75F40126R00020 Request for Proposal FDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST)

R3 - Performance Work Statement (PWS) OOSH Workstream Support Scenario

(For Evaluation Purposes only)

1.0 Background

The Food and Drug Administration (FDA) Office of Occupational Safety and Health (OOSH) requires ongoing support to achieve its mission of protecting the safety and health of the FDA workforce. Due to staff turnover and organizational changes, contractual support is essential to prevent delays in mission-critical safety and health activities planned for FY 2026. This action provides the necessary subject matter expertise and professional services to support OOSH across several key workstreams.

2.0 Objective

The objective is to obtain professional services and subject matter expertise to ensure the successful execution and continuous improvement of the OOSH program. The contractor shall provide strategic and technical support to achieve the desired outcomes across all in-scope workstreams.

3.0 Scope

The contractor shall be responsible for delivering the outcomes and results defined in the performance requirements below. The scope focuses on the following Occupational Safety and Health (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

The performance requirements in Section 4 are organized according to these workstreams, and all deliverables in Section 5 shall directly support these requirements.

4.0 Performance Requirements

The contractor shall perform all tasks and deliver all products as outlined in the table below.

Performance will be measured by the successful and timely achievement of the specified standards.

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

Requirement

(The "What")

Performance Standard

(The "How Well") Acceptable Quality Level (AQL)

4.1 Program Management:

The contractor shall manage the project, track progress, and report status.

Monthly Status Reports (MSRs) must be delivered via email to the COR. The Work Plan and Strategic Approach must be kept current in the designated SharePoint folder.

100% of MSRs submitted by the 5th business day of the following month.

The work plan must be updated within 48 hours of any change.

4.2 Policy and Compliance:

OSH-related policies and checklists must be current, compliant, and effectively implemented.

All policy revisions must address stakeholder feedback.

≥95% of deliverables submitted on or before agreed-upon deadlines; ≤5% of deliverables require substantive rework due to technical inaccuracies;100% of deliverables accepted by the COR within two review cycles.

4.3 Safety Manuals and

Guides: OSH safety manuals, guides, and plans must be developed and maintained to be accurate and relevant.

Manuals and guides must undergo periodic or annual revision and be delivered by their respective deadlines.

Content Resolution Matrices must be created for each major revision.

≥95% of deliverables submitted on or before agreed-upon deadlines; ≤5% of deliverables require substantive rework due to technical inaccuracies;100% of

4.4 Safety Training: OSH-

related training content and courses must be developed, updated, and delivered to the FDA workforce. This includes training needs assessments, development of scenario-based exercises, and maintenance of training records and compliance reporting.

At least one eLearning course undergoes a complete annual review and update. A gap analysis is completed for up to two eLearning courses.

≥95% of deliverables submitted on or before agreed-upon deadlines; ≤5% of deliverables require substantive rework due to technical inaccuracies;100% of

4.5 Communications and

Coordination: OOSH information must be communicated effectively across multiple modalities to segmented audiences and the agency as a whole.

100% of tasks shall be completed in accordance with agreed-upon timelines and meet defined technical accuracy and regulatory compliance standards (e.g., OSHA, NRC, FDA policies), as validated through COR review.

100% of newsletters published monthly. ≤5% of deliverables require substantive rework due to technical inaccuracies and 100% of deliverables accepted by the COR within two review cycles.

4.6 Technical Assistance

and Exposure Assessments: Specialized technical support and environmental assessments must be completed accurately and on time.

100% of tasks shall be completed in accordance with agreed-upon timelines and meet defined technical accuracy and regulatory compliance standards (e.g., OSHA, NRC, FDA policies), as validated through COR review.

≥95% of deliverables submitted on or before agreed-upon deadlines; ≤5% of deliverables require substantive rework due to technical inaccuracies;100% of

5.0 Deliverable Schedule

Unless otherwise specified, all deliverables shall be submitted in accordance with timelines defined in the COR-approved Work Plan and are subject to COR review and acceptance. All deliverables shall be provided in soft copy using Microsoft Office products and must comply with Section 508 of the Rehabilitation Act of 1973.

Workstream Activity or Deliverable Due Date

Program Management Twelve Monthly Status Reports (MSRs) Monthly

Program Management OSIST Program & Workstreams Project status meeting Biweekly

Policy

Revise three OOSH policies (e.g. Laboratory Staff On- Boarding and Off-Boarding Checklist, Reproductive Health Hazard Policy, REPORTING OCCUPATIONAL SAFETY

AND HEALTH WORKPLACE INCIDENTS AND NEAR

MISSES).

As defined in the COR-approved Work Plan

Safety Manuals

Revise and update twelve (12) safety manuals and guides on a periodic or annual basis (e.g., Nanomaterials Safety Guide, Bloodborne Pathogens Exposure Control Plan, Chemical Hygiene Plan), in accordance with established review cycles.

Training Provide up to 4 hybrid virtual/in-person training courses (e.g.

lifting/hoisting, RCRA compliance, DOT Hazmat Ground Shipper, powered industrial trucks)

As defined in the COR-approved Work Plan

Training

Conduct training needs assessments to identify gaps and prioritize development efforts.

Develop and deliver incident-specific training modules and scenario-based training exercises (e.g., drills, tabletop exercises, simulations).

Training

Maintain comprehensive training records and certification tracking systems to ensure all personnel meet required training standards. Generate compliance reports and dashboards for management review.

As defined in the COR-approved Work Plan

Training

Conduct comprehensive training needs assessments to identify content and skill gaps, current and emerging regulatory requirements, and evolving safety challenges across FDA facilities and operations. Perform gap analysis comparing and documenting current training programs against regulatory mandates, industry best practices, and organizational safety objectives to prioritize training development efforts.

Communication Publish 12 monthly OOSH Newsletters. Monthly

Communication Facilitate and support outreach initiatives including National Safety Month (June) and National Biosafety Month (October).

As defined in the COR-approved Work Plan

Communication Assist with developing and publishing eight digital display advertisements to be shown internally within FDA.

As defined in the COR-approved Work Plan

Technical Assistance

Maintain a repository of all FDA primary barrier equipment that is repaired, tested and/or certified to account for all units and their functional state

As defined in the COR-approved Work Plan

Technical Assistance

Isoflurane exposure assessment of up to 100 workers, report of results, and development of an exposure assessment strategy, and initial characterization of Similar Exposure Groups.

As defined in the COR-approved Work Plan

Technical Assistance

Conduct four (4) drills and/or exercises in accordance with applicable Federal Select Agent Program (FSAP) regulations and the FSAP Guidance Document. These activities shall include coordination with designated site personnel, external emergency responders, or relevant stakeholders; planning and execution of each drill or exercise; and preparation of after-action reports documenting performance, areas for improvement, and recommendations for corrective actions.

6.0 Other Requirements

The following areas are governed by the terms set forth in the base IDIQ:

https://selectagents.gov/regulations/index.htm https://selectagents.gov/regulations/index.htm https://selectagents.gov/compliance/guidance/drills/index.htm

• Government-Furnished Property, Material, Equipment, or Information

(GFP/GFM/GFE/GFI)

• Security

• Travel not anticipated

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

• Period of Performance: twelve months from award.