Sources Sought CBER-2025-130197 vFinal.pdf

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Purchase of preventative maintenance and calibration services for general laboratory equipment for Division of Biological Standards and Quality Control (DBSQC), Office of

Compliance and Biologics Quality (OCBQ), Center for Biologics Evaluation and Research (CBER)

CBER-2025-130197

The U.S. Food and Drug Administration (FDA) is conducting market research to support the acquisition of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, digital thermometers, hygrometers, and chart recorders for DBSQC.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required product. Other Than Small Business (OTSB) 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

See below.

Alternative Solutions

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.

Response Instructions

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:

Section 1: Respondent Overview

- 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.

Section 2: Descriptive Information

- 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.

Section 3: Past Performance

- Three (3) years of past performance service information, if not the manufacturer of the equipment identified herein, where the respondent has provided same or substantially similar service solutions on the same or near-same brand name equipment.

- 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.

- 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.

- 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).

- Identification of any specifications deemed too restrictive.

- If a large business, identify the subcontracting opportunities that would exist for small business concerns.

- Standard commercial warranty and payment terms.

- 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.

- Though this is not a request for quote, informational pricing is encouraged for both the purchase of the instrument and a lease of the instrument.

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 July 23, 2025 by 13:00 hours (Central Time in Jefferson, Arkansas) to david.kramer@fda.hhs.gov. Reference HFP-2025-130197.

Notice of Intent

Responses to this Sources Sought announcement will assist the Government in determining whether 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.

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).

Statement of Work

Purchase of preventative maintenance and calibration services for general laboratory equipment for DBSQC/OCBQ/CBER

CBER-2025-130197

1. Introduction:

This Statement of Work (SOW) is for the purchase of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers, hygrometers, and chart recorders and hygrometers for DBSQC.

2. Background:

DBSQC serves as a Standards Preparation and Testing laboratory for CBER. DBSQC is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by Sponsors (Industry) for licensing and lot release approvals are tested in DBSQC, OCBQ, CBER. This SOW is for the acquisition of onsite preventative maintenance and calibration services for general equipment for DBSQC. See attached DBSQC Equipment list.

3. Scope:

This SOW is for the purchase of onsite preventative maintenance and calibration services for general equipment of OCBQ (DBSQC and DMPQ) managed by DBSQC. Examples include refrigerators, freezers, refrigerator/freezer combo units, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers and hygrometers, chart recorders for DBSQC. The contractor shall have current ISO 17025 accreditation for the calibration services and associated documentation.

4. Technical Requirements:

The scope of the desired contract is preventative maintenance and calibration services including:

a. On-site conduct of preventive maintenance, calibration and/or certifications; and

b. Development of relevant standard operating procedures (SOP) and forms for the work being contracted.

5. Deliverables:

The number of services solicited may increase or decrease annually up to 25% of the contract due to changes in priority or purchase or surplus of equipment. The required deliverables include:

a. Evidence of current ISO 17025 accreditation certificate for calibrations;

b. Evidence of performance to ISO 17025 accredited laboratories;

c. Relevant standard operating procedures (SOP) and forms;

d. Copies of current calibration certifications for the devices used for the conduct of preventative maintenance, calibrations and/or certifications;

e. Credentials and training certificates of the service engineers/technicians; and

f. Certificates after the work within two weeks of the work via email.

The due dates for the preventative maintenance, calibration, certification of equipment of DBSQC may fall on different days all through the year. The above activities for all the equipment in the contract will be scheduled for no more than five (5) visits per year.

6. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

N/A

7. Contractor Provided Special Material Requirements

N/A

8. Security

The contractor Technicians/Customer Service Representatives are required to use FDA White Oak Campus visitor’s parking lot and are required to report to the guards at Building 75 or Building 52/72 Loading Dock, who will contact an FDA employee, who serves as a contact. FDA employees must escort the contractor Technicians/Customer Service Representatives within the buildings.

9. Travel

Service contract shall include all travel by the contractor to the stated Place of Performance.

10. Period of Performance

Base Period: 09/01/2025 – 08/31/2026 Option Year 1: 09/01/2026 – 08/31/2027 Option Year 2: 09/01/2027 – 08/31/2028 Option Year 3: 09/01/2028 – 08/31/2029

Option Year 4: 09/01/2029 – 08/31/2030

11. Place of Performance

Buildings 52/72 and 75.

Federal Research Center 10903 New Hampshire Avenue Silver Spring, MD 20993

12. Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Independence Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

13. Contract Administration

Technical Point of Contact (POC):

To be provided at time of award.