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

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

This Performance Work Statement (PWS) outlines the requirements for an Indefinite-Delivery/Indefinite-Quantity (IDIQ) contract to provide enterprise-level technical and programmatic support services for the Food and Drug Administration's (FDA) Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) program. The objective is to ensure FDA facilities, laboratories, and workplaces operate safely and effectively to protect product integrity, employee and visitor health, and the environment.

The contractor will provide comprehensive technical, engineering, program management, and professional services across FDA headquarters and nationwide facilities. The scope includes:

• IDIQ-level and Order-level Program Management

• Transition-in and Transition-out services

• Occupational Safety, Policy, 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

• 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 (White Oak Federal Research Center) and field laboratories. Specific locations are detailed in Attachment C2.

Performance will be assessed based on core standards including Timeliness, Technical Accuracy, Regulatory Compliance, Responsiveness, Documentation Completeness, and Stakeholder Satisfaction. Specific metrics and acceptable quality levels (AQLs) are defined, such as 95% of deliverables submitted on time and 98% documentation accuracy rate. The contractor must develop and maintain a Quality Control Plan (QCP) with measurable performance indicators.

• Applicable Standards and Regulations: Compliance with OSHA, NSF/ANSI 49, ANSI Z10, BMBL, NIH design standards, and other referenced regulations is required.
• Deliverables: Key deliverables include a Program Management Plan (PMP), Monthly Status Reports (MSR), various assessment reports, SOPs, training materials, and data dashboards. A Performance Deliverable Summary Table (PDST) outlines specific requirements.
• Personnel Qualifications: Minimum education, certification, licensure, and experience requirements are detailed for various labor categories, with specific substitution policies outlined.
• Quality Control: A comprehensive Quality Control Plan (QCP) is required, detailing the contractor's internal management system for quality assurance, including performance monitoring, deliverable review, and corrective actions.
• Security & Access: Badging, facility access, and compliance with FDA security requirements will be specified per Task Order.

Form / Attachment / Pricing Sheet

This document is a "Commitment to Protect Non-Public Information Employee Agreement" (FORM FDA 3398) required by the Department of Health and Human Services, Food and Drug Administration (FDA). It is used to ensure that individuals accessing non-public information during official duties, under a contract, agree to protect this information.

• Agreement to not release, publish, or disclose non-public information.
• Commitment to protect information in accordance with specific U.S. Code provisions (21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905) and other relevant laws.
• Acknowledgment of potential criminal penalties for violations.
• Fields for signature, typed name, and date of the employee.
• Fields for a witness's signature, typed name, and date.
• A section for "Description of Information Released."

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 sensitive or non-public FDA information. It outlines the confidentiality obligations and legal ramifications for individuals involved.

Solicitation / RFP / RFQ

This document is a Request for Proposal (RFP) for the FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) contract. It outlines the requirements for an Indefinite Delivery Indefinite Quantity (IDIQ) contract to provide enterprise-level scope, performance standards, and integrated service requirements for Occupational Safety, Policy, and Laboratory Quality Support services across FDA headquarters and nationwide laboratory and field facilities.

The IDIQ PWS includes task areas such as:

• 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
• Training Development and Management

Task orders will be issued with specific scopes, technical requirements, deliverables, and performance standards. Task Order 1 involves CBER BSL-3 Annual Re-Verification and Decontamination Services.

• Contract Type: Indefinite Delivery Indefinite Quantity (IDIQ)
• Ordering Period: Five (5) years from the date of contract award.
• Task Order Performance Periods: May not exceed five (5) years from the date of task order issuance.
• Maximum Contract Value: $14,500,000
• Primary Place of Performance: FDA Headquarters – White Oak Federal Research Center, Silver Spring, MD.

Proposals will be evaluated on a best-value trade-off basis, considering factors such as Corporate Experience, Technical Approach, Management Approach, Past Performance, Price, and Subcontracting Plan (for other than small businesses).

Non-price factors (Factors 1-4) are combined and are significantly more important than price.

This solicitation is for commercial services. Small business status is addressed, with specific requirements for NAICS Code 541690 (Other Scientific and Technical Consulting Services) with a size standard of $19.0 million.

• The solicitation uses Standard Form 1449 (SF-1449).
• Offerors must be registered in the System for Award Management (SAM).
• Numerous attachments are incorporated, including PWS documents, a price workbook, and forms for certifications and agreements.

Form / Attachment / Pricing Sheet

This document, "Attachment C2 – OSIST Facility Inventory (Locations and Storage Footage)," provides a detailed inventory of facilities associated with the FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) program. It lists various locations, their regions, cities, states, and the specific centers or departments operating within them.

• Facility Locations: A comprehensive list of facilities across different regions (Field, NCR, White Oak).
• Center(s): Identifies the specific FDA centers or departments (e.g., CDER, HFP, OC/HFP, NCTR, CDRH, CVM, CBER, OC) associated with each facility.
• Lab Room Area (ft²): Quantifies the laboratory space available at each location.
• Sum of Labs: Indicates the total number of labs at each location.
• Totals: Provides aggregated data for different regions and a grand total for lab room area and number of labs.

This inventory is crucial for bidders to understand the physical footprint and operational distribution of the OSIST program. It may inform logistical planning, resource allocation, and the scope of services required for any related contract. Bidders should review this to gauge the scale and geographical spread of facilities they might be expected to support or interact with.

Form / Attachment / Pricing Sheet

This document is an Excel workbook designed for bidders to submit pricing information for the FDA OSIST opportunity (RFP No. 75F40126R00020). It includes instructions and specific tabs for detailing labor rates, equipment certification and repair costs, task order pricing, and a staffing-to-price crosswalk.

• Instructions Tab: Provides guidance on cell colors (yellow for input, blue for calculated), tab functions, and submission requirements (native Excel format, specific file naming, no structural alterations).
• Tab 1 - IDIQ Labor Rate Schedule: Requires bidders to enter fully burdened hourly ceiling rates for 15 labor categories across 5 years. Rates are fixed within ordering periods and can only escalate between periods.
• Tab 2 - Equipment Certification and Repair: Requires rates for 6 equipment categories for certification and decontamination services across 5 years.
• Tab 3 - Task Order 1 BSL-3 Pricing: Details labor hours and ODCs for a specific task order. Labor rates auto-populate from Tab 1. Bidders must identify required ODCs.
• Tab 4 - Workstream Scenario: Outlines labor and ODCs for workstream support tasks for evaluation purposes only. Assumptions must be explained in the Basis of Estimate (BOE).
• Tab 5 - Staffing-to-Price Crosswalk: Links technical proposal staffing to price workbook hours. Unexplained variances may be considered performance risk.
• Basis of Estimate (BOE): A separate 5-page narrative is required to accompany this workbook.

This workbook is critical for bidders to accurately price their proposals. It dictates the format and content for all cost submissions, including labor rates, equipment costs, and task-specific pricing. Consistency between this workbook and the technical proposal is essential, as variances may impact the evaluation of performance risk. Bidders must adhere strictly to the specified format and submission requirements.

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 or sensitive information.

• Background Investigations: Required for employees working in DHHS space for 30+ days 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).
• Personal Identity Verification (PIV) Cards: Required for employees in DHHS space for 30+ days. Employees must obtain a PIV card to access property without an escort.
• PIV Card Process: Involves logging into the NBIS eAPP system, completing required forms, and providing specific personal information. The FDA Personnel Security Specialist facilitates this process.
• Required Identification: For PIV card issuance, employees must present two forms of identification, one of which must be a current photo ID. Specific acceptable documents are listed.
• Foreign Nationals: Residency requirements (3 of the past 5 years in the U.S.) apply for background investigations for foreign nationals.
• Data Protection: Contractors must protect the privacy of employee information and prevent unauthorized disclosure.

This document is critical for bidders to understand the personnel security requirements for any staff who will be working on the contract. It details the types of background investigations, the process for obtaining PIV cards, and the documentation needed. Failure to comply can result in denied access and negatively impact contract performance. Bidders must ensure their proposed personnel can meet these requirements.

Performance Work Statement (PWS)

To obtain professional biosafety, safety engineering, industrial hygiene, labor security, and Occupational Health and laboratory safety support services for the FDA's ten (10) active BSL-3 laboratories located at the White Oak Campus. Services include annual re-verification and vaporized hydrogen peroxide (VHP) decontamination to support scheduled preventive maintenance and regulatory compliance.

• 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 contractors meet Personal Protective Equipment (PPE) and entry requirements.

• Issue required verification reports and certificates.

• Provide consultation and compliance assessments.

• Perform HVAC airflow and pressure differential testing.

• Conduct failure scenario testing (HVAC and power).

• 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: Submitted within 14 business days post-testing.

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

• Site Visits: Up to 4 visits completed as scheduled.

• Base Period: August 1, 2026 – February 28, 2027.

• Three (3) 12-month option years.

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

• Work may also occur at other NCR FDA facilities.

• Contractor personnel must meet IDIQ labor category qualifications, obtain Level V Public Trust clearance, maintain medical clearance and vaccinations, pass respirator fit testing, wear required PPE, and provide documentation of up-to-date TB testing, Polio vaccination/titer, and seasonal flu vaccination.

• Contractors must complete FDA-provided Laboratory Visitor Training.

• Specific requirements for "No Contact with Avian Species" for applicable labs (Suites 4&5).

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

Form / Attachment / Pricing Sheet

This document lists equipment located in CBER BSL-3 Areas (suites, rooms, corridors) intended for decontamination. It is provided for informational purposes only.

• Lists various types of equipment including Autoclaves, Freezers (-80, -30, -4), BSC Class II A2/B1, HEPA Vacuums, HEPA Banks, Water Polishers, Incubators, and Animal Rack Motors.
• For each item, it includes Area (ft²), Item Type, FDA#, Serial #, Model #, and Make.

This document serves as an inventory of existing equipment within the BSL-3 areas. Bidders responding to a solicitation related to these areas should use this list to understand the current equipment landscape, which may be relevant for planning decontamination services, equipment removal, installation, or other related tasks.

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. This support is essential to prevent delays in mission-critical safety and health activities planned for FY 2026 due to staff turnover and organizational changes.

The contractor will provide strategic and technical support across 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

Performance will be measured by the successful and timely achievement of specified standards. Key performance indicators include:

• Monthly Status Reports (MSRs) submitted by the 5th business day.

• Work plan updated within 48 hours of any change.

• ≥95% of deliverables submitted on or before agreed-upon deadlines.

• ≤5% of deliverables requiring substantive rework due to technical inaccuracies.

• 100% of deliverables accepted by the COR within two review cycles.

• Specific metrics for policy revisions, manual updates, training course reviews, and communication tasks.

• Period of Performance: Twelve months from award.

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

• Travel is not anticipated.

• Deliverables to be provided in soft copy using Microsoft Office products.

• Compliance with Section 508 of the Rehabilitation Act of 1973.

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

• Security requirements apply.

Form / Attachment / Pricing Sheet

This document is Attachment R4, a Past Performance Questionnaire. It is designed to collect feedback from references on a contractor's past performance on previous contracts. This information is used to assess the contractor's ability to successfully perform on a new opportunity.

• Solicitation # and Offeror Name: Fields to identify the specific opportunity and the contractor being evaluated.
• Reference Information: Details about the person completing the questionnaire (Name, Title/Role, Email, Agency/Company, Phone).
• Contract Information: Basic details about the contract being referenced (Contract #, Total Contract Value, Period of Performance, Prime/Sub status, Description of product/service).
• Rating Categories: Defines performance levels (Very Good, Satisfactory, Marginal, Unacceptable, Not Applicable) with corresponding codes (VG, S, M, U, NA) and detailed descriptions.
• Assessment Elements: Specific areas to be rated, including:
  • Cost/Price Control
  • Schedule Adherence
  • Performance
  • Quality
  • Business Relations
  • Personnel Qualifications
  • Overall Rating
• Narrative Sections: Spaces for supporting narrative for each assessment element, as well as sections for contractor strengths, weaknesses, and a re-award decision.
• Certification: A statement by the undersigned that the ratings and comments are accurate.

Bidders should be aware that this questionnaire will likely be sent to their past clients or references. The responses will directly impact the evaluation of their past performance, which is often a significant factor in contract awards. Understanding the criteria and rating scales will help bidders prepare their references and potentially address any known performance issues proactively.

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 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 how to use the template, including:
  • Submitting questions in the 'Questions' tab, one per row.
  • Using dropdowns for Solicitation Section, Attachment Reference, and Response Type.
  • Limiting questions to the RFP and provided attachments.
  • Avoiding proprietary information in questions.
• Questions Tab: A table with columns for Question #, Solicitation Section, Attachment Reference, Page #, Question, Response Type (Technical/Contractual), and Government Response. This tab is pre-populated with rows for up to 150 questions.
• Lists Tab: Provides predefined options for Solicitation Sections, Attachment References, and Response Types, which should be used in the 'Questions' tab.

This template is essential for bidders who have questions about the OSIST RFP. It outlines the specific process and format required for submitting inquiries to the government, ensuring that questions are clear, relevant, and properly categorized. Using this template correctly will facilitate efficient communication and clarification of solicitation details.

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 serves as a guideline for offerors to submit proposed Individual Subcontracting Plans, aligning with FAR Subpart 19.7.

• Project Information: Fields for Solicitation/Contract No., Title of Acquisition, Contractor's Name, Period of Performance, Total Contract Amount, and details on options and modifications.
• Subcontract Plan Requirements: Outlines essential information required by FAR Subpart 19.7, defining "subcontract."
• Small Business Goals: Provides space to detail dollar and percentage goals for various small business categories (Small Business, Small Disadvantaged Business, WOSB, HUBZone, VOSB, SDVOSB) for base year and option years.
• Methodology: Requires description of how goals were developed and sources identified.
• Subcontracting Opportunities: A table to list products/services to be subcontracted and the types/sizes of businesses that will supply them.
• Administrator Information: Fields for the individual administering the subcontracting program, including their name, title, contact information, and a checklist of their responsibilities.
• Assurances: Sections for contractor assurances regarding good faith efforts, timely payments, and record keeping.

This template is crucial for bidders to understand the subcontracting requirements and goals that will be imposed if they are awarded a contract. It details the specific categories of small businesses the government aims to support through subcontracting and the reporting obligations involved. Bidders should use this template to formulate their own subcontracting plans as part of their proposals, demonstrating their commitment to small business utilization.