SAM #CBER-2026-133990

Annual Preventive Maintenance and Repair Service for Cozzoli Vial Filling Machines at FDA CBER

The FDA's Center for Biologics Evaluation and Research (CBER) is seeking small business sources for an annual preventive maintenance and repair service agreement for Cozzoli Vial Filling Machines. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Biologics Evaluation and Research (CBER) - Office of Acquisition and Grant Services - OEM Highlight: - Cozzoli is the Original Equipment Manufacturer (OEM) for the vial filling machines - Equipment Details: - Cozzoli Vial Filling Line machines - Serial numbers: UT42-974, CR200i-CWS-69, BT15-75 - Services Requested: - Annual on-site preventive maintenance visit - Includes labor, travel, consumables, replacement parts, software and firmware updates - Unlimited technical support - Service records and reports - Unique Requirements: - Maintenance must be performed by trained and certified service engineers - All work must follow Cozzoli OEM specifications - Only OEM-certified replacement parts may be used - Compliance with Section 508 accessibility standards - All costs must be included in the firm fixed price - Place of Performance: - CBER, Building 52/72, Sterility Suite, Room 5297, 10903 New Hampshire Ave., Silver Spring, MD 20993 - Period of Performance: - Base year plus four option years (annual service agreement)

Description

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER), requirement for Preventive Maintenance and Repair Service Agreement for Cozzoli Vial Filling Machine.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is 811210 - Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million.

Statement of Work

Purchase of On-site preventive maintenance for COZZOLI® Filling Machine

Part I: General Information A. Objective This requirement is for annual on-site preventive maintenance for COZZOLI® Filling Machine of Division of Biological Standards and Quality Control (DBSQC) within CBER. The COZZOLI® Vial Filling Machine is used for the preparation of CBER standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions. B. Background Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. DBSQC maintains a well-equipped Standards preparation capacity to prepare standards for potency testing and share them with manufacturers and other regulatory agencies. Standards are used to test assay validity for products. An important part of the laboratory activities involves testing influenza vaccines for potency and identity. The COZZOLI® Vial Filling Machine is used for filling measured volume of biological standards in the vials for lyophilization and subsequent distribution. The use of a filling machine is critical for the preparation of Standards and for the mission of CBER, since the standards prepared support testing for licensing, lot release, and other regulatory decisions. C. Scope This SOW is for the purchase of on-site preventive maintenance for COZZOLI® Filling Machine of Division of Biological Standards and Quality Control (DBSQC). The COZZOLI® Vial Filling Machine is in the Sterility Suite, Room 5297, Bldg. 52/72 at White Oak campus.

Part II: Work Requirements Technical Requirements One on-site preventive maintenance per year for a COZZOLI® Vial Filling Machine. Equipment: Cozzoli Filling Line; Cozzoli Serial Number: UT42-974; Cozzoli Serial Number: CR200i-CWS-69; Cozzoli Serial Number: BT15-75. A service contract under 75F40123P00100 was previously in place for the preventive maintenance and repair of the Cozzoli Filling Machine. The previous contract ended on October 16, 2025, and there has been no service contract since. All components are operating normally. Performance requirements The contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year. The consumables required for PM visit shall be included in the contract. All costs for labor, travel, and parts required for preventative maintenance shall be included. The maintenance and repair activities shall be performed by trained and certified service engineers, following OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, and subassemblies. The contractor shall include unlimited software and firmware updates during the entire coverage period(s). The contractor shall include unlimited technical support (via phone and email) on software and hardware issues, Monday through Friday (excluding Federal Holidays). Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, staffed by senior engineers for troubleshooting. All maintenance and repair pricing must include costs for labor, travel, replacement parts, components, subassemblies, and other necessary expenses. Deliverables: Service Records and Reports The contractor shall, upon completion of each preventive maintenance visit, provide a report detailing the work performed in the contractor format, distributed by email to the COR and CS.

Place of Performance CBER 10903 New Hampshire Ave., Building 52/72, Sterility Suite 5th floor. Room 5297 Silver Spring, MD 20993.

Period of Performance Base Period: July 1, 2026 through June 30, 2027 Option Year 1: July 1, 2027 through June 30, 2028 Option Year 2: July 1, 2028 through June 30, 2029 Option Year 3: July 1, 2029 through June 30, 2030 Option Year 4: July 1, 2030 through June 30, 2031

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Holidays and Government Closures Service/Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows: New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type: Firm Fixed Price Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. All interested parties may respond, including small business manufacturers or small businesses capable of supplying a U.S.-made product/service. Responses shall include at minimum: Business name, SAM Unique Entity ID, address, website, size status, point of contact, mailing address (if different), phone number, and email address. Include this information if responding to provide a product manufactured by another firm. Sufficient descriptive literature demonstrating that offered products and services meet the requirements, including specifications, certifications, brochures, and other relevant information. Three (3) years of past performance data for similar products/services, including details such as date, description, value, client information, and manufacturer details if different from the respondent. The capability to initiate service on-site within the specified time. Estimated response time from initial call to technician on-site for the specified instrument. Service/repair plans available for the Cozzoli filling machine. If applicable, GSA Schedule contract(s) and SINs, including detailed list of items included and excluded. Information on any applicable Best in Class (BIC) or other Government-wide contracts. Availability of AbilityOne Contracts that meet the requirement. Capability and understanding of accessibility testing and customization per Section 508 standards, including Accessibility Conformance Reports if available. Indication if specifications are too restrictive; failure to provide this info will be interpreted as adequacy of specifications. If a large business, subcontracting opportunities for small businesses. Standard warranty and payment terms. Place of manufacture or service performance and other info relevant to Buy American and Made in America requirements. Informational pricing (not a quote).

The government is not responsible for locating or securing any information not identified in the response.

The Government encourages comments and suggestions regarding the specifications. While responses will not be directly addressed, they will be considered in finalizing the specifications for the upcoming solicitation.

Interested Parties shall respond with capability statements via email to nick.sartain@fda.hhs.gov on or before April 28, 2026, 13:00 hours (Central Time in Jefferson, Arkansas). Reference: CBER-2026-133990.

Notice of Intent

Responses will help determine if future requirements should be set aside for small business, made available for full and open competition, or procured through sole-source procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or pay for responses. The Government may use the information provided for any necessary purpose. Responses should be complete and detailed to demonstrate qualifications.

Weblinks in responses will not be opened or viewed.

Responses must demonstrate capability, not just affirm it. The Government is under no obligation to acknowledge receipt or provide feedback. A pre-solicitation and solicitation may be published later, but responses to this notice are not sufficient responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included. The Government reserves the right to use any non-proprietary technical information in subsequent solicitations.

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