GovernmentResponses_Amendment0001.xls
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- FDA's Adverse Event Reporting System (FAERS) II
- Solicitation number
- FDA-SOL-18-1192468
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Questions and Answers (Q&A)_AmendmentNo.0001
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Sheet1
| FDA-SOL-18-1192468 FAERS II | |||||
| Government responses to potential Offeror Questions | |||||
| No. | Attachment Section | Page # | Text Reference | Question | Governement Response |
| 1 | Attachment 1, 1.1 | Pg. 1 | 1.1. Brief Description of Supplies or Services | Question: RE: COTS REQUIREMENT. In order to enhance competition, allow prospective contractors to provide innovative solutions, and provide a broader range of possible solutions to the Government, will the Government consider amending the RFP to accept either 1) unique [products/solutions] or 2) commercial item [products/solutions] rather than the requirement that the [product/solutions] be commercially-available-off-the-shelf (“COTS”)? | The Government will only consider COTs solutions for the FAERS II program. |
| 2 | Attachment 2, 3.3 | Pg. 12 | The FDA has identified a suite of Commercial-Off-the-Shelf (COTS) pharmacovigilance software products to replace the current legacy FAERS case processing, data management and data analytics modules and acquire new COTS pharmacovigilance software products for the call center. The current FLARe subsystem which is based on ArisGlobal’s Lifesphere Intake and Triage Module and the FAERS Public Dashboard developed using Qlik’s Qlik Sense will not be replaced. The products identified include are ArisGlobal’s Lifesphere modules (excluding Lifesphere Intake and Triage Module), and RxLogix’s PV Reports & PV Signal. Equal to products must meet the requirements / salient characteristics identified in IDIQ SOW sections 3.3.1, 3.3.2, 3.3.3, and 3.3.4. In addition, equal to products must meet the features and functionalities identified in RFP Attachment No. 4: FAERS II Requirements. | Question: Please confirm that offerors are permitted to bid an “equal to” solution as long as the product meets “the requirements / salient characteristics identified in IDIQ SOW sections 3.3.1, 3.3.2, 3.3.3, and 3.3.4”. | Per the IDIQ Statement of Work Equivalent products must meet the requirements / salient characteristics identified in IDIQ SOW sections 3.3.1, 3.3.2, 3.3.3, and 3.3.4. In addition, equivalent products must meet the features and functionalities identified in RFP Attachment No. 4: FAERS II Requirements. |
| 3 | Attachment 1 | Pg. 64 | Proposals are due to Jody O’Kash no later than 12:00 PM Eastern Time (local), June 26, 2018. | Question: We respectfully request a 2 week extension to the deadline for proposal submission so that we can effectively respond to the governments requirements in the solicitation. | The proposal due date has been extended to Monday, July 9th at 3pm ET. |
| 4 | Att 1 IDIQ Terms and Conditions | 4 | 1.4 Pricing Terms | Question: Will the government please provide an estimated start date of the IDIQ for pricing purposes? | It is expected the Contract will be awarded in September 2018 |
| 5 | Att 1 IDIQ Terms and Conditions | 4 and 61 | 1.4 Pricing Terms – IDIQ Labor Rates and 4.0 Submission Instructions | Question: Since additional labor categories may not be added, and the IDIQ rates proposed are to be used for the DME order as well as future orders, please confirm the proposed IDIQ Labor Rates shall apply to both prime and subcontractor labor and no additional subcontractor pricing is required or sealed bids are required. | Correct the IDIQ Labor Rates identified for each Labor Category apply to both prime and subcontractor employees. |
| 6 | Attachment 6 Pricing Sheet | Summary Tab column F ‘Other Direct Costs’ | Question: Please clarify what is included in the $2.75M plug number for Other Direct Costs. | Anciliary Software that may be needed for integration efforts, data reporting, and analytics. It is expected a minimum of 95% of all integration, reporting, and analytics will be covered by the base system suite of pharmacovigilance COTs products (for example: ArisGlobal Lifesphere, Rx Logix, Qlilksense, Moveit, etc...) | |
| 7 | Attachment 6 Pricing Sheet | General | Question: May the offeror modify the template to include additional tabs, and rows on the Labor tabs in order to provide forward pricing data in accordance with disclosed accounting practices as it relates to the proposed IDIQ Labor Rates? | No, the proposed Labor Rates will be set for the life of the IDIQ. | |
| 8 | Attachment 7 Small Business Plan | Question: Please clarify if the small business plan subcontracting goals should be reflected in terms of the offeror’s proposed total evaluated price, or the estimated $36M ceiling value of the IDIQ as written in the solicitation. | The contract ceiling amount of $36M should be used for percentages identified in the small business subcontracting plan. | ||
| 9 | Attachment 6 Pricing Sheet | Assumptions Tab | Question: Please clarify if the fee caps proposed for Material Handling, G&A, and Profit on the ‘Assumptions’ tab apply only to Other Direct cost items added on future orders or if they also apply to required Software License and Maintenance prices proposed for the IDIQ. | Only Material Handling will be applied to Other Direct Costs. The FDA is requesting MH, G&A, and Profit percentages to understand how they are applied to the firm fixed price for the Software and License Maintenance prices. Please note no new products outside of ODCs will be added to future orders. | |
| 10 | Attachment 6 Pricing Sheet | IDIQ level License and Maintenance tabs – ‘Average Amounts’ | Question: On each yearly tab for the Licenses and Maintenance prices for IDIQ evaluation where there are multiple bands of concurrent users listed for a quantity 1 price offering, the template says ‘Average Amount’, but the template is calculating a subtotal for these variable prices instead of an average. Please confirm if the evaluation model is calculating these items correctly and update either the label or the formula to consistently be an Average or a Subtotal. | FDA tested the calculation and it is calculating the Average and is correct. | |
| 11 | Attachment 6 Pricing Sheet | IDIQ level License and Maintenance tabs – ‘Average Amounts’ | Question: On each yearly tab for the Licenses and Maintenance prices for IDIQ evaluation where there are multiple bands of concurrent users listed for a quantity 1 price offering, is the offeror to provide the unit pricing where quantity 1 reflects the unit price for each individual user or does quantity 1 reflect a price covering all users within a band? For instance on a 1-50 concurrent number of users, will the unit price reflect each user within the band and extended price would be 50 times unit price for 50 users or is it 1 price to cover up to 50 concurrent users? | The FDA is not requesting a license structure for named users. Therefore quantity 1 reflect a price covering all users within a band | |
| 12 | Question: On each yearly tab for the Licenses and Maintenance prices for IDIQ evaluation where there are multiple bands of concurrent users listed for a quantity 1 price offering, does the unit price for each higher band reflect only the additive amount of additional concurrent users or should it include the price of all users inclusive of lower bands? | We are requesting bands of concurrent users. We have updated the quanitites for each band to start with 1. For example: 1-50, 1-100, 1-200 etc... | |||
| 13 | Sub Offeror cost proposals may be placed in sealed envelopes clearly marked on the outside with the following information: RFP No.: FDA-SOL-18-1192468 | Question: Please provide the number of hard copies required for sealed bids from sub offerors and if a CD is required. | This statement was removed. Per the answer to question no. 5 there should be one set of pricing that represents prime and subcontractor labor rates and product pricing. | ||
| 14 | Attachment 1, 4.4 – 4.4.5 | Pgs. 67 - 69 | 4.4 SPECIFIC BUSINESS PROPOSAL INSTRUCTIONS (VOLUME II) | Question: Please confirm that the narrative portions of Volume II Business Proposal, including the requirements listed in 4.4.1 – 4.4.5 may be provided in Microsoft Word or Adobe Pdf. Question 2: If allowed please provide the naming convention for the electronic file. | The narrative portion of the Technical, Business, and Past Performance Volumes for the duplicate CDs shall be submitted in MS Word and Adobe formats. The MS Word and Adobe versions shall contain the same naming convention identified in the Organization of Proposals section. |
| 15 | Attachment 1, IDIQ CONTRACTOR-SITE TAB (Tab 3) #2, and Attachment 6 | Indirect Rates - The Offeror must identify the percentages to be applied to the indirect cost categories (Fringe / Column E, Overhead / Column F G&A, and Profit / Column G )for Contractor-site labor categories for each IDIQ Year. | Question: The columns in Attachment 6 do not align with the requirements noted in the RFP. For instance: Fringe = Column D Overhead = Column E G&A = Column FProfit – Column G | The columns identified in the question are correct and the RFP has been updated to correct the mistake. | |
| 16 | ASSUMPTIONS: TABTab 8: Assumptions: Contractor Assumptions must be documented in the Assumptions tab. Examples of acceptable assumptions includes but is not limited to: | Question: Please confirm that this should be Tab 10. | Yes the tab should be 10 not 8. | ||
| 17 | Request for Proposal (RFP): FDA-SOL-18-1192468 | Question: To assist in COTS product recommendation (AG, RxLogix or Equal) and to minimize delivery risk and meet the aggressive deliverables, please confirm prime contractor must have trained resources and experience implementing the proposed COTS products | Per the RFP the FDA intends to evaluate the extent to which the Offeror's (prime and subcontractor) combined relevant corporate experience is recent (performed within the last three years) and demonstrates configuration, integration, and implementation of a pharmacovigilance system similar to the FAERS II System in terms of scope and technology. | ||
| 18 | Attachment 1 | .1 Brief Description of Services….”obtain continued operations and maintenance support of the legacy FAERS system currently running on Oracle AERS” | Question: This is not referenced further in any attachments. Please confirm this is not in scope of the IDIQ. | Statement has been deleted from Attachment 1. O&M support of Legacy FAERS is not covered under thes scope of the FAERS II requirement. | |
| 19 | Attachment 1 | Question: It is our understanding that Relevant Experience can be provided by both the prime and subcontractor. Please confirm that at least one project must be from the Prime contractor. | Per the RFP the FDA intends to evaluate the extent to which the Offeror's (prime and subcontractor) combined relevant corporate experience is recent (performed within the last three years) and demonstrates configuration, integration, and implementation of a pharmacovigilance system similar to the FAERS II System in terms of scope and technology. | ||
| 20 | Attachment 1, 5.4 | 76 | 5.4 PAST PERFORMANCE AS A CONFIDENCE ASSESSMENT | Question: To evaluate the confidence of the offer as defined in 5.4, please confirm the past performances must be of the prime offeror | Past performance references can be for the proposed team (prime and subcontractor) |
| 21 | Attachment 2 | 9 | 2. Purpose ….”tool to meet CDER’s and CBER’s pre-market and post market, surveillance, product quality and outreach objectives | Question: Please confirm that CBER is not included in the scope for this solicitation and that offerors are not expected to price that scope in their bid. | CDER and CBER is included in the scope of the IDIQ. The CBER requirements are included in the RTM. |
| 22 | Attachment 2 | 12 | 3.3 Task Area 3 ….”Tracktor and DQRS shall be replaced” | Question: Please provide more details regarding the activities and offerors responsibilities to replace Tracktor and DQRS in addition to data migration and building FAR/BPDR data entry screens, e.g. activities/deliverables needed for communication with District offices, integration with eDRLS, business process/work flow configuration etc. | All of the above. It's a complete implemnetation of the OPQ (Office of Pharmaceutical Quality) needs as described in the RTM. That includes establishement of data migrations, transactional system, reporting and workflow establishements. |
| 23 | Attachment 3 | 2.2.2 Data Migration | Question: Please provide more detail regarding the data attributes/format of the approximately 15M reports that need to be migrated including the need to migrate historical data and case versions, data quality/consistency of existing data set etc. | ICH E2B(R2).xml standard makeup the current data attributes and format of ICSRs. Currently, FAERS has more than 15 million ICSR reports. We need a complete migration of these reports including all case versions and historical data. The new database must keep all existing data format. quality, and ICH E2B(R2).xml standard intact. | |
| 24 | Attachment 1 | Evaluation Approach: Corporate Relevant Experience | Question: Please confirm that offerors experience using equivalent products will be rated equal to those with ArisGlobal and RXLogic product experience. | Yes, offerors with experience with equivalent products will be rated equal to those equal to ArisGlobal and RxLogix | |
| 25 | Attachment 1 | The total amount for Years 1-5 for both Government Site (Tab 2) and Contractor Site (Tab 3) Labor Categories (for all ordering periods plus Options), plus the total average amounts for Years 1-5 of the License and Maintenance for the ArisGlobal and Rx Logix volume tables, plus total amount for Qilksense and MoveIt for all ordering periods, plus the price of the FAERS II DME task order, plus ODC Plug-in price”. | Question: The Government requires specific licenses of ArisG Intake and Triage starting year 3 from ArisG. If ArisG will not provide price quotes to all prospective contractors the government will remove this as part of their evaluated pricing and requirements. | The FDA is accepting the Aris Global’s Lifesphere Intake and Triage Module or equivalent products and maintenance. The offeror must provide pricing for ArisGlobal Intake and Triage or equivalent products. | |
| 26 | Attachment 1 | The brand names ArisGlobal and RX Logic are explicitly listed throughout the solicitation. | Question: Please explain on what basis these products are specifically identified? | Based on market research the identified name brand products fit to FDA's requirements. | |
| 27 | RFP Attachment 3 FAERs II DME SOW / Section 3 |
Attachment 4, Tab Case Management 19 / 20 Sprint Cycle 1:
• Case Management
• Sprint Cycle 2:
• Dictionary Management From Requirements Spreadsheet – Tab – Case Management
| CM 3.2 - The system shall support "Auto Coding" features for all reports including post-market, pre-market and product quality. | Question: Will the Government consider moving Case Management functionality to Sprint Cycle 2; given that Case Management has dependencies on Dictionary Management which will be implemented during Sprint Cycle 2? | FDA has determined Case management UAT can be completed without dependencies such as the Data Dictionary. The FDA has determined the Auto-Coding feature can be completed during Sprint Cycle 1 using the default COTS data dictionary. | ||
| 28 | RFP Attachment 3 FAERs II DME SOW / Section 3 | 19 / 20 | Sprint Cycle 1: |
• Analytics (Initial Setup) / Production Sprint Cycle 2:
| • Analytics (FAERS II) | Question: Can Govt. provide clarify Analytics functionality deployed in Production as part of Sprint Cycle 1 vs Sprint Cycle 3? | Sprint Cycle 1 is the out of the box implementation for Analytics and Signal Detection including User Testing. Sprint Cycle 3 is where modular UAT commences with the migrated data. | ||
| 29 | RFP Attachment 3 FAERs II DME SOW / Section 3 | 19 / 20 | Sprint 2: | |
| • Data Migration from Legacy FAERS | Question: Can Govt. provide clarity around UAT/testing requirements for each sprint cycle deliverable deployment in Pre-Production e.g. Sprint Cycle 1 deliverables - Case Management UAT approach given the data migration will not be completed until Sprint Cycle 2 | Complete data migration is not necessary to test, validate, and verify out of the box and configurable functionality. Please see the answer above for more information. | ||
| 30 | RFP Attachment 3 FAERs II DME SOW / Section 3 | 19 / 20 | Sprint 3 |
• System Integration Sprint 4
| • System Integration | Question: Can Govt. provide clarity on scope of system integration part of Sprint 3 and Sprint 4? | Sprint 3 is the implementation of the System Integration Requirements from the RTM. Sprint 4 is a hardening sprint in which full regression testing takes place. | ||||
| 31 | RFP Attachment 3 FAERs II DME SOW / Table 8 | 24 | Less than 10 Low or Medium defects, less than 3 high defects, and less than 1 major defect are discovered during UAT. | Question: Can the government provide recent performance management results related to “Reliability and Quality” standards related to FDA data quality (e.g., defects discovered during UAT) from legacy FAERS/FBIS releases as a benchmark in order for Offerors to make an accurate determination of their ability to meet these performance standards? | The performance benchmark for Reliability and Quality is for the new FAERS II system with the new proposed pharmacovigilance COTs products not the Legacy FAERs / FBIS solution. | |
| 32 | RFP Attachment 2 IDIQ SOW | As stated in RFP Attachment 2 IDIQ SOW. Additional task orders are expected under this IDIQ for Drug Information functions and potentially Data Analytics and Reporting. | ||||
| As stated in DME SOW – Page 5 / Section 1.1 - Implement, integrate, modernize, and enhance FAERS II to perform PV Data Analytics and Signal Management | Question: Can Govt clarify if Attachment 3 - DME SOW includes the scope for Analytics and Drug Information functions or will it be included in a future task order? | The DME SOW includes Analytics and Signal Detection. It does not include Drug Information which may be a separate future task order. | ||||
| 33 | RFP Attachment 2 IDIQ SOW . Section 3.3 | Page 12 | Current legacy FAERS case processing and data management applications, Tracktor and DQRS shall be replaced and absorbed into the proposed integrated FAERS II system. In addition, FLARe and FAERS Public Dashboard shall be absorbed in its current state into the integrated FAERS II system | Question: The Government requires enhancements to ArisG LifeSphere Intake and triage (agTracker) that necessarily involves ArisG implementation services resources. If ArisG is unwilling to provide the resources and a price estimate to all prospective contractors then the government will remove this requirement out of all of the evaluated criteria. | See response to Question No. 25. The Government will not remove this requirement from the evaluation criteria. The Offeror may propose an equivalent product and associated maintenance for evaluation purposes. | |
| 34 | Requirements Spreadsheet | Instructions | Definition of FM, C and CM - | As per the instructions, any requirement that can be met by “configuration” (less than 8 hours of effort) is not considered “Fully Meet” criteria. | ||
| Question: Can the Government consider changing the Go/No-Go threshold since many of the requirements are unique to the FDA (batch printing, FAR/BPDR, etc. ) and the Government is expecting almost 34 out of 760 requirements to be met by configuration e.g. The system shall have the capability to configure data checks that can be applied to the incoming ICH E2B R2 or ICH E2B R3 XML based on existing and future FDA defined data standards. | The Government will not change thresholds identified. | |||||
| 35 | Requirements Spreadsheet | EB-Electronic Submission | The system shall have the capability to configure data checks that can be applied to the incoming ICH E2B R2 or ICH E2B R3 XML based on existing and future FDA defined data standards. | Question: Can the government please provide anticipated future data standards so that we can accurately assess if the COTS product can meet “future” data checks requirements as configurable? | Examples of future data standards are regional requirements and combination products. | |
| 36 | Attachment #1/4.1 Organization of Proposals | 62 | Description of Volume II is missing from section | Question: Please provide Volume II content, organization, and page limitations? | See revised RFP Attachment 1 | |
| 37 | Attachment #1/4.2 FACTOR 2/Part 1/e. | 65 | e. The Offeror shall complete the Task Mapping Matrix (RFP Attachment 12 ) for Task Order One to identify both Key and Non-key Personnel, including labor categories, roles, and levels of effort, and their relevant skills and task assignments. | Question: Please confirm that for non-key personnel offerors should provide a role or LCAT in Row 1 of the task mapping matrix (Attachment 12)? | Offerer must provide both Key and Non-key personnel in Row 1 of the task mapping matrix. | |
| 38 | Attachment #1/5.3 Evaluation Approach of Trade-Off Factors | 75 | FACTOR 3 / TECHNICAL APPROACH TO FAERS II DME | Question: Factor 3/Part 1 – Technical Approach to Configuring, Integrating, and Implementing FAERS II – Should this be labeled Factor 2/Part 1 and not Factor 3/Part 1? | Yes it should be labeled Factor 2/ Part 1. RFP has been updated. | |
| 39 | Attachment #2/ Product Quality Defect Reporting tools and technologies | 37 | Tracktor: This application contains the FAR & BPDR records since 2009…. DQRS – Legacy System: The older DQRS system contains 15+ years of data. | Question: Is the system of record for FARS and BPDRs Tracktor or DQRS? | The system of record for FARs and BPDRs is Tracktor. | |
| 40 | Attachment 4 | Tab: DG-Data Migration | Question: As part of data migration activity and retirement of FBIS, do we need to migrate saved reports from user’s mailboxes? | No. | ||
| 41 | Attachment 4 AL-Analytics | The system shall provide the ability to use logical operators like AND or OR within a data field to query for results. | Question: Is a full ‘Free-hand’ end user reporting capability where they can select any available field and dynamically build selection criteria based on available fields required – or they are more of a set of predefined criteria that are prebuilt? | Both. | ||
| 42 | Attachment 4 | Tab: AL-Analytics | Question: Do we need ability to go back in time and run the report as of a specific date? | Yes. | ||
| 43 | Attachment 4 | Tab: DG-Data Migration | Question: Do we anticipate loss of features after we migrate from FAERS/DQRS/Tracktor to FAERS II based on the differences in COTS capabilities? If yes, what are the requirements to archive the existing datasets? | No. | ||
| 44 | Attachments 3 and 4 | Question: What is the objective behind the sprint scope definition provided in the RFP? According to the RFP, Case Management, Workflow and Dictionary Management are required to be delivered in different sprints. These are integrated requirements which should be executed together and can be delivered in one sprint. | Refer to response in Question No. 28 and 30. | |||
| 45 | Attachments 3 and 4 | Question: Timelines defined for sprints assume an incremental 3-month effort, sprint on sprint, however due to significant dependency of some functionalities over one another like case management, workflow and dictionary management, is there flexibility in terms of reallocating scope per sprint and the corresponding timeline ? | Yes as proposed in the WBS, but in-line with the deliverable table. | |||
| 46 | Attachments 3 and 4 | Question: The DQRS system also contains FAR & BPDR data, the 2009 – 2017 data is duplicative of the Tracktor data. If the data captured is exactly the same is de-duplication of data expected as part of data migration activity ? | Tractor has same data but additional data items. This will be an update to exisiting data. No de-duplication action is required. | |||
| 47 | Attachments 3 and 4 | Question: Is performance testing in-scope for this engagement? If yes, what are the existing benchmarks for FAERS I system? | Yes, as per the non-functional requirements in RTM. | |||
| 48 | Attachment #3/2.1.1.1 Technical Environment Provisioning | Question: What is the turnaround time for infrastructure provisioning assuming work with system administrators at FDA's data center starts on week 2 of contract award date ? | Infrastructure has been provisioned. | |||
| 49 | Attachment 3/ 11.2 Appendix 2 | 37 | The new Data Analytics and Signal Management software shall fit within RAPID to read information from the RAPID Data Lake. | Question: What technology stack details and architecture can FDA provide about the RAPID data lake? | Amazon Web Services (AWS), Secure Data Broker, technologies such as Docker and Kubernetes or automated orchestration engines such as Ansible. |
Supported by REST API’s for application layer services and JDBC/ODBC support for database access.
| 50a | Attachment 3/ 11.2 Appendix 2 | 39 | All reports from FAERS are extracted by Mercado, another data warehouse. This extraction shall also use an ETL process. | Question: Is the downstream data feed from FAERS II in-scope for the FAERS II implementation or will it be a scope for a different task order? | In scope. Refer to requirements under SI10.1 |
| 50b | Attachment 3/ 11.2 Appendix 2 | 35 | In addition, for pre-market ICSRs, an acknowledgement that includes the information on the Investigational New Drug (IND) number, FDA received date, Manufacturer Control Number (MCN) and the FAERS II Case ID shall be sent to the FDA internal review system like DARRTS/Panorama (an external component of FAERS) indicating the receipt of the ICSR for the IND. | What is the intention of preserving the Mercado integration if the FAERS II Analytics and Signal functionality will be replacing legacy FAERS reporting? Will count validation or reconciliation activities amongst the reports in the two systems be part of the scope? | Refer to requirements under SI10.1 |
| 51 | Attachment 3/ 11.2 Appendix 2 | 35 | In addition, for pre-market ICSRs, an acknowledgement that includes the information on the Investigational New Drug (IND) number, FDA received date, Manufacturer Control Number (MCN) and the FAERS II Case ID shall be sent to the FDA internal review system like DARRTS/Panorama (an external component of FAERS) indicating the receipt of the ICSR for the IND. | Question: The requirements document to not specify an integration with DARRTS or Panorama. How will this requirement be evaluated by FDA? | Refer to requirements under SI10.1 |
| 52a | Attachment 3 / 2.1.1 | 7 | In Fiscal Year 2017, Legacy FAERS had approximately 45 active queries and/or public canned reports. The contractor shall create reports with similar functions and purposes that will be available in the new FAERS II solution when it goes into Production. | Question: Is the intention to recreate all 45 queries/reports in FAERS II or will the scope be greater? | The purpose is to evaluate whether the proposed tool(s) can be used to create canned queries and reports. The number of canned queries and reports to be recreated will be determined at the end of Sprint 0. |
| 52b | Attachment 3 / 2.1.1 | 7 | n Fiscal Year 2017, Legacy FAERS had approximately 45 active queries and/or public canned reports. The contractor shall create reports with similar functions and purposes that will be available in the new FAERS II solution when it goes into Production. | Is FDA willing to consider live dashboards as replacement for specific report during requirements? | Yes, as long as it meets the requirements. |
| 53 | Attachment 3 / 2.1.5 | 11 | Reconfigure the data source from legacy FAERS to the new proposed FAERS II solution to the Data Analytics and Signal Management tool deployed on the existing cloudbased RAPID environment in FDA GovCloud when the full FAERS II solution is ready for production. | When FDA intends to switch the source for Analytics and Signal from legacy FAERS to FAERS II, does FDA intend to de-activate the legacy FAERS data and bring data from FAERS II or will we only source the new cases from FAERS II? How does FDA intend to account for differences in data from enhanced coding/validation as part of the data migration from legacy FAERS to FAERS II? | Data Analytics tool will retrive data from the RAPID Data Lake. |
| 54 | Attachment 1 | Volume III, Section B – Small Business Subcontracting Plan | Question: The period of performance is 5 Years, 1 base and 4 option periods; what are the period dates? | Per RFP section 2.1: The ordering period is five years from the effective date of award. In accordance with 52.217-8 Option to Extend Services (1999) the Government reserves the right to extend services 6-months beyond the ordering period. For the purpose of filling out the Small Business contract Plan: Base Period = IDIQ Year 1 (12-month ordering Period), Option Period 1 = IDIQ Year 2 (12-month ordering Period), Option Period 2 = IDIQ Year 3 (12-month ordering Period), Option Period 3 = IDIQ Year 4 (12-month ordering Period), Option Year 4 = IDIQ Year 5 (12-month ordering Period), 6-month Extension = (6-month ordering period). | |
| 55 | Attachment 1 | Volume III, Section B – Small Business Subcontracting Plan | Question: What is the NAICS Code for the scope of work? | Per the FBO posting the NAICS code is 541512 - Computer Systems Design Services | |
| 56 | Attachment 1 Terms and Conditions: Organization of Proposals | Pg. 62 | Executive Summary | Question: Please confirm that the Executive Summary should be provided electronically (on a CD) and if so, should it be provided as a separate file? If it is a separate electronic file, please clarify the naming convention. | The Executive Summary may be submitted as a separate file on the Technical Volume CD. The naming convention for the Executive Summary shall be as follows: 1192468_CompanyName_ExecutiveSummary |
| 57 | Volume I / FACTOR 2 / PART I: TECHNICAL APPROACH TO CONFIGURING, INTEGRATION, AND IMPLEMENTING FAERS II (Parts 1 and 2) |
(Maximum Page limit 30 pages) Electronic File No. 2 Label Naming Convention: 1192468_CompanyName_Factor2_TechnicalApproach
NOTE:
Volume 1 / Factor 2 documents not included in the technical approach page limit:
• Volume I / Factor 2 / Part 1 / Appendix A: Key Personnel Resumes and: Letters of Commitment (3-pages per resume)
• Volume I / Factor 2/ Part 1 / Appendix B: Work Breakdown Structure
| • Volume I / Factor 2/ Part 2 / Appendix C: Relevant Experience (3-pages per project) | Question: Should Appendices A – B be included in Electronic File No. 2? If so, since the WBS will be developed in MS Project can Electronic File #2 be provided as an Adobe pdf? Otherwise please specify how the Appendices should be provided electronically. | The WBS shall be Appendix B of Electronic File No. 2 and may be submitted in Adobe pdf format only. In the MS Word file please write the following - Appendix B - WBS -Intentionallly Blank (see Adobe version for WBS details). Appendix A - Key Personnel Resumes and Letters of commitment shall be submitted in MS word and Adobe pdf formats. The Adobe pdf Letters of commitment must be signed per the instructions. | ||||
| 58 | Attachment 1 Terms and Conditions | |||||
| Organization of Proposals | 62 | Part 3: Product Accessibility Templates for each IT Product proposed | Question: Will the government provide a template for the PATs? | See RFP Attachment 13. | ||
| 59a | Attachment 1 Terms and Conditions: Organization of Proposals | Pg. 63 | Factor 2 of Volume 1 should be organized to align with the requirements tabs in RFP Attachment 4 No. : FAERS II Requirements. | Question 1: Should this say that Factor 1 should be organized to align with the tabs in attachment 4 not Factor 2? | No, it should not say Factor 1. Factor 2 of Volume 1 should be organized by activities to be completed during Sprint 0 and Sprint Cycles 1-5 and shall address each FAERS II functional and non-functional areas to be configured, integrated, and implemented (for example: EB – Electornic Submission, DM – Dictionary Management, CM- Case Management – etc). | |
| 59b | Attachment 1 Terms and Conditions: Organization of Proposals | Pg. 63 | Factor 2 of Volume 1 should be organized to align with the requirements tabs in RFP Attachment 4 No. : FAERS II Requirements. | Question 2: Also is this referring to the organization of the hard copy submission of Attachment 4 within Volume I? Please clarify the government’s intent regarding this requirement. | No, it is not referring ot the organization of the hard copy submission of Attachment 4. See above response for clarification regarding the organization of Factor 2. | |
| 60a | Attachment 1 Terms and Conditions, Factor 1, Part 1 (e.) | Pg. 65 | e. The Offeror shall complete the Task Mapping Matrix (RFP Attachment 12 ) for Task Order One to identify both Key and Non-key Personnel, including labor categories, roles, and levels of effort, and their relevant skills and task assignments. The complete instructions for completing the Task Mapping Matrix are located in the instructions tab of the spreadsheet. | Question 1: Is the Task Mapping Matrix included as part of Appendix A? Please provide guidance since this section is not included in the Organization of Proposals section/table of Attachment 1. | Included in Volume I /Factor 2 / Part 2 / Appendix D. See Organization of Proposal. | |
| 60b | Attachment 1 Terms and Conditions, Factor 1, Part 1 (e.) | Pg. 65 | e. The Offeror shall complete the Task Mapping Matrix (RFP Attachment 12 ) for Task Order One to identify both Key and Non-key Personnel, including labor categories, roles, and levels of effort, and their relevant skills and task assignments. The complete instructions for completing the Task Mapping Matrix are located in the instructions tab of the spreadsheet. | Question 2: Please confirm that the Task Mapping Matrix should be provided as a separate electronic file. If so, please provide the naming convention. | It has been added to the Organization of Proposals section as Appendix D. Shalll be submitted in MS Word, Adobe pdf, and Excel. Electronic Naming Convention Provided for Excel file. | |
| 61a | Attachment 3 DME SOW | Question 1: Please confirm that offerors should include in their response, an approach to the requirements in Attachment 3 DME SOW. | No, the offeror does not need to provide a response to Attachment 3:DME SOW. See RFP instructions and evaluation for detail on information to include in proposals and what will be evaluated. | |||
| 61b | Attachment 3 DME SOW | Question 2: If a response is required, please provide instructions regarding within which Volume the response should be provided and what the page limit is for the section. | See response above. | |||
| 62 | Attachment 3 DME SOW | Question: What is the evaluation criteria for the DME Task Order response? | See response to 61a. | |||
| 63 | Pg. 74 | Statement of Relative Order of Importance: | ||||
| Technical evaluation factors 3 and 4 when combined are significantly more important than price. As technically rated proposals become more equal, price may become the determining factor in the award decision. The Government reserves the right to award without discussions if the Contracting Officer determines discussions are not necessary. | Question: Please confirm this should say that “Technical evaluation factors 2 and 3 are significantly more important than price…” as factor 4 is price. | Correct, it should say factors 2 and 3. The RFP has been updated to state evaluation factors 2 and 3. | ||||
| 67 | FACTOR 2 – Technical Approach to FAERS II DME, d. | The Offeror shall submit resumes for Key Personnel (three pages limit per resume) identified in the FAERS DME SOW. | Are Offerors allowed to submit additional resumes with our proposal, to show the resources that will support the key personnel? | No the Offeror may not submit additional Key Personnel resumes. | ||
| 68 | General Question | Can the FDA provide Informatica licenses for data migration in all environments? | The entire COTs solution must be identified in the License and Maitenance tabs and calculated in the cost of the FAERS DME task Order (if applicable) | |||
| 69 | General Question | Can (Drug Information) requirements be implemented post FAERS II going live? | This will be a separate task order in the future. | |||
| 70 | Section 2.1.1 | 7 | Currently, FDA reports reside in the Legacy FAERS data reporting repository. In Fiscal Year 2017, Legacy FAERS had approximately 45 active queries and/or public canned reports. The contractor shall create reports with similar functions and purposes that will be available in the new FAERS II solution when it goes into Production. | Are the reports being referenced to, reports from the analytics component of legacy FAERS or from the COTS transactional component of FAERS? | Both. | |
| 71 | RFP Attachment 3 FAERs II DME SOW, Section 2.1.5 | 11 | Reconfigure the data source from legacy FAERS to the new proposed FAERS II solution to the Data Analytics and Signal Management tool deployed on the existing Cloud based RAPID environment in FDA GovCloud when the full FAERS II solution is ready for production. | Can the Government please clarify this approach? Is the Government first looking to set up an instance for the analytics component on a -non-cloud environment pointing to legacy FAERS followed by another instance set up on the Govcloud and pointing to the new FAERS II instance or is the Government looking to set up one instance on Govcloud but pointing to two data-sources? | The Data Analytics and Signal Management tool shall point to the RAPID Data Lake which is on the Govcloud. | |
| 72 | RFP Attachment 3 FAERS II DME SOW, Section 7 | 23 | The contract type for this task order is Firm Fixed Price (FFP). | The DME SOW currently shows the contract type as being Firm Fixed Price with payment due upon completion and acceptance at the sprint cycle level. Since we are using an agile methodology, can you define your criteria for “acceptance” in an iterative environment without causing development to mimic a waterfall approach? | The criteria for “acceptance” of Sprint Cycles 1-4 is UAT acceptance of each Sprint in Pre-Prod. The criteria for acceptance of Sprint Cycle 5 is UAT acceptance and release of System Functional and non-functional areas into the production environment. Per the inspection and acceptance clause the FDA COR will be responsible for inspecting and accpeting deliverables. | |
| 73 | RFP Attachment 3 FAERS II DME SOW, Section 2.1.5 | 11 | Please note that Build/Sprints must be scoped and defined for modular functional implementation based on the second or third level functional requirements provided in the validated and approved FDA Requirements document. | In order to understand the scope of work and accurately estimate the level of effort under this firm fixed price contract, could the FDA elaborate on Section 2.1.5? Will this be used as the basis for FDA’s formal acceptance and to approve payment at the end of the sprint? It is also unclear whether FDA will base their acceptance criteria on the satisfactory implementation of “second” or “third” level functional requirements. Please identify when FDA will use “second” versus “third” level functional requirements? | The lowest level of the requirements from the RTM will be used to validate the functionality. In addition, criteria for “acceptance” is UAT acceptance by the FDA's COR for of each Sprint. | |
| 74 | RFP Attachment 3 FAERS II DME SOW, Section 2.1.8 | 12 | The Contractor shall, alongside the FDA Project Manager coordinate, lead, and execute the UAT effort during finalization of modular builds/sprints for the FAERS II Program. The Contractor shall be responsible for all aspects of the UAT effort and shall perform a variety of tasks including the creation/maintenance of the UAT plan, producing detailed test cases based on existing business requirements, providing subject matter expertise to all FAERS II Integrated Project Team (IPT) members. | In order to understand the scope of work and accurately estimate the level of effort under this firm fixed price contract, could the FDA elaborate on Section 2.1.8 User Acceptance Testing (UAT)? While we are held responsible for all aspects of the UAT effort, we are not given unilateral authority to coordinate, lead and execute. In the event of delays caused by FDA personnel or events beyond our control (i.e. Government shutdown where contractor staff will continue to work but FDA staff may be unavailable), what recourse will the contractor have to recover lost time and cost under this firm fixed price contract? | UAT is a collaborative effort between the contractor and FDA business stakeholders. The FDA will ensure end users are available for UAT for each Sprint Cycle. The contractor is responsible for delivering the functionality per the sprint schedule and quality of the scripts The Contracting Officer will determine the course of action if events occur outside of the Contractor's control. | |
| 75 | RFP Attachment 3 FAERS II DME SOW, Section 8 | 24 | Table 8, 100% Instance availability to pertinent stakeholders in all four environments for testing and use | In order to understand the scope of work and accurately estimate the level of effort under this firm fixed price contract, could the FDA elaborate on Section 8, Table 8 Performance Metrics row labeled Environment Availability which states “100% Instance availability to pertinent stakeholders in all four environments for testing and use”? This is an unrealistic performance metric which would require multiple redundancies and would increase costs exponentially. Please elaborate on acceptable quality levels below 100% and what their affect may be on timely acceptance/payment. | The instance must be up 99% of the time for the relevant stakeholders in each specific environment. In the event the environment is not availabe as a result of something outside of the contractor's control such as a network outage the Contractor would not be held liable. | |
| 76 | RFP Attachment 3 FAERS II DME SOW, Section 2.3.6 | 16 | The expected value of this task order requires the contract to have an Integrated Baseline Review (IBR) for Earned Value Management (EVM) purposes. Accordingly, the Contractor shall deliver Integrated Program Management Report (IPMR) Formats 1, 3, 6, and 7. | The Earned Value Management (2.3.6) section excludes Format 5 (variance analysis) from reporting. Please confirm that variance analysis is not required. | Section 2.3.6 has been updated. Cost variances will not be required because the contract type for the task order is FFP. Schedule variance will still need to be reported. Format 5 is not required. | |
| 77 | Attachment 12, Task Mapping Matrix | Attachment 12 appears to be focused on resources that can already be named, however, the instructions do not address resource which are TBD. Does the row for “Experience” refer to the minimum # of years required and does the row for “Certification (YR)” refer to the minimum number of years a resource has been certified for TBD resources? If the labor category does not require a certification, do we list it as “N/A”? | Does the row for “Experience” refer to the minimum # of years required |
Response: Yes
Does the row for “Certification (YR)” refer to the minimum number of years a resource has been certified Response: Yes
If the labor category does not require a certification, do we list it as “N/A” Response: Yes
| 78 | Attachment 6, FAERS DME, cell F174 | Total Amount for the FY18 FAERS DME TO | In Attachment 6, cell F174 of the “FAERS DME” tab is labeled as “Total Amount for the FY18 FAERS DME TO” but does not include the Project Management cost/subtotal in cell F164. Should this be included? | Yes the Project Management cost/subtotal in cell F164 should be included in the total amount for FY18 FAERS DME TO. | |
| 79 | Attachment 6, DME | Table 6: Sprint Cycle 2: Sprints 1 and 2 | Rows 49 through 56 are a repeat of “Table 5: Sprint Cycle 2: Sprints 1 and 2” (rows 40 through 47). Should these rows be removed? | Yes the table should be deleted. Please see revised attachment no. 6. | |
| 80 | RFP Attachment 3 FAERS II DME SOW, Section 2.1.1 | 6 and 7 | ArisGlobal LifeSphere Modules or Equivalent; RxLogix PV Reports and PV Signal or Equivalent Implementation | When the Government recommended ArisGlobal and RxLogix, did they vet that the product largely, out of the box with minor configuration, will meet the requirements of FDA FAERS? | Refer to response in Question No. 26. |
| 81 | RFP Attachment 3 FAERS II DME SOW, Section 2.1.10 System Integration Support | 13 | The Contractor shall integrate the current FLARe and FAERS Public Dashboard components as subsystems of with FAERS II. FLARe uses ArisGlobal LifeSphere Intake and Triage module (previously known as agTracker) software and FAERS Public Dashboard uses QlikSense software, respectively. | For RxLogix tools, the Spotfire visualization tool is used. However, the RFP it mentions QlikSense technology. Does FAERS II require us to integrate QlikSense with the RxLogix signals tool? | No, integration is required between QlikSense and RxLogix signals tool. These are separate tools for different functionalities. |
| 82 | In column D of the product tabs in the Pricing Template, should the unit price include the cost for 50 user licenses at each tier, or do you want a specific cost per user at each tier? Should maintenance also be handled in the same manner? | See updated pricing sheet and answer questions 11 and 12. Since the FDA is purchasing Term licenses it is expected maintenance is included in the cost of the license and annual renewal. | |||
| 83 | RFP Attachment 3 FAERS II DME SOW, Section 7 | The SOW surrounding the FAERS II DME requirements (Attachment 3), has tasks and work items that have significant dependencies from product companies and contractor staff other than the Prime Contractor for this effort. For work of this significance, scope, size and complexity, HHS, including FDA, has set a precedence to utilize a contract type that would enable the FDA to have some flexibility within sprints to accommodate necessary changes to items that would provide FDA the best chance of successful execution on FAERS II. Would the FDA consider T&M or Cost Plus Award Fee (CPAF)? | No. | ||
| 84 | The Attachment 4 FAERSII Requirements Spreadsheet identifies a place where the product vendors (e.g. ArisGlobal and RxLogix) will provide information on how their product meets the FDA FAERS II requirements. As we work through each sprint, we often find that what software vendors commit to delivering may not always match exactly the FDA’s interpretation of the requirements. During these discussions, to meet the FDA required work items, we need the flexibility through these sprints to move items with the sprint framework to most appropriately build the system to be fully functional for the FDA. In addition, the external dependencies of other FDA staff and Contractors can also hold up our ability to complete sprint deliverables. The scope of this work has significant responsibility on the product and external dependencies, yet the Contract Type of FFP is placing all the liability and responsibility on the Prime. Based on this, would the FDA consider having a direct contractual relationship with the product vendors around their requirements and warranty so the Prime Contractor for FAERS is not liable or responsible for pieces beyond their control? Would the FDA consider splitting the Contract type to FFP for licenses only and T&M or CPAF for the Services work? | No. | |||
| 85 | General Question | A large amount of the DME SOW’s requirements are based on an assumption that the products that the ArisGlobal and RxLogix products currently meet a large amount of the requirements with out of the box functionality. |
For those of who have spent significant time working in software product companies, we often find that what software vendors commit to for OOB software functionality that has not yet been fully completed or fully tested. We cannot prevent a product vendor from making claims about a product function and how it meets the requirement. In no instance should the Prime Contractor be held responsible for items that they do not have the ability or authority to change. Any assertion that has been made by the product vendor, about the FAERS II requirements from their meetings and demonstrations with the FDA, should not be the liability and responsibility of the Prime Contractor.
| Since this is currently a FFP task, and payment on deliverables is currently based on review and acceptance by the COR, does the FDA recognize that the FDA is putting an undue burden on the Prime Contractor (SI) to be responsible for product warranty and that we have no control over? Would the Government be willing to buy the product and licenses directly with the vendors and provide the services work through the FAERS II contract as T&M? | The Prime is responsible for establishing teaming relationships necessary to carry-out tasks identified in the SOW. The Offeror is responsiblie for completing RFP Attachment 4 and understanding the full Functionality of the COTs tool they are offering. The Contractor may propose equivalent solutions. No, the Government will not purchase the product directly with the vendors. No, the Government will not issue a TM or LH task order for the services. | ||||
| 86 | In Section 3 of the FDA DME SOW, the deliverables already state the specific functionality to be delivered by sprint and by frequency and due date. Because we have acknowledged that there is a large dependency on product claims and external dependencies (e.g. data center), the current deliverables timeline has detail that does not provide the opportunity to leverage the best practices of agile development. For example, the miss of a deliverable in one sprint, due to a product or external dependency issue, will most likely have a cascading effect on another sprint. Based on that, we believe the FDA should consider moving the Contract type to T&M for Services work so that we are not unduly and inappropriately withheld from payment on services due to factors outside of the Prime Contractor’s direct control. Would the FDA consider making this a T&M contract for services only? | Payment of services is based on delivery of Sprints. Movement of Functional and non-functional areas between Sprint Cycles does not impact delivery of a Sprint Cycle. |
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