FinalResponseAugust1.xlsx
XLSX spreadsheet 36 KB Posted
- Solicitation number
- 16-223-SOL-00079
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Updated - Responses to Vendor Questions No. 65
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| File | Type | Posted |
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| Attachment4PricingSheet.xls | XLS spreadsheet | |
| Attachment4PricingSheet.xls | XLS spreadsheet | |
| FinalResponseAugust1.xlsx | XLSX spreadsheet | |
| 16-223-SOL-00079.docx | DOCX document | |
| CAERS_FACTS_Data_Screen_Redacted.pdf | ||
| Attachment4PricingSheet.xls | XLS spreadsheet | |
| Attachment5EPLCArtifacts.pdf | ||
| 16-223-SOL-00079.docx | DOCX document | |
| Attachement1PharmacovigilanceIDIQSOW.docx | DOCX document | |
| Attachment8Product_Features_and_Functionalities_Table.xlsx | XLSX spreadsheet | |
| Attachment2PharmacoviglianceTO_SOW.docx | DOCX document | |
| Attachment7LABOR_CATEGORYdescriptions.doc | DOC document | |
| Attachment6NDA_Form_3398_FINAL.pdf | ||
| Attachment4PricingSheet.xls | XLS spreadsheet |
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Sheet1
| Question ID | Solicitation Document | Solicitation Text | Page Number | Question | CFSAN Response | Technical? | Notes(To Be removed before final response) | |
| 1 | The “Labor” tab within the provided pricing sheet (Attachment 4) currently has pre-populated LOE hours. Does the FDA expect submitters to stay within these hour estimates, or are they meant solely as sample text and vendors may propose alternative Level of Effort to complete the work. | Yes responding contractors must stay within the LOE provided. | Contractual | |||||
| 2 | According to the solicitation, the value of the task orders to be issued is estimated to be a minimum of $25,000.00 and a maximum of $7.0M for the five (5) five year period. Does this cover both software licensing and services, or just services? | The ceiling amount of the contract for a period of five years is $7.0M. This includes licensing and services. | Contractual | |||||
| 3 | 3. The SOW states that SMT runs signal detection statistical analysis against CAERS data using Oracle Empirica Signal software. Is this expected to continue with the new system? | It is expected that Empirica Signal will be phased out by the time the solution is implemented. Analyitcs tools expected to be used downstream of the solution are SAS Analytics and SAP Business Objects. | Business | Done | ||||
| 4 | 4. Should the contractor’s response include pricing that reflects hosting costs at the WODC and ADC? | FDA will be providing the servers and storage to host the solution. | IT | Done | ||||
| 5 | 5. Should the contractor’s response include pricing that reflects hosting costs of implementing and running a helpdesk including staff, ticketing system and a phone response system? | Yes, if such services are not included in the licensing costs for the proposed COTS solution. | Business | Done | ||||
| 6 | 6. The data entered into the CAERS application is stored in the CAERS Oracle 11g Database. Is the new system restricted to using an Oracle database as well? | Yes, FDA would like to use Oracle for the new proposed solution to store the database. There will be new database for the new solution and contractor is expected to perform data migration from CAERS database to CAEMS | IT | Done | ||||
| 7 | 7. Will the legacy and new system run in parallel in production until a final cutover is determined? | Yes | Business | Done | ||||
| 8 | 8. Can commercial qualifications/past performance not entered in PPIRS still be taken into consideration for a “positive” rating? | No. Those that do not have active evaluations in PPIRS will be considered "neutral". | Contractual | |||||
| 9 | 9. Would the FDA consider extending the RFQ response date to August 11, 2016 in order to provide the most fair and complete proposal responses for both the IDIQ and Task Order requests? | FDA will extend the response date to 5pm EST on Tuesday, August 9th. | Contractual | |||||
| 10 | (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). | The requirement for SCA Labor Standards is only required under flow down clauses to subcontractors, and does not appear to be a requirement of the prime contractor. Is the SCA Labor Standard applicable only to subcontractor? Or is this an error, and the clause is not applicable to this procurement? | This clause was not selected and is not applicable. | Contractual | ||||
| 11 | (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). | IF the SCA applies to the procurement, can FDA provide the applicable Wage Determination Order which applies? | This clause was not selected and is not applicable. | Contractual | ||||
| 12 | 52.227-14 Rights In Data-General. (MAY 2016) | Could FDA provide the May 2016 version of FAR 52.227-14. The latest version accessible on the acquisition.gov website references a day of May 2014. | This was a typo. Solicitation has been updated to change the date to May 2014. | Contractual | ||||
| 13 | Pricing Worksheet | Can offerors propose labor categories in addition to the current seven categories in the “Labor” worksheet in order to ensure access to necessary labor categories to cover all six task areas (e. g help desk staff, security ATO specialists, etc.)? If so would you like us to us to use zero (0) hours in columns E and F so we do not alter overall pricing worksheet totals.? If Yes, can those labor categories be used in Labor and TO Pricing for TO 1? | No. Offerors may not bid additional labor categories. | Contractual | ||||
| 14 | Pricing Worksheet | Can labor categories be added to the IDIQ, post award, in response to specific Task Order proposal? | No. Offerors may not bid additional labor categories post award. | Contractual | ||||
| 15 | The system shall allow the user to scan paper submissions using OCR configured to minimize RM time by adding page numbers, case identifiers, and other data to document scans. | Does the FDA already utilize an OCR platform that they would prefer we interface with.? If so, what is that platform? | No | Business | Done | |||
| 16 | Users with Data Entry role also have access to the Thesaurus Management System (TMS) Oracle Forms Application to resolve any custom symptom terms added. The TMS Forms Application is connected to the TMS Database. In the case of global symptom terms (that are Preferred Terms (PT) in the MedDRA dictionary), they are resolved automatically within the CAERS application as the CAERS DB has a DB Link to the TMS DB. | (a) Does CFSAN plan to continue to use Oracle TMS for thesaurus management? (b) Is TMS used for product (drug) coding as well as MedDRA coding? | (a) No, Oracle TMS is not expected to be the thesaurus management component of the new system. | |||||
| (b) No, TMS does not contain product information | Business | Done | ||||||
| 17 | General Question | 12-month access to COTs Pharmacovigilance software and associated maintenance | As we read the Pricing Sheet Attachment 4 the FDA is asking for pricing by year which implies that you are asking for a Term license (pricing by year for licenses and maintenance)? Is that a correct assumption? | Correct. We're interested in the total cost of the software each year, including support and maintenance. If the product being proposed offers annual terms for licenses, that would be appropriate. | Business | Done | ||
| 18 | Does the government have a timeframe (number of years of data) for how much of the current data in CAERS will be migrated from CAEMS to CAERS? | The criteria to determine which adverse event cases, and which elements from within them, is still be finalized. It is likely that approximately 12 years of case data will be migrated. The size of CAERS case data is approximately 2GB, across 115,000 case records. Supporting documents managed by the system are approximately 240GB in 400,000 files. | Business | Done | ||||
| 19 | Will the offeror be allowed to put a material handling or G&A charge on the license costs from the software vendor? | Vendors may include material handling fees and G&A. Additional costs shall be identified in the assumptions tab, and properly applied in the task order pricing, if appicable. | Contractual | |||||
| 20 | Is the Government open to suggestions on the environment architecture beyond the currently structure implemented for CAERs (development, testing, pre-production, production)? | Yes open to suggestions but Government would like to maintain at least four environments Dev, Test, PP and Production to compaince with current FDA EPLC and standards. | IT | Done | ||||
| 21 | Is the expectation that any proposed cloud environments for CAERs be implemented on a system that holds a current status of FedRAMP compliant? | Yes, Any Cloud solution must be FedRAMP compliant. | IT | Done | ||||
| 22 | Can the Government provide redacted CDER MedWatch E2B and AER submission XML samples for review? | CFSAN is considering a modification of the E2B file format, currently used by CDER, to accommodate data specific to CFSAN regulated products for adverse event and product problem data interchange between CDER FAERS and the COTS to be implemented. This format will be defined as part of the solution, based on the capabilities of the proposed COTS. Please refer to http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm for the latest implementation guide of E2B for drugs. | Business | Done | ||||
| 23 | Can the Government elaborate on what it is referring to in Attachment 8 when it references rational questionnaires? | The term "Rational Questionnaire" is used to describe a browser accessible form for collecting data from submitters of information collections. In this case, the collection is regarding adverse event and product problem reports. The "Rational" concept refers to the dynamic presentation of question prompts and user interface controls which will display, hide, or modify based on submitter responses to previous questions, in order to keep the form as concise and context appropriate as possible. |
Examples can be found on the Safety Reporting Portal at www.SafetyReporting.hhs.gov. This site hosts rational questionnares for dietary supplements already, and is accessible by the public.
| UI controls must support common html forms for collecting text and list of value selections, and more advanced controls like image capture and processing on supporting browsers. | Business | Done | ||
| 24 | What third-party sources need to be accounted for in terms of importing product data, and what is the size of the data that needs to be imported? | Potential sources for product dictionary information are the National Institutes of Health Dietary Supplement Label Database, commercial sources such as Mintel, and internal FDA databases of voluntary product registration data. Product attributes that enable accurate identification of products in adverse event and product problem reports (by report submitters on the front end, and by FDA on the backend), and which will reduce records managment data entry, present the greatest value to CFSAN. |
| See also: Question 45 | Business | Done | ||||
| 25 | RFQ; Supplemental Instructions, Paragraph 10(b) | How are quote submission evaluated to derive “best value to the Government”? What are the ranking/weights of evaluation factors/criteria? | See section vii of the Combined Synopsis posted in FBO | Contractual | ||
| 26 | Attachment I IDIQ SOW, Section 2.1 | Please describe the anticipated benefits when consumers, healthcare providers, industry contributors and FDA staff submit reports through mobile devices? | Convenience of submission is expected to drive report volumes in two ways: Improved accessiblity beyond traditional desktop systems, and access to common mobile camera hardware will enable positive product identification without data entry by submitters (complex or lengthy product composition information, product usage instructions and warnings, and other label information could be captured in a single image, vs tedious data entry.) | Business | Done | |
| 27 | Attachment 8 Product Features and Functionalities, Req ID 1 | How would the FDA benefit from reports processing through Electronic Medical Records (EMR) and Electronic Health Record (EHR) systems at the healthcare providers’ point of service? | The ability to process electronic medical or health records is not a requirement of this request for proposal. | Business | Done | |
| 28 | Attachment 8 Product Features and Functionalities, Req ID 8 | What is the anticipated impact to CAEMS of improved paper forms (#3500, 3500A and 3500B) capture processing via a seamless XML conversion? | Reducing data entry, and the costs and data error opportunities it presents, is the greatest value expected from XML AER processing. XML based data interchange is expected to be developed between CAEMS and SRP, Industry members via FDA Electronic Submission Gateway (ESG), and CDER FAERS. | Business | Done | |
| 29 | Attachment 8 Product Features and Functionalities, Req ID 8 | Does the system need to be secure, with limited access, to safeguard HIPPA privacy rules compliance? If so, what are the Government's security requirements? | All appropriate measures must be taken to protect sensitive data. Please refer to privacy and confidential information clauses and section 6.5 of the Solicitation document. | Contractual | ||
| 30 | Attachment 8 Product Features and Functionalities, Req ID 28 | Does the FDA currently subscribe to or have an OAUTH service available to support the Reporter's log in via Facebook, Twitter or LinkedIn accounts? If so, who is the provider? | No | Business | Done | |
| 31 | Attachment 8 Product Features and Functionalities, Req ID 29 | What access or subscriptions to services does the FDA have in place to provide feeds for information on product ingredients, brands, manufacturer? | Related to question 24 |
| Data sources are being evaluated, both commercial and from within the FDA. At this time, it is expected that attributes will be combined from multiple data sets to create the dictionary with the most appropriate data for, and greatest market coverage of, CFSAN regulated products. | Business | Done | ||||
| 32 | Attachment 8 Product Features and Functionalities, Req ID 20 and 42 | Can the FDA describe what their vision for a "rationale questionnaire" is? What logic does the design of the form need to support? What logic does the software need to support? | Answered by question 23 | Business | Done | |
| 34 | Will the Document Image Management System (DIMS) file server be transitioned to the Ashburn Data Center (ADC) as part of the effort in Task Order 1, or will it continue to reside in the White Oak Data Center (WODC)? | DIMS is a Windows based File Server to store the Case documents. The government expect that the proposed solution will provide files storage and management capabilities for the CAEMS' cases. FDA plans to discontinue use of DIMS after implementing CAEMS. | IT | Done | ||
| 35 | Is DIMS a commercial-off-the-shelf product or an in house application? Are there any specifications for this system? | DIMS is a Windows based File Server. Also Refer response to Q60. | IT | |||
| 36 | Does the government intend to issue a task order under this IDIQ for the operations and maintenance of CAERS? | No | Contractual | |||
| 37 | Do you intend to migrate the current Business Object (BO) reports as part of this effort? If so, how many BO reports currently exist and what are the requirements for the current BO reports? | BO reports are generated from the existing system to track basic business process metrics such as workflow status and report sources and volumes, and counts of reports processed with speficied characteristics such as regarding certain product types or containing certain ingredients. There are less than 15 such reports. Additionally, there are reports saved by individual users. Training on the new universe(s) could allow users to re-create these themselves. | Business | Done | ||
| 38 | How many reports and cases are stored in the CAERS system? | There are approximately 115,000 adverse event and product problem cases in the CAERS. There may be multiple reports related to each case. | Business | Done | ||
| 39 | In what format and through what mechanism does CAERS receive electronic reports submitted through the Safety Reporting Portal (SRP) website? | The existing CAERS is not integrated with the SRP. SRP HL7 XML submissions are transmitted through the FDA ESG and retreived from a shared network folder by the CAERS team. These submissions have embedded PDF versions of their XML data. These PDF files are used by records management resources for data entry into the current CAERS. | Business | Done | ||
| 40 | What is the length of the transition period in the incumbent contractor's contract? | This is a new contract for CFSAN. | Contractual | |||
| 41 | Can the Government supply an estimated award date for pricing purposes? | End of September | Contractual | |||
| 42 | Section L does not mention the requirement to use a Gov furnished quantity of 20 on the TO Pricing tab. Should this amount be contractor estimated? | The Government is not furnishing licenses. The Government clearly states in section 2.2 of the TO SOW the contractor shall provide licenses to suport 20 users. The "20" in the pricing sheet represents the number of users the licenses should support. | Contractual | |||
| 43 | Should the Task Order Pricing Total be included in the Summary Tab Subtotal for Year 1? | Yes the Task Order Pricing should be included in the Summary Tab Subtotal for Year 1. The pricing sheet has been updated to include. | Contractual | |||
| 44 | In reference to the following requirement, can you provide a definition of the data elements, format, and structure of information from ORA FACTS Oracle database report data? Req ID 15: The system shall create new case records from ORA FACTS Oracle database report data | Stored procedures access elements in several tables in ORA FACTS to create cases in the CAERS system. See attachment for FACTS interface screen in legacy CAERS, which represents the nature of data pulled via this connection. Detailed documentation will be available post award. | Business | Done | ||
| 45 | In reference to the following requirements, can you provide the a definition of the data elements and structure of the required food product dictionary for CFSAN, including examples of use cases in which tags could be used. Ex. Potential contaminant? Etc .Req ID 3: The system shall provide the ability to add "tags" to products within its dictionary to maintain product characteristic and categorization data specific to CFSAN regulated products and public health activities. Req ID 5: The system shall house a dictionary of CFSAN regulated product identifiers and characteristics, such as product and brand names, ingredients, label warnings, images, instructions for use, firm contact information, etc. for report data standardization. | Related to question 24 |
The product dictionary will be developed based on the capabilities of the COTS selected and product datasets available at design time. The specific elements to be included in the product dictionary are still being determined. Product attributes to include will be data related to identification (brand, product, variety, strength, form, formulation number), composition (ordered ingredient names, ingredient amounts), label data (warnings, instructions) manufacturer information (Name, address, contact information), etc., with metadata such as last update date and information source.
| Additionally, custom information in a many to many relationship will provide a "tag" that can be associated to products in the dictionary. Examples: "Pre-workout", "Artificial Sweentener", "Hair Product" | Business | Done | ||||
| 46 | In reference to the following requirement, can you please expand on what is meant by "case level aggregation of all source reports"? Req ID 4: The system shall allow the user to store case data from multiple reports, various sources and follow-up report submissions. The system shall allow for the convenient review of case data at the source report level and a case level aggregation of all source reports | CAERS cases may be composed of data from multiple reports. These reports about the same patient in the same event come from healthcare professionals, friends or family members of the patient, attorneys, or industry members. Any of these reporters may then provide follow-up information later. All of these versions and subsequent data sets need to be organized and conveniently navigable in the application interface. If possible, an aggregating view of the best/latest information will be displayed to case reviewers. | Business | Done | ||
| 47 | In reference to the following requirement, can you please confirm that the referenced system is the Safety Reporting Portal (SRP)? Req ID 16: The system shall create new case records from Reporting Platform submissions | This RFP includes requirements for a new web-based, mobile-accessible reporting platform for use by CFSAN that supports the requirements described. It is expected that CFSAN will phase out it's dependency on the SRP for a smaller scale, lower cost, more closely controlled solution to be provided as part of the work described by this RFP. |
| This platform will be accessible by the reporting public. The report data entered there will be processed through the Electronic Submission Gateway and be routed to the COTS main system for processing, coding, additional data entry, medical review, etc. | Business | Done | ||||
| 48 | In reference to the following requirement, what forms of Industry XML is accepted; e.g., E2B R2, E2B R3 (and at what time), HL7? Req ID 17: The system shall create new case records from industry XML AER submissions. | CFSAN is currently considering developing HL7 or E2B compliant messages for transmission of mandatory dietary supplement adverse event reports between industry and the system to be implemented. This format will be developed as part of the solution, and CFSAN is open to developing alternate formats based on the constraints or strengths of the COTS solution proposed. | Business | Done | ||
| 49 | Do external systems that require data access require any level of access beyond read-only access? Would these external systems such as SAP Business Objects (BO) and SAS (or other software), run off of the transactional database? Recommendation would be for a high amount of analytics to be run on a replicated database. Reference the following requirement: Req ID 19: The system shall allow access to AE and PC data by external systems, such as SAP Business Objects and SAS analytics software | Yes, read-only. Currently BO runs off the transactional database although Government would like to consider a separate reporting database for BO and SAS analytics. | IT | Done | ||
| 50 | What product dictionaries must be supported? Are multiple versions of MedDRA required to be maintained in the system concurrently? Reference the following requirement: Req ID 48: The system shall allow the User to conduct coding and standardization dictionary management for product dictionaries and controlled vocabularies (MedDRA, etc.), including importing product data from external FDA or 3rd party sources (e.g. NIH Dietary Supplement Label Database) | Product dictionary is described in #24 and #45 |
| Multiple versions of MedDRA must be supported, unless the COTS has the ability to gracefully manage changes (via re-assignment, etc. of terms) from MedDRA version to version. | Business | Done | ||||
| 51 | Appendixes-are they included in or out of the 15 page count per section? | Not included in page count per section | Contractual | |||
| 52 | Please confirm FAR 352.231–70 Salary Rate Limitation (DEC 2015) only applies to CPFF task orders under this IDIQ and not Labor Hour or FFP task orders. | This clause applies to all contract types to include labor hour and fixed price. | Contractual | |||
| 53 | Will the public facing AE submissions portal (accessible by mobile devices) mentioned on page 7 of the IDIQ SOW document replace the existing Safety Reporting Portal for CFSAN’s needs? | It is expected that the COTS component/module that offers this functionality will be of lower cost and greater capability (in terms of mobile browser and hardware feature utilization). This will eventually replace the SRP for CFSAN's adverse event and product problem reporting. If the solution is flexible and cost effective enough, it may replace the SRP for CFSAN's other SRP form, the Reportable Food Registry. | Business | Done | ||
| 54 | Does the scope of the task order include creating an automated interface with the SRP and CAEMS? | Yes | Business | Done | ||
| 55 | Will the CAERS, TIMs and DIMS data repositories and applications be decommissioned as part of the CAEMS COTS PV implementation? | TMS will not be decommissioned. CAERS and its file storage component DIMS will be decommisioned after CAEMS implementation. CAEMS will not use TMS, instead use dictionaries managed in the COTS solution used for CAEMS implementation. | Business/IT | Done | ||
| 57 | Does the 1 month timeline include preceding activities for: IT Investment Management (RQST-IT) MAT list approval, CCB, infrastructure provisioning and initial configuration with sample data user for user to interact with ? | Yes. These processes can begin once the COTS solution is identified. | Business | Done | ||
| 58 | Please confirm the AE reports received by ORA and submitted to CAERS/CAEMS from the FACTS system are NOT printed out and manually re-entered into the CAERS/CAEMS system | Case creation and report data population from FACTS data is automated through stored procedures on the CAERS side. Some minor data entry is performed to handle situations where attributes describing the same adverse event data are not stored in the same format or with the same cardinality. | Business | Done | ||
| 59 | Please provide the number of AE reports, attachments and other data items that need to be migrated from CAERS to the new COTS solution and the total number of files by type and overall size of the databases. | Answered by question #18, #38 | Business | Done | ||
| 60 | What technology is DIMS based on? How much supporting documentation is currently stored in DIMS, # of documents, total size of repository, etc. Is DIMS to be replaced by the COTS solution? | DIMS is Windows File server. The government expects that the proposed COTS solution will provide the file storage capability for CAEMS' cases. FDA plans to discontinue the use of DIMS after implementing the CAEMS solution. |
| DIMS currently contains approximately 240GB of supporting documentation for CAERS cases, in 400,000 files. | IT | Done | ||
| 61 | What technology is TMS based on? How many terms are currently stored in TMS, total size of repository, etc. Is DIMS to be replaced by the COTS solution? | DIMS replacement answered by question #60 |
| TMS is Oracle based COTS product and is currently managed separately from CAERS. TMS contains approximately 500,000 terms in 30GB. With CAEMS implementation, CFSAN plans to use dictionaries managed in the COTS product. | IT | Done | ||||
| 62 | ||||||
| 63 | What Federal procurement Schedule is this procurement utilizing? | This is not a Federal Supply Schedule purchase. Per part i. of the combined synopsis is for commericial items and prepared in accordance with FAR Subpart 12.6 and supplemented by Part 13 | Contractual | |||
| 64 | Has the FDA perform market research on pharmacovigilance software products and if so, what is their product of choice? | Yes FDA posted a sources sought notice. FDA has not selected a product but as result of market research has determined there's more than one product capable of meeting FDA's needs. | Contractual | |||
| 65 | If the Contractor is required to recommend the best fit software based on the requirements provided and provide a price quote? If yes, we request a 2 week extension to the current due date to provide us an adequate amount of time to access those requirements and obtain the most favorable pricing for the FDA. | The quote due date will be extended to 5pm EST on Tuesday, August 9th. | Contractual | |||
| 66 | Please confirm 60 users per year is the basis for quoting COTs software product and maintenance costs.Will the FDA consider pricing based on active cases? If yes, please provide the current or estimated active case count and estimated case growth rate for years 2 to 5 of the IDIQ in agreement with the Pricing Worksheet. | Quantities in the Licenses and Maintenance tab have changed to be more representative of anticipated actuals. Prior to release into production it is anticipated approximately 20 users will require access to the software. Once the product is implemented into production it is anticipated CFSAN will require a maximum of 40 users. The government will consider pricing based on "active" cases. CAERS receives approximately 10,000 reports per year, with occasional update information being recieved for older cases. Task Order 1 SOW section 1.1 describes expected reporting trends | Business | Done | ||
| 67 | Are the existing interfaces shown in Figure 1: included to in the scope of the task order (CAEMS to FARM, CAEMS to CERES, FACTs to CAEMS, EASE to CAEMS, SRP to CAEMS, AE Portal to CAEMS) ? Are other interfaces required? | Figure 1 describes the configuration of the system to be replaced. There will be several interfaces supplying adverse event and product problem report data to the system to be developed. These will be with FACTS, SRP, and CDER's Central Triage Unit software (for accessing CFSAN AERs received by CDER). FARM and CERES will not interface with the CAEMS. CAEMS is expected to provide built in document management, terminology thesaurus, and product dictionary features, replacing DIMS and TMS. Finally, it is expected that the AE portal described in the RFP will be part of the COTS solution proposed and accept adverse event and product problem reports from the public. | Business/IT | Done | ||
| 68 | Please confirm all infrastructure hardware will be provided (Development, Testing, Pre-Production, and Production) to the awarded contractor (GFE) and will meet recommend server and data storage sizing requirements in agreement the COTs vendor sizing recommendations for 60 users.Please confirm all CAEMS infrastructure is separate (not shared) with the existing CAERS solution in place across all computing environments. | FDA will provide all infrastructure hardware required for COTS solution once approved by FDA on MAT list. CAEMS infrastructure will be separate from existing CAERS infrastructure. | IT | Done | ||
| 69 | Please provide legacy migration data files counts by file or data type (FDA forms, attachments, XML, flat files, etc). Please confirm FDA will provide the functional data fixes for the contractor to implement as part of the data migration. | The government expects to work with the contractor to map legacy system data to the proposed COTS system, and providing business level input to the ETL process. The contractor is expected to develop a data migration plan. This is described in section 2.5 of the Task Order 1 Statement of Work. The scope of data to be migrated is described in questions 18 and 60. | Business | Done | ||
| 70 | What data elements are in a FACTS Electronic Download? | |||||
| Complete decision tree and data elements from the SRP | The nature of the FACTS interface is addressed in question 44. |
| The specific data to be captured and the conditional logic that will dictate reporting form behavior are being finalized. The Safety Reporting Portal forms can be accessed by the general public and explored to understand the nature of the data to be collected and the show/hide logic. | Business | Done | |||||
| 71 | Complete data elements and structure of the required food product dictionary for CFSAN, including examples of use cases in which tags could be used. Ex. Potential contaminant? Etc. | Answered by #45 | Business | Done | |||
| 72 | Expand on what is meant by "case level aggregation of all source reports" | Related to Question #46 | Business | Done | |||
| 73 | Complete data elements and structure of the required food product dictionary for CFSAN | Answered by #45 | Business | Done | |||
| 74 | Define data elements, format, and structure of information from ORA FACTS Oracle database report data | Related to Question #44 | Business | Done | |||
| 75 | Confirm that the referenced system in this requirement is the Safety Reporting Portal | The system referenced in this requirement is the new reporting platform, described in Question #47 | Business | Done | |||
| 76 | Clarify what forms of industry XML is required: E2B R2, E2B R3 (and at what time), HL7? | Addressed in #22, #48 | Business | Done | |||
| 77 | Confirm that external systems require read-only access | ||||||
| Confirm that any SAP BO and SAS (or other software) would be run off of the transactional database. Recommendation would be for a high amount of analytics to be run on a replicated database | Same as Question 49 | IT | Done | ||||
| 78 | Clarify if coding for products (WHODD) is required | ||||||
| Clarify if synonym list for products is required to be maintained in the product dictionary (to accommodate mis-spellings or similar names for the same product, etc.) | Support for WHO Drug Dictionary coding is not required. The product synonym list for automatic and manual product name standardization must be conveniently maintainable by CFSAN users. | Business | Done | ||||
| 79 | What product dictionaries to support? |
Are multiple versions of MedDRA required to be maintained in the system concurrently?
| Same as Question 50 | Business | Done | ||||
| 80 | Is there a limit to where the contractor's facility can be located relative to the Wiley building in College Park , MD or will that specification be stated in the individual Task Order? | See section 5.2 of the solicitation for more information on Travel. | Contractual | |||
| 81 | What is the format. source of the medical records? Is the terminology in ICD 9/10 for these? | The records referenced are hardcopy scans of forms provided by submitters on a voluntary basis. These can be accessed by case safety reviewers as PDF files, but are not classified with any kind of metadata. | Business | Done | ||
| 83 | Can the IDIQ contract be used FDA-wide, that is , can other Centers issue Task Orders under this IDIQ contract ? | |||||
| This contract is limited to CFSAN. | Contractual | |||||
| 84 | Is there an incumbent contractor for either the IDIQ, or the Task Order included in the solicitation package? If so, can FDA share the name and contract value? | This is a new contract for CFSAN. | Contractual |
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