FDA-SSN-75F40126Q00214.pdf

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 Office of

Pharmaceutical Quality and Research (OPQR), which requires license maintenance service update for process automation software and SIMATIC SIPAT (Siemens PAT) software update service for a Pharmaceutical

Manufacturing Virtual Plant via SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 (or equivalent).

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of providing services 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 513210 – Software

Publishers, Small Business Size Standard is $47.0 million.

The FDA/OPQR requires license maintenance service update for process automation software and SIMATIC

SIPAT (Siemens PAT) software update service for a Pharmaceutical Manufacturing Virtual Plant via

SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 (or equivalent) for a One-Year Base with Four-Year Options

Period of Performance.

Schedule of Supplies or Services and Price/Costs

Base Year: 09/30/2026 - 09/29/2027

Item No. Description Qty. Unit Unit Price Subtotal

Digital Twin: Software Update Service for Process Automation Software 1 12 Months $ $

SIPAT: SIMATIC SIPAT Concurrent

Method Support 1 12 Months $ $

ProcessCare – Plus: PA Process Care

Contract - Plus 1 12 Months $ $

004 ProcessCare – Plus System Extension 1 12 Months $ $

Field Service Hours: Field Service

Block of Hours 32 hrs + (12 from

Process Care for a total of 44 hours travel and on-site time)

1 12 Months $ $

Field Service Travel and Living

Expenses 1 12 Months $ $

Option Year 1: 09/30/2027 - 09/29/2028

Item No. Description Qty. Unit Unit Price Subtotal

Digital Twin: Software Update Service for Process Automation Software 1 12 Months $ $

SIPAT: SIMATIC SIPAT Concurrent

Method Support 1 12 Months $ $

ProcessCare – Plus: PA Process Care

Contract - Plus 1 12 Months $ $

004 ProcessCare – Plus System Extension 1 12 Months $ $

Field Service Hours: Field Service

Block of Hours 32 hrs + (12 from

Process Care for a total of 44 hours travel and on-site time)

1 12 Months $ $

Field Service Travel and Living

Option Year 2: 09/30/2028 - 09/29/2029

Digital Twin: Software Update Service for Process Automation Software 1 12 Months $ $

SIPAT: SIMATIC SIPAT Concurrent

Method Support 1 12 Months $ $

ProcessCare – Plus: PA Process Care

Contract - Plus 1 12 Months $ $

004 ProcessCare – Plus System Extension 1 12 Months $ $

Field Service Hours: Field Service

Block of Hours 32 hrs + (12 from

Process Care for a total of 44 hours travel and on-site time)

1 12 Months $ $

Field Service Travel and Living

Option Year 3: 09/30/2029 - 09/29/2030

Digital Twin: Software Update Service for Process Automation Software 1 12 Months $ $

SIPAT: SIMATIC SIPAT Concurrent

Method Support 1 12 Months $ $

ProcessCare – Plus: PA Process Care

Contract - Plus 1 12 Months $ $

004 ProcessCare – Plus System Extension 1 12 Months $ $

Field Service Hours: Field Service

Block of Hours 32 hrs + (12 from

Process Care for a total of 44 hours travel and on-site time)

1 12 Months $ $

Field Service Travel and Living

Option Year 4: 09/30/2030 - 09/29/2031

Digital Twin: Software Update Service for Process Automation Software 1 12 Months $ $

SIPAT: SIMATIC SIPAT Concurrent

Method Support 1 12 Months $ $

ProcessCare – Plus: PA Process Care

Contract - Plus 1 12 Months $ $

004 ProcessCare – Plus System Extension 1 12 Months $ $

Field Service Hours: Field Service

Block of Hours 32 hrs + (12 from

Process Care for a total of 44 hours travel and on-site time)

1 12 Months $ $

Field Service Travel and Living

Period of Performance (1-Year Base + 4-Year Options): as outlined in each item description.

The contractor shall be required to meet the following Maintenance and Technical Support

Requirements:

At minimum the contractor shall provide:

• Delivery of software license updates

• Software license updates and testing

• Two business-day response to all software defect inquiries

• Availability of feature (level) updates

• Technical assistance for system platform troubleshooting

• On-site assistance for license updates

• Patch/Bug fix, Telephone/Helpdesk assistance.

Description of Deliverable Quantity Digital Twin: Software Update Service for Process

Automation Software

SIPAT: SIMATIC SIPAT Concurrent Method Support 1 ProcessCare – Plus: PA Process Care Contract - Plus 1 ProcessCare – Plus System Extension 1 Field Service Hours: Field Service Block of Hours 32 hrs + (12 from Process Care for a total of 44 hours travel and on-site time)

Field Service Travel and Living Expenses 1

Digital copies of Software, Licensing Key, and User Manuals or equal need to be 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.

Terms of Use

Perpetual License: FDA shall have the ability to retain the license in order to run the Virtual Plant platform with no time restriction. FDA shall have the ability to purchase new features and extensions and to gain access to technical support and product upgrades.

The COR may approve any changes to the delivery schedule by mutual agreement of the parties.

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, Unique Entity ID, 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, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• 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.

• 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.

Interested Parties shall respond with capability statements by email to Contract Specialist (CS) /

Terina.Hicks@fda.hhs.gov on June 23, 2026, by 1:00PM Washington, DC Local Time or sooner. Reference

FDA-SSN-75F40126Q00214. For information regarding this Sources Sought, please contact Terina Hicks (CS) by June 18, 2026, by 1:00PM Washington, DC Local Time.

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 procured 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).

mailto:Terina.Hicks@fda.hhs.gov