NOI-PCA-NIDA-09054.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

Notice of Intent to Sole Source Solicitation Number: NOI-PCA-NIDA-09054 Solicitation Type: Sole Source (Non-Competitive) Title: Pharmacogenomic Analysis of

Participants Enrolled in the STAR-B Randomized Clinical Trial of Semaglutide for Alcohol Use Disorder

NAICS / Size Standard: 541380/ $19 million

Introduction

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO

AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN

COMPETITION. The National Institute on Drug Abuse, Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Novogene Corporation, Inc.

to provide Human Whole Genome Sequencing services to the Division of Intramural Research in accordance with the following information.

Background Information

The Semaglutide Therapy for Alcohol Reduction - Baltimore (STAR-B) study is a randomized, placebo-controlled clinical trial evaluating semaglutide for the treatment of Alcohol Use Disorder (AUD). The study includes collection of biospecimens for pharmacogenomic analyses intended to identify genetic factors associated with treatment response, adverse events, alcohol-related outcomes, and relevant clinical phenotypes. The resulting data will support precision medicine approaches and improve understanding of the biological mechanisms underlying variability in treatment outcomes.

STAR-B was designed in coordination with the STAR-T study conducted at Oklahoma State University. The studies utilize harmonized protocols, outcome measures, and statistical analysis plans that include pooled and comparative analyses across studies.

Purpose and Objectives

The purpose of this acquisition is to acquire comprehensive genomic laboratory and bioinformatics services for pharmacogenomic analysis of biospecimens collected from STAR-B participants.

Contractor Requirements

The Contractor shall:

1. Receive and process biospecimens supplied by the Government.

2. Perform DNA extraction (if required).

3. Conduct quality control assessment of DNA quantity and integrity.

4. Perform genome-wide genotyping and/or sequencing as specified by the Government.

5. Generate raw and processed genomic data files.

6. Conduct standard bioinformatic processing and quality-control procedures.

7. Deliver data and associated documentation to the Government.

8. Maintain chain-of-custody and sample-tracking documentation throughout the project.

Sole Source Justification

For this requirement, the Government has determined that Novogene Corporation Inc. is the only source available to satisfy the Government's complete scientific requirement without introducing an unacceptable methodological variable into two harmonized clinical trials.

The NIDA Intramural Research Program (NIDA IRP) and the Oklahoma State University Center for Health Sciences (OSU-CHS) are conducting two harmonized clinical trials evaluating semaglutide for alcohol reduction:

• STAR-B – Semaglutide Therapy for Alcohol Reduction – Baltimore, conducted through the NIDA Intramural Research Program; and

• STAR-T – Semaglutide Therapy for Alcohol Reduction – Tulsa, conducted through the Oklahoma State University Center for Health Sciences.

The STAR-B and STAR-T studies have been intentionally designed as harmonized clinical trials. Maintaining consistency in the methods used to generate and analyze data is necessary to permit scientifically valid comparison, integration, and interpretation of results across the two studies.

The Oklahoma State University Center for Health Sciences utilizes Novogene Corporation Inc. for the genomic analysis services associated with the STAR-T study. To preserve the harmonized research design, the corresponding STAR-B genomic services conducted through the NIDA Intramural Research Program must utilize the same provider and consistent analytical methodology.

Regulatory Authority

Pursuant to Revolutionary FAR Overhaul (RFO) FAR 12.102(a), for an acquisition valued at or below the Simplified Acquisition Threshold, the Government must document a decision that only one source is available and the basis for that decision when restricting competition.

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

http://www.acquisition.gov/

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. FAR clause at 52.204-13 System for Award Management Maintenance, applies to this acquisition.

The provisions at FAR clause 52.203-17, Contractor Employee Whistleblower Rights, applies to this acquisition.

The provisions at FAR clause 52.222-41, Service Contract Labor Standards, applies to this acquisition.

The provision at FAR clause 52.225-25, Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications, applies to this acquisition.

FAR clause FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, applies to this acquisition.

HHSAR clause 352.239-78, Information and Communication Technology Accessibility Notice HHSAR clause

352.239-79, Information and Communication Technology Accessibility

HHSAR clause 352.232-71, Electronic Submission of Payment Requests

Additional Information

The North American Industry Classification System (NAICS) Code is 541380 and the Small Business Size Standard is $19 million. This acquisition is being conducted under RFO FAR Part 12, Acquisition of Commercial Products and Commercial Services, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026.

This notice is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B.

Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by September 15, 2026, at 3:00PM ED and must reference NOI-PCA-NIDA- 09054. Responses shall be submitted electronically to zachary.fetters@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:zachary.fetters@nih.gov.