Simulations Plus GastroPlus Software Licenses

The Department of Health and Human Services (HHS), Centers for Disease Control (CDC) plans to procure, on a sole source basis, Simulations Plus GastroPlus Software Licenses from: Simulations Plus, Inc. P.O. Box 12317 Research Triangle Park, NC 27709

The closing date of this notice is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code (NAICS) is 513210 - Software Publishers, and the small business size standard is $47M.

Background The Office of Research and Standards (ORS) located within the Office of Generic Drugs (OGD) under the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) conducts internal research projects using a variety of computational tools to support modeling and simulation pertaining to generic drug products. ORS is in need of a contract to Simulations Plus to procure GastroPlus Software.

Objectives The purpose of this requirement is twenty (20) GastroPlus licenses with five DDDPlus (includes licenses to the Digit™ and MedChem Designer) licenses and five MembranePlus licenses to accommodate the need for commercial physiologically based pharmacokinetic (PBPK) modeling software.

Requirements The Office of Research and Standards (ORS) located within the Office of Generic Drugs (OGD) under the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is in need of a contract to Simulations Plus to procure GastroPlus Software for a base year period and four one-year option periods. GastroPlus software is the only known software that uses the ACAT model to predict oral absorption and combines non-oral delivery routes (such as ocular and pulmonary) in the prediction model. The ACAT model is widely accepted in the scientific community and many absorption models already built by FDA scientists have been created using the ACAT model. DDDPlus is a companion software that allows for the prediction of in vitro dissolution and lot-to-lot variability. MembranePlus is a companion software that allows for the prediction of the in vitro permeability of drugs.

Equipment/Software Specifications

1. GastroPlus licenses – Quantity 20

Minimum Specifications:- Standard, individual, perpetual licenses

2. DDDPlus (includes licenses to the Digit™ and MedChem Designer) – Quantity 5

Minimum Specifications:
-Standard, individual, perpetual licenses

3.MembranePlus™ – Quantity 5
Minimum Specifications:
-Standard, individual, perpetual licenses

This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government’s needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI to determine if the party can perform the requirement.

Responses to this notice shall be submitted via email to Miguel Diaz, at miguel.diaz@hhs.gov, no later than 12:00 P.M. EST on Monday, August 10, 2026 (08/10/26).

A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered for the purpose of determining whether to conduct a competitive procurement. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number “7571TE-NOI-FDA132771 - Simulations Plus GastroPlus Software Licenses” on all correspondence.

Capability Statement Submission Instructions: Interested companies should review the information provided and then submit a response that provides feedback, if any, and that addresses all of the information listed. Capability statements and responses shall be submitted via email to miguel.diaz@hhs.gov no later than 12:00 PM EST on June 06, 2026. The subject line for the email heading shall be “7571TE-NOI-FDA132771 - Simulations Plus GastroPlus Software Licenses” Please provide enough detail and depth to enable Government review and assessment. The due date for receipt of statements is August 10, 2026, 12:00 PM, EST. All responses must be received by the specified due date and time in order to be considered.

Please add a cover letter to your response with the following information:
1.Company Name

2.Company Unique Entity ID number

3.Company points of contact, mailing address, telephone and website address

4.Any Governmentwide Acquisition Contract (GWAC), General Services Administration (GSA) Schedule vehicle, or other available procurement vehicles your company maintains that could meet this requirement

5.Business Size relative to NAICS code 513210 - Software Publishers

6. Type of Company (e.g., large business, small business, 8(a), woman owned, veteran owned, etc.) as registered in the System for Award Management (SAM)
7. Identify any/all teaming arrangements

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or pay for the information provided in response. The Government reserves the right to use information provided by the 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.

Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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.

Any solicitation resulting from the analysis of information obtained will be announced to the public in SAM in accordance with FAR Part 5. However, responses to this notice will not be considered adequate to 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).

This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of HHS. HHS/OMAS does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, HHS/OMAS may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against HHS shall arise as a result of a response to this notice or HHS’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or 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.