IRV Exhaust and Vacuum Pump Replacement

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

This Performance Work Statement (PWS) outlines the construction services required to replace obsolete vacuum pump systems at the FDA Pacific Southwest Laboratory and District Office in Irvine, CA, and to correct an exhaust issue in Room 2309.

• Vacuum Pump Replacement: Replace end-of-life vacuum pump systems that are no longer supported by available parts, posing a risk to the facility's vacuum system. The new system must have matching or better capacity and include N+1 redundancy.

• Room 2309 Exhaust Correction: Address VHP detection alarms in Room 2309 by directly ducting isolators to the outside via an exhaust fan. This work will utilize design drawings and specifications dated August 15, 2025.

• General Responsibilities: The contractor will be responsible for all labor, materials, equipment, surveys, engineering, electrical/mechanical work, commissioning, inspections, and any necessary structural modifications.

• The project must be completed within 222 calendar days of the Notice to Proceed (NTP).

• The contractor must maintain a safe working environment and minimize interruption to FDA operations.

• Compliance with NIH Design Requirements Manual (DRM), Section 12.4, is required.

• Place: U.S. Food and Drug Administration (FDA) facility, 19701 Fairchild, Irvine, CA.

• Period: To be completed within 222 calendar days of the NTP or negotiated completion date.

• Contract Type: Firm Fixed Price.

• Staffing: Requires a qualified team including a Project Manager, Superintendent, engineers, and clerical staff. Key personnel identified in the proposal must be approved.

• Security: Compliance with HHS and FDA security clearance requirements (HSPD-12) is mandatory. Badging process may take up to 1 month.

• Submittals: Numerous submittals are required, including communication plans, safety plans, shop drawings, equipment cutsheets, and O&M manuals.

• Deliverables: Includes physical and electronic deliverables such as O&M manuals, warranties, record drawings, and specifications.

• Working Hours: Field work is generally Monday-Friday, 6 AM to 5 PM, with shutdowns preferred on weekends or after hours.

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

This Performance Work Statement (PWS) outlines the requirements for construction services to replace obsolete vacuum pump systems at the U.S. Food and Drug Administration (FDA) Pacific Southwest Laboratory and District Office in Irvine, CA, and to correct the exhaust system in Room 2309.

• Vacuum Pump Replacement: Replace end-of-life vacuum pump systems that are no longer supported by available parts, posing a risk to the facility's vacuum system. This includes providing new equipment with matching or better capacity, ensuring N+1 redundancy, integrating a new control panel with the existing Building Automation System (BAS) and local alarms, and providing independent isolation valves for service.

• Room 2309 Exhaust Correction: Address issues in Room 2309 where Vaporized Hydrogen Peroxide (VHP) detection systems have indicated levels exceeding safe limits. This involves directly ducting isolators to the outside via an exhaust fan, utilizing design drawings and specifications dated August 15, 2025.

• General Contractor Responsibilities: The contractor will be responsible for all labor, materials, insurance, training, equipment, surveys, engineering, repairs to housekeeping pads, integration with existing BAS, and any necessary electrical or mechanical work. They must also coordinate shutdowns to minimize disruption and provide temporary utilities for shutdowns exceeding three days.

• The contractor must ensure compliance with the NIH Design Requirements Manual (DRM), specifically Section 12.4.

• Performance is measured by the successful replacement of vacuum pumps and correction of the exhaust system, meeting all specified requirements and standards.

• Location: U.S. Food and Drug Administration (FDA); 19701 Fairchild, Irvine, CA.

• Period of Performance: The work is a Construction Services delivery type, a Firm Fixed Price contract. Performance is to be completed within 222 calendar days of the Notice to Proceed (NTP) or an agreed-upon negotiated date.

• Contract Type: Firm Fixed Price.

• Staffing: Requires key personnel including a Project Executive, Project Manager, Quality Control, and Construction Superintendent, as well as administrative and technical staff.

• Security: Compliance with HHS and FDA Security Clearances and requirements is mandatory, including application processes and badge requirements.

• Submittals: A comprehensive list of submittals is required, including communication plans, project schedules, safety plans, shop drawings, equipment cutsheets, progress meeting minutes, and various technical reports.

• Deliverables: Include O&M Manuals, warranties, final reports, and demonstration/training materials.

• Working Hours: Field work is generally Monday through Friday, 6 A.M. to 5 P.M., with shutdowns coordinated for after-hours or weekends.

Form / Attachment / Pricing Sheet

This document is a questionnaire for vendors to provide information regarding their capabilities and interest in supplying Exhaust and Vacuum Pump systems for the FDA IRV (Infectious Respiratory Virus) project. It serves as a Sources Sought response to gauge market capacity and gather technical and business details.

The questionnaire is divided into several sections:

• Section A – Business Information: Collects standard company details, contact information, UEI, CAGE code, business size, and relevant NAICS codes.
• Section B – Technical Capability: Inquires about the types of exhaust and vacuum pump systems offered, whether they are Commercial Off-the-Shelf (COTS), manufacturers, and specific performance characteristics (capacity, pressure, materials, controls).
• Section C – Installation and Integration: Assesses experience with installing HVAC/exhaust systems, particularly in sensitive environments like laboratories or healthcare facilities, and handling hazardous exhaust.
• Section D – Schedule and Risk Considerations: Seeks information on equipment lead times and potential schedule risks.
• Section E – Financial Capability: Gathers data on annual revenue and the ability to obtain bonds and finance upfront costs.
• Section F – Past Performance: Requests details on up to two previous projects, including customer information, scope, contract value, and period of performance.
• Section G – Commerciality and Supply Chain: Focuses on market availability, estimated lead times for components (fans, pumps, controls, ductwork), and country of origin.
• Section H - Comments: Allows vendors to provide additional comments or ask questions.

Vendors interested in this opportunity should complete this questionnaire thoroughly to demonstrate their capabilities and provide the government with the necessary information to determine acquisition strategy and potential sources for the IRV Exhaust and Vacuum Pump systems. The responses will inform future solicitations.

Forms / Attachments / Pricing Sheets

This document contains the "IRV Exhaust Drawings" for the FDA Irvine RM 2309 Exhaust Design project. It serves as a comprehensive set of architectural and engineering drawings detailing the proposed modifications.

• Project Identification: Details the project name, location, and key personnel.
• Sheet Index: Lists all included drawings, categorized by discipline (Cover Sheet, Architectural, Structural, Mechanical, Electrical, Demolition).
• Vicinity and Location Maps: Provides geographical context for the project site.
• Basis of Design: Outlines structural and mechanical considerations, including roof structure, penthouse exterior wall, roof penetrations, ducting materials, equipment support, and BAS integration.
• Abbreviations and Symbols: Defines terms and graphical representations used throughout the drawings.
• Applicable Codes and Standards: Lists relevant building codes and industry standards.
• Demolition Plans: Details areas requiring demolition for the new exhaust system installation.
• Structural Drawings: Illustrates framing plans, sections, and details related to the building structure.
• Mechanical Drawings: Depicts the layout of the new exhaust system, including ductwork, fans, and equipment.
• Electrical Drawings: Shows power distribution, wiring, and connections for the new mechanical equipment.
• Schedules: Includes fan schedules, air valve schedules, and mechanical equipment connection schedules.

These drawings are critical for bidders to understand the full scope of work, including the extent of demolition, structural modifications, mechanical system design, and electrical requirements. They provide the detailed technical specifications necessary for accurate bidding and project execution.

Form / Attachment / Pricing Sheet

This document, "TABLE OF CONTENTS - 00 01 10", serves as a comprehensive index for the specifications and procurement requirements of the project. It outlines the structure of the document by dividing it into various divisions and sections, providing a roadmap for all subsequent technical specifications and contractual requirements.

• Procurement and Contracting Requirements: Includes sections related to seals pages and the table of contents itself.
• Specifications: Organized into divisions covering:
  • Division 01: General Requirements (e.g., Summary, Work Restrictions, Substitution Procedures, Project Management, Submittals, Quality Assurance, Temporary Facilities, Product Requirements, Execution Requirements, Cutting and Patching, Selective Demolition, Fire Prevention, Indoor Air Quality, Waste Management, Closeout Procedures, Record Documents, Demonstration and Training, Commissioning).
  • Divisions 02 through 06: Not Used.
  • Division 07: Thermal and Moisture Protection (e.g., Existing Roof Modifications, Roof Accessories).
  • Divisions 08 through 22: Not Used.
  • Division 23: Heating, Ventilating, and Air-Conditioning (HVAC) (e.g., Basic Requirements, Hangers and Supports, Testing/Adjusting/Balancing, Instrumentation and Control, Variable Frequency Drives, Ducts and Casings, Air Duct Accessories, HVAC Fans).
  • Division 25: Integrated Automation (Not Used).
  • Division 26: Electrical (e.g., Basic Requirements, Equipment Wiring, Grounding and Bonding, Boxes, Identification, Low-Voltage Power Conductors, Raceway, Enclosed Switches and Circuit Breakers).

This document is crucial for bidders as it provides a detailed outline of all technical specifications and requirements that will govern the project. By reviewing the table of contents, bidders can quickly understand the scope of work, identify all relevant specification sections, and assess the complexity and requirements of different project components. This aids in determining the project's suitability and in preparing a comprehensive bid.