INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institutes of Health, 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 to Bioqual, Inc., 4 Research Ct Ste 100, Rockville, Maryland 20850 University of Bristol, Barley House, Oakfield Grove, Bristol BS8 2BN for Nipamovir in vivo study in rhesus macaques. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $15.0 REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2005-98 effective 19 Jan 2017. 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 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE This is a request for a preclinical test service that is anticipated to run from September 2018 to December 2019. The preclinical development is dependent on biological experimentation that is not concurrent with the appropriations calendar and fiscal year of the federal government. Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892 United States DESCRIPTION OF REQUIREMENT 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 work has been done to select candidates that show early promise to move forward as drug candidates. The company, Bioqual has worked successfully with the above laboratory on a previous requirement. The previous work established protocols for the required in vivo research tasks of the NIDDK proposal. While these involve use of components within Bioqual's programs, the results cannot be considered as off-the-shelf deliverables. The tasks that have been successfully performed and optimized by Bioqual staff in Bioqual facilities are a foundation for the preclinical development of the most attractive drug candidate. The Food and Drug Administration (FDA) requires a data package be compiled and submitted before and Investigative New Drug (IND) can be approved. An IND is required to more a drug to clinical trials. Bioqual is experienced with the required research and the subsequent production of technical reports that to be utilized in IND submissions to the FDA. Proposed project will be to continue and expand the prior experiments and the in vivo performance of a new drug candidate that is designed to inactivate HIV. The animal studies are the next item in the critical pathway to assembling a regulatory data package for submission to the FDA. Bioqual will next need to perform detailed mechanism-based studies in non-human primates (NHP) infected with SIV, the monkey version of HIV. Animals receiving the drug will be monitored for changes in viral load and evidence of toxicity from the compound. Task Area 1 Contractor to discuss and define experimental design with NIDDK Investigator for in vivo administration of test and co-administered and control drug. Contractor and Investigator will determine type of data to be collected and frequency such as: number of monkeys, weights, age, viral load, and any other measurements to be made before, during, and after project; instructions for preparation and use of drug, storage of dry drug, use of drug solution, etc. Contractor to prepare and provide written protocol for NIDDK signature of acceptance. Task Area 2 Contractor shall acquire and maintain monkeys that meet the requirements of Task1. Contractor will receive from NIDDK Investigator active pharmaceutical ingredient (API) in sufficient quantity to meet the experimental design of Task 1 and all relevant handling instructions Task Area 3 Contractor shall prepare and administer drug to monkeys infected with SIV per the test protocol of Task 1, collect necessary samples, take and record all required measurements and communicate any concerns regarding drug (e.g. changes in physical properties of dry compound or dispersion) or animal health to investigator as soon as practicable. Task Area 4 At interval of 2 weeks, Contractor shall prepare and provide oral status report for discussion with and comments by NIDDK Investigator. Task Area 5 At termination of experiments, Contractor shall prepare and provide draft written report for review by NIDDK Investigator. Task Area 6 Following review and discussion of results by Investigator and Contractor, Contractor shall prepare and provide final written study report including the interpretation of in vivo test results. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), 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 shall be submitted electronically by 11:00AM Eastern Standard Time, on Tuesday, August 31, 2018 to
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