Inactive

****Amendment 1 containing Q&A is issued: Statement of Work, dated 29 June 2020, is deleted. Statement of Work, dated 02 July 2020, is added. ****** 1. Background The FDA receives Investigational New ... ****Amendment 1 containing Q&A is issued: Statement of Work, dated 29 June 2020, is deleted. Statement of Work, dated 02 July 2020, is added. ****** 1. Background The FDA receives Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions 5from sponsors. Within these submissions’ sponsors include clinical pharmacology and pharmacometric data (PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation) output from Phoenix Quantum. These data must be independently analyzed and verified by Office of Clinical Pharmacology reviewers and pharmacometricians. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses. This software is essential to the review of sponsor submissions. These reviews are on strict schedules with timelines that must be met per the various user fee acts governing such work (Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Mission-critical functions. These activities have a direct impact on public health. 2. Objective The FDA’s objective is to obtain the annual Phoenix Quantum software licenses, brand name or equal, to allow Office of Clinical Pharmacology drug reviewers to complete the review of INDs, NDAs, BLAs, ANDAs, and other submissions from sponsors, the primary role of the Office. 3. Instructions to Quoters This solicitation is issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. Quoters shall certify their quotes to be valid for at least 30 days. Quoters shall be Original Equipment Manufacturers, authorized resellers and/or servicing agents of the software manufacturer. Quoters should ensure that all information is provided to determine technical acceptability and that their initial submission represents their best pricing. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation. Quotations must meet all the requirements of this solicitation in order to be considered technically acceptable. Quoters shall submit all assumptions in their quotation. All Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Please submit questions to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by July 1, 2020, 5PM Eastern Time. Please submit quotes to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by 9 July, 2020, 12PM Eastern Time. 4. Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed?price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non?cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation should contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.