Mouse Asexual Blood Stage Malaria Model Service

INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisitions on behalf of the National Center for Advancing Translational Sciences intends to negotiate and award a contract for Mouse Asexual Blood Stage Malaria Model Services. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 - Testing Laboratories with a Size Standard of 15.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-99, dated June 15, 2018. STATUTORY AUTHORITY This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 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. DESCRIPTION OF REQUIREMENT Project Description Project Title: Mouse Asexual Blood Stage Malaria Model Service Background Information and Statement of Need Malaria affects an estimated 250 million people worldwide, particularly in the tropical regions of Sub-Saharan Africa, and approximately 650,000 patients die each year. Even while on current therapies, patients remain infectious for a period of time, allowing further mosquito-borne transmission to others. Control of parasite transmission is critical for elimination and eradication of malaria. However, most antimalarial drugs are not active against sexual stage P. falciparum parasites-called gametocytes-which are responsible for the spread of malaria from person-to-person via mosquitoes. Torin2 was identified as a lead molecule in a new class of gametocytocidal antimalarial drugs. As part of a lead optimization program, researchers are using a gametocyte viability assay, an asexual stage parasite assay, malaria asexual animal testing, gametocyte animal testing, liver stage animal testing, and non-human primates testing to optimize the Torin2 series and advance a drug candidate through pre-clinical development and early clinical development. The scope of work for this acquisition is for mouse asexual blood stage malaria model service. The service will measure efficacy and acute toxicity of Torin2 analogs on a quarterly basis. Period of Performance The period of performance for this acquisition is twenty-four months starting upon award. Requirements Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to complete the below requirements. This acquisition is for services to measure the survivability of mice and parasite clearance following administration of drug either once on day 2 post infection, once a day on days 2 and 3 post infection, or once a day on days 2, 3, and 4 post infection. Each time the service is performed, positive control (chloroquine) with 5 mice, vehicle control with 5 mice, and 10 indicated unknown compounds (5 mice each group for unknown compounds) must be tested for a total of 12 groups. In addition: 1. The positive control group of 5 mice must be treated with chloroquine p.o. on day 2 and day 3; the negative control group with 5 mice will be treated with vehicle on day 2 and day 3. The remaining 10 groups (5 mice in each group) must be individually treated with 10 unknown compounds p.o. (Dosages for unknown compounds will be determined by the Government before the start date of each service). 2. At day 0, 5X106 P. berghei-infected erythrocytes (ANKA strain) must be inoculated into the intraperitoneal cavity of mice that weigh 24 to 30 g. Animals must be separated randomly into 12 groups including positive and negative control groups. 3. At day 2 after infection, tail blood samples must be taken for determination of parasitemia (it must be >3%) before oral administration of test compounds at a volume of 10 ml/kg body weight. 4. Each group of mice must receive the first dose of test compound after determination of parasitemia on day 2 after infection. Optionally, a second dose of drug would be delivered on day 3, 24 h after the first dose. Optionally, a third dose would be delivered on day 4, 48 h after the first dose (depending on PK and efficacy of unknown compounds, single, two or three-day dosage for unknown compounds may be specified by the Government ahead of each service). Tail blood samples for determination of parasitemia will be taken on days 3, 5, and 7 post infection. If the parasitemia is between 0.5% and 3% on day 3 post infection then an additional blood smear should be performed on day 4. After the 7th day, blood smears should be taken biweekly for 31 days. Mice that are blood film negative on day 31 post infection are considered cured. Compounds are considered active when the survival time of the treated mice is greater than twice that of the control mice (i.e., 12 to 14 days). 5. Plasma of selected mice on selected days in the ten tested groups will be collected at time points TBD by the Government and the frozen samples will be sent to the Government for PK analysis. Final Report This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. This report shall be submitted on or before contract expiration. Options This acquisition includes seven option quantities for seven additional iterations of the study described above in the Requirements section of this Statement of Work. Pursuant to FAR 52.217-6 Option for Increased Quantity, the Government may, by unilateral contract modification, require the Contractor to perform the option quantities specified below. Study Period of Performance Price ($) Study 1 - Base Award 24-months from date of base award To be proposed Study 2 - Option Quantity 1 24-months from date of base award To be proposed Study 3 - Option Quantity 2 24-months from date of base award To be proposed Study 4 - Option Quantity 3 24-months from date of base award To be proposed Study 5 - Option Quantity 4 24-months from date of base award To be proposed Study 6 - Option Quantity 5 24-months from date of base award To be proposed Study 7 - Option Quantity 6 24-months from date of base award To be proposed Study 8 - Option Quantity 7 24-months from date of base award To be proposed If the option quantity is exercised, the additional study does not lengthen the period of performance; instead the additional study must be completed within the twenty-four-month period of performance. 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 must include clear and convincing evidence of the offeror's capability of fulfilling the agency's need. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. 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 Tuesday, August 28, 2018 at 2:00 PM Eastern Time and must reference number NIHDA201800471. Responses must be submitted electronically to Jeffrey Schmidt, contact@example.gov, and must reference the solicitation number NIHDA201800471, on your electronic request. FAX requests are not accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."