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 (NIH), CLINICAL CENTER (CC), OFFICE OF PURCHASING AND CONTRACTS (OPC) ON BEHALF OF THE NURSING DEPARTMENT, CLINICAL CENTER (CC) AT THE NATIONAL INSTITUTES OF HEALTH (NIH) INTENDS TO NEGOTIATE AND AWARD A CONTRACT WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION TO METABOLON NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE THE INTENDED PROCUREMENT IS CLASSIFIED UNDER NAICS CODE 541712 WITH A SIZE STANDARD OF 1,000 NUMBER OF EMPLOYEES. REGULATORY AUTHORITY THE RESULTANT CONTRACT WILL INCLUDE ALL APPLICABLE PROVISIONS AND CLAUSES IN EFFECT THROUGH THE FEDERAL ACQUISITION CIRCULAR (FAC) 2005-95-1, JANUARY 19, 2017 THIS ACQUISITION IS CONDUCTED UNDER THE PROCEDURES AS PRESCRIBED IN FAR SUBPART 13.106-1 SIMPLIFIED ACQUISITION PROCEDURES. 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-SIMPLIFEID ACQUISITION PROCEDURES ARE EXEMPT FROM THE REQUIREMENTS OF FAR PART 6-COMPETITION REQUIREMENTS. GENERAL INFORMATION 1. TITLE- ANALYSIS ENDOTOXIN BLOOD SAMPLE ANALYSIS 2. BACKGROUND INFORMATION: THE CLINICAL CENTER AT THE NATIONAL INSTITUTES OF HEALTH (NIH) IN BETHESDA, MARYLAND, IS THE NATION'S LARGEST HOSPITAL DEVOTED ENTIRELY CLINICAL RESEARCH. IT IS A NATIONAL RESOURCE THAT MAKES IT POSSIBLE TO RAPIDLY TRANSLATE SCIENTIFIC OBSERVATIONS AND LABORATORY DISCOVERIES INTO NEW APPROACHES FOR DIAGNOSING, TREATING, AND PREVENTING DISEASE. APPROXIMATELY 1,500 STUDIES ARE IN PROGRESS AT THE NIH CLINICAL CENTER. APPROXIMATELY, HALF OF THE STUDIES ARE THE FIRST TESTS OF NEW DRUGS OR MEDICAL TREATMENTS IN HUMANS. THE REST ARE NATURAL HISTORY STUDIES WHICH INCLUDE MANY RARE DISEASES. THESE LONG-TERM STUDIES LEAD TO A BETTER UNDERSTANDING OF HOW DISEASES DEVELOP AND RESULT IN IMPROVEMENTS IN PREVENTION AND TREATMENT. 3. PURPOSE OR OBJECTIVE: CLINICAL CENTER HAS A CLINICAL SUPPORT TEAM TO ADDRESS A BOARD VARIETY OF ROUTINE MEDICAL ISSUES THAT MAY ARISE DURING A COURSE OF TREATMENT. CRITICAL CARE MEDICINE DEPARTMENT IS NEEDED A SERVICE TO OBTAIN ANALYSIS OF THE METABOLOMIC RESPONSE IN SERUM FROM HUMAN VOLUNTEERS WHO HAVE BEEN CHALLENGED WITH INTRAVENOUS ENDOXTOXIN . THIS SAMPLES ARE UNIQUE AS THEY REFLECT A PHASE 1 STUDY .THE DATA WILL PROVIDE UNIQUE INFORMATION THAT REFLECT THE INITIAL RESPONSE OF HUMANS . 4. DELIVERY DATE: AFTER CONTRACT AWARD. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Vendor will provide global metabolomic profiling of 161 human plasma samples by the following methods: • VENDOR SHALL BE ABLE TO SURVEY A WIDE RANGE OF VERY POLAR TO NON-POLAR COMPOUNDS (TYPICALLY 400-1000) EXTRACTED FROM AS LITTLE AS 50 ΜL OF BIOFLUID (HUMAN PLASMA). • EXTRACTED SAMPLES ARE TO BE SPLIT INTO FIVE ALIQUOTS FOR DIFFERENT CHROMATOGRAPHY AND MS PLATFORMS, THREE UHPLC-MS METHODS AND ONE HYDROPHILIC INTERACTION CHROMATOGRAPHY (HILIC)-MS, WITH ONE ALIQUOT HELD IN RESERVE; LC-MS SAMPLES ARE SPIKED WITH 11 STANDARDS AT KNOWN CONCENTRATIONS. • THESE FOUR CHROMATOGRAPHY AND MS SYSTEMS COMPLEMENT EACH OTHER IN THE RANGE OF BIOCHEMICALS MEASURED, PROVIDING BROAD COVERAGE OF METABOLIC SPACE WITHIN EACH SAMPLE. • FOR COMPOUNDS OBSERVED ON MULTIPLE PLATFORMS, THE PLATFORM WITH THE BEST ANALYTICAL CHARACTERISTICS (E.G. FEWEST INTERFERING PEAKS OR HIGHEST SIGNAL TO NOISE) IS TO BE GENERALLY USED FOR THE ANALYSIS OF THAT COMPOUND. • VENDOR SHALL HAVE A SPECTRAL LIBRARY OF OVER 4100 STANDARD AUTHENTIC METABOLITES AND OVER 7000 -UNNAMED PREVIOUSLY OBSERVED METABOLITES. • VENDOR MUST PROVIDE A SUITE OF SOFTWARE PACKAGES TO AUTOMATICALLY INTEGRATE EACH ION ACROSS RETENTION TIME AND THEN USES THAT IONIC INFORMATION, WHICH MAY INCLUDE ADDITIONAL MS/MS FRAGMENTATION INFORMATION AND RETENTION TIME, TO IDENTIFY THE COMPOUND. AFTER A COMPOUND IS IDENTIFIED IN A SAMPLE, ONE OF THE CHARACTERISTIC AND HIGHER ABUNDANCE IONS IS USED TO DETERMINE A RELATIVE CONCENTRATION OF THAT COMPOUND IN EACH SAMPLE. DAY TO DAY INSTRUMENT VARIATION CAN BE ADDRESSED THROUGH SIMPLE SCALING OF MULTIDAY MEANS, BUT REQUIRES THE SAMPLES TO BE RANDOMIZED ACROSS THE RUN DAYS FOR EACH EXPERIMENT. • OTHER QC STEPS INCLUDE ADDITION OF AN INTERNAL STANDARD (HUMAN PLASMA), A PURE WATER BLANK, AND A SOLVENT BLANK FOR EACH ASSAY PLATE. FINALLY, WHEN THE SOFTWARE HAS FINISHED ANALYZING THE SAMPLE, ALL OF THE DATA IS LOADED INTO A VISUAL USER INTERFACE THAT ALLOWS CURATION OF THE DATA FOR QC PURPOSES, LEADING TO INCLUSION OF ONLY THOSE COMPOUNDS WITH THE HIGHEST DEGREE OF CONFIDENCE IN THE FINAL DATA SET. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION THE INTENDED SOLE SOURCE IS THE ONLY KNOWN SOURCE TO MEET THE TECHNICAL NEEDS OF THE CONSULTATION SERVICES. 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. 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 A TECHNICAL PROPOSAL, A COST-PRICE PROPOSAL, THE PERIOD OF PERFORMANCE, 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 MUST BE RECEIVED BY JULY 10, 2017, 12:00 PM EASTERN TIME AND MUST REFERENCE SOLICITATION NUMBER 17-012086. RESPONSES MAY BE SUBMITTED ELECTRONICALLY TO PRISCILLA ABALOS CONTRACTING SPECIALIST AT
[email protected] FAX RESPONSES WILL NOT BE ACCEPTED. "ALL RESPONSIBLE SOURCES MAY SUBMIT A CAPABILITY STATEMENT, PROPOSAL, OR QUOTATION, WHICH SHALL BE CONSIDERED BY THE AGENCY."