Sources Sought.pdf

*THREEFOLD SOURCES SOUGHT FOR

PRODUCT(S) MADE IN AMERICA & SMALL BUSINESS MANUFACTURER(S)

THIS NOTICE IS FOR MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Sources Sought Number: 75F40126SS131706

Information regarding any technical point of contact will not be provided and no appointments for presentations will be made.

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether any future requirements 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. Interested Parties shall respond with capability statements which are due by email to howard.nesmith@fda.hhs.gov by 1:00 PM (Central Time), July 16, 2026, Referencing 75F40126SS131706.

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), requires the acquisition of a Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus.

*Part One Product(s) Made In America

Executive Order 14005 of January 25, 2021, was issued Ensuring the Future is Made in All of America by All of America's Workers, which directs Federal agencies to maximize the use of goods, products, and materials produced in, and services offered in, the United States through their financial assistance awards and procurements.

In compliance with Executive Order 14005 the FDA is seeking potential provider(s) who can provide and install an Electro-Mechanical Dynamic Load Frame System which is Made in America. Regardless of North American Industry Classification System (NAICS) Code Business Size Standards all interested parties who can provide the product(s) described herein Made in America may respond to this Notice.

*Part Two Small Business Manufacturer(s)

Potential provider(s) considered a Small Business under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and is capable of providing the FDA with the product(s) described herein and Made in America may respond to this Notice.

*Part Three

Product(s) Made Outside America Potential provider(s) no matter their North American Industry Classification System (NAICS) size who can provide the product(s) described herein which is made Outside America may also respond to this Notice.

mailto:howard.nesmith@fda.hhs.gov

All responses shall be submitted via email to Howard.Nesmith@fda.hhs.gov and provide:

• Proposed Product Information and Description

• Capability Statement which indicates proposed product(s) is Made in America

• Business Name

• Unique Entity ID (SAM) Number

• Business Contact Information to include point of contact name, mailing address, phone number and email address

• NAICS Small Business Program Representations (Small or Large)

• Country of Origin of proposed product(s) if Made Outside America

Background:

The FDA/CDER/OPQ, intends to use the requested Biopharmaceutics Classification System (BCS) / Automated Solubility Apparatus to reduce the need for in vivo bioequivalence studies, where solubility must be tested to determine the drug's BCS classification and its qualification for BCS-based biowaiver. Based upon OGD's review of collected NDAs, only 50% conducted comprehensive solubility testing, which revealed incomplete solubility data in these NDAs. To address these gaps, OPQR has been working on solubility testing of selected model drugs with the purpose of creating a solubility database and supporting OGD's modeling work, which will support the development of a decision-making framework to identify similar formulations of a Sponsor's BCS Class III drug products that would meet the requirements for a biowaiver and facilitate the approval of generic drug products. However, solubility testing is a labor-intensive process that can impact both project timelines and staff resources. In addition, it is anticipated that the recently created OGD BCS Class III solubility database will need to be expanded to support regulatory issues across OPQ and OGD. To address this anticipated regulatory science workload, an automated solubility apparatus will be critical to efficiently conduct multiple solubility test procedures simultaneously. This automated solubility apparatus will enhance FDA's capacity to perform solubility testing and investigations, supporting reviewers in making BCS-based biowaiver determinations. The equipment will help ensure project timelines are met, maintain testing quality and efficacy, and address regulatory gaps.

Minimum Technical Requirements:

Any catalog number, manufacturer brand name, or proprietary description used in this solicitation is used as descriptive only, not restrictive, and used to indicate type, function, or desired quality.

System shall be newly manufactured, latest model, not used, refurbished, or previously used for demonstration.

• Samples containers must be able to maintain sample temperature at 37°C

• Must be able to keep samples being stirred with adjustable speed during the incubation time, even for the very thick sample.

• Multiple sample containers should be able to be operated at the same time.

• Apparatus must withdraw samples at different time points

• Must be able to either filter the withdrew sample in line or centrifuge the sample before sampling.

• It is a plus if the apparatus can perform dilutions

• It is a plus if the apparatus can monitor the pH.

• It is a plus if the apparatus can be directly connected with HPLC analysis.

mailto:Howard.Nesmith@fda.hhs.gov

• Must have a warranty, including parts and labor, for at least one year.

• Must include Delivery, Installation, and On-site training

• Must cover all costs associated with system crating, shipping, and delivery.

• Must verify proper system operation via on-site performance testing including hardware and

Must Must provide on-site training for at least 6 scientists.

• Must provide appropriate support to network computer.

FOB Destination & Place of Performance:

U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) 10903 New Hampshire Avenue Silver Spring, MD 20993, USA

Respondents shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the General Requirements/Specifications identified herein. Though the target audience is Small Business Manufacturers or Small Businesses capable of supplying services of a Small Business, all interested parties may respond. At a minimum, responses shall include the following:

• Business name, DUNS 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 service can meet the herein General Requirements/Specifications. All descriptive material necessary for the government to determine whether the offered meets General Requirements/Specifications including technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the respondent to meet the General Requirements/Specifications;

• If applicable, identification of the respondent’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 General Requirements/Specifications;

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

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

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

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 shall 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/or a 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 shall be included in your response.

The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).