Preventive Maintenance and Repair Service Agreement for Cozzoli Vial Filling Machine.

Active

Contract Opportunity

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

1. 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 have been without service contract. 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 the service engineers who are trained and certified, and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

-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 related issues and trouble-shooting capabilities, 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 including software, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

-All maintenance and repair pricing must encompass costs for labor, travel, replacement parts, components, subassemblies, and any other necessary expenses related to the system.

- Deliverables: Service Records and Reports

The contractor shall, commensurate with the completion of each preventive maintenance visit a report identifying 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 Labor Day

Martin Luther King, Jr.’s Birthday Columbus Day

Washington’s Birthday Veterans Day

Memorial Day Thanksgiving Day

Juneteenth Day Christmas Day

Independence 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. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, SAM Unique Entity ID number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);


• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.


• Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.


• The offeror’s capability to initiate service on-site within the time specified above.


• Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call.


• Service/repair agreement plans that are available for the Cozzoli filling machine from the respondent.


• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.


• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.


• Identification of AbilityOne Contracts available that can meet the requirement.


• Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).


• Provide information if any of these specifications are too restrictive. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.


• If a large business, identify the subcontracting opportunities that would exist for small business concerns;


• Standard commercial warranty and payment terms;


• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed; and


• Though this is not a request for quote, informational pricing is required

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before April 28, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2026-133990.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

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