NOTICE OF INTENT_ NICHD-23-118.pdf

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FULL OR OPEN COMPETITION. The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition (Including brand-name) to Frontage Laboratories, 700 Pennsylvania Drive | Exton, PA 19341 to procure Antiviral Rat Molecule Study.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard 1000.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2023-02 effective 3/16/2023. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6— Competition Requirements.

Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States

DESCRIPTION OF REQUIREMENT

This requirement is to provide research to advance the testing of a new class of antiviral molecules. Results from each set of tests done are added to the file that will eventually be submitted as the Investigative New Drug Application. The continuity of the project is enhanced using as few CRO’s as possible.

Chemists in the NIDDK Synthetic Bioactive Molecules Section, Laboratory of Bioorganic Chemistry have designed and synthesized a series of compounds that are targeted to disrupt the zinc finger assembly of the HIV nucleocapsid protein 7 (NCp7). This family of molecules operates by a different mechanism than any approved drug used to treat HIV viral infections. Substantial in vitro

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

work has been done to select candidates that show early promise to move forward as drug candidates.

REQUIRED FEATURES AND SPECIFICATIONS

Follow confidential protocols from the NIDDK lab and provide written documentation of all deviations from established protocols. Experience in studying drug metabolism and compliance with FDA requirements and drug development protocols is required. Final reports must be delivered with all data and protocols clearly written and summarized. Obtaining this service will allow the NIDDK lab to pursue advanced experiments without needing to continually repeat established protocols repeatedly.

The study services must include:

Study whether there is reproductive toxicity of SAMT-247 molecule;

Dose female rats with SAMT-247 formulated in gel, observe clinical signs;

Mate untreated males with treated females and control group females;

Examine any effects of offspring because of SAMT-247 treatment.

TASK AREAS

Task Area 1 – Molecule Delivery – The Contractor shall utilize the NIDDK provided molecules for these studies. NIDDK will provide antiviral molecule(s) under confidentiality for the proposed reproductive studies.

Task Area 2 – Final Report – The Contractor shall perform reproductive studies, followed by delivery of final analysis and protocol report.

Task Area 2.1 – Reproductive Rat Study – The Contractor shall perform reproductive study in rats to provide:

Measuring reproductive performance study in rats Mate untreated males with treated females, observe whether there are clinical signs in offspring because of treated females.

Observe all clinical signs and provide final report. Detailed data for clinical signs and categories for reporting to be provided to Contractor upon award. Data to be provided in excel file (includes experimental details, results, and summary).

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined that Frontage has developed proprietary analytical expertise to study the target molecules that other companies/contractors will not have access to.

The incumbent company, Frontage, is a full-service contract research organization (CRO) fully familiar with the technical documentation required by the Food and Drug Administration (FDA).

Frontage was originally recommended by the toxicologists at NCATS who work on the drug development program for orphan diseases. This is a follow-on contract NIDDK worked successfully with the company on a previous contract. It is important to continue with the same vendor to avoid issues with the consistency of data to be submitted to the FDA. The next round of tests on derivatives of the parent molecule will require expertise with SAMT-247, to determine whether there is any improvement in activity.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, 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 Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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 to this notice (NICHD-23-118) shall be submitted electronically by 11:00 AM Eastern Standard Time, on May 1, 2023.

Assessment of Capability The contractor will be evaluated on their capability to provide the product to the specifications as stated on the solicitation.

http://www.sam.gov/