Sol_75N98026Q00976.pdf

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National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q00976

JADDUA JOHNSTON

+10

000-000000

08/07/2026

08/24/2026 0800 ED

Multiple

The purpose of this COMPETITIVE COMBINED

SYNOPSIS / SOLICITATION is to acquire

Pharmacokinetic (PK) studies for

RXFP1-agonists

Period of Performance: 08/31/2026 to

08/30/2027

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 address:

HTTPS://ACQUISITION.GOV/FAR

Continued...

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OPTIONAL FORM 336 (4-86)

Sponsored by GSA FAR (48 CFR) 53.110

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NSN 7540-01-152-8067

75N98026Q00976

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award Management

Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government Entity

Code Maintenance (Aug 2020);

HHSAR 352.222-70, Contractor Cooperation in

Equal Employment Opportunity Investigations

(Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.212-5 Contract Terms and Conditions

Required to Implement Statutes or Executive

Orders/Commercial Products and Commercial

Services (Jan 2025)

FAR 52.217-8 Option to Extend Services (Nov

1999)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

Award enclosure:

Quote

Statement of Work

IPP Invoicing and Payment Provisions

To avoid delay in payment, all invoices must be uploaded into the invoicing processing platform

(IPP) (https://www.ipp.gov). The invoice must match the line item description on the purchase order. It must also state that payment is to be made using a three-way match.

You are reminded that only the contracting officer of record can make any changes to this award any changes made at the direction of the program without an executed modification and null and void and are done at the contractor's own risk.

COMBINED SYNOPSIS / SOLICITATION (COMPETITIVE)

Title: Pharmacokinetic (PK) studies for RXFP1-agonists

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q00976. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold (if applicable).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a (Firm-Fixed-Price) to the offeror responsible whose proposal represents the best value to the Government.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular effective August 7, 2026

(iv) The associated NAICS code is 541380 Testing Laboratories and Services, and the small business size standard is $19.0 million.

This requirement is unrestricted.

(v) Description of Requirement:

Period of Performance:

These are the last round of PK studies required to complete the project for publication. Turnaround time from contractor is estimated at 5 working days.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Male C57BL/6J mice

• Intraperitoneal administration (10 mg/kg)

• Four (4) test compounds

• Single-dose PK study

• n=3 animals per time point

• Eight (8) sampling time points

• Collection of plasma, lung, liver, and heart tissues

• Quantitative bioanalysis of drug concentrations in all matrices

• Calculation of standard pharmacokinetic parameters

• Delivery of electronic data files and final study report

Specific Requirements:

The Contractor shall perform PK studies in male C57BL/6J mice to determine systemic exposure and tissue distribution of four RXFP1 agonist compounds. Data generated under this study will be used to compare pharmacokinetic profiles with previously characterized lead compounds, including ML290, and support ongoing medicinal chemistry and publication efforts.

LEVEL OF EFFORT:

In vivo studies by specialist contractor with turnaround time of 5 working days.

GOVERNMENT RESPONSIBILITIES

No government-furnished data, property or facilities.

Data reports generated under the contract will be reviewed by Team Leader (PI) Dr. Juan Marugan within NCATS. No workspace, desktop computers and telephones will be provided for contractor personnel. No access will be required to government facilities.

DELIVERY OR DELIVERABLES

Raw concentration data for plasma and tissue samples.

Calculated pharmacokinetic parameters.

Electronic Excel data files.

Final study report summarizing methods, results, and PK analyses.

REPORTING REQUIREMENTS

Contractor will provide one report with the final results at the end of the study requested.

OTHER CONSIDERATIONS

Travel:

NA

Key Personnel:

Information System Security Plan:

Data Rights:

Governments will have the rights of disclosure upon the data provided from the studies.

Section 508—Electronic and Information Technology Standards:

NA

Publications and Publicity:

The contractor will not write and publish articles of data produced as a result of the requirements of the

SOW.

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.

The contract is expected to generate information or date which is confidential. The contractor should share the information or data only

(vi) Delivery Location:

NIH/NCATS- 9808 Medical Center Drive, Rockville, MD 20850

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any agency-specific instructions as required.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered.

(b) Evaluation Factors:

• Price

• Technical capability

• Past performance

• Delivery schedule

(c) A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable.

(xiv) Submission Requirements:

Responses must include sufficient information to demonstrate the offeror’s capability to provide the required product or service. Quotes shall include, at a minimum:

• Unit and total price

• Shipping and handling costs

• Delivery timeframe after award

• Delivery terms

• F.O.B. point (destination or origin)

• Product or catalog numbers (if applicable)

• Product/service description

Additional evaluation considerations may include past performance, warranty, lifecycle cost, maintenance availability, and environmental or energy efficiency.

Responses must include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by August 24, 8:00AM EST and must reference solicitation number 75N98026Q00976. Responses may be submitted electronically to Jaddua.Johnston@nih.gov

(xv) Point of Contact: Jaddua Johnston Contracting Specialist, Phone Number: 240-569-0006

Email: Jaddua.Johnston@nih.gov mailto:Jaddua.Johnston@nih.gov

Version 12-23-2025-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Pharmacokinetic (PK) studies for RXFP1-agonists

Statement of Need and Purpose:

The purpose of this requirement is to conduct pharmacokinetic (PK) studies in mice to determine plasma and tissue exposure levels of four RXFP1 agonist compounds following intraperitoneal administration.

The resulting PK data will support candidate prioritization, interpretation of structure-activity relationships, and completion of a medicinal chemistry manuscript describing the RXFP1 agonist series. Funding source: Account 8041779 – CRADA – NCATS Roche.

Background Information and Objective:

To address challenges associated with the discovery of effective RXFP1 small-molecule agonists, the project team developed complementary disease-relevant functional assays and integrated these data with medicinal chemistry optimization efforts. This approach enabled a systematic re-evaluation of the ML290 series and identification of compounds with improved biological activity and drug-like properties.

Additional PK studies are required to characterize systemic and tissue-specific exposure profiles in plasma, lung, liver, and heart tissues and to support final compound selection and publication activities.

Period of Performance:

These are the last round of PK studies required to complete the project for publication. Turnaround time from contractor is estimated at 5 working days.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Male C57BL/6J mice

• Intraperitoneal administration (10 mg/kg)

• Four (4) test compounds

• Single-dose PK study

• n=3 animals per time point

• Eight (8) sampling time points

• Collection of plasma, lung, liver, and heart tissues

• Quantitative bioanalysis of drug concentrations in all matrices

• Calculation of standard pharmacokinetic parameters

• Delivery of electronic data files and final study report

Specific Requirements:

The Contractor shall perform PK studies in male C57BL/6J mice to determine systemic exposure and tissue distribution of four RXFP1 agonist compounds. Data generated under this study will be used to compare pharmacokinetic profiles with previously characterized lead compounds, including ML290, and support ongoing medicinal chemistry and publication efforts.

LEVEL OF EFFORT:

In vivo studies by specialist contractor with turnaround time of 5 working days.

GOVERNMENT RESPONSIBILITIES

No government-furnished data, property or facilities.

Data reports generated under the contract will be reviewed by Team Leader (PI) Dr. Juan Marugan within NCATS. No workspace, desktop computers and telephones will be provided for contractor personnel. No access will be required to government facilities.

DELIVERY OR DELIVERABLES

Raw concentration data for plasma and tissue samples.

Calculated pharmacokinetic parameters.

Electronic Excel data files.

Final study report summarizing methods, results, and PK analyses.

REPORTING REQUIREMENTS

Contractor will provide one report with the final results at the end of the study requested.

OTHER CONSIDERATIONS

Travel:

NA

Key Personnel:

Information System Security Plan:

Data Rights:

Governments will have the rights of disclosure upon the data provided from the studies.

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

The contractor will not write and publish articles of data produced as a result of the requirements of the

SOW.

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.

The contract is expected to generate information or date which is confidential. The contractor should share the information or data only .

ATTACHMENTS

Instructions: Include the following attachments with all SOWs

1. Independent Government’s Cost Estimate

2. Market Research Document

3. Evaluation / Selection Criteria

Title