Sol_75N98026Q00989.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

75N98026Q00989

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

Maximum Tolerated Dose (MTD) Evaluation of PIP4Kgamma Lead Compound NCGC00592266 in Mice

Period of Performance: 09/04/2026 to

10/30/2026

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:

Continued...

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NSN 7540-01-152-8067

75N98026Q00989

HTTPS://ACQUISITION.GOV/FAR

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: Maximum Tolerated Dose (MTD) Evaluation of PIP4Kgamma Lead Compound NCGC00592266 in Mice.

(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 75N98026Q00989. 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 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) and the small business size standard is 1000 employees.

This requirement is unrestricted.

(v) Description of Requirement:

Period of Performance:

Documentation of results and presentation of findings to NCATS via email and conference calls by the vendor over approximately a 1-month period following receipt of the purchase order and initiation of the study.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment, animals, and facilities required to perform the work described below.

Specific Requirements:

The Contractor shall conduct a non-GLP maximum tolerated dose (MTD) study of NCGC00592266 in CD- 1 SPF mice. The study will include five dose groups with 3 male and 3 female mice per group (n = 30 total animals). The compound will be administered by intraperitoneal (IP) injection once at each dose level.

Dose levels will be determined in consultation with NCATS prior to study initiation.

The Contractor shall perform:

• Animal acclimation and veterinary supervision

• Dose formulation preparation prior to dosing

• Clinical and cage-side observations

• Post-dose monitoring

• Body weight monitoring

• Necropsy and tissue preservation for animals found dead or moribund

• Preparation of a standard non-GLP study report

The Contractor will notify NCATS of any significant toxicity observations during the study.

LEVEL OF EFFORT:

Estimated level of effort:

• 1 PhD-level Study Director

• 1 Scientist

• Technical and animal care staff as required

• Estimated study duration: approximately 3 weeks in-life phase plus reporting period

GOVERNMENT RESPONSIBILITIES

NCATS will provide:

• Required quantity of NCGC00592266

• Relevant compound handling and formulation information

• Technical consultation as needed during study conduct.

DELIVERY OR DELIVERABLES

The Contractor shall provide:

1. Standard non-GLP MTD study report

2. Summary of clinical observations and tolerability findings

3. Body weight data

4. Mortality and toxicity observations

5. Necropsy findings for animals requiring tissue preservation o Final report delivered electronically to: Tej Poudel (tej.poudel@nih.gov) and Juan

Marugan (maruganj@mail.nih.gov)

REPORTING REQUIREMENTS

Progress updates shall be provided by email as needed during study execution. A final study report shall be submitted upon completion of the study.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Information System Security Plan:

Data Rights:

All data generated under this study shall be considered confidential and the property of the U.S.

Government.

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Data will not be published without permission of the government

Confidentiality of Information:

Data will be kept confidential

(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 75N98026Q00989. 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 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Maximum Tolerated Dose (MTD) Evaluation of PIP4Kgamma Lead Compound NCGC00592266 in Mice.

Statement of Need and Purpose:

This purchase order supports a non-GLP maximum tolerated dose (MTD) study of the PIP4Kgamma lead compound NCGC00592266 in CD-1 mice following intraperitoneal (IP) administration. The study will evaluate tolerability, clinical observations, and dose-related toxicity across multiple dose levels to support selection of safe and effective dose ranges for future pharmacokinetic and efficacy studies. Data generated from this study will support advancement of NCGC00592266 into further preclinical development.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability through biomedical research.

The National Center for Advancing Translational Sciences (NCATS), Early Translation Branch, is part of NIH and focuses on accelerating the development and implementation of diagnostics and therapeutics across a broad range of diseases and conditions.

PIP4Kgamma (phosphatidylinositol-5-phosphate 4-kinase gamma) is a lipid kinase involved in phosphoinositide signaling and regulation of cellular processes including membrane trafficking, autophagy, and metabolic homeostasis. Because PIP4Kgamma is enriched in the central nervous system, it represents a promising therapeutic target for neurological and metabolic disorders. The lead compound NCGC00592266 is being advanced to evaluate its safety, pharmacological properties, and in vivo tolerability to support continued preclinical development.

Period of Performance:

Documentation of results and presentation of findings to NCATS via email and conference calls by the vendor over approximately a 1-month period following receipt of the purchase order and initiation of the study.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment, animals, and facilities required to perform the work described below.

Specific Requirements:

The Contractor shall conduct a non-GLP maximum tolerated dose (MTD) study of NCGC00592266 in CD- 1 SPF mice. The study will include five dose groups with 3 male and 3 female mice per group (n = 30 total animals). The compound will be administered by intraperitoneal (IP) injection once at each dose level.

Dose levels will be determined in consultation with NCATS prior to study initiation.

The Contractor shall perform:

• Animal acclimation and veterinary supervision

• Dose formulation preparation prior to dosing

• Clinical and cage-side observations

• Post-dose monitoring

• Body weight monitoring

• Necropsy and tissue preservation for animals found dead or moribund

• Preparation of a standard non-GLP study report

The Contractor will notify NCATS of any significant toxicity observations during the study.

LEVEL OF EFFORT:

Estimated level of effort:

• 1 PhD-level Study Director

• 1 Scientist

• Technical and animal care staff as required

• Estimated study duration: approximately 3 weeks in-life phase plus reporting period

GOVERNMENT RESPONSIBILITIES

NCATS will provide:

• Required quantity of NCGC00592266

• Relevant compound handling and formulation information

• Technical consultation as needed during study conduct.

DELIVERY OR DELIVERABLES

The Contractor shall provide:

1. Standard non-GLP MTD study report

2. Summary of clinical observations and tolerability findings

3. Body weight data

4. Mortality and toxicity observations

5. Necropsy findings for animals requiring tissue preservation o Final report delivered electronically to: Tej Poudel (tej.poudel@nih.gov) and Juan Marugan (maruganj@mail.nih.gov)

REPORTING REQUIREMENTS

Progress updates shall be provided by email as needed during study execution. A final study report shall be submitted upon completion of the study.

OTHER CONSIDERATIONS

Travel:

Key Personnel:

Information System Security Plan:

Data Rights:

All data generated under this study shall be considered confidential and the property of the U.S.

Government.

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Data will not be published without permission of the government

Confidentiality of Information:

Data will be kept confidential

ATTACHMENTS

Title