Sol_75N98026Q00993.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

75N98026Q00993

JADDUA JOHNSTON

+10

000-000000

08/08/2026

08/24/2026 0800 ED

Multiple

The purpose of this COMPETITIVE COMBINED

SYNOPSIS / SOLICITATION is to acquire mouse PK/PD Study Services for NNMT

Inhibitors

Period of Performance: 09/04/2026 to

12/03/2026

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:

HTTPS://ACQUISITION.GOV/FAR

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NSN 7540-01-152-8067

75N98026Q00993

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: Mouse PK/PD Study Services for NNMT Inhibitors

(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 75N98026Q00993. 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:

The period of performance shall be up to three (3) months from receipt of the purchase order. Final study results shall be provided to NCATS by email upon study completion, with the final study report delivered within three (3) weeks after completion of the study.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all personnel, materials, equipment, laboratory resources, supplies, facilities, and other resources necessary to perform the services described in this Statement of Work, except for those items specifically identified as Government-furnished.

All work shall be conducted independently by the Contractor using its established standard operating procedures, validated or fit-for-purpose analytical methods, quality systems, and routine study workflows.

Specific Requirements:

The Contractor shall provide commercially available nonclinical study services necessary to complete the required mouse PK/PD studies, including animal handling, dosing, biological sample collection, bioanalytical testing, pharmacokinetic analysis, data management, and reporting.

1. Study Design o Single-dose mouse study for each of 8+2=10 test articles o Routes of administration: IV and PO o Dose levels: predefined by NCATS o Sample size: n=3 mice per time point

2. Sample Collection o Plasma collection at specified time intervals.

3. Bioanalysis o Quantitation of parent compound in plasma o Quantitation of 1-MNA in plasma o Analysis to be performed using the Contractor’s established, fit-for-purpose bioanalytical methods

4. Data and Reporting o Plasma concentration-versus-time tables and curves o Standard PK parameters, as applicable, from IV and PO data o Summary of plasma 1-MNA results over time o Final report in Excel and/or PDF format

Test Articles: 10 compounds to be supplied by NCATS: 8 will be for monitoring parent only and 2 where we will monitor parent and 1-methylnicotinamide.

LEVEL OF EFFORT:

The Contractor shall provide the personnel, equipment, laboratory resources, and facilities necessary to complete the required services within the specified period of performance.

GOVERNMENT RESPONSIBILITIES

NCATS will provide the ten NNMT inhibitor test articles, dosing information, compound handling instructions, and technical points of contact for study coordination.

DELIVERY OR DELIVERABLES

The Contractor shall provide the following deliverables:

1. Plasma concentration data for test article and 1-MNA

2. Concentration-versus-time tables and curves

3. Calculated PK parameters

4. Final study report summarizing methods, results, and data outputs

Results shall be sent by email to the designated NCATS points of contact.

REPORTING REQUIREMENTS

The Contractor shall provide the final study report within three (3) weeks after completion of the study. All work shall be completed within the period of performance.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

N/A

Information System Security Plan:

N/A

Data Rights:

All data generated under this order shall be considered confidential and the property of the Government.

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

Data generated under this order shall not be published without prior written permission of the Government.

Confidentiality of Information:

The Contractor shall maintain the confidentiality of all Government-furnished information and all data generated under this order.

(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 75N98026Q00993. 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:

Mouse PK/PD Study Services for NNMT Inhibitors

Statement of Need and Purpose:

NCATS requires commercially available, fee-for-service mouse pharmacokinetic/ pharmacodynamic (PK/PD) study services to evaluate nicotinamide N-methyltransferase (NNMT) inhibitor test articles. The Contractor shall perform single-dose oral (PO) and intravenous (IV) studies in mice using Government-defined dose levels and collect biological samples at predefined time points. The Contractor shall quantify concentrations of the test article and 1-methyl nicotinamide (1-MNA) using established bioanalytical methods, calculate standard pharmacokinetic (PK) parameters, and provide the resulting data and final study report.

The purpose of this acquisition is to obtain standardized in vivo PK/PD data to compare systemic exposure and plasma 1-MNA suppression across three Government-supplied NNMT inhibitor test articles using commercially available laboratory capabilities and established study methodologies.

Background Information and Objective:

NCATS requires commercially available mouse PK/PD study services to support comparative evaluation of NNMT inhibitor test articles. This effort is limited to the performance of established in vivo dosing, biological sample collection, bioanalytical testing, pharmacokinetic analysis, and reporting services. The objective is to generate standardized PK and PD data that support comparison of systemic exposure and pharmacodynamic response following single-dose IV and PO administration.

Period of Performance:

The period of performance shall be up to three (3) months from receipt of the purchase order.

Final study results shall be provided to NCATS by email upon study completion, with the final study report delivered within three (3) weeks after completion of the study.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all personnel, materials, equipment, laboratory resources, supplies, facilities, and other resources necessary to perform the services described in this Statement of Work, except for those items specifically identified as Government-furnished.

All work shall be conducted independently by the Contractor using its established standard operating procedures, validated or fit-for-purpose analytical methods, quality systems, and routine study workflows.

Specific Requirements:

The Contractor shall provide commercially available nonclinical study services necessary to complete the required mouse PK/PD studies, including animal handling, dosing, biological sample collection, bioanalytical testing, pharmacokinetic analysis, data management, and reporting.

1. Study Design o Single-dose mouse study for each of 8+2=10 test articles o Routes of administration: IV and PO o Dose levels: predefined by NCATS o Sample size: n=3 mice per time point

2. Sample Collection o Plasma collection at specified time intervals.

3. Bioanalysis o Quantitation of parent compound in plasma o Quantitation of 1-MNA in plasma o Analysis to be performed using the Contractor’s established, fit-for-purpose bioanalytical methods

4. Data and Reporting o Plasma concentration-versus-time tables and curves o Standard PK parameters, as applicable, from IV and PO data o Summary of plasma 1-MNA results over time o Final report in Excel and/or PDF format

Test Articles: 10 compounds to be supplied by NCATS: 8 will be for monitoring parent only and 2 where we will monitor parent and 1-methylnicotinamide.

LEVEL OF EFFORT:

The Contractor shall provide the personnel, equipment, laboratory resources, and facilities necessary to complete the required services within the specified period of performance.

GOVERNMENT RESPONSIBILITIES

NCATS will provide the ten NNMT inhibitor test articles, dosing information, compound handling instructions, and technical points of contact for study coordination.

DELIVERY OR DELIVERABLES

The Contractor shall provide the following deliverables:

1. Plasma concentration data for test article and 1-MNA

2. Concentration-versus-time tables and curves

3. Calculated PK parameters

4. Final study report summarizing methods, results, and data outputs Results shall be sent by email to the designated NCATS points of contact.

REPORTING REQUIREMENTS

The Contractor shall provide the final study report within three (3) weeks after completion of the study. All work shall be completed within the period of performance.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

N/A

Information System Security Plan:

N/A

Data Rights:

All data generated under this order shall be considered confidential and the property of the Government.

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

Data generated under this order shall not be published without prior written permission of the Government.

Confidentiality of Information:

The Contractor shall maintain the confidentiality of all Government-furnished information and all data generated under this order.

ATTACHMENTS

Title

The Contractor shall maintain the confidentiality of all Government-furnished information and all data generated under this order.

The Contractor shall maintain the confidentiality of all Government-furnished information and all data generated under this order.