FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) IDIQ

Form / Attachment / Pricing Sheet

This document is a "Commitment to Protect Non-Public Information Employee Agreement" (FORM FDA 3398) used by the Department of Health and Human Services, Food and Drug Administration (FDA). It requires individuals who access non-public FDA information in the performance of their official duties, under a contract, to agree not to release, publish, or disclose such information. It also obligates them to protect the information in accordance with relevant laws and regulations.

• Agreement to protect non-public information.
• Acknowledgment of relevant legal provisions (21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905).
• Understanding of potential criminal penalties for violations.
• Fields for signature, typed name, date, and a description of the information released.
• A section for a witness signature, typed name, and date.

Bidders may be required to have their personnel complete and sign this form as part of the contract performance, particularly if the work involves access to non-public information. It outlines the confidentiality obligations and legal consequences for individuals involved in the contract.

Performance Work Statement (PWS)

To obtain professional biosafety, safety engineering, industrial hygiene, labor security, and Occupational Health and laboratory safety support services for the annual re-verification and vaporized hydrogen peroxide (VHP) decontamination of ten (10) active BSL-3 laboratories located at the FDA White Oak Campus.

• Conduct annual re-verification of all BSL-3 suites.

• Perform VHP decontamination of BSL-3 laboratories and associated equipment.

• Evaluate and verify compliance with CDC, NIH, USDA/APHIS, and applicable federal biosafety requirements.

• Validate HVAC airflow, pressure differentials, alarm systems, and failure scenarios.

• Ensure contractor personnel meet Personal Protective Equipment (PPE) and entry requirements.

• Provide consultation and compliance assessments.

• Review biosafety documentation and maintenance programs.

• Identify deficiencies and review corrective actions.

• Provide final verification reporting and certification.

• All re-verification testing must comply with applicable CDC, NIH, USDA/APHIS, and industry standards.

• VHP decontamination must demonstrate 100% biological indicator kill verification.

• Draft Verification Report due within 14 business days post-testing.

• Final Verification Report due within 10 business days post-comment receipt.

• Base Period: August 17, 2026 – February 28, 2027.

• Three (3) 12-month option years.

• Primary Location: FDA White Oak Campus, Silver Spring, MD.

• Work may occur at other NCR FDA facilities.

• Contractor personnel must meet IDIQ labor category qualifications, obtain Level V Public Trust clearance, and maintain medical clearance and vaccinations.

• Personnel must pass respirator fit testing and wear appropriate respiratory protection (N-95 or PAPR).

• Required PPE must be worn.

• Documentation of up-to-date negative TB testing, Polio vaccination/titer, and seasonal flu vaccination is required.

• Completion of FDA-provided Laboratory Visitor Training is mandatory.

• Specific personnel must sign a 'No Contact with Avian Species' form for Suites 4&5.

• Travel is not anticipated but requires prior written approval if necessary.

Form / Attachment / Pricing Sheet

This document, "FDA Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)", outlines the mandatory security clearance and background investigation procedures for contractor employees working for the FDA, particularly those accessing DHHS-owned or leased space, equipment, or non-public information.

• Background Investigations: Required for contractor employees working in DHHS space or accessing sensitive information. Investigations are conducted by the Defense Counterintelligence and Security Agency (DCSA) at no cost to the contractor, except for fingerprinting outside the FDA Personnel Security Office.
• Risk Designation: The contract is designated as Tier 1 (Non-Sensitive Low Risk). However, the document outlines three potential risk designations (Tier 1, Tier 2, Tier 4) and their implications.
• Personal Identity Verification (PIV) Cards: Required for contractor employees in DHHS space for 30 days or more. The process involves logging into the NBIS eAPP system, submitting forms, and obtaining a PIV card.
• Residency Requirements: Foreign nationals must have resided in the U.S. for at least three of the past five years to qualify for a PIV card.
• Non-Public Data Protection: Contractors must protect the privacy of employee information and prevent unauthorized disclosure.
• Identification Documents: Lists acceptable forms of identification for PIV card issuance, requiring two forms, one of which must be a current photo ID.

This document is critical for bidders to understand the personnel security requirements for any staff who will perform work under this contract. It details the background investigation process, PIV card requirements, and necessary documentation, which may impact hiring and onboarding timelines. Failure to comply can result in denied access and negatively impact contract performance.

Form / Attachment / Pricing Sheet

This document lists equipment within CBER BSL-3 Areas for Decontamination. It appears to be an informational attachment to a solicitation, providing details on existing or required equipment. Bidders may use this list to understand the current state of equipment, potential needs for replacement or augmentation, or to inform their technical approach and pricing.

• Area: Identifies specific areas within the BSL-3 facility.
• Item Type: Categorizes the equipment (e.g., Autoclave, Freezer, BSC Class II, HEPA Bank, Water Polisher).
• FDA# / Item ID: Unique identifiers for the equipment.
• Serial #: Serial number of the equipment.
• Model #: Model number of the equipment.
• Make: Manufacturer of the equipment.

This list provides a detailed inventory of decontamination-related equipment within the specified BSL-3 areas. Bidders should review this list to understand the existing equipment landscape, which may influence their understanding of the scope of work, potential challenges, and the types of equipment they may need to service, replace, or procure as part of the overall opportunity.

Statement of Work (SOW) / Performance Work Statement (PWS)

To obtain professional services and subject matter expertise to ensure the successful execution and continuous improvement of the Food and Drug Administration (FDA) Office of Occupational Safety and Health (OOSH) program. The contractor will provide strategic and technical support.

The scope focuses on the following OSH-related workstreams:

• Policy and Compliance Strategies

• Safety Manuals, Plans, Guides, and Directives

• Safety Training

• Laboratory Quality Management Systems (LQMS)

• Communications and Coordination

• Technical Assistance

• Program Management: Monthly Status Reports (MSRs), Bi-weekly Project status meetings, updated Work Plan and Strategic Approach.

• Policy and Compliance: Revision of three OOSH policies, ensuring policies are current, compliant, and effectively implemented.

• Safety Manuals and Guides: Periodic or annual revision and delivery of twelve (12) safety manuals and guides.

• Safety Training: Development and delivery of up to 4 hybrid training courses, conducting training needs assessments, developing incident-specific training modules and scenario-based exercises, maintaining training records, and conducting gap analysis for eLearning courses.

• Communications and Coordination: Publication of 12 monthly OOSH Newsletters, facilitation of outreach initiatives (e.g., National Safety Month), and development of digital display advertisements.

• Technical Assistance and Exposure Assessments: Maintenance of primary barrier equipment repository, Isoflurane exposure assessment for up to 100 workers, and conducting four (4) drills/exercises in accordance with Federal Select Agent Program (FSAP) regulations.

• Period of Performance: Twelve months from award.

• Primary Place of Performance: White Oak Federal Research Campus, Silver Springs, MD.

• All deliverables to be provided in soft copy using Microsoft Office products and comply with Section 508 of the Rehabilitation Act of 1973.

• Travel is not anticipated.

• Government-Furnished Property, Material, Equipment, or Information (GFP/GFM/GFE/GFI) will be provided.

• Security requirements apply.

Form / Attachment / Pricing Sheet

This document is Attachment R4, the "Past Performance Questionnaire," for the OSIST OC-2026-132216 / RFP 75F40126R00020 opportunity. It is designed to collect feedback from references regarding a contractor's past performance.

• Contract Information: Fields for Contract #, Total Contract Value, Period of Performance, Offeror's role (Prime or Sub), and a Description of product/service provided.
• Rating Categories: Defines five performance levels (Very Good, Satisfactory, Marginal, Unacceptable, Not Applicable) with corresponding codes (VG, S, M, U, NA) and detailed descriptions of what each rating signifies.
• Assessment Elements: Provides a structured way to rate contractors on specific aspects including:
  • Cost/Price Control
  • Schedule Adherence
  • Performance
  • Quality
  • Business Relations
  • Personnel Qualifications
• Overall Rating: A section for an overall contractor performance rating.
• Strengths and Weaknesses: Open fields to detail contractor strengths and weaknesses.
• Re-award Decision: A question asking if the contractor would be awarded the contract again, with space for justification.
• Certification: A statement for the signatory to certify the accuracy of the provided information.

Potential bidders should use this form to understand the specific criteria and performance aspects that will be evaluated as part of the past performance assessment for this opportunity. It guides how references should provide feedback and what information is crucial for evaluating a contractor's suitability.

Form / Attachment / Pricing Sheet

This document is an Offeror Question & Answer Template for the FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) Request for Proposal (RFP) 75F40126R00020. It provides instructions and a structured format for offerors to submit questions regarding the solicitation and its attachments.

• Offeror Information: Fields for Company Name, Point of Contact (POC) Name, and Email.
• Instructions: Guidance on submitting questions, including:
  • Writing questions in the 'Questions' tab.
  • One question per row.
  • Using dropdowns for Solicitation Section, Attachment Reference, and Response Type.
  • Limiting questions to the RFP and provided attachments.
  • Avoiding proprietary information in submitted questions.
• Questions Tab: A template with columns for Question #, Solicitation Section, Attachment Reference, Page #, Question, Response Type (Technical/Contractual), and Government Response.
• Lists Tab: Provides predefined options for Solicitation Sections, Attachment References, and Response Types to be used in the 'Questions' tab.

This template is crucial for bidders to formally ask clarifying questions about the RFP. It ensures that questions are organized, relevant, and submitted in a standardized format, facilitating efficient review and response by the government. Bidders must use this template to submit any questions they have about the solicitation documents, including the PWS, facility inventory, price workbook, and security clearance standards.

Form / Attachment / Pricing Sheet

This document is a template for a Subcontracting Plan, required for contracts exceeding $900,000 ($2,000,000 for construction), excluding small businesses. It outlines the minimum requirements for Individual Subcontracting Plans as per FAR Subpart 19.7 and HHS recommendations.

• Project Information: Fields for Solicitation/Contract No., Title of Acquisition, Contractor's Name, Period of Performance, Total Contract Amount, and option periods.
• Subcontracting Goal Data: Requires detailed dollar and percentage goals for various small business categories (Small Business, Small Disadvantaged Business, WOSB, HUBZone, VOSB, SDVOSB) for base and option years.
• Plan Type Selection: Options for Individual, Master, or Commercial plans.
• Methodology Description: Section to describe how goals were developed and sources identified.
• Subcontracting Opportunities: A table to list products/services to be subcontracted and the type of business supplying them.
• Administrator Information: Details for the individual administering the subcontracting program.
• Assurances: Contractor assurances regarding good faith efforts, timely payments, and cooperation with reporting requirements.

This template guides potential bidders on the specific information and goals they must provide if they are required to submit a subcontracting plan as part of their proposal. It details the structure and content expected for subcontracting goals, outreach efforts, and reporting, which are critical components of contract compliance for larger contracts.

Solicitation / RFP / RFQ

This solicitation is for an Indefinite Delivery Indefinite Quantity (IDIQ) contract to provide Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) support services for the FDA's Occupational Safety and Health (OSH) mission. The services will be performed across FDA headquarters and nationwide laboratory and field facilities.

• IDIQ-level program management and governance.

• Task Areas include: Program and Order Management, Transition Services, Occupational Safety, Policy, and Laboratory Quality Support, Primary Barrier Equipment Maintenance and Certification, Industrial Hygiene Support Services, Information and Data Systems Support, and Training Development and Management.

• Enterprise-wide performance requirements and service expectations.

• Deliverables include Monthly Status Reports, technical reports, and certification documentation.

• Adherence to applicable regulatory, safety, and technical standards (e.g., OSHA, ANSI/ASSP Z10, NSF/ANSI 49, ISO, BMBL).

• Task orders may be firm-fixed-price, time-and-materials, labor-hour, or a combination.

• Contract Type: Indefinite Delivery Indefinite Quantity (IDIQ).

• Ordering Period: Five (5) years from the date of contract award.

• Task Order Performance Periods: Maximum of five (5) years from the date of task order issuance.

• Contract Maximum: $14,500,000.

• Guaranteed Minimum: Obligated base period of the first task order.

• Primary Place of Performance: FDA Headquarters – White Oak Federal Research Center, Silver Spring, MD.

• Proposals are due by 07/10/2026, 1200 ET.

• Proposals will be evaluated on a best-value trade-off basis.

• Non-price factors (Corporate Experience, Technical Approach, Management Approach, Past Performance) are significantly more important than price.

• Evaluation factors are listed in descending order of importance.

• Specific proposal submission instructions are detailed in Section L, including format requirements, electronic submission, and proposal volumes.

• The acquisition is being conducted as a Request for Proposal (RFP).

• NAICS Code: 541690 (Other Scientific and Technical Consulting Services), Size Standard: $19.0 million.

• Attachment C1: OSIST IDIQ Performance Work Statement (PWS).

• Attachment C3: OSIST Price_Workbook (Excel).

• Attachment R1: CBER Annual Re-Verification of BSL-3 Suites PWS (for Task Order 1).

• Offerors must be registered in the System for Award Management (SAM).

Statement of Work (SOW) / Performance Work Statement (PWS)

The objective of this Indefinite Delivery/Indefinite Quantity (IDIQ) contract is to obtain enterprise-level technical and programmatic support services for the Food and Drug Administration's (FDA) Occupational Safety and Health Program across all FDA facilities.

The contractor will provide comprehensive technical, engineering, program management, and professional services. The scope includes:

• IDIQ-level and Order-level Program Management

• Transition-in and Transition-out services

• Occupational Safety and Laboratory Quality Support

• Primary Barrier Equipment Maintenance and Lifecycle Management

• Enterprise Industrial Hygiene Program Architecture

• Information & Data Systems Program Support

• EOSH Training Development and Management Services will support headquarters and nationwide field laboratories.

• Period of Performance: Five (5) year IDIQ ordering period. Task Orders may be Firm-Fixed-Price (FFP), Labor Hour (LH), Time-and-Materials (T&M), or hybrid.

• Place of Performance: FDA facilities nationwide, including headquarters and various field laboratories.

• Compliance with numerous standards and regulations including OSHA, NSF/ANSI 49, ANSI Z-10, BMBL, and others.

• Development and implementation of a Quality Control Plan (QCP).

• Personnel must meet minimum education, certification, and experience requirements, with specific substitution policies outlined.

• Adherence to security and access requirements as specified per Task Order.

• Deliverables include Monthly Status Reports (MSR), various technical reports, plans, and documentation as detailed in the Performance Deliverable Summary Table (PDST).

Form / Attachment / Pricing Sheet

This document, "Attachment C2 – OSIST Facility Inventory (Locations and Storage Footage)," provides a detailed inventory of facilities, their regions, cities, states, and associated centers. It also includes data on lab room area and the sum of labs for each facility and region.

• Facility List: Details various facilities across different regions (Field, NCR, White Oak) with their respective locations.
• Center(s) Information: Specifies the centers associated with each facility (e.g., CDER, HFP, OC/HFP, NCTR, CDRH, CVM, CBER).
• Area and Lab Counts: Summarizes the total lab room area (in square feet) and the total number of labs for different groupings, including Field, Jefferson, National Capital Region (NCR) outside White Oak, and White Oak (WO).
• Grand Total: Provides an overall summary of lab room area and the total number of labs across all listed facilities.

This attachment is crucial for bidders to understand the physical footprint and operational capacity of the OSIST facilities. It may inform logistical planning, resource allocation, and the scope of services required for the opportunity. The detailed breakdown of lab space and number of labs can help in assessing the scale of operations and potential requirements for support services.

Form / Attachment / Pricing Sheet

This document is an Excel workbook containing pricing templates and instructions for offerors responding to RFP No. 75F40126R00020 for FDA OSIST. It requires bidders to input proposed labor rates, equipment certification and repair rates, and task order pricing.

• Tab 1 - IDIQ Labor Rate Schedule: Requires fully burdened hourly ceiling rates for 15 labor categories across 5 years. Rates are fixed within ordering periods and may escalate between periods.

• Tab 2 - Equipment Certification and Repair: Includes certification rates for 6 equipment categories and decontamination rates for primary barrier equipment (BSC Class I, BSC Class II, Lab Ventilation Hoods) across 5 years.

• Tab 3 - Task Order 1 BSL-3 Pricing: Details labor hours, categories, and rates for a specific task order. Offerors must identify required Other Direct Costs (ODCs). This is a firm-fixed-price order.

• Tab 4 - Workstream Scenario: Outlines labor and ODCs for Workstream Support Tasks 3-7 for evaluation purposes only. Does not guarantee a task order.

• Tab 5 - Staffing-to-Price Crosswalk: Links technical proposal staffing to price workbook hours, requiring explanation for any variances.

• Submit in native Excel format (.xlsx).

• Do not alter tab names, column structure, or locked formulas.

• Labor categories must match Tab 1 exactly across relevant tabs.

• A separate 5-page Basis of Estimate (BOE) narrative in PDF format must accompany this workbook.

This workbook is critical for developing and submitting a compliant price proposal. Offerors must accurately populate all required fields, ensuring consistency between technical and pricing documents to avoid performance risk evaluations. The data entered here will be used to evaluate the total task order value and workstream scenario costs.