Notice of Sole Source: GastroPlus PBPK and PBBM modeling platform subscription

Active

Contract Opportunity

Solicitation Title: GastroPlus PBPK and PBBM modeling platform subscription

Solicitation Number: 7571TE26Q00153

Notice Type: Special Notice

RFO Reference: RFO 12 (Acquisition of Commercial Products and Commercial Services)

NAICS Code: 513210

NAICS Size Standard: $47 million average annual receipts

PSC Code: DA10

Set-Aside (if applicable): None: Non Competitive Other Than Small Business

Anticipated Contract Type: Firm Fixed Price

Anticipated Period of Performance:

Base Year: September 1, 2026-August 31, 2027

Option Period 1: September 1, 2027 -August 31, 2028

Option Period 2: September 1, 2028 -August 31, 2029

Option Period 3: September 1, 2029 -August 31, 2030

Responses Due: Friday, August 14, 2026, 5:00 PM EDT

Government Point of Contact:

Name: Dorothy Fessler

Title: Contract Specialist

Email: Dorothy.Fessler@psc.hhs.gov

1. Background

This is a Notice of Intent to Sole Source for the acquisition of commercial products and commercial services prepared in accordance with the Revolutionary FAR Overhaul (RFO) Part 12, Acquisition of Commercial Products and Commercial Services.

Notice number 7571TE26Q00153 is issued to announce the Government's intent to negotiate and award a sole-source purchase order to Simulations Plus Inc. for twenty (20) GastroPlus licenses and five (5) DDDPlus licenses.

The Office of Mission Government Acquisition Solutions (OMAS), Office of Acquisition (OA), on behalf of 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), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Simulations Plus Inc. 800 Park Offices DR STE 401, Research Triangle Park, North Carolina 27709 for software licenses to accommodate the need for commercial physiologically based pharmacokinetic (PBPK) modeling software.

This notice incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

2. Description of Requirement

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.

2.1 Requirement Summary

ORS has a requirement for a contract for twenty (20) GastroPlus and five (5) DDDPlus Software licenses for a base year and three one-year option periods.

2.2 Software Specifications:

1. GastroPlus licenses – Quantity 20

Minimum Specifications:

• Standard, individual licenses

1. DDDPlus – Quantity 5

Minimum Specifications:

• Standard, individual licenses

2.3 Period of Performance:

This contract consists of a base year and three option years, beginning on September 1, 2026. The base period and option years are defined below:

BASE: September 1, 2026-August 31, 2027

Option Period 1: September 1, 2027 -August 31, 2028

Option Period 2: September 1, 2028 -August 31, 2029

Option Period 3: September 1, 2029 -August 31, 2030

2.4 Place of Performance:

U.S. Food and Drug Administration White Oak campus, Silver Spring, MD, USA

Food and Drug Administration

10903 New Hampshire Avenue

Building 75, Room 4686

Silver Spring, MD 20993

2.5 Order Type

This is a Firm Fixed-Price order.

This notice is not a request for competitive quotations or offers. The Government intends to negotiate and award a sole-source purchase order to Simulations Plus Inc. Any responsible source that believes it is capable of meeting the Government's requirement may submit a capability statement and supporting information by the response date identified in this notice. The Government will consider all responses received solely for the purpose of determining whether to conduct a competitive procurement. Responses received after the closing date may not be considered.

Capability statements shall clearly demonstrate the respondent's ability to provide the required GastroPlus and DDDPlus software licenses, including any supporting documentation establishing that the respondent is the manufacturer or an authorized reseller, if applicable.

This notice incorporates Provision 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services, and FAR 52.212-2, Evaluation—Commercial Products and Commercial Services, by reference. Interested sources shall comply with the instructions and requirements set forth in this notice. Interested sources submitting a capability statement in response to this notice must be registered in the System for Award Management (SAM) at https://sam.gov at the time of response submission. Responses received by the due date will be reviewed to determine whether they demonstrate the capability to satisfy the Government's requirement. The Government will consider all timely responses solely for the purpose of determining whether another responsible source can satisfy the Government's requirement and whether a competitive procurement should be conducted.

52.212-2(a) Evaluation of Responses. Responses received by the closing date identified in this notice will be reviewed to determine whether they demonstrate that another responsible source is capable of satisfying the Government's requirement. The Government will consider all timely responses solely for the purpose of determining whether a competitive procurement should be conducted. This notice is not a request for competitive quotations or offers and does not constitute a commitment by the Government to award a contract.

52.212-2(b) Capability Determination. Capability statements shall clearly demonstrate the respondent's ability to provide the required GastroPlus and DDDPlus software licenses, including documentation establishing that the respondent is the Original Equipment Manufacturer (OEM) or an authorized reseller, if applicable. The Government will evaluate the information submitted to determine whether another source is capable of meeting the Government's requirements.

3. Inspection/Acceptance and Order of Precedence:

This notice incorporates Clause 52.212-4 Terms and Conditions – Commercial Products and Commercial Services by reference. Deliveries will be evaluated for acceptance in accordance with the criteria specified in FAR 52.212-4 and the notice addenda below:

52.212-4(b) Inspection and acceptance will be at destination by the COR or assigned Technical Point of Contact (TPOC) in accordance with FAR clause 52.212-4(b). In accordance with FAR 52.212-4(b), the Government has the right either to reject or to require correction of nonconforming supplies and services. Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with agreement requirements. Services are nonconforming when they are not in conformity with the agreement requirements. The Government may reject nonconforming supplies and services with or without disposition instructions.

The COR will load the software and licensing to verify that the platform can execute high performance and scalable visual modeling tools. The COR shall have 30 working days to inspect and verify that the software is operational, functional and compatible with FDA server and software.

52.212-4(r) Order of precedence. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in Clause 52.212-4(r). The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

4. Incorporated Provisions:

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This notice incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Interested sources should review the listed provisions. Any information requested by an applicable provision should be included with the respondent's capability statement or response to this notice. In lieu of submitting the full text of those provisions, interested sources may identify the applicable provision by paragraph identifier and provide the requested information with their capability statement or response to this notice. Also, the full text of a provision may be accessed electronically at this/these address(es):

www.acquisition.gov/browse/index/far

https://www.acquisition.gov/far-overhaul

https://www.acquisition.gov/hhsar

(End of provision)

FEDERAL ACQUISITION REGULATIONS (FAR) – PROVISIONS INCORPORATED BY REFERENCE:

Provision No.

Provision Title

Date

52.212-1

Instructions to Offerors—Commercial Products and Commercial Services

DEVIATION DATE NOV 2025

52.212-2

Evaluation—Commercial Products and Commercial Services (Tailored see text under Section 3)

DEVIATION DATE NOV 2025

52.203-11

Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

SEPT 2024

52.203-18

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements — Representation

JAN 2017

52.204-7

System for Award Management—Registration

DEVIATION DATE NOV 2025

52.233-2

Service of Protest

DEVIATION DATE APR 2026

52.240-90

Security Prohibitions and Exclusions Representations and Certifications

DEVIATION DATE NOV 2025

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) – PROVISIONS INCORPORATED BY REFERENCE:

This contract incorporates one or more HHSAR provisions by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR provisions may be accessed electronically at this address:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

Provision No.

Provision Title

Date

352.239-73

Electronic and Information Technology Accessibility Notice

DEC 2015

5. Contract Clauses:

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far

https://www.acquisition.gov/far-overhaul

https://www.acquisition.gov/hhsar

(End of Clause)

Clause No.

Clause Title

Date

52.212-4

Terms and Conditions – Commercial Products and Commercial Services (Tailored see text under Section 4)

DEVIATION DATE NOV 2025

52.203-12

Limitation on Payments to Influence Certain Federal Transactions

JUN 2020

52.203-17

Contractor Employee Whistleblower Rights

NOV 2021

52.204-13

System for Award Management – Maintenance

Deviation Date NOV 2025

52.209-6

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Deviation Date NOV 2025

52.217-8

Option to Extend Services

NOV 1999

52.217-9

Option to Extend the Term of the Contract

MAR 2000

52.222-35

Equal Opportunity for Veterans

DEVIATION DATE APR 2026

52.226-8

Encouraging Contractor Policies to Ban Text Messaging While Driving

MAY 2024

52.227-14

Rights in Data General

MAY 2014

52.232-33

Payment by EFT—System for Award Management

OCT 2018

52.232-39

Unenforceability of Unauthorized Obligations

JUN 2013

52.233-3

Protest After Award

DEVIATION DATE APR 2026

52.233-4

Applicable Law for Breach of Contract Claim

DEVIATION DATE APR 2026

52.244-6

Subcontracts for Commercial Products and Commercial Services

DEVIATION DATE NOV 2025

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) – CLAUSES INCORPORATED BY REFERENCE:

This contract incorporates one or more HHSAR clauses by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

Clause No.

Clause Title

Date

352.203-70

Anti-Lobbying

DEC 2015

352.227-70

Publications and Publicity

DEC 2015

352.232-71

Electronic Submission of Payment Requests

DEVIATION DATE APR 2026

352.239-74

Electronic and Information Technology Accessibility

DEC 2015

6. Authorized Reseller / Servicing Agent

The contractor shall be the Original Equipment Manufacturer (OEM) or an authorized reseller and/or servicing agent of the software manufacturer.

7. INVOICING INSTRUCTIONS

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

If your company is already registered to use IPP, you will not be required to re-register.

If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

- Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

- Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

- Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

- Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

8. Government Points of Contact

Contracting Officer (CO)

Jesse Weidow

Jesse.Weidow@hhs.gov

Contract Specialist (CS)

Dorothy Fessler

Dorothy.Fessler@hhs.psc.gov

COR contact information will be provided on award.

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