IRV Lab Exhaust and Vacuum Pump Replacement

Drawings / Plans

This document contains architectural and engineering drawings for the "FDA Irvine RM 2309 Exhaust Design" project. The project involves installing a mechanical exhaust system to reduce vaporized hydrogen peroxide (VHP) concentrations in Room 2309. This includes ductwork, controls, and minor architectural and electrical modifications.

• Scope: Installation of a new exhaust system for Room 2309, including ductwork, fans, and integration with the existing Building Automation System (BAS).

• Materials: UV-stable plastic or 316 stainless steel ducting is specified for corrosion resistance.

• Structural Considerations: Details on roof and penthouse roof structures, including feasible penetration sizes and reinforcement requirements.

• Mechanical Details: Specifics on roof penetrations, duct materials, equipment support, and BAS integration.

• Demolition: Plans outline areas requiring demolition for the new system installation.

• Electrical: Power distribution and connections for new equipment are detailed.

• Controls: Integration with the existing BAS for temperature, airflow, and exhaust fan control is specified.

• Architectural Plans: Floor plans, reflected ceiling plans, building sections, wall sections, and demolition plans.

• Structural Drawings: Roof and shed roof framing plans, sections, and details.

• Mechanical Drawings: Symbol lists, general notes, floor plans, sections, schedules, diagrams, and details related to the exhaust system.

• Electrical Drawings: Symbol lists, general notes, floor plans, single-line diagrams, and schedules for power distribution.

• Bid Set Date: August 15, 2025

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

To provide construction services for the replacement of obsolete vacuum pump systems and to correct the exhaust in room 2309 at the FDA Pacific Southwest Laboratory and District Office in Irvine, CA.

• Replacement of end-of-life vacuum pump systems (currently AES-Dekker Laboratory Vacuum System Model AES-VMX0153MA2-45-DS) with new equipment of matching or better capacity.

• Correction of VHP detection alarms in room 2309 by directly ducting isolators to the outside via an exhaust fan.

• Relocation of electrical, mechanical, commissioning, third-party inspections, site walks, surveys, additional engineering, BAS integrations, or structural building system components as necessary.

• Provision of new control panel integrated with existing BAS and alarms.

• Utilization of power feed to the existing vacuum system.

• Provision of independent isolation valves and disconnect means for service.

• Utilization of design drawings and specifications dated August 15, 2025, for the Room 2309 Exhaust work.

• Work to be completed within 222 calendar days of the Notice to Proceed (NTP) or negotiated completion date.

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

• Project goals include providing a safe working environment, maintaining FDA operations with minimal interruption, and ensuring a safe work environment for all personnel.

• Period of Performance: To be determined at time of award, with work commencing promptly upon contract execution and NTP.

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

• Firm Fixed Price contract type.

• Contractor must provide all necessary labor, material, insurance, training, and equipment.

• Contractor must provide equipment cutsheet submittals and shop drawings for FDA review and approval before procurement.

• N+1 redundancy must be integrated into the new vacuum system.

• Contractor must assess and provide repairs or additions to any housekeeping pad as needed.

• Contractor must keep equipment shutdowns to a minimum and coordinate with FDA.

• Contractor must provide temporary utilities for any shutdown longer than three (3) days; weekend shutdowns are preferred.

• Contractor must provide all inspection and testing, except where required by code, specification, or detailed elsewhere.

• Contractor must comply with HHS and FDA Security Clearances requirements.

• Contractor must appoint a Project Manager as the Government's primary point of contact.

• Contractor must hold weekly progress meetings and provide meeting minutes.

• Contractor must notify the government 15 business days prior to utility shutdowns.

• Contractor must issue submittals for review and allow 10 business days for review.

• Contractor assumes all risk and liability for damages.

• Contractor is responsible for quality control and correcting deficiencies prior to acceptance.

• Contractor is responsible for removing construction and demolition debris daily.

• Government will provide site utility drawings, points of contact, and photographs of work-site conditions.

• Submittals include communication plan, project kick-off meeting, project schedule, safety plan, shop drawings, and equipment cutsheets.

• Deliverables include O&M Manuals, as-built drawings, warranties, and final reports.

• Project schedule includes key milestones for submittals, construction, inspection, and close-out, totaling 222 days.

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

This document outlines comprehensive specifications for a construction project at FDA IRV Rm 2309 in Irvine, California (PCN# 47PA0325F0006). The primary objective is to ensure the quality, safety, and proper execution of work related to existing roof modifications, HVAC systems, and electrical installations, while minimizing disruption to ongoing FDA operations and maintaining indoor air quality.

• General Requirements (Division 01): Covers administrative and procedural aspects including work restrictions (e.g., limiting operations to specific areas, scheduling disruptive work during unoccupied hours), substitution procedures, detailed submittal requirements (electronic via GSA PMIS), quality assurance and control, general references, temporary facilities and controls, safety and health (requiring a Site-specific Construction Safety and Health Plan and Hot Work Permits), product requirements, execution requirements, cutting and patching, selective demolition, fire prevention, indoor air quality management, non-hazardous waste management (50% diversion goal), closeout procedures, project record documents, and demonstration & training for government personnel.

• Thermal and Moisture Protection (Division 07): Details specifications for existing roof modifications to accommodate new construction and drainage, including a 2-year unlimited workmanship guarantee. Also covers roof accessories like curbs and equipment rails.

• Heating, Ventilating, and Air Conditioning (HVAC) (Division 23): Provides basic requirements for HVAC systems, including hangers and supports, testing, adjusting, and balancing (TAB) procedures (requiring NEBB or AABC certified firms), instrumentation and control performance specifications (expanding existing Automated Logic BAS), variable frequency drives (VFDs must be UL listed and seismically certified), HVAC ducts and casings (specifying materials like 316L Stainless Steel and leakage classifications), air duct accessories, and HVAC fans.

• Electrical (Division 26): Outlines basic requirements for electrical work, equipment wiring, low-voltage electrical power conductors and cables (including color coding), grounding and bonding (system resistance ≤ 5 ohms), hangers and supports (requiring seismic restraint design by a Structural Professional Engineer), raceways, boxes, identification for electrical systems, wiring devices (including GFCI requirements), and overcurrent protective devices.

• Contractor is solely responsible for developing and implementing a Quality Control Plan.

• Indoor Air Quality Management Plan requires specific MERV ratings for filtration media and pre-occupancy testing.

• A minimum 50% diversion by weight of non-hazardous construction and demolition waste is targeted.

• Grounding system resistance must not exceed 5 ohms.

• All work must comply with local, State, and Federal codes, regulations, and manufacturer instructions.

Work is for FDA IRV Rm 2309 in Irvine, California. Construction activities must be coordinated to minimize disruption to FDA operations, with disruptive work preferably performed during Government unoccupied hours (after 4 PM, weekends).

• Extensive coordination with FDA, GSA, Architect, Engineer, and other trades is required.
• Electronic submittals via GSA's Project Management System (PMIS) are mandatory for many items.
• Contractor must provide training to Government O&M personnel and support the commissioning process, including Functional Performance Testing (FPT).
• Strict environmental controls, waste management, and hazardous material handling procedures are mandated.

Form / Attachment / Pricing Sheet

This document is a vendor response questionnaire for a Sources Sought notice regarding IRV Exhaust and Vacuum Pump Construction. It is designed to gather information from potential vendors to help the government determine the capabilities of small businesses and other concerns for this requirement.

The questionnaire is divided into several sections:

• Section A – Business Information: Collects standard company details, UEI, CAGE code, business size, and NAICS codes.
• Section B – Technical Capability: Gathers information on offered exhaust and vacuum pump systems, including whether they are Commercial Off-the-Shelf (COTS), manufacturers, performance specifications (capacity, pressure, materials, controls, noise), and compliance with various industry standards (OSHA, NFPA, ASME/ASHRAE/SMACNA, EPA).
• Section C – Installation and Integration: Assesses experience with HVAC/exhaust systems in occupied facilities, specifically in laboratory, research, or healthcare settings, and experience with hazardous exhaust systems. It also inquires about capabilities for coordinating shutdowns, temporary utilities, meeting FAR Part 36, and overall safety/QA/QC/scheduling approaches.
• Section D – Schedule and Risk Considerations: Asks for estimated equipment lead times and identification of key schedule risks.
• Section E – Financial Capability: Inquires about average annual construction revenue for recent fiscal years and the ability to obtain performance bonds, payment bonds, federal insurance, and upfront financing.
• Section F – Past Performance: Requests details on up to two past projects, including customer information, contract type, scope, value, and period of performance.
• Section G – Commerciality and Supply Chain: Focuses on market availability and estimated lead times for components (fans, pumps, controls, ductwork), as well as country of origin.
• Section H - Comments: A section for vendors to provide any additional relevant comments.

This questionnaire is crucial for potential bidders responding to the Sources Sought. It outlines the specific information the government needs to assess vendor capabilities, technical expertise, installation experience, financial stability, and past performance related to IRV exhaust and vacuum pump systems. Completing this accurately will help vendors demonstrate their suitability for potential future solicitations.