SSN 75F40126SSN133285.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 consumables and materials, or equivalent products, for a capillary electrophoresis instrument (Protein Simple Maurice system [a Biotechne Brand], model: Maurice – OBM, serial number: KF-1804) which is used to conduct regulatory research and testing supporting review of complex biopharmaceuticals. The consumables required include cartridges, reagents and standards for assessment of size and charge variants of biological products including therapeutic monoclonal antibodies, fusion proteins, enzymes, cytokines and recombinant peptide drug products. Size and charge variants are typically identified as critical quality attributes of therapeutic proteins, and OPQR research staff provide subject matter expertise to regulatory assessors based on hands-on expertise acquired in the lab with the Maurice system.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 325413 – In Vitro Diagnostic Substance Manufacturing; with a Small Business Size Standard of 1,250 employees, and you believe that your firm would be able to provide the FDA with the products described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns—especially firms offering 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 .

The Government requires the following ProteinSimple Maurice consumables, or equivalent products that meet or exceed the salient characteristics listed below.

Salient Characteristics for “or equal” products:

1. System Integration: All items shall physically fit and interface with the internal capillary tray, optical imaging sensors, and fluidic blocks of the existing government-owned ProteinSimple Maurice system without modifying the instrument hardware or software.

mailto:suzanne.martella@fda.hhs.gov

2. Pre-Assembled Design: Electrophoresis cartridges shall feature a pre-assembled, fully enclosed glass capillary system with an integrated waste bin to eliminate manual capillary handling and assembly.

3. Precision Range: Reagents and kits shall deliver a resolution threshold capable of detecting protein charge and size variants within an operational range of pH 3.0 to 10.17.

4. Quality Standards: Consumables shall be manufactured under ISO 9001 and ISO 13485 certified quality management systems to ensure lot-to-lot consistency.

5. Traceability Documentation: All materials shall ship with a manufacturer Certificate of Analysis (CoA) verifying molecular weight validation, expiration dating, and compliance with factory standards.

Required Items:

• Maurice Turbo CE-SDS Application Kit, Catalog # PS-MAK01-TS or equal

• Maurice cIEF Method Development Kit, Catalog # PS-MDK01-C or equal

• Maurice cIEF System Suitability Kit, Catalog # 046-044 or equal

• iCE Electrolyte Kit, Catalog # 102506 or equal

• Maurice cIEF Cartridges, Catalog # PS-MC02-C or equal

• Maurice icIEF 400 Cartridges, Catalog # PS-MC02-400 or equal

• Maurice CE-SDS IgG Standard, Catalog #046-039 or equal

• 0.5% Methyl Cellulose Solution, Catalog # 102505 or equal

• 1% Methyl Cellulose Solution, Catalog # 101876 or equal

• Maurice cIEF Fluorescence Calibration Standard, Catalog # 046-025 or equal

• Maurice CE-SDS 25x Internal Standard, Catalog # 046-144 or equal

• Maurice cIEF pI Marker - 4.05, Catalog # 046-029 or equal

• Maurice cIEF pI Marker - 5.85, Catalog # 046-030 or equal

• Maurice cIEF pI Marker - 7.05, Catalog # 046-032 or equal

• Maurice cIEF pI Marker - 8.40, Catalog # 046-033 or equal

• Maurice cIEF pI Marker - 9.50, Catalog # 046-047 or equal

• Maurice cIEF pI Marker - 10.17, Catalog # 046-035 or equal

• Maurice cIEF 500 mM Arginine, Catalog # 042-691 or equal

Deliveries: Due to strict manufacturer-defined shelf-life limitations on the required microfluidic cartridges and chemical reagents, the Government cannot accept a single, bulk delivery. To ensure chemical stability and data integrity, the Government intends to structure the resulting contract as a Firm-Fixed-Price contract consisting of a Base Period and three (3) Option Quantities/Periods executed as follows:

• Base Period (Immediate Need): Delivery within 30 days of contract award (Funded with current FY26 funds).

• Option Quantity 1: Delivery at the 90-day post-award interval.

• Option Quantity 2: Delivery at the 180-day post-award interval.

• Option Quantity 3: Delivery at the 270-day post-award interval.

Delivery Location

The equipment is located and servicing shall be performed at the Center for Drug Evaluation and Research (CDER) at the following address:

US FDA / CDER

White Oak Campus Loading Dock 10903 New Hampshire Avenue BLDG 52/72, Room 2208 Silver Spring, MD 20993-0002

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 products offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service 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 above and product specifications for each required item.

• 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.

• 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 2:00 pm (Central Time in Jefferson AR) on July 24, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN13285.

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.

mailto:suzanne.martella@fda.hhs.gov