FDA's Adverse Event Reporting System (FAERS) II

Amendment No. 6 The purpose of Amendment no. 6 is to extend the proposal due date to Monday, August 21, 2017 at 9 am Eastern Time. Amendment No. 5 The purpose of Amendment no. 5 is to notify offerors that they may fix the formulation error in cell H127 of the IDIQ Gov-Site Labor Tab to =C127+D127+E127+F127+G127. AND Notify offerors the following text shall be considered deleted from the IDIQ Terms: Section 4.4.9 "Rounding: All Total Dollar amounts provided shall be rounded to the nearest dollar." Attachment 8, FAERS pricing sheet formulas for total amounts are not rounded to the nearest dollar and should be left as is. Amendment No. 4 The purpose of Amendment No. 4 is to submit changes to RFP Attachment 8: FAERS Pricing Sheet / IDIQ Licenses and Maintenance tab to add more licensing options to Years 4 and 5 and to correct the formula for Year 5. Please see the revised attachment for more detail. Amendment No. 3 The purpose of Amendment No. 3 is to submit changes to RFP Attachment 1: IDIQ Terms an Conditions and RFP Attachment 8: FAERs Pricing Sheet / IDIQ Licenses and Maintenance tab. The following sections of RFP Attachment Attachment 1 have been updated as a result of Amendment No. 3: a. FAERS DME technical approach - Parts 1 and 2 b. FAERS O&M technical approach - Part 2 c. GSRS technical approach - Part 2 Please note: Amendment No. 3 changes are highlighted in pink. The following changes have been made to RFP Attachment 8: FAERS Pricing Sheet as a result of Amendment No. 3: a. IDIQ Licenses and Maintenance Tab: Formulas in cells I27, I35, and I44 have been updated to equal the average amounts for years 3, 4, and 5. b. IDIQ Licenses and Maintenance Tab: Correction to text in Row 25 column B. The description should consistently cite 150 users. Amendment No. 2 The purpose of Amendment No. 2 is to submit changes to RFP Attachment 1: IDIQ Terms and Conditions to clarify the following: 1) Offeror's shall not make changes to the original pricing sheet, unless allowed in the specific pricing instructions. 2) Specifically, the offeor may not change the Government recommended Labor Categories. 3) The offeor may update the indirect cost allocation formulas to better reflect their accounting practices. 4) The following text has been removed from the Assumptions: Tab 8 Instructions - Identifying changes to the original pricing sheet must be documented in the Assumptions Tab. Please note, Amendment No. 2 changes are highlighted in green. Amendment No. 1 The purpose of Amendment No. 1 is to provide Government responses to proposal questions. Please see attached documents for more detail. (i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the FAR part 12, 15, and 19 procedures. In order to Streamline this requirement FAR part 12 procedures were used to the maximum extent possible. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is FDA-SOL-17-1180187 and is being issued as a Request for Proposal (RFP). (iii) This solicitation and incorporated provisions are those in effect through Federal Acquisition Circular 2005-95. (iv) This solicitation is in accordance with FAR 19.805, Competitive 8a procedures and is limited to eligible 8a companies. The Small Business Administration acceptance number is 0353/17/878. 8a Companies with the capability to meet our requirement as defined in the solicitation attachments are encouraged to respond. The NAICS code is 541512, Computer Systems Design Services. The small business size standard is $27.5M. The Government intends to issue an Indefinite Delivery Indefinite Quantity (IDIQ) Contract with a five year ordering period. In addition to the IDIQ contract, FDA intends to simultaneously issue and award three task orders under this IDIQ. At the discretion of the Contracting Officer, the government may use Labor Hour, Time and Materials, Firm Fixed Price contract types, or a combination thereof, for the task orders. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government's determination of contract type. (v) & (vi) The FDA requires the purchase and implementation of a Pharmacovigilance Commercial Off the Shelf (COTS) product to replace FDA's Adverse Event Reporting System (FAERS), continued Operations and Maintenance (O&M) of Legacy FAERs, and Development, Modernization and Enhancments (DME) / O&M of FDA's Global Substance Registration System (GSRS) (please see the solicitation attachments for more detail on FDA's requirements). (vii) PERIOD OF PERFORMANCE: (est) 09/14/2017 - 09/13/2022 (viii) The provision at FAR 52.212-1 titled, "Instructions to Offerors -Commercial" (JAN 2017), applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709. (ix) The provision at FAR 52.212-2, titled, "Evaluation of Commercial Items" (OCT 2014), is applicable to this acquisition. This evaluation will be conducted using a combination of Go / No criteria and best value methodology. The Government reserves the right to establish a competitive range and award without discussions. Technical merit will more important than price in evaluating proposals (Please see RFP Attachment No. 1: IDIQ Terms and Conditions for Instructions to Offerors and Evaluation Criteria) (xiv & xv) N/A (xvi & xvii) All questions must be submitted in writing to Jody.O'Kash@fda.hhs.gov no later than Wednesday, August 2, 2017 at 1pm ET. Please note the FDA solicitation number (FDA-SOL-17-1180187) and project title (FAERS II) must be identified in the subject line of all correspondence and submittal of questions. Answers to all questions will be posted as an amendment to the solicitation on Federal Business Opportunities. Technical and Business Proposals are due no later than Friday, August 18, 2017 at 12pm ET. See attached IDIQ Terms and Conditions, Section 4.1 for general instructions on proposal submissions.