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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 Biological Evaluation and Research (CBER) requirement for a 96 well Absorbance/Fluorescence Multimode microplate reader for Endotoxins Testing.

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. 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-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.

Statement of Work (SOW)

Purchase of a 96 well Absorbance/Fluorescence Multimode microplate reader for Endotoxins Testing

General

A. Introduction

Division of Biological Standards and Quality Control (DBSQC), Office of Biologics Compliance and Quality, is responsible for confirmatory lot release testing of biologicals and in-support testing required for licensing. This SOW is for the purchase of a 96 well plate reader that supports both absorbance/fluorescence based quantitative endotoxin detection assays in the Laboratory of Microbiology, in vivo Testing and Standards (LMIVTS) laboratory of DBSQC using LONZA’s test reagents and recommended procedure(s). By combining two detection methods in one plate reader, the reader footprint is reduced and maintenance is simplified.

The absorbance technology of the reader will be used for bacterial endotoxin testing for biological license application in-support testing as well as lot release testing of biological products using compendial endotoxin assays (i.e., kinetic chromogenic and kinetic turbidimetric techniques).

The fluorescence technology of the reader will be used to evaluate Recombinant Factor C (rFC) as an alternate reagent in lieu of LAL for BLAs and/or testing the candidate material in international endotoxin collaborative studies to calibrate new common, harmonized endotoxin standards to be shared by WHO, USP and EDQM. Evaluation of rFC technology is highly critical since there has been a push to move from animal-based LAL reagent to synthetic rFC under the 3R principle and EU directive to replace all testing using animals or animal-based reagents by 2026.

B. Background

Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation and Testing laboratory of CBER. DBSQC performs bacterial endotoxin test using an approved method, with the absorbance read in a reader that can accommodate assay plates DBSQC intends to replace the current reader with one than can accommodate 96 well plates and has the capability of both absorbance and fluorescence measurements. This will allow the current quantitative endotoxin detection assays to be performed in the Laboratory of Microbiology in accordance with the 21 Code of Federal Regulations 601.12, as well as new methods that are performed in 96 well plates and require either absorbance or fluorescence readers.

C. Scope

This SOW is for the purchase of a 96 well plate reader that supports both absorbance/fluorescence based quantitative endotoxin detection assays in the Laboratory of Microbiology, in vivo Testing and Standards (LMIVTS) laboratory of DBSQC. This purchase includes software used for analysis of results, as well as equipment Qualification (IQ/OQ/PQ) prior to routine use in the laboratory in accordance with cGMP and DBSQC quality guidance.

D. Technical Requirements

A 96 well absorbance/fluorescence plate reader that supports both absorbance/fluorescence-based quantitative endotoxin detection assays. It is essential that the reader use Lonza’s WinKQCL analysis software (item 11 below) as this is critical to performing tests that are approved within our Quality system.

1. Plate reader: Absorbance and fluorescence

2. Read positions: top/bottom

3. Light source: Xenon Flash

4. Detection: Silicon photodiode Absorbance) and PMT (Fluorescence)

5. Wavelength Range: Absorbance: 230 to 1000 nm; Fluorescence: 230 to 850 nm. Monochromator based wavelength selection

6. Fluorescence Sensitivity: Fluorescein,
7. Temperature Control: 5 C above ambient to 42 C

8. Power: Autosensing: 100 – 120 V, 50 – 60 Hz

9. Dimensions: W = 42.5 cm (16.73”) x D = 45.7 cm (17.99”) x H = 25.3 cm (9.96”)

10. Weight: 34.8 lbs

11. The plate reader should be controlled by Lonza's WinKQCL® Endotoxin and Analysis Software or equivalent to support quantitative endotoxin detection assays

12. Warranty: minimum 1 year including parts and labor

13. Onsite training

14. Unlimited phone technical support

Qualification (IQ/OQ/PQ):

1. Provide Equipment qualification protocol for FDA review and address any comments / suggestions

2. Execute Equipment qualification based on FDA approved protocol

3. Prepare qualification report with data and any deviations

4. Provide qualification report for FDA review and address any comments / suggestions

5. Qualification should be performed within 30 days after the delivery of the instrument.

Additional Requirements

A. Security

The contractor Technicians / Customer Service Representatives are required to use White Oak campus parking lot and are required to follow FDA security procedures. Once the contractors enter the Security Desk at Bldg. WO75 Atrium or Loading Dock at Bldg. 52/72. FDA employees must escort the contractor Technicians and/or Customer Service Representatives during their presence in the building.

B. Place of Delivery

Attn: to be completed at time of award

Building 52/72, Loading Dock

10903 New Hampshire Avenue

Silver Spring, MD 20993.

C. Place of Performance

Building 52/72, Ground Floor

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993.

FOB Point Destination. All items shall include shipping, handling and in-side delivery, installation, training and Qualification (IQ/OQ/PQ) to the destination identified herein and shall be completed within 90 calendar days of award.

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 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.

• Past performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. 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).

• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in 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 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 June 21, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2023-118214.

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.

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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