specialized and small business firms to participate as part of an offeror team. The solicitation is not being revised. | |
| 7 | Section L | OSIST_RFP | p. 39 | Would FDA consider alternative acquisition approaches that increase direct participation opportunities while maintaining program integration? | Contractual | No. The acquisition approach is established by the solicitation, which will not be revised. Offerors should propose to the requirement as solicited. | |
| 8 | Section L | OSIST_RFP | p. 42-43 | If a subcontractor is proposed to perform substantially all work associated with a particular task area (e.g., Training Development and Management), how will the Government evaluate the relevance of that subcontractor's experience and past performance relative to the Prime Contractor's experience? | Contractual | The Government evaluates corporate experience and past performance at the team level, weighing a subcontractor's experience to the extent of its proposed role, and will evaluate the offeror's approach to integrating prime and subcontractor capabilities. | |
| 10 | PWS Section 1.3 Scope | C1 - OSIST IDIQ Performance Work Statement (PWS) | Can the Prime Contractor satisfy specialized technical requirements through qualified subcontractors and teaming partners, or must all required capabilities reside within the Prime Contractor organization? | Contractual | Yes. Capabilities need not all reside with the prime. The team must collectively perform the full scope, and the prime remains responsible for overall performance. | ||
| 11 | Key Personnel Requirements | R3 - OOSH Workstreams Sample PWS | Are Certified Industrial Hygienists (CIHs) required as key personnel at the IDIQ level? | Technical | No. | ||
| 12 | Industrial Hygiene Support | R3 - OOSH Workstreams Sample PWS | What percentage of anticipated task order work is expected to involve Industrial Hygiene support services? | Technical | The Government does not guarantee the percentage of work associated with any individual task area. Workload will depend upon mission requirements, funding availability, and future task order needs. | ||
| 13 | Primary Barrier Equipment Suppor | C1 - OSIST IDIQ Performance Work Statement (PWS) | May offerors utilize qualified subcontractors to perform certification, maintenance, and testing of primary barrier equipment? | Technical | Yes. | ||
| 14 | Training Development & Management | C1 - OSIST IDIQ Performance Work Statement (PWS) | What percentage of anticipated work is expected to support training development, curriculum design, and training management services? | Technical | See response to Question 12. | ||
| 15 | Past Performance | R4 - Past Performance Questionnaire | Will occupational safety, OSHA compliance, safety program management, and training development projects be considered relevant past performance? | Contractual | Such experience may be relevant to the extent it is similar in scope, magnitude, complexity, and responsibilities to this requirement. The Government evaluates the relevance of each reference. | ||
| 16 | Place of Performance | C1 - OSIST IDIQ Performance Work Statement (PWS) | Will remote performance be permitted for policy development, training development, program management, and compliance support tasks when appropriate? | Technical | No. Remote performance is not permitted unless a task order expressly authorizes it. The place of performance for each task order will be specified in the applicable task order. As stated in the solicitation, performance may occur at FDA facilities nationwide, and task orders may identify specific performance locations and requirements. Offerors should propose in accordance with the solicitation requirements and should not assume that any particular work may be performed remotely unless specified in the applicable task order. | ||
| 17 | Contract Scope | None / N/A | Will remote performance be permitted for policy development, training development, program management, and compliance support tasks when appropriate? | Contractual | See response to Question 16. | ||
| 18 | C1 - OSIST IDIQ Performance Work Statement (PWS) | Does the Government anticipate evaluating offerors on their ability to perform all OSIST task areas at the IDIQ level, or will specialized capabilities be evaluated at the individual task order level? | Contractual | Offerors are evaluated at the IDIQ level on capability to perform the full scope, per Sections L and M. Specialized capability is not separately evaluated at the task-order level in this source selection. | |||
| 19 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 7 | Instructor-led training topics list includes Marine Safety, Powered Industrial Truck Operations, Hoisting/Rigging/Crane Operations. Please confirm that these topics are part of the requirements. | Technical | Yes. | ||
| 20 | R3 - OOSH Workstreams Sample PWS | 5 | 6.0 says "Travel not anticipated". However the worklocation indicates that this work could cover outside the National Capital Region (NCR). If there is a need to provide workstream support for sites that are outside the NCR, will government amend this language? | Contractual | No amendment is required. The "travel not anticipated" statement applies only to the R3 evaluation scenario. Task orders may require nationwide performance, and any travel will be identified in the applicable task order. | ||
| 21 | C3 - OSIST Price_Workbook | Task Order 1 in Tab 5 Staffing-Price Crosswalk does not have a space for Task 1 and 2 hour. Do Offeror’s put hours for Task 1 and 2 in rows 5-24 that are currenlty labeled "Task Order 1" ? Or are Tasks 1 and 2 part of the Workstream Pricing? If not, please specify where Offeror's should price Tasks 1 and 2 as Task Areas 1 and 2 are not Workstreams. | Contractual | Price Task Areas 1 and 2 the same way as Task Areas 3 through 7: break out by applicable labor category and proposed hours, and include all labor in the overall scenario pricing. | |||
| 22 | RFP M.5.3 and L.4.1; OSIST PWS 2.0; Workstream PWS 3.0 | M.5.3 and L.4.1 of The RFP and The Workstream PWS state that Workstream Support (Tasks 3 to 7) consist of the following: | |||||
| • | Policy and Compliance Strategies | ||||||
| • | Safety Manuals, Plans, Guides, and Directives | ||||||
| • | Safety Training | ||||||
| • | Laboratory Quality Management Systems (LQMS) | ||||||
| • | Communications and Coordination | ||||||
| • | Technical Assistance |
However, in the PWS, Tasks 1-3 are as follows:
| • | Task Area 3 – Occupational Safety, Policy, and Laboratory Quality Support |
| • | Task Area 4 – Primary Barrier Equipment Maintenance |
| • | Task Area 5 – Industrial Hygiene Support Services |
| • | Task Area 6 – Information & Data Systems Program Support |
| • | Task Area 7 – Training Development and Management |
| Please resolve the Task Area subject discrepancy so that Offeror’s can adequately price. | Contractual | The R3 workstreams do not map one-for-one to PWS Task Areas 3 through 7. The solicitation has been amended; refer to the revised Sections L.4.1 and M.5.3. | |||||
| 23 | Section M | 80 | This section states "Past performance of proposed subcontractors may be considered to the extent that the subcontractor is proposed to perform meaningful aspects of the requirement, consistent with the Offeror’s proposed approach." Can the Government please define what meaningful aspects of the requirement means? | Contractual | The Government does not set a percentage threshold. It will weigh the subcontractor's proposed role, responsibilities, and contribution to performance. A signed teaming or subcontracting agreement is required where a subcontractor is expected to perform a substantial portion of the work (generally 25 percent or more). | ||
| 24 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 16 | Project Manager requirement "PMP certification is mandatory". Can this requirement be satisfied by the Project Manager in process of training to sit for the PMP exam within 6 months of contract award or completely removed? | Technical | The PMP certification requirement for the Project Manager has been removed. A PMP certification is not required at the time of proposal submission or after contract award. Refer to the amended OSIST IDIQ PWS. | ||
| 25 | Section L | None / N/A | 39 | This is a single-award Full and Open IDIQ. Will the Government recognize teaming arrangements in which a small business performs the Information and Data Systems (PWS Task Area 6) and Training (PWS Task Area 7) scope as a subcontractor to the prime? Are there any restrictions on the prime's use of subcontractors for these task areas at the IDIQ or task-order level under FAR 52.219-14? | Contractual | Yes. A small business may perform Task Areas 6 and 7, or other portions of the requirement, as a subcontractor. No task-area-specific subcontracting restrictions apply. Offerors remain responsible for compliance with the applicable limitation on subcontracting. | |
| 26 | Section L | None / N/A | 38 | For an Offeror that is other-than-small, will the Section L.9 Small Business Subcontracting Plan and the required Workshare Allocation Table be scored under an evaluation factor, and does the Government have target small-business subcontracting goals (percentage of total contract value) for this requirement? | Contractual | Yes. The Subcontracting Plan is evaluated under Factor 6 (Section M.9) on an Acceptable/Unacceptable basis. The Workshare Allocation Table informs the consistency assessment across factors. Subcontracting goal expectations are stated in Section L.9(d); justify any proposed goals that differ. | |
| 27 | Section C | C1 - OSIST IDIQ Performance Work Statement (PWS) | Task Area 6 | Will the Information and Data Systems scope in PWS Task Area 6 (dashboards, document repository solutions, database/inventory tracking tools, enterprise database transfers) be issued as discrete task orders, or will it always be bundled with the occupational-safety / industrial-hygiene / biosafety task orders? This affects how a specialized IS subcontractor would be staffed and priced. | Technical | Task Area 6 will generally be bundled with the occupational-safety, industrial-hygiene, and biosafety task orders rather than issued as discrete task orders. | |
| 28 | Section C | C1 - OSIST IDIQ Performance Work Statement (PWS) | Task Area 7 | PWS Task Area 7 references industry-standard eLearning authoring tools (Articulate, Lectora) and Section 508 compliance. Will the Government furnish the existing LMS platform, authoring-tool licenses, and any GFE/GFI, or is the Contractor expected to provide these tools and licenses at its own cost? | Technical | The FDA will provide one license for each required eLearning authoring tool, as needed, and LMS administrative access to the existing LMS platform. | |
| 29 | Section M | R4 - Past Performance Questionnaire | 30 | For a prime/subcontractor team, will the Government evaluate the past performance of proposed subcontractors who will perform the Information Systems and Training task areas, and what relevancy thresholds (dollar value, scope, recency) apply to subcontractor past-performance references under Factor 4? | Contractual | Yes. Subcontractor past performance is considered to the extent of the subcontractor's proposed role. Relevance is assessed by scope, magnitude, complexity, and recency. No separate dollar-value or scope thresholds apply to subcontractor references. | |
| 30 | Section H | C5 - FDA Contractor Personnel Security Clearance Standard | N/A | Do personnel performing the Information and Data Systems (Task Area 6) and Training (Task Area 7) work require the same personnel security clearance / suitability level as personnel performing on-site laboratory and biosafety work, or is a lower investigation tier acceptable for IS/training staff who do not access BSL-3 spaces? | Contractual | The contract risk designation is revised to Tier 2 for all contractor personnel. No task-area-specific suitability tiers apply. Refer to the amended solicitation and R1. | |
| 31 | Section H | None / N/A | 28 | Will the submission allow for the inclusion of additonal support personnel in addition to Key Personnel positions? | Contractual | Yes. The Program Manager is the only Key Personnel position; offerors may propose additional non-key personnel to support their approach. | |
| 32 | Section F | None / N/A | 13 | Does FDA anticipate resident contractor personnel at White Oak or other FDA locations? | Technical | Yes. FDA anticipates that personnel providing significant support under IDIQ task orders will work part-time onsite within the NCR, including White Oak and other FDA locations, as required. Each task order will specify any onsite attendance requirements. Onsite availability will be subject to Federal space availability. | |
| 33 | Section B | None / N/A | 4 | Should travel be proposed at the IDIQ level or task-order level? | Contractual | At the task order level. Travel is not proposed at the IDIQ level; if required, it will be addressed as an ODC under the applicable task order. | |
| 34 | Section B | None / N/A | 5 | Section B.1.2 excludes replacement parts or consumables exceeding task order thresholds from the equipment recertification rates. Can the Government define or provide an example of the dollar threshold that determines when a consumable shifts from rate-included to a separately priced ODC, or confirm this threshold will be defined in each individual task order? | Contractual | Refer to the amended PWS. It sets a default threshold for incidental repairs, parts, and consumables included in the fixed-price recertification rates; task orders may set a higher threshold up to the PWS maximum. Amounts above the applicable threshold are separately authorized and priced as an ODC. | |
| 35 | C1 - OSIST IDIQ Performance Work Statement (PWS) | Does FDA anticipate simultaneous execution of multiple task orders across multiple facilities? | Technical | Yes. | |||
| 36 | C1 - OSIST IDIQ Performance Work Statement (PWS) | Can FDA provide a complete inventory of primary barrier equipment covered under this contract? | Technical | No. FDA is currently updating the inventory of primary barrier equipment. The most recent version is provided as R7_OSIST NCR Inventory for reference purposes only and should not be considered a complete or final inventory for contract performance. | |||
| 37 | C1 - OSIST IDIQ Performance Work Statement (PWS) | What level of nationwide travel should offerors assume for industrial hygiene support? | Technical | Historically, nationwide travel for industrial hygiene support has been very limited. However, Offerors should propose an approach capable of supporting the nationwide scope described in the solicitation, as future task order requirements may require support at FDA facilities outside the National Capital Region. | |||
| 38 | C1 - OSIST IDIQ Performance Work Statement (PWS) | What level of nationwide travel should offerors assume for Occupational Safety, Policy, and Laboratory Quality Support support? | Technical | Historically, nationwide travel for Occupational Safety support has been very limited. Historically, Policy and Laboratory Quality Support activities have generally been performed without significant travel. However, Offerors should propose an approach capable of supporting the nationwide scope described in the solicitation. | |||
| 39 | C1 - OSIST IDIQ Performance Work Statement (PWS) | Can FDA provide historical industrial hygiene assessment volumes? | Technical | No. Historical industrial hygiene assessment volume data is not available. | |||
| 40 | C1 - OSIST IDIQ Performance Work Statement (PWS) | Can FDA provide historical training volumes and student counts? | Technical | No. Historical training volume and student count data is not available. | |||
| 41 | Task Area 3 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 4 | C1 Task Area 3 requires support to the Institutional Biosafety Committee (IBC), Radiation Safety Committee, and similar chartered groups. Can the Government identify the other standing safety committees at FDA that may require contractor support under this task area and the approximate frequency of their meetings? | Technical | No. The number, composition, and support requirements of FDA chartered groups continue to change as the Agency modernizes. Accordingly, FDA cannot identify all standing safety committees or provide meeting frequencies at this time. Offerors should describe their approach to managing evolving requirements and structure their pricing to accommodate variability in the level and type of support required. | |
| 42 | Task Area 4 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 5 | C1 Task Area 4 requires maintaining a centralized repository of certification status for all primary barrier equipment and proactively monitoring expiration dates. Does FDA currently have an existing database or asset management system for this purpose that the contractor would maintain and enhance, or is the contractor expected to design and implement a new repository? | Technical | FDA currently maintains a spreadsheet that serves as the repository for certification status of primary barrier equipment. The contractor will be expected to maintain and enhance this existing repository; development and implementation of a new repository is not required. | |
| 43 | Task Area 5 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 5 | C1 Task Area 5 requires the contractor to serve as architect of FDA's enterprise industrial hygiene program and align it with AIHA and ANSI/ASSP Z10 frameworks. Can the Government describe the current maturity level of the enterprise IH program (e.g., initial build-out vs. ongoing maintenance and continuous improvement) to help offerors calibrate the level of effort required? | Technical | FDA's industrial hygiene program is currently decentralized, with OOSH providing policy direction, technical expertise, and the Designated Agency Safety and Health Official function. Centers, Offices, and Programs are responsible for executing their industrial hygiene and occupational safety and health activities in alignment with FDA/OOSH requirements. While the concept of an occupational health and safety management system has been introduced, implementation has not yet begun. Accordingly, offerors should anticipate supporting the development and implementation of an enterprise-wide industrial hygiene program and associated management system from the ground up. | |
| 44 | Task Area 7 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 7 | C1 Task Area 7 requires eLearning development using Articulate, Lectora, or other approved authoring software. Can the Government confirm which authoring tools are currently approved for use within the FDA EOSH Training Program, and identify the FDA Learning Management System (LMS) to which completed eLearning modules must be uploaded? | Technical | Yes. The FDA EOSH Training Program is authorized to use Articulate 360 and Lectora for eLearning development. Articulate Storyline 2 is currently used to update existing training courses. Completed eLearning modules are uploaded to the FDA's internal Learning Management System (LMS). Additional LMS details will be provided as appropriate during contract performance. | |
| 45 | Task Area 7 | C1 - OSIST IDIQ Performance Work Statement (PWS) | 7 | C1 Task Area 7 requires instructor-led training delivery for HAZWOPER, powered industrial truck operations, hoisting/rigging/crane, marine safety, RCRA, DOT hazardous materials, and shipping infectious substances. Can the Government provide the approximate annual frequency and average participant volume for each course type to support subcontractor and staffing planning? | Technical | No. The instructor-led training courses are generally offered virtually, with participant counts ranging from approximately 5 to 50 attendees per session. Courses are typically offered either annually or biannually. FDA does not maintain historical course frequency and participant data in a format that would support reliable forecasting for this requirement. Contractor support is limited to training administration functions, including logistics management, instructor procurement, venue coordination (as applicable), registration, attendance tracking, and Section 508 compliance reviews. Contractor support does not include delivery of the training courses. | |
| 46 | 2.2 | R1 - CBER BSL-3 Suite PWS | Is VHP generation equipment (generators, hoses, sensors, monitoring equipment) contractor-furnished for all decontamination activities, or does the Government have any existing VHP equipment available as GFE? If contractor-furnished, should equipment costs be embedded in labor/service rates or captured separately as an ODC? | Technical | The contractor shall furnish all VHP equipment/supplies/accessories necessary to perform the required decontamination services. No Government-furnished VHP equipment will be provided. Offerors shall include all costs associated with providing and operating the required equipment in their proposed pricing for the applicable services. | ||
| 47 | Section L | None / N/A | 48 | The RFP states that decontamination areas "may vary by option year based on prior work or unanticipated needs." Can the Government provide any historical data on the typical number of decontamination events per year or the square footage decontaminated annually to support realistic pricing? | Technical | Historical decontamination requirements have averaged approximately 8,960 square feet annually. This information is provided for historical planning purposes only and does not guarantee future decontamination requirements, which may vary based on prior work completed, operational needs, and mission requirements. Offerors shall develop their technical and price proposals based on the requirements set forth in Task Order 1 and Attachment R2 of the solicitation. | |
| 48 | Section L | None / N/A | 48 | For Task Order 1 pricing, R1 Section 4 notes that decontamination areas may vary by option year based on prior work or unanticipated needs. Should offerors price all ten suites listed in R2 for both the base period and all option years, or should the option year pricing reflect a different or reduced scope assumption? | Contractual | Yes. Price all ten suites in Attachment R2 for the base and all option periods. The note on potential variation reflects operational flexibility and does not require alternative pricing assumptions. | |
| 49 | 4 | R1 - CBER BSL-3 Suite PWS | 4 | The decontamination schedule in R1 Section 4 targets the 2nd-3rd week of November and recertification in the 2nd week of December. Are these firm scheduling requirements or estimated target periods? What is the typical total duration (days) for completing decontamination and re-verification of all ten suites based on prior performance history? | Technical | The decontamination and recertification timeframes identified in R1 Section 4 are firm scheduling requirements for 2026 intended to accommodate scientific operations, future scheduling would be estimated to be similar. Decontamination is generally required during the second week of November. For 2026, FDA anticipates decontamination will require approximately four (4) days, assuming two suites can be completed per day. In subsequent years, if all suites are active, decontamination may require up to five (5) days. Recertification is typically completed in one (1) day, generally beginning around 9:00 a.m. and concluding by 6:00–7:00 p.m., assuming no certification failures or equipment/system issues. For 2026, recertification is required to occur on December 14, 2026. | |
| 50 | 2.2 | R1 - CBER BSL-3 Suite PWS | 3 | R1 Section 2.2 states decontamination applies to the ten BSL-3 suites in Attachment R2. Can the Government confirm whether the ten suites are decontaminated sequentially (one at a time) or in parallel (multiple suites simultaneously), and whether the contractor is expected to have sufficient VHP generator capacity to run multiple suites concurrently if that is the Government's preferred approach. | Technical | The ten BSL-3 suites are decontaminated in parallel rather than sequentially. The contractor shall provide sufficient VHP generator capacity to decontaminate a minimum of two (2) suites per day. FDA may permit decontamination of up to three (3) suites per day; however, more than three (3) suites per day is not feasible due to operational constraints. Offerors remain responsible for proposing an approach sufficient to meet the required schedule. | |
| 51 | R1 - CBER BSL-3 Suite PWS | R1 Section 6 states normal operating hours are Monday through Friday, 7:30 AM to 4:00 PM, excluding Federal holidays. Given the compressed decontamination and recertification window (November and December), can the Government confirm whether after-hours or weekend work will be authorized if needed to meet the performance timeline, and whether premium time costs would be reimbursable as an ODC? | Technical | No. Weekend and after-hours work generally cannot be accommodated because direct Government supervision is required during all decontamination and recertification activities. The only anticipated exception is the recertification day, which is expected to occur on a Monday and may extend beyond normal operating hours, typically concluding around 6:00 p.m. after completion of required testing, including verification of the power failure scenario. Offerors shall propose a firm-fixed price that reflects the labor effort, staffing approach, scheduling, and resources reasonably necessary to successfully perform and complete the required services. The Government will not consider separate reimbursement for overtime, premium time, or similar additional labor costs. | |||
| 52 | R1 - CBER BSL-3 Suite PWS | Can the Government confirm the current pressure cascade configuration for the BSL-3 suites (e.g., anteroom-to-corridor and suite-to-anteroom differential pressure setpoints) and whether the contractor is expected to validate against a Government-provided design specification or against industry standards such as the NIH Design Requirements Manual and BMBL? | Technical | During decontamination activities, the ventilation system is shut down and laboratory doors are sealed to prevent VHP migration. Accordingly, pressure differentials between the laboratory rooms and anterooms, and between anterooms and adjacent hallways, are expected to be approximately zero during the decontamination process. The contractor shall utilize appropriate chemical indicators throughout the suites to demonstrate VHP exposure and biological indicators to verify successful decontamination. FDA expects contractors to perform decontamination and verification activities in accordance with applicable industry standards and best practices, including relevant requirements and guidance contained in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) and the NIH Design Requirements Manual (DRM). | |||
| 53 | 4.4 | R3 - OOSH Workstreams Sample PWS | 2 | R3 Section 4.4 requires at least one eLearning course to undergo a complete annual review and update, and a gap analysis for up to two eLearning courses. Can the Government provide the approximate number and scope of existing OOSH eLearning courses that may be subject to review, and whether existing course files will be provided as GFI? | Technical | Yes. Existing eLearning course files will be provided as Government-Furnished Information (GFI) in either Articulate or Lectora format, as available. |
The Government currently maintains approximately 35 active OOSH eLearning courses. This number may change over the course of the contract as courses are retired and new courses are developed.
The contractor should anticipate reviewing and updating up to five (5) eLearning courses annually. The scope of work for each course will vary and may include: (1) a review with no required revisions, (2) migration of a course from Articulate Storyline to Articulate Rise, or (3) comprehensive updates incorporating extensive subject matter expert (SME) comments, such as revisions to grammar, audio, and technical or regulatory content. In some instances, a course may require more than 100 SME comments to be addressed.
The eLearning courses primarily cover laboratory and general safety training required by the Occupational Safety and Health Administration (OSHA), the U.S. Nuclear Regulatory Commission (NRC), and the Federal Select Agent Program (FSAP). The courses incorporate applicable U.S. Department of Health and Human Services (HHS) and FDA policies and procedures and are designed using adult learning principles, including knowledge checks and interactive components. Course lengths range from microlearning modules to approximately 60 minutes.
| 54 | 5 | R3 - OOSH Workstreams Sample PWS | 4 | R3 Section 5.0 requires an Isoflurane exposure assessment of up to 100 workers. Can the Government clarify the expected geographic distribution of the affected workers (e.g., White Oak only, or across multiple field sites), as this directly affects travel assumptions, sampling equipment needs, and level-of-effort estimates? | Technical | The Isoflurane exposure assessments will be conducted at the FDA White Oak campus in White Oak, Maryland. No field site travel is anticipated for this effort. Offerors should base their staffing, sampling equipment, travel, and level-of-effort assumptions accordingly. | |
| 55 | 5 | R3 - OOSH Workstreams Sample PWS | 4 | R3 Section 5.0 identifies a 12-month period of performance from award. Can the Government confirm whether the Workstream scenario will be issued concurrently with Task Order 1 at IDIQ award, or whether it represents a future task order that may be issued at any point during the ordering period? | Technical | Workstream Support Evaluation Scenario (Attachment R3) is provided as a sample of a potential future task order. It is not anticipated to be issued concurrently with Task Order 1 at IDIQ award and may be issued at any point during the ordering period, subject to the availability of funding. Because the task order will be developed based on available funding, the final scope, level of effort, and specific requirements may vary from the sample scenario provided in the solicitation. | |
| 56 | 4.1 | R3 - OOSH Workstreams Sample PWS | 2 | R3 Section 4.1 requires a Work Plan and Strategic Approach to be maintained in a designated SharePoint folder. Can the Government confirm whether the contractor will be provided access to an existing FDA/OOSH SharePoint environment, or whether the contractor is expected to establish and host a SharePoint site? If Government-hosted, can the Government confirm the access provisioning timeline post-award? | Technical | The contractor will be provided access to the existing FDA/OOSH SharePoint environment. Access will be granted after contractor personnel have been appropriately credentialed and provided FDA IT system access. The contractor is not required to establish or host a separate SharePoint site. | |
| 57 | 5 | R3 - OOSH Workstreams Sample PWS | 3 | R3 Section 5.0 identifies biweekly OSIST Program and Workstreams Project status meetings. Can the Government confirm the expected format and duration of these meetings (e.g., virtual, in-person, or hybrid), the typical attendee list from the Government side, and whether the contractor is responsible for preparing and distributing meeting materials and minutes? | Technical | The biweekly OSIST Program and "Workstreams Project"t Status Meetings will generally be conducted in a hybrid format, with meeting duration varying based on program needs. The Contractor shall be responsible for scheduling the meetings, preparing agendas, and documenting and distributing meeting records/minutes. At a minimum, the OSIST Program Meeting will include the FDA Technical Lead, COR, and Contractor Program Manager. The "Workstreams Project" Status Meeting will include the FDA Technical Lead, COR, and Contractor Project Manager and/or Program Manager. Additional Government and contractor personnel may participate as needed. | |
| 58 | 5 | R3 - OOSH Workstreams Sample PWS | 3 | Can the Government provide the anticipated participant count, required frequency, and geographic locations for each of the four instructor-led training courses identified in R3 Section 5.0? Specifically, will courses be delivered only at White Oak or at multiple FDA facilities, and are virtual delivery options acceptable for all four courses? | Technical | Instructor-led training courses are generally delivered virtually, and virtual delivery is acceptable for all four courses. Participant counts range from approximately 5 to 50 attendees per course, offered annually or biennially as specified in the applicable task order. FDA does not maintain course frequency and participant data in a format that supports reliable forecasting. Contractor support is limited to training administration, including logistics management, instructor procurement, registration, attendance tracking, and Section 508 reviews, and does not include course delivery. | |
| 59 | 4.4 | R3 - OOSH Workstreams Sample PWS | R3 Section 4.4 requires comprehensive training records and certification tracking systems and generation of compliance reports and dashboards for management review. Does FDA currently have a training records system (e.g., an LMS or HRIS module) that the contractor will populate and maintain, or is the contractor expected to establish and host an independent tracking system? | Technical | OOSH currently has access to an internal Learning Management System (LMS), and the Contractor will be granted appropriate administrative access to support training records management and compliance tracking. In limited circumstances, the Contractor may be required to establish independent tracking mechanisms for training provided to individuals who do not have access to the FDA LMS, as specified in the applicable Task Order. | ||
| 60 | 4.4 | R3 - OOSH Workstreams Sample PWS | 2 | R3 Section 4.4 requires a training needs assessment including gap analysis comparing current programs against regulatory mandates, industry best practices, and organizational safety objectives. Can the Government describe the scope of this assessment (for example, whether it covers the full FDA enterprise, only OOSH-managed programs, or a specific subset of facilities or employee populations)? | Technical | The training needs assessment encompasses FDA's Occupational Safety and Health regulatory compliance requirements for all FDA employees and contractors. The assessment shall evaluate training requirements derived from applicable Federal regulations, consensus standards, authoritative guidance, FDA policies and guidance, and industry best practices. The assessment shall include a gap analysis identifying training status (e.g., achieved, in progress, or planned) against applicable requirements. | |
| 61 | 5 | R3 - OOSH Workstreams Sample PWS | 4 | R3 Section 5.0 requires publication of 12 monthly OOSH Newsletters. Can the Government describe the current newsletter production process, specifically, whether OOSH staff provide content drafts that the contractor formats and publishes, or whether the contractor is responsible for independently researching, writing, and designing each issue from scratch? | Technical | OOSH will provide newsletter themes and topics. The Contractor shall be responsible for independently researching, writing, designing, and producing each monthly newsletter. OOSH Federal staff will review content for technical accuracy, audience appropriateness, and policy alignment prior to publication. | |
| 62 | 5 | R3 - OOSH Workstreams Sample PWS | 4 | R3 Section 5.0 requires support for National Safety Month (June) and National Biosafety Month (October) outreach initiatives. Can the Government describe what deliverables or activities are typically associated with these events (e.g., promotional materials, events, presentations, social media content) and confirm whether these activities fall within the digital display advertisement requirement or are separate deliverables? | Technical | Deliverables may include themed newsletter content, digital display advertisements, staffing outreach events (e.g., FDA Biosafety Awareness Day and/or Laboratory Safety Day), development of "Message from the Commissioner" content, and other awareness themes, activities, and outreach materials. These activities are within the scope of the outreach support requirements. Digital display advertisements developed for these initiatives may satisfy the digital display advertisement requirement, as applicable. | |
| 63 | Section L | None / N/A | 45 & 53 | Section L.6 Factor 4 says to provide up to 3 references in the past 5 years; howewever, in section M.4 Factor 1 on page 53 says 5 contracts withing the past 5 years. Please clarify. | Contractual | There is no discrepancy. Factor 1 (Corporate Experience) allows up to five contracts; Factor 4 (Past Performance) allows up to three references. The same contracts may be used for both, provided each factor's requirements are met. | |
| 64 | Section L | None / N/A | 50 | Submission of a subcontracting plan is required for offerors other than small business; however, Attachement R6 indicates one is only need if the estimated cost of the contract may exceed $900,000. Please confirm that R6 HHS Subcontracting Plan Template is not needed as part of the submission if no subcontract will exceed $900,000 and will not reneder the proposal being ineligible for award. | Contractual | All offerors other than small business concerns shall submit a Subcontracting Plan in accordance with Section L.9. Applicability is determined by the total value of the IDIQ, which exceeds the subcontracting plan threshold. It is not based on the value of any individual order or subcontract. Attachment R6 is the required template. Failure to submit an acceptable plan may render the proposal ineligible for award. | |
| 65 | Section A | None / N/A | 8 | RFP C.2 “Each task order shall include a Task Order Performance Work Statement (TO PWS) that defines the specific scope, technical requirements, deliverables, performance standards, and place of performance applicable to that order.” (p.8) The OOSH Workstream PWS identifies “Primary Place of Performance: White Oak Federal Research Campus, Silver Springs, MD.” (p.5) | |||
| Should offerors consider the OOSH Workstream resources to be on client-site? If so, will the Government provide 1) office space, 2) office furniture, 3) laptops/desktop computing equipment, 4) network connections, 5) telephone instruments and connection? | Technical | Yes. The National Capital Region (NCR), including the White Oak Federal Research Campus, is anticipated to be the primary place of performance for on-site personnel. The Government will provide required on-site personnel with appropriate workspace, office furnishings, Government-furnished IT equipment, network access, and other office resources necessary to perform contract requirements. |
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