SOURCES SOUGHT ONLY.pdf

75F40124SS00477

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SOURCES SOUGHT NOTICE ONLY

This is a SOURCES SOUGHT NOTICE for market research purposes only in accordance with Federal Acquisition Regulation (FAR) Part 10 for an upcoming acquisition for Food and Drug Administration (FDA).

FDA seeks information concerning firms interested, to include small business socio-economic categories, capable and qualified of providing a Mechanistic Chromatography Modeling Software License Support and Maintenance Services.

This Sources Sought Notice shall not be construed as a formal solicitation or as an obligation on the part of FDA to acquire any products or services. Information provided in response to this posting is strictly voluntary and given with no expectation of compensation, and clearly provided at no cost to the Government. A formal solicitation may be executed and posted separately at a future date. FDA is interested only in identifying interested and capable contractors for this service and receiving industry feedback to improve the acquisition process as part of market research.

The planned North American Industry Classification System (NAICS) code is 541519 (this NAICS is being used for informational purposes only and may be changed dependent upon the usage of a strategic source).

Comments and/or suggestions on the attached salient characteristics are encouraged and can be included in your responses.

Objective:

The objective is to purchase a new license for mechanistic chromatography modeling and simulation platform including adsorption isotherms model for different mode of chromatography, and fluid flow effects in a chromatography column.

In order for a Vendor’s software to be deemed acceptable, the following salient characteristics shall be met:

Mechanistic chromatography modeling software:

• Mechanistic modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality.

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• Mechanistic model libraries including different adsorption isotherms that can be applied to different mode of chromatography such as Affinity, Ion-exchanger, HIC, mixed-mode...

• Mechanistic model libraries for membrane separation

• Streamlined modeling workflow from calibration experiments to simulation.

• Seamless lab integration through optimal linking to AKTA system and

UNICORN software.

• Visual tools for easy interpretation of simulation outputs to support the fulfilment of quality by design obligation.

• Component-centric data structure enables plug and play with different methods, system parts, and columns.

• Collaboration and knowledge management shared databased within and between projects.

• Tamper-proof and back-traceable data and user management

• Simulates preparative liquid chromatography processes with a computer.

• Creates digital twins of downstream processes using mechanistic models.

• Enables increased process understanding for smarter and faster process development.

• Applies to a wide range of molecules and applications from early process development to late stage, scale-up, troubleshooting; and chemistry, manufacturing, and controls (CMC)

• Custom modeling capabilities to create user defined models.

• Parameter estimation from experimental data to support model validation.

• Global sensitivity analysis to analyze the impact of inputs, and model parameters on process outputs.

• Ability to estimate physical properties of components using only a few experiments.

• Ability to run optimization and characterization.

Maintenance and Technical Support:

At minimum the contractor must:

• Delivery of software updates

• One business-day response to all software defect inquiries

• Availability of feature (level) upgrades

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Training:

• Standardized 3-day training by the vendor.

• A standard license package includes the installation on one computer and one user account, but you can add more computer licenses and user accounts as you need them.

• During your chosen license period, updates and technical support are free.

Deliverables

Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.

Schedule: Delivery shall be no later than 15 days after contract award.

Vendor is not responsible for installation of the software. FDA staff will install the software.

How to Respond: Interested Parties shall respond with capability statements on or before August 16, 2024, by 2:00 pm (Eastern Time). Reference 75F40124SS00477, via email to Lilibeth.Deato@fda.hhs.gov. Interested offerors shall provide the following information:

a. Contact information:

- Name of company

- Business title and Point of Contact.

- Business address, Email address, and Phone number

- Business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB),

- Unique Entity Identifier (UEI) and Data Universal Numbering System (DUNS) Number & CAGE Code

- Provide this same information if responding to provide a product manufactured by another firm.

b. Capability statement expressing interest and the ability to meet the requirements shall be limited to 6 pages and should address the following:

- Describe how the contractor shall meet all the technical requirements identified on the salient characteristics.

- If, Small Business, can your company meet the requirement specified in FAR 52.219- 14 Limitations on Subcontracting

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The contractor shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified. 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 other than small business interested parties may respond. At a minimum, responses shall include the following:

• Capability statement must unequivocally demonstrate 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, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products/services 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 –Unique Entity Identifier (UEI), DUNS number and size status) if not the respondent.

• If on GSA, 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.

• 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; and

• 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 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.

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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 or 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 the 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. 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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