Final Responses to RFI Questions (version 1).xlsx
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- Solicitation number
- FDA-RFI-2026-131159
About this file
This file contains a detailed Request for Information (RFI) responses from the Food and Drug Administration (FDA) regarding their Contact Center Optimization project. The RFI seeks industry insights for modernizing the FDA's technology and service for information intake, focusing on developing an enterprise Customer Relationship Management (CRM) system and a tiered contact center solution to handle approximately 127,500 annual inquiries and complaints across multiple Centers, Offices, and Programs.
Key requirements include developing a centralized Tier 1 contact center, implementing a unified intake tool (UIT), integrating with existing systems like Adverse Event Management System (AEMS), and supporting multiple communication channels including web, email, phone, and potentially social media. The solution must be FedRAMP High compliant, support AI and automation features, provide multilingual capabilities, and include comprehensive case management. The RFI response deadline is November 10, 2025, with the FDA anticipating a lead system integrator model and potentially consolidating multiple existing contact center platforms and intake mechanisms into a single enterprise solution.
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| File | Type | Posted |
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| Amendment 3.pdf | ||
| Amendment 2.pdf | ||
| Amendment 1.pdf | ||
| Contact Center Optimization RFI with attachment.pdf |
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Consolidated Responses
| Amendment 2 | RFI no. FDA-RFI- 2026-131587 October 31, 2025 Page 2 | |
| ID | Question | Response |
| 1 | Can FDA confirm whether this RFI focuses only on public inquiries and complaints (as noted under “Immediate Scope”) or also includes internal help desk operations (e.g., ERIC/IT support) referenced later in the document? | It includes both, and other contact or call centers that would need to be identified through in-depth discovery. |
| 2 | FDA notes that the Unified Intake Tool (UIT) is under development — can FDA share technical specifications, data models, or integration standards to ensure compatibility with proposed CRM and Tier 0 solutions? | UIT is a web interface that allows public users to submit inquiries and complaints (voluntary reporting) through a series of web forms. Scope of UIT is to consolidate FDA's multiple web entry points for public (voluntary) inquiries and complaints into one simplified and unified intake web tool. The application is being built/deployed on FDA’s AWS environment using React and Node.js. UIT prefers to utilize the API(s) to send data to the CRM. |
| 3 | The RFI states that UIT integration with downstream systems (e.g., AEMS, CRM) is out of scope but also references seamless UIT integration requirements. Should respondents include conceptual design considerations only or also technical integration planning? | UIT project team will handle the integrations for UIT but will need CRM implementation team to provide API(s) to allow UIT to send data to CRM and handle sending data to any downstream systems and/or data warehouse(s)/lake(s). Conceptional design should suffice. |
| 4 | Is FDA seeking a single enterprise CRM platform for all Centers and Offices, or would a federated/multi-platform integration approach be acceptable if interoperability and governance are maintained? | Preference is single enterprise CRM, but if multi-platform approach has better advantages and benefits, then FDA is open to exploring this option. |
| 5 | Are there ongoing modernization or system consolidation efforts (e.g., existing ServiceNow, Salesforce, or Appian implementations) that may constrain or influence the proposed architecture? | Currently, there are no ongoing modernization or system consolidation efforts for existing CRM solutions. There is an effort underway to modernize Adverse Event Management System (AEMS) that handles safety evaluation and regulatory response. This modernization effort it out of scope for this RFI, but an integration between the CRM and AEMS may be required. |
| 6 | Can FDA specify which downstream systems the CRM must integrate with? | Refer to “High-Level Business Requirements for Enterprise Section” in the attachment provided with RFI. Also, see response to question 13. |
| 7 | Should vendors propose integration or migration of ERIC into the future CRM/contact center ecosystem? | Yes, initial scope should focus on Contact Centers, but the ERIC help desk can be included as a future phase. |
| 8 | Can FDA clarify whether a cloud, hybrid, or on-premises environment is preferred, or if this will be determined later during acquisition planning? | If the proposed solution requires using a vendor cloud, then it must be FedRAMPed; otherwise solution must be built or hosted in FDA GovCloud environments. Access will be provided to vendor once they’re brought on as FDA contractors. |
| 9 | The RFI references integration with ACD, CIC, SharePoint, Salesforce, and Microsoft Outlook—will API documentation and data standards be made available to support integration planning? | Where applicable API documentation and standards will be provided, but there might be instances where they need to be defined in developing the solution. |
| 10 | Is there a preference for middleware (e.g. Mulesoft) already in use at FDA? | Mulesoft is already in use at FDA |
| 11 | If a cloud deployment is preferred, does FDA have a preferred FedRAMP-authorized provider or contract vehicle (AWS, Azure, Google Cloud)? | FDA is technology agnostic as long as it is a FedRAMP-authorized provider. |
| 12 | Should vendors assume that the CRM must already possess or obtain a FedRAMP Moderate or High ATO, and is there a desired timeframe for ATO achievement? | CRM must possess FDA ATO for the environment that matches the categorization of the data. FDA ATO should be completed prior to going into production. |
| 13 | What existing identity management systems are in place to support SSO integration? | The FDA uses a number of identity management solutions to support SSO integration, including PING Federate, PING Access, PING Directory, KeyFactor, HID Global, and Entrust (nShield/nCipher). |
| 14 | Can FDA provide estimated contact volumes by tier (0–3) to support scalability and staffing projections? | Approximate annual contact (email, phone) for inquiries and complaints is 127,500 with the following breakdown by center: |
Tier 0 is not measured in these counts.
Tier 1 - Approximate annual contact (phone, email, self-service tickets, etc.) for FDA's internal help desk (ERIC) is 277,000.
Tier 2 - 60%
| 15 | Should respondents assume 24x7 Tier 1 operations, or will the call center operate within standard business hours? | Plan for 24x7 Tier 1, but initially it will be within standard business hours to support inquiries and complaints. |
| 16 | Will FDA provide existing SOPs, scripts, and content for Tier 1 agents, or should vendors plan to develop them? | For the immediate scope (Inquiries and Complaints), vendors will need to work with FDA SMEs to develop scripts and SOPs. For the long-term scope, FDA will provide existing SOPs, scripts, and content for Tier 1 agents and vendors are to evaluate and provide suggestions for improvements and efficiencies that apply best practices. |
| 17 | Are there multilingual support requirements beyond English (e.g., Spanish or other high-demand languages)? | Not at this time. You may want to consider how a translation tool may improve use of Tier 0 support as a way to minimize Tier 1 contact or to improve voluntary reporting of problems with an FDA regulated product. |
| 18 | Does FDA expect inclusion of AI and automation features (chatbots, predictive routing, NLP) in initial implementation, or should these be presented as future enhancements? | Include in initial implementation. |
| 19 | Is hybrid call center model (onshore remote + co-located support) acceptable to FDA? | A hybrid call center model (onshore remote + co-located support) could be an option FDA may consider. CSR’s need to be working in the US. |
| 20 | Will the FDA provide an estimated call volume breakdown per COP for planning Tier 1 resources? | See response to question 11. |
| 21 | Will data migration include historical records across all Centers, or only those tied to public inquiries and complaints? | Ideally both for the purposes of reports and trend analysis, but FDA would like to explore options proposed by vendors. |
| 22 | Will FDA provide source system inventories, data dictionaries, and mapping templates for planning and cost estimation? | Where applicable and available, FDA will provide the source system inventories, data dictionaries and mapping templates. |
| 23 | Are there specific data retention and archival policies (e.g., FOIA compliance) that must be built into the CRM’s data management design? | Yes. FDA has data retention and records management policies the CRM will need to accommodate. |
| 24 | Does FDA anticipate using a lead system integrator (LSI) model overseeing multiple vendors, or a single prime contractor responsible for full delivery? | FDA anticipates using a lead system integrator (LSI). |
| 25 | How will FDA coordinate cross-Center governance and change management given existing autonomy of individual Centers and Offices? | FDA has established a centralized shared service model where Centers, Offices, and Programs (COPs) remain key stakeholders. Based on industry best practice, vendors are asked to provide a coordinated approach and implementation of governance, change management, communication, and training that will lead to a cohesive and effective contact center across the Agency. |
| 26 | Does FDA already have change management, communication, or training frameworks that vendors should align with? | See response to question 19. |
| 27 | Is FDA seeking train-the-trainer materials or direct end-user training delivery? | FDA is seeking direct end-user training delivery. |
| 28 | Will FDA share any lessons learned or evaluation results from prior contact center or CRM modernization efforts? | FDA does not have any evaluations or lessons learned from prior contact center or CRM Modernization effort. |
| 29 | Can FDA identify if there is a current incumbent vendor or contractor supporting the existing contact center operations? | FDA has multiple contact centers supported by multiple vendors and federal employees. |
| 30 | If not, can FDA provide an estimated budget range or level of effort (FTEs) anticipated for implementation and ongoing operations? | See response to question 10 regarding current volume for inquiries and complaints (public facing) and ERIC (internal). ** |
| 31 | Should responses assume transition support from incumbent staff or greenfield implementation from the ground up? | For the immediate scope it will be more of a greenfield implementation since there is no current tiered contact center for handling inquiries and complaints. For the long-term scope, transition support from incumbent staff will be available where applicable. |
| 32 | Can FDA confirm whether supporting appendices (case studies, architecture diagrams) will be considered in the review, or only the 10-page primary submission? | FDA will consider supporting materials in the appendices during the review. |
| 33 | The RFI permits a 5-page appendix — may this include cost models, visuals, or pricing tables, or should those remain in the main narrative? | Summary of the cost/pricing should be in the main narrative with models, visual, or tables provided in the appendix. |
| 34 | Will non-government reviewers (contractor support) participate in the evaluation process, and if so, will NDAs be in place to ensure confidentiality? | Non-government reviewers will not be participating in the evaluation process. Only government FTEs will be participating in the evaluation process. |
| 35 | Is it the Government's intent that the respondent provide the FTE for the contact center? | The Governement's intent is to provide FTE for Tier 2/Tier 3. Vendor is asked to propose resourcing for Tier 0 work and Tier 1 support. |
| 36 | Will FDA consider an outsourced managed service approach as a solution? | Yes |
| 37 | What technology is used for public outreach and follow up activities? | Currently, public outreach includes website (fda.gov) and social media. Follow-up with the public is through phone and/or email depending on complaint type/severity and if contact infomration is provided. |
| 38 | What system delivers UIT capability? How does the UIT system currently in place not meet the requirements for CRM in this RFI that FDA is hoping to accomplish with a new system? | See response #2 UIT details. UIT does not record or save submitter information. It is just a web-based user interface. |
| 39 | Can the government share more details regarding the current multiple intake mechanisms and web-based structures to receive inquiries and complaints every year? | Mulitple web-based structures will be consolidated into one interface through the UIT project. See response to question #2 for more details. |
| 40 | Will the Government please describe the differences in how you use the Salesforce and ServiceNow packages? Please provide a brief description of the types of information that is maintained in the current named CRM systems and how the FDA is using each of the individual systems. Some level of understanding is needed in order to propose a single system or consolidation path. | a) ServiceNow is used for internal helpdesk - supports all FDA users requesting administrative, information technology, facilities, human resources, application/system, travel management, and financial management support (ERIC). It also includes , tier 2 desk side support, and systems admin support and service delivery. |
b) Salesforce is currently used by some teams to triage and manage inquiries/complaints received from the public while some teams are using ServiceNow.
| 41 | Please provide more technical details around the "Adverse Event Management System" so we can more clearly understand how to incorporate this into our approach. Could the AEMS requirements be provided? For future integration with the solution, will AEMS have REST API functionality? | AEMS receives complaints data from multiple sources. Each source system needs to send data to AEMS in a specific format (ie. BAER XML, HL7 ICSR V3, email, PDF) depending on the type of complaint. It is anticipated that complaints will flow from the new Enterprise CRM to AEMS. |
| 42 | Would FDA consider including the FDA website as part of the scope of work? | Yes |
| 43 | Will FDA consider an outsourced managed service approach as a solution? | Yes |
| 44 | Interpreting the term "vice" here as "instead of" means regulated industry intake as defined is not in scope. Following sections including "Advanced Case Management" make reference to regulatory inquiries. Please confirm the scope of the RFI as it relates to references to regulatory inquiries. | No response. |
| 45 | Can the government confirm if the UIT to AEMS integration has a dependency on CRM case creation? | Yes, it does. |
| 46 | Can the government confirm if the Contact Center solution needs to create AEMS and CRM cases at the same time and link them with a unique key to reference or will the system need to wait for an AEMS outcome before it creates a CRM case? | The contact center solution will need to create the CRM case first then pass on the required data to AEMS. |
| 47 | What system delivers UIT capability? How does the UIT system currently in place not meet the requirements for CRM in this RFI that FDA is hoping to accomplish with a new system? | See response #2 UIT details. UIT does not record or save submitter information. It is just a web-based user interface. |
| 48 | If the intent of the future state system is to consolidate and streamline systems and capabilities, why was the UIT project continued? | See response #2 - Scope of work for UIT is needed to ensure the public can easily send complaints and report adverse events. FDA is open to Vendor suggestion on how to best incorporate UIT function into overall solution and technical approach. |
| 49 | Can FDA provide a list of existing systems requiring integration that includes placement (on-prem/cloud), whether the system offers an endpoint or API to facilitate connectivity, and the underlaying data source supporting the system? | This information will come out during the Discovery phase. |
| 50 | Could the government kindly clarify whether integration with downstream systems, such as AEMS, falls within the scope of this project? The RFI specifies that this integration is out of scope on page 8; however, page 1 of the requirements document suggests that integration with downstream systems is included. | UIT to AEMS integration is out of scope as it will be handled outside of this RFI and will be implemented before this project would kick-off. |
As noted on page 7 under "Compatibility - Critical Integration Points", UIT to CRM integration is required as is CRM to AEMS integration too. Once the above integrations are implemented, the UIT to AEMS integration will no longer be required.
51 Can you clarify the critical systems and databases to be connected to based on the requirements in each tier?
For systems such as AEMS, can you clarify where these systems are currently hosted? (ie- Oracle, Azure, AWS, etc.).
Are there other systems and databases that are not critical, but that FDA would wish to connect to in each tier? For inquires and complaints, some of the centers have their own CRM solution. FDA's preference is for a single enterprise CRM solution where exisiting data may need to be migrated to new solution. If a single CRM enterprise solution is not feasible, then there are a few CRM solutions developed for the centers that will need to be integrated with primary CRM solution for Tier 1.
52 The RFI mentions that the "enterprise CRM system will consolidate the disparate tools currently used across the FDA centers". What tools/platforms are you specifically expecting to come under the functionality of the CRM? Please name the tool and/or provide a quick summary of it's functionality. FDA currently has multiple CRM platforms/tools (Appian, Genesys, Salesforce, Service Now, email) and is looking to move towards one enterprise CRM. FDA does not have an opinon or expectation of which tools/platforms should "come under the fucntionality of the CRM". Vendor is asked to propose a solution for an enterprise CRM.
See below response to question #72
| 53 | The RFI requests information on how proposed solutions leverage AI to improve performance (Page 10, Section 2(g), “Functionality”). Can FDA confirm whether vendors are expected to integrate with any existing FDA AI platforms (Elsa), or whether respondents may propose their own commercial or custom AI solutions that meet all applicable security, privacy, and performance requirements? | FDA requires integration with Elsa (FDA's existing AI platform). | ||
| 54 | Please provide more technical details around the "Unified Intake Tool" so we can more clearly understand how to incorporate this into our approach. Could the UIT requirements be provided? For future integration with the solution, will UIT have REST API functionality? | UIT can utilize REST API f to send data to the CRM. The API will need to be provided by the Vendor/CRM solution. See response #2 for more details about UIT. | ||
| 55 | What level of AI and automation adoption is FDA open to (chatbots, predictive routing, etc... for case triage)? | FDA is open to any level of AI and automation, but will require integration with Elsa (FDA's existing AI platform). | ||
| 56 | What systems does Appian interact with in your current environment? | In terms of CRM use, Appian is used as a standalone by specific group(s). | ||
| 57 | The RFI mentions “routing complaints to the Adverse Event Management System (AEMS)”. Can the FDA clarify: | |||
| • | What percentage of current inquiries trigger AEMS routing (estimated annual volume)? | |||
| • | Does AEMS have existing API endpoints for external system integration, or will FDA require custom interface development? | |||
| • | What are the mandatory data fields AEMS requires for case creation, and are there Center-specific variations (e.g., CDER vs. CDRH adverse event data models)? | |||
| • | When an adverse event case is routed from CRM to AEMS, should the CRM maintain a "read-only" view of AEMS case status, or does FDA expect full bi-directional synchronization with case ownership transfer?" | AEMS integration is tentative, and data connectivity will be available once the system is operational. | ||
| 58 | The RFI mentions “the Unified Intake Tool (UIT) currently under development as the consolidated webform entry point”. To ensure seamless integration: | |||
| • | What is the current UIT development status: requirements gathering, design, development, testing, or production deployment? What is the anticipated launch date for production? | |||
| • | Does UIT have a defined API specification for external systems to consume submissions? If so, can the FDA provide API documentation (endpoints, authentication method, data schema, rate limits)? | |||
| • | Who is the UIT vendor/development team, and will they be available to collaborate on CRM integration during our implementation? | |||
| • | If UIT is not production-ready within the proposed implementation timeline, should the CRM solution include temporary webform capabilities, or would FDA prefer to wait for UIT completion before migrating web intake channels?" | UIT will be production ready prior to implementation timeline. Refer to response #2 for more details on UIT. | ||
| 59 | RFI, Security, bullet 6.a.i | 11 | The RFI requires FedRAMP High compliance. To streamline the ATO process: | |
| • | Does FDA prefer to leverage existing FedRAMP High ATOs (e.g., Salesforce Government Cloud, AWS GovCloud) and perform FDA-specific risk assessment, OR does FDA require a separate FDA-specific FedRAMP authorization for this system? | |||
| • | Who is the FDA's Authorizing Official (AO) for this system, and what is their current workload/availability to support ATO activities? Should we anticipate a 6-month, 12-month, or longer ATO timeline based on the capacity of the FDA CISO office? | |||
| • | Does the FDA have a preferred System Security Plan (SSP) template or NIST 800-53 control baseline we should use, or should we leverage the FedRAMP High baseline template? | |||
| • | Are there any FDA-specific security controls beyond NIST 800-53 High baseline that must be implemented (e.g., additional PIV requirements, data residency constraints, specific encryption algorithms)?" | |||
| Cloud service providers must have an existing FedRAMP ATO which the agency will evaluate as part of an FDA specific authorization. |
The FDA CIO is the agency’s Authorizing Official. You will work with the Risk and Compliance team and the assessment team to complete the ATO activities. The typical time frame for an ATO is 8 – 12 weeks and will be conducted concurrently with system deployment.
FDA has template for SSP (includes the NIST 800-53 controls that apply to the security baseline commensurate with the system’s security categorization )and various other security related document that can be shared.
There are no FDA-specific security controls beyond NIST 800-53 High baseline that must be implemented (e.g., additional PIV requirements, data residency constraints, specific encryption algorithms)
| 60 | Has there been an Enterprise CRM solution that has been chosen or preferred? | "FDA seeks solutions for a structured tiered contact center and enterprise CRM system to support the integrated customer journey for inquiries and complaints raised to FDA." The enterprise CRM solution has not been determined and the FDA asks vendors/respondents to propose a solution bases on requirements laid out in the RFI. |
| 61 | Is the CRM Solution the choice of the contractor or the FDA? | FDA is tool agnostic, but will make final decision on which solution to implement. |
| 62 | Is the contractor expected to replace the FDA Automated Call Distribution system with their own CRM/Telephony system? Is the RFI requesting specifics on what CRM/Telephony system the contractor would utilize to handle the volume of 127,500 calls per year? | FDA currently uses Genesys ACD and would prefer to continue, but open to vendor providing a recommendation that would easily integrate with an enterprise CRM. |
| 63 | What information is stored in AEMS and what needs to be synchronized? | This will come out during Discovery phase |
| 64 | Once the system has been developed, who owns the developed database? | FDA will own the database. |
| 65 | Are there any accessibility requirements in the development of the website self-serve, systems, etc? | Yes - systems must all be 508 compliant |
| 66 | Can you share current processes for drafting CRM solutions? | FDA does not have a process for drafting or developing a CRM solution. Instead high-level business requirements were provided as an attachment to the RFI. It is expected the vendor will provide in their response the strategy and approach in developing the CRM solution. |
| 67 | Can you share the current forms used to capture a complaint/inquiry? | UIT will handle inquiry & complaint intake. |
| 68 | Does the system need to tabulate complaints/inquiries, i.e. frequency on a product? | Yes. This would be included with the overall reporting and analytics. |
| 69 | Can complaints and inquiries be made through chat? | Yes. This would be a required capability for the broader self-service solution integrated with enterprise CRM solution. |
| 70 | What are done with the inquiries and complaints once captured? Need to be assigned through CRM? | Once logged as a case in the CRM and depending on the complexity of the inquiry, it would be triaged by Tier 1, Tier 2, or Tier 3 teams. |
Complaints will also be logged in the CRM for traceability and passed onto AEMS or Complaints Management System (CMS) for triaging.
| 71 | Is there currently an LMS (Learing Management System) system in place that requires integration? If not, is there a requirement to include an LMS system in the application suite? | FDA currently has an LMS system. |
| 72 | How many contact center agents and support specialists are employed at the FDA today? |
We have enough CSR's to cover the volume of operations as they exist today.
| 73 | Who is the current telephony provider and who is responsible for managing the telephony infrastructure (i.e. internal, 3rd party, PSTN provider, contractor) | FDA is currently using Genesys ACD and is being managed internally. |
| 74 | Can FDA please provide an inventory of each call center today, including business function, technology, and number of staff? | See above response to question #72 |
| 75 | What is FDA currently using for knowledge management? | For ERIC, it is ServiceNow |
| 76 | Could the government kindly provide the standard operating hours for your contact center's live agents, along with any guidelines or expectations pertaining to agent availability and responsiveness during those periods? | For Centers: Normal business hours 8 a.m. - 4:30 p.m. ET, weekdays. Phase 2 Services are available 24/7. |
If emergency, then it is 4:30 p.m. to next business start time; all day on weekends - very limited staff
| 77 | What social media platforms is FDA considering, and what actions would FDA like to perform (e.g. Case submission, social listening, checking status of submitted case)? | X, Facebook, LinkedIn |
| 78 | Genesys - Does FDA intend to use Genesys as the telephony system for this Contact Center, or are other phone systems being considered? | See reponse to question # 62 |
| 79 | What is the current email volume and are emails sent individually or are updates sent in batch? If both, can you clarify email volume for each type (batch and individual)? |
See answer 14
| 80 | Which of the existing platforms (Appian, Genesys, Salesforce, ServiceNow) are most entrenched or have existing integrations FDA expects to retain? | Genesys and ServiceNow is the most entrenched integration. FDA has no expectations on which platform(s) to retain. This will depend on Vendor's proposed solution. | |
| 81 | Are there any licensing constraints or existing contracts FDA has with CRM or contact center platforms? | There are existing licensing FDA has for Salesforce, Appian, Genesys, and ServiceNow. Depending on the enterprise CRM solution to be implemented, FDA will need to consolidate or eliminate licenses. | |
| 82 | Will FDA provide access to UIT development teams for integration planning? | Yes | |
| 83 | Can the government describe the 100 different intake mechanisms by centers? For the 20 different web based structures by centers, what platforms does the government use for this? | Vendor only needs to focus on the scope as defined in the RFI. Consolidation of the intake mechanisms is underway and out of scope of this RFI. See response to questions 50 & 51 for more details on integration. | |
| 84 | What is the implementation timeline for the UIT? Is there a specific team that will be responsible to work integration points with other systems? | UIT will be production ready prior to implementation timeline. Refer to response #2 for more details on UIT. | |
| 85 | Can the government provide a list of CRM instances and platforms that are in use for potential consolidation? | Refer to above response for question # 72 | |
| 86 | To ensure future compatibility, can the government share whether the UIT leverages standard APIs or middleware frameworks that vendors should plan to accommodate in their design assumptions? | Vendor should assume API(s) will need to be developed to allow UIT to send data to the enterprise CRM. For transformational APIs to handle the various downstream systems, the government suggests providing an estimated level of effort & cost to build an API (including discovery, analysis, design, build, and test). | |
| 87 | UIT to AEMS and UIT to CRM Integration are mentioned separately. Please elaborate on the expected routing logic and touchpoints for the two paths. | Refer to above response for question # 50 | |
| 88 | Please elaborate on scope and level of detail to provide for "technology stacks". | Please provide architectural diagram to show proposed solution design along with technology/platform (ie. Service now, Salesforce, Oracle, MariaDB, MuleSoft, Informatica, etc.) | |
| 89 | This section has additional outbound relationship management features beyond "intake". Is this part of the long term scope beyond the immediate focus of the RFI? | Yes | |
| 90 | Will this initiative replace the existing contact center contracts and systems, or is FDA considering a phased or hybrid model to operate in tandem during transition? | This will depend on the vendor's implementation approach. | |
| 91 | Are there specific systems or platforms that FDA intends to retain or sunset as part of the modernization (e.g., UIT, AEMS, ServiceNow)? | This will depend on the vendor's solution and implementation approach. FDA is open to retaining and/or sunsetting systems. | |
| 92 | Can the FDA address the more than 100 intake mechanisms and more than 20 different web-based structures that are currently in place to receive and process 200,000 inquiries and complaints? Specifically, are there plans (or preferences) to eliminate or consolidate many of these existing channels, and if so, please share with us the timeline for doing so, and the targeted number that would remain once consolidation is completed? | Intake consolidation is underway. UIT will consolidate web-based structures that allow the public to submit inquiries and complaints (see response #2 for more UIT details). Vendor will need to consider UIT for intake, along with emails and phone calls. | |
| 93 | There was no mention of a mobile app or other mechanism for intake via mobile devices. Is this something that the FDA would be interested in acquiring? | UIT is handling intake via mobile devices. If vendor's proposal includes enhancing or replacing UIT to provide a better overall solution, FDA is open to considering it. | |
| 94 | Is the FDA anticipating leveraging Artificial Intelligence (AI) and Machine Learning (ML) for self-service, quality assurance, reporting/analytics, etc? | FDA is open to considering AI solutions. | |
| 95 | Reference "Comprehensive Case and Ticket Management": This question relates to our response and recommendation of a CRM application or Incident Managment application. CRM applications are typically "case" centric and manage the entirety of the customers relationship. The term "Tickets" typically refers to a help desk solution which typically involves a single interaction focused on the closure of that single incident/ticket. Is the FDA seeking a hybrid CRM solution which is suitable for both areas? | Yes - should support both - case management and incidents. | |
| 96 | The FDA appears to use 2 current channels/methods for consumers and agencies to contact the FDA. Is the Agency actively interested in supporting other channels, if so what channels would be integrated with Self-Service and CRM? Is the UIT managing those integrations ? | See responses to above questions #2,3, and 77 | |
| 97 | Page 4 notes that FDA uses more than 100 intake mechanisms and more than 20 different web-based structures to | ||
| receive and process 200,000 inquiries and complaints every year. Could FDA share additional details on the breakout of these inquiries by intake, tier, by month and the anticipated growth or seasonal variance rates to inform call center structure, capacity and scalability planning? | See response to above question #84 | ||
| 98 | How many current Customer Service Reps (CSR's)are there? | We have enough CSR's to cover existing scope with current business processes. | |
| 99 | How many skills/queues/departments are represented by these existing CSRs? | At least 14 functional areas in addition to the programatic contact centers functions. Queues are established as needed to support business functions. | |
| 100 | Is there an existing Learning Management System (LMS) in place? | Yes | |
| 101 | Is management of the Knowledge Library part of scope for the vendor or is that to be done by FDA staff? | Both - FDA staff is responsible for keeping knowledge library content up-to-date. Vendor is resposible for maintaining the knowledge library as a feature/function. | |
| 102 | Is there an existing Enterprise Document Management System (EDMS) in place? | Yes | |
| 103 | The RFI notes that several FDA organizations currently use tools such as Appian, Genesys, Salesforce, and ServiceNow. Can FDA clarify whether Genesys is the primary platform currently used for inquiry and complaint management, or whether usage is limited to specific Centers or programs? Understanding the existing footprint will help respondents better define integration and migration strategies. | See above response to question #72 | |
| 104 | Are there any limitations on where Tier 1-3 personnel should be located? Can they be on contractor site? | There are no limitations on location of tiered support personnel as long as support is available during defined/required hours. | |
| 105 | Will the ERIC support personnel functions be fully provided by FDA resources? Are the contractor responsibilities to provide the overall Contact Center and Enterprise CRM solution for this? | Depends on what the vendor proposes. | |
| 106 | To estimate number of agents it is important to have additional data like number of calls by function and average hold time. Will the FDA please provide this data? | See above response to question #72 | |
| 107 | Is it the Government's intent to have the respondent provide the personnel to perform the consolidation/update of Tier 0 information? | FDA subject matter experts (SMEs) will provide Tier 0 information. Respondent will provide personnel for architecting/designing Tier 0 approach and for managing the implementation of Tier 0. | |
| 108 | Is it the Government's intent that the respondent provide the FTE for the contact center? | See above response to question #35 | |
| 109 | What ACD is in use today and is the FDA open to replacing it as a part of future phases? | See above response to question #73 | |
| 110 | Is there an existing knowledge base in place today and, if so, what brand is it? | ServiceNow is being used as the knowledgebase for ERIC Helpdesk (Phase 2) and ERIC Admin. | |
| 111 | What role does Genesys play in your existing environment? | Primary role is for receiving and routing calls. | |
| 112 | Can the government provide a breakdown of annual volume of inquiries/contacts by channel? By center/Office? | See above response to question # 72 | |
| 113 | Can FDA provide volumes associated with the Strategic Case Types? | See above response to question # 72 | |
| 114 | Is the contractor absorbing the current FDA staff, if so how many are there? Will the contact center staff remain employed by FDA ? | No, contractors will not be absorbing FTE's | |
| 115 | How many call centers are merging? | The call centers as a whole will not be merging. Primary objective is to consolidate the Tier 1 across the call centers within the scope of this RFI. Tier 2 and Tier 3 for inquiries and complaints will remain with each respective center. | |
| 116 | How many reps are handling this work now? | See above response to question # 72 | |
| 117 | What are the hours of operation for the initial phase of the call center? Is it open 365 days of the year? | See above response to question # 76 | |
| 118 | What languages are currently offered or want to be offered? | See above response to question #17 |
| 119 | Does the contact center perform any outbound contacts to gain additional information on complaints/inquiries? | Yes, when in some case where additional information or follow-up is required |
| 120 | Does the contact center transfer calls to other external departments? | There are escalation paths that are not always within the same business unit. |
| 121 | What level of security will the employees need, special background checks? | Level of security will be Public Trust |
| 122 | What is the average talk time, average handle time, hold and after call? | See above response to question #72 |
| 123 | What is the required response rate, answer rate? | See above response to question #72 |
| 124 | What is the current process for quality assurance? | See above response to question #72 |
| 125 | Process for escalation management? | See above response to question #72 |
| 126 | Is there currently training that would be provided to contractor? | Where applicable with supporting documents, training may be provided to contractors. |
| 127 | Will there be FDA oversight within the contact center? | While there will be oversight by FDA, there are no plans to phsycially place FDA resources at contact center for oversight. |
This will also be the same in Phase 2.
| 128 | Who is completing the analysis, research and multi-departmental coordination on complaints/inquiries? | For any inquiry that is deemed complex, it will be handled by Tier 2 and Tier 3 resources with each respective center. Complaints are logged by Tier 1 and passed onto Tier 2/Tier 3 for further analysis |
| 129 | What subject matter experts are required for contract? | SMEs requirements will be detailed in the solicitation should the FDA release one. |
| 130 | It states that the FDA receives approximately 127,500 calls every year. What is the yearly volume for emails, social media inquiries, and any other form of customer inquiries to the FDA that the contractor would need to support? | See above response to question #14 |
| 131 | Is there currently a Staff Scheduling system in place? If not, is there a requirement to inlude a staff scheduling application as part of the application suite? | No |
| 132 | The bullet states "Establish an enterprise Tier 1 call center to accommodate current and anticipated volume for all FDA COPs". Is this a virtual or physical call center? | See response to question # 19 under Consolidated Responses tab |
| 133 | What is the name of the ACD currently in use? | See response to question # 26 under Technical and Integration tab |
| 134 | What is the current Tier 1 staffing model in terms of full-time employees versus contractors? | See above response to question # 72; Tier 1 staffing for inquires and complaints are full-time employees. |
| 135 | Are there any constraints or expectations regarding retaining existing Tier 1 staff? | See above response to question # 115 |
| 136 | Are there union or federal employment considerations that would affect staffing recommendations? | Depends on what the vendor proposes, but this is not expected. |
| 137 | What are FDA’s target service level agreements for Tier 1 and Tier 2 response and resolution times? | For inquiries and complaints this will be based on the outcome of discovery. |
SLAs will be provided with the solicitation should the FDA decide to release one.
| 138 | Will FDA provide internal training resources or should the vendor lead all training efforts? | See above response to question #127 |
| 139 | What training formats does FDA prefer (e.g., LMS, instructor-led, video)? | FDA is open to vendor's suggestions on training formats. |
| 140 | What is the timeline for onboarding across FDA Centers? | Depends on what the vendor proposes. |
| 141 | Are there any constraints or preferences regarding geographic location of Tier 1 call center agents? | See response to question # 19 |
| 142 | Will FDA provide Tier 2 and Tier 3 subject matter experts or should the vendor propose staffing for those tiers? | Yes |
| 143 | Will FDA provide access to existing knowledge bases or is the vendor expected to build them from scratch? | Both |
Yes, there will be access to the exisiting knowledge base provided.
| 144 | Are there any preferred tools or platforms for knowledge management and content creation? | No |
| 145 | What volume of inquiries and complaints is expected to be handled by Tier 0 self-service annually? | Undetermined |
| 146 | Will FDA provide access to existing training materials, SOPs, and communication templates? | Yes |
| 147 | Are there any expectations for multilingual support or accessibility compliance in the CRM and contact center solution? | See response to question #17 |
| 148 | Which organizations have more mature triaging process and technologies and can the government provide information on these? | No Response |
| 149 | Will domain expertise (Tier 2 and Tier 3) be supplied by the FDA or by the contractor? | FDA will supply Tier 2 and Tier 3 domain expertise |
| 150 | Please describe anticipated contractor scope regarding content creation versus management and maintenance of knowedge content. | See response to question #102 |
| 151 | Under "Geographic and time zone coverage", "service level agreements" are mentioned. Can FDA share any prospective details on SLAs? | See above response to question # 139 |
| 152 | Can you pls provide clarification on the call centers and number of calls? | See above response to question # 1; Tier 1 staffing for inquires and complaints are full-time employees. |
| 153 | Can FDA provide a list of the current contact centers in operation across Centers, Offices, and Programs (COPs)? | See above response to question # 1; Tier 1 staffing for inquires and complaints are full-time employees. |
| 154 | Are there existing vendors or contractors currently managing any of these contact centers or CRM systems (e.g., ERIC Help Desk, Appian, Genesys, Salesforce, ServiceNow)? | See response to question #29 |
| 155 | Could FDA clarify whether the envisioned Tier 1 enterprise call center is expected to operate as a centralized, contractor-managed facility supporting all Centers, Offices, and Programs (COPs), or if the intent is to maintain hybrid operations where certain COPs retain internal Tier 1 capability? | Tier 1 enterprise call center is expected to operate as a centralized, contractor-managed facility supporting all Centers, Offices, and Programs (COPs) |
| 156 | Does FDA have an anticipated staffing model or preferred ratio between federal employees and contractor resources for the Tier 1 contact center operations, or should respondents propose a recommended model based on best practices and workload analysis? | Respondents should propose a recommended model based on best practices and workload analysis. |
| 157 | Does the government have a preferred telephony or CRM system from the list provided (Salesforce, ServiceNow, AWS Connect, Genesys)? In other words, does the government have systems that perform better than others? | See response to question # 62 |
| 158 | Is the FDA anticipating one awardee, or are you considering one contractor for Tier 0 calls and another one (or more) for Tiers 1 and above? | See response to question #24 |
| 159 | We request that the government clarify the applicable FedRAMP baseline. We suggest evaluating the FedRAMP Moderate standard to promote open competition, as currently, limited vendors support both CRM and CCaaS solutions at the FedRAMP High level. | This is dependent on the categorzation of the data. If the data is high then the cloud soluiton needs to be high as well. |
160 Does the FDA plan to leverage existing HHS Zero Trust reference architectures, or will the integrator propose a new ZTA overlay for the contact center ecosystem? The integrator is not expected to propose a new ZTA overlay. FDA will leverageHHS Zero Trust Architecture.
161 Regarding "Replace real names with system-generated codes or identifiers that cannot be traced back to individual staff members:" When would this be applicable to day to day operations? What security standards would this be part of? See above response to question # 162
162 Does the identity management requirement apply to internal users (i.e. not public users) or both? See above response to question # 162
| 163 | What identity provider does FDA use for authentication and single sign-on? | See response to question # 13 |
| 164 | Will FDA provide security monitoring or is the vendor expected to manage a security operations center? | Depends on the implementation and where it is hosted. If hosted in FDA's ecosystem, then FDA would manage the SOC, If hosted on vendor's ecosystem, then vendors do their own monitoring. |
165 Are there any specific compliance or audit requirements beyond FedRAMP, FISMA, and NIST that vendors should be aware of? Standard NIST and FedRAMP auditing requirements are the baseline for FDA systems. Deviations and/or compensating controls are considered on a case-by-case basis.
| 166 | What are FDA's current KPIs? Will those change with new product? | For inquiries and complaints FDA is requesting vendors to collaborate with center SMEs and provide their recommendations on KPI and other metrics that should be generated and monitored. | |
| 167 | What contact center business value metrics does FDA consider critical when evalauating technology options? | See above response to question # 168 | |
| 168 | Is there a preference for where the reporting and analytics would be surfaced? (ie. within CRM, data warehouse, Tableau, or other application) | See above response to question # 168 | |
| 169 | How will FDA measure performance across the integrated journey (Tier 0–3)? Are there existing SLAs or KPIs we should align with? | See above response to question # 168 | |
| 170 | What type of reporting is desired, i.e. what KPI’s/stats, in what frequency, format? | See above response to question # 168 | |
| 171 | What reporting cadence and format does FDA expect for performance metrics? | See above response to question # 168 | |
| 172 | Does FDA require real-time performance dashboards or periodic reporting? | See above response to question # 168 | |
| 173 | Can the government provide additional metrics or targets on historical interactions, as staffing depends greatly on the average handle time for an interaction and daily/hourly contact volumes? | See above response to question # 168 | |
| 174 | The RFI references “multiple CRM platforms” across FDA’s Centers, Offices, and Programs. To scope data migration accurately: | ||
| • | Can FDA provide a complete inventory of current CRM systems by Center, including: platform vendor (Salesforce, ServiceNow, Genesys, Appian, custom), instance count, record volumes, and data retention periods? | ||
| • | For Centers using Salesforce currently, what edition/version are deployed (e.g., Professional, Enterprise, Unlimited), and what level of customization exists (custom objects, Apex code, integrations)? | ||
| • | Are there any Centers that do NOT currently use a CRM system and rely entirely on email/Excel/manual processes? If so, which Centers and estimated inquiry volumes? | ||
| • | What is FDA's policy on historical data migration: should all historical cases be migrated regardless of age, or is there an acceptable threshold (e.g., migrate only the last 3 years, archive older data)?" | Inventory of CRM services will be part of Discovery process - there are not many as it relates to Inquiries and Complaints. |
There are customers who are not currently using a CRM.
Historical data migration may be needed. Volume and approach will depend on outcome of Discovery phase. The FDA is asking vendors to propose possible approaches and include assumptions where needed.
| 175 | How much data will be transferred from current system to new one? | It depends on the proposed solution and approach. | |
| 176 | What format would the data export be in? | It depends on outcome of Discovery and the proposed solution/approach. | |
| 177 | Which legacy systems are in scope for data migration? | Possible legacy systems for data migration may include Salesforce, ServiceNow, Appian, Excel. This all depends on proposed soultion/approach. | |
| 178 | Is historical data required to be migrated, or only active cases? | The Governement is open to vendor proposal on how to approach historical data. | |
| 179 | Will FDA provide data dictionaries or schemas for legacy systems? | The FDA will provide data dictionaries and/or schemas for legacy systems where available. | |
| 180 | What are FDA’s expectations for data quality, validation, and cleansing during migration? | The FDA expects a phased approach starting with immediate scope of complaints and inquiries and poduct/program areas (Foods, Drugs, Devices, etc..) and then expand approach to accommodate the long term scope to ensure data is accurate, complete, and consistent. | |
| 181 | Please elaborate on the data to be migrated. For example, general descriptions of schema, types of data, volumes, and how it can be accessed. | Refer to reponses to questions #176-182 | |
| 182 | Are there existing change management frameworks FDA prefers or expects vendors to follow? | None. | |
| 183 | Given the current government shutdown, does FDA anticipate any impact on procurement milestones or decision timelines associated with this RFI or a potential follow-on solicitation? Understanding whether submission deadlines or subsequent acquisition activities may be delayed will help industry plan resources appropriately. | The FDA intents to move forward the RFI given the current government shutdown. Any critial change, such as RFI due date, will be made in the form of an amendment and posted on SAM.gov | |
| 184 | What contracting vehicle or acquisition strategy does FDA anticipate using after this RFI (e.g., BOOm BPA, CIO-SP4, OASIS+)? | The FDA will determine the appropriate contracting vehicle based on the results of market research. | |
| 185 | Will FDA consider industry-led demonstrations to validate solution concepts? | The FDA will make the decision based on the results of market research. | |
| 186 | Is there a Servcie Contract Act (SCA) requirement? | The FDA will make the decision based on the results of market research. | |
| 187 | Is the Executive Summary included in the 10 page limit or is it separate? | Yes | |
| 188 | Does the 11 point font requirement apply to content written in diagrams and graphics? | Yes | |
| 189 | Is there a limit to the number of attendees vendors may have on a one-to-one meeting? Who from the FDA should vendors expect to be meeting with? | The FDA will make the decision based on the results of market research. | |
| 190 | • | Does FDA anticipate this RFI leading to one comprehensive solicitation or several phased procurements over time (e.g., design, CRM implementation, call center operations)? | The FDA will make the decision based on the results of market research. |
| 191 | • | Will FDA consider multiple-award vehicles or is the intent to select a single prime integrator for any future solicitation? | The FDA will make the decision based on the results of market research. |
| 192 | • | Is there an estimated timeline for the follow-on solicitation or Industry Day mentioned for November 2025? | The FDA will make the decision based on the results of market research. |
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File details come from the government source that posted it. Updated .