75F40126SSN131715.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY

COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS

ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought Notice (SSN) on behalf of Center for Drug Evaluation and Research (CDER)’s Office of Pharmaceutical Quality Research (OPQR) in order to determine if there are existing small business sources capable of providing a process analytical technology (PAT) rig with near infrared (NIR) spectrometer. The laboratory has found a system will meet their needs: the ConsiGma standalone PAT Test Rig with NIR spectrometer, or an equivalent product. Offered products shall meet or exceed the specifications listed below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees, and you believe that your firm would be able to provide the FDA with the product described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum specifications included below—to include the country of manufacture of products offered.

Minimum Requirements/Specifications:

The Process Analytical Technology (PAT) Rig shall:

1. Be constructed from stainless steel product contact metal surfaces with pharmaceutical grade metal finish.

2. Be constructed from FDA-compliant materials for all non-metal product contact equipment parts.

3. Have passed factory acceptance testing and site commissioning prior to shipping.

4. Be calibrated prior to shipping.

5. Undergo installation and operational qualification after installation, including recalibration if required.

mailto:suzanne.martella@fda.hhs.gov

6. Be portable with casters and brakes.

7. Consist of a vertical tube or chute through which pharmaceutical powders can flow with minimal to no mixing or turbulence.

8. Contain a sealable insertion point in the vertical tube or chute into which the NIR spectrometer can be inserted into the flowing powder with minimal to no disruption to powder flow.

9. Permit continuously adjustable speed at which powder exits the bottom of the vertical tube or chute to match the flow rate of the incoming powder.

10. Permit flow of cohesive powder through the tube or chute without impacting the accuracy or precision of the NIR spectrometer.

11. Be adaptable to continuous manufacturing operation which includes options for the seamless integration of upstream and downstream unit operations.

12. Include a minimum of one (1) year parts and labor with warranty from date of installation/commissioning.

The Near Infrared (NIR) Spectrometer shall:

1. Be constructed from stainless steel product contact metal surfaces with pharmaceutical grade metal finish.

2. Consist of FDA compliant materials for all non-metal product contact equipment parts.

3. Have passed factory acceptance testing and site commissioning prior to shipping.

4. Be calibrated prior to shipping.

5. Undergo installation and operational qualification after installation, including recalibration if required.

6. Have a minimum wavelength range from 1200 – 2000 nm.

7. Include a reflection probe with a sapphire window capable of interfacing with the PAT rig as described above.

8. Include measures to reduce stray light.

9. Have high accuracy and precision of the collected light.

10. Include an integrated data acquisition and data storage system to enable real time assessment of the NIR spectra. Spectral data exported from the system must be compatible with standard spectral processing software (e.g., Unscrambler, SIMCA, etc.).

11. Include detachable accessories for reference measurement (i.e., attach accessories containing background and validation standard, which are traceable to a standard setting organization such as ASTM or NIST), to the reflection probe.

12. Include a minimum of one (1) year parts and labor with warranty from date of installation/commissioning.

Delivery, Installation, Training and Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used and refurbished or previously used for demonstration.

2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

3. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

4. Installation shall be conducted by factory-certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected.

5. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.

6. The Contractor shall provide all labor, travel, and tools to install, qualify, and recalibrate the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications.

7. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization for at least two (2) attendees. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

8. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service call), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery Terms: Delivery, installation, qualification, and training are expected to be completed within 40 weeks of contract award at the below address:

Food and Drug Administration Center for Drug Evaluation and Research (CDER) 5901 Ammendale Road, Suite D Beltsville MD 20705

POC: will be appointed and contact information will be given upon contract award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, Unique Entity ID (SAM) 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 again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product to include date of sale, description of services provided, contract dollar value, client name, client address, client 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of what the responding firm is regularly engaged in manufacturing or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified herein.

• If applicable, identification of the firm’s GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• 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.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of manufacture or 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 for the products would be helpful for market research purposes.

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

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 10:00 am (Central Time in Jefferson AR) on April 24, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN131715.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

mailto:suzanne.martella@fda.hhs.gov