FDA-RFI-75F40125Q00020 Business Data Enrichment Services.docx

Request for Information for the Food and Drug Administration (FDA) FDA-RFI-75F40125Q00020 Business Data Enrichment Services - Request for Information

October 24, 2024

Introduction

The purpose of this request for information is to obtain technical and/or business information and input from the marketplace for project planning purposes regarding the availability of existing or potential solutions, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing Business Data Enrichment Services to implement an enterprise master data management program to improve the completeness and accuracy of existing and incoming data, and ensure all business data are accurate, consistent, and fit for purpose across operational and analytical systems that interact with the Agency. This goal is accomplishable through a multi-tiered approach aimed at prioritized and focused components of enterprise data management and enterprise data interoperability.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ). The RFI does not commit the Government to award a contract now or in the future for any supply or services whatsoever. Furthermore, the FDA will not accept unsolicited proposals.

The Government is not responsible for any cost incurred by stakeholders in furnishing information. All costs (time/material/services) associated with responding to this RFI will be solely at the interested stakeholder's expense. Not responding to this RFI does not preclude participation in any future RFI, Vendor Day, or RFQ, if any are issued. Any information submitted by stakeholders to this RFI is strictly voluntary. All submissions will become Government property and will not be returned. The Government reserves the right to request clarifying remarks from RFI submissions. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the questions contained in this notice. The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

Background

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and more affordable as well as helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FDA’s work and business are extremely information intensive. As such, the Agency continues to increase its reliance on the successful operation, maintenance, and enhancement of its information technology (IT) systems, which enable FDA to meet the following statutory requirements:

· The Drug Supply Chain and Security Act (Title II, Drug Quality and Security Act, 2013): The Act addresses risks in the pharmaceutical distribution supply chain by establishing a national system enabling stakeholders and regulators to trace each product package.

· Executive Order 14001: President Biden signed Executive Order 14001 on January 21, 2021 ordering immediate action to secure supplies necessary for responding to the COVID-19 pandemic and increasing Department of Health and Human Services (HHS) role in the Public Health Supply Chain.

· Executive Order (EO) 14017 On America’s Supply Chains: President Joseph R. Biden issued EO 14017 in response to which HHS delivered its report on what it has done to help make our public health supply chain and industrial base more resilient, diverse, and secure.

· The Food and Drug Omnibus Reform Act of 2022: Grants more power to FDA to perform inspections at home and abroad.

· The Safe Medical Devices Act of 1990, Medical Device Amendments of 1992, and Mammography Quality Standards Act (MQSA) of 1992

· The Food and Drug Administration Amendments Act (FDAAA) of 2007

· The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)

· The FDA User Fee Act and its associated amendments

· Prescription Drug User Fee Act (PDUFA)

· Generic Drug User Fee Act (GDUFA)

· Medical Device User Fee Act (MDFUA)

· Biosimilar User Fee Act (BSUFA)

· Over-The-Counter Monograph Drug User Fee Program (OMUFA)

· Animal Drug User Fee Act

· Animal Generic Drug User Fee Act

· The FDA Modernization Act of 1997

· The FDA Food Safety Modernization Act

· The Drug Quality and Security Act

· The Sunscreen Innovation Act

· The 21st Century Cures Act

· The FDA Reauthorization Act of 2017 (FDARA)

· The Federal Information Security Management Act (FISMA)

· The Federal Food, Drug, and Cosmetic Act

To accomplish this, FDA uses the One Health strategy to develop stronger cross-Center and cross-office relationships, exchange educational experiences within the Agency and with other Federal agencies, and further public and global health. The key priorities of this strategy are:

· Advancing Regulatory Science and Innovation: A wide range of regulatory activities, include setting standards for products that address unmet public health needs; identifying and mitigating the spread of disease using informatics; modernizing toxicology and hazard assessments; protecting the food supply; and regulating tobacco.

· Strengthening the Safety and Integrity of the Global Supply Chain: Complex global supply chains, international trade, the foreign sourcing and manufacture of regulated products, and increased volume and complexity of imported products have forced FDA to reevaluate its approach to supply chain safety. FDA must require more and better information about product supply chains and monitor this information throughout the product life cycle.

· Strengthening Compliance and Enforcement Activities to Support Public Health: FDA enforcement actions affect not only the manufacture and distribution of foods, drugs, biologics, medical devices, tobacco, and cosmetics, but also their development and marketing. Enhancing FDA’s compliance and enforcement programs will strengthen the Agency’s focus on preventing problems and responding rapidly when violations occur.

In support of the Agency’s mission, FDA has established an Information Technology Strategy Plan (2024 – 2027). More than a roadmap, this plan is a shared FDA vision for excellence. This unified approach will innovate and enhance public health outcomes by focusing on six key goals:

1. Enhancing Collaboration: Create a Shared OneFDA Ecosystem.

2. Strengthening Infrastructure: Modernize and secure IT infrastructure.

3. Modernizing Services: Optimize IT services for stability and adaptiveness.

4. Sharing Data: Drive efficiency and innovation.

5. Adopting AI and Innovations: Embrace emerging technologies.

6. Cultivating Talent and Leadership: Develop technology expertise and leadership.

FDA has identified the need to improve the data management of regulated and related business entities throughout their full lifecycle, from pre-market through postmarket activities. FDA has a vision to create an environment where regulatory data and submission information are based on common standards, are available electronically and available to support advanced analytics to better inform regulatory decisions for improving public health. It is critical that each business entity is correctly identified, validated, and verified, and that FDA has access to third-party business information relating to that entity. This includes but is not limited to applying data standards, formatting, and data cleansing, matching and/or merging, and enriching data as needed.

The Federal Food, Drug, and Cosmetic Act requires that most manufacturers and processors of FDA-regulated products register their facilities with FDA, and in many cases also provide FDA with a listing of their products in commercial distribution. Due to various factors, FDA registration and other facility identification data were inaccurate and incomplete, especially with foreign business entities. The Agency has been harmonizing the tracking of regulated establishments (unique entity), products, associated application data, regulatory activities, and adverse events to address the following findings:

· No single source of truth for corresponding business-related data, from investigational to pre-market and postmarket and safety surveillance phases

· Difficulty in exchanging information between IT systems

· Inconsistency of data format and content across multiple IT systems

· Out-of-date data (due to the multiple and inconsistent versions of data maintained in many IT systems)

· Insufficient management of multiple data identifiers

· Inability to track data changes and their provenance over time.

To uphold the Agency’s responsibilities, FDA has multiple ongoing projects and activities that require business information and support services to help establish business entity identities, assess regulatory and product risk, determine a business entity’s involvement in FDA-regulated activities, and track product supply chains.

The FDA Safety and Innovation Act of 2012 (FDASIA), requires FDA to specify a Unique Facility Identifier System for drug manufacturers to accurately identify their establishments (unique entity) and their importers when registering with the Agency. FDA has initiated an Enterprise Master Data Management program to harmonize the data and identifiers for all business entities throughout the Agency. This requires integration with third-party data, subscription and/or services (e.g., GS1, LEI, SAMS.gov or other industry/international unique entity identifier etc.) to identify and validate each registration in accordance with FDASIA. Additionally, FDA is embarking on a global strategy of regulatory information-sharing across multiple domestic and foreign regulatory agencies. Linking of regulatory information from diverse sources to the correct business entity requires accurate identification and verification of that entity with universally recognized unique facility identifiers. FDA plans to use third-party systems with their matching, validation, verification, and business information services to ensure that regulatory information from multiple diverse sources is properly linked to the correct business entities.

FDA requires access (through most commonly known secure data distribution methods subscription, file transfer, download, web services or portals or application program interfaces/APIs) to and use of retail sales data (i.e., point of sale) from all outlets for past and future years for use in mission-critical work and future surveillance efforts. FDA’s previous data access consisted of national data for edible and non-edible categories/modules/departments, sent both as raw files for years and as direct access to this data over a rolling five-year period in a “live” online database (e.g., packaged foods, perishable foods, tobacco). FDA also gained access to weekly out-of-stock reports (e.g., Baby Formula/Electrolytes, pediatric and adult analgesics, upper respiratory medicines, OTC medicines, and selected commodities).

We are requesting continued direct access to data with options for additional geographies (region, county, designated market area (DMA), state, or metropolitan statistical areas (MSAs)) and timeframes (e.g., weekly vs. 1-month lag) with the option for eCommerce data and consumer panel and eating pattern data so that we can have the most current available data to run queries and extract data for reports. We also may require specific data pulls of raw data as well as specific reports. Data that are compatible with our existing scanner data are necessary to continue ongoing research projects that use data of identical characteristics and to develop new research projects since the national data projections would not align with competitor data to allow observation of trends. The data will therefore allow FDA to expand time-series research projects by implementing the same analytical approach with the most recent data.

Office of Data Analytics and Research The FDA Office of Digital Transformation has tasked the Office of Data, Analytics and Research (ODAR) to review data management and other related services. This includes technical oversight of data-centric system development processes, policies, methodologies, and management of IT infrastructure to ensure FDA has a robust IT foundation that enables data interoperability and enables development of enterprise-wide, multi-Center, and Center-specific data management capability necessary to meet FDA’s mission.

Instruction

Please review and provide objective and comprehensive responses to the questions listed in the Excel file, Attachment A - RFI Questionnaire. All stakeholders must provide their responses in Attachment A, as emailed responses submitted external to the RFI Response template or outside the designated limitations will not be considered. We will not accept any other documents except for Attachment A. Multiple submissions by the same company or same company in teaming or joint ventures will not be considered. Please ensure you are objective and specific with experience in your responses while addressing the questions. A complete response should include answers to all the questions in Attachment A. Please note that a stakeholder's failure to provide a complete response to a question will be interpreted to mean that the stakeholder is unable to demonstrate stakeholder capability to provide the required services. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide technical support").

Stakeholders will not receive individualized or group feedback on any suggestions provided in the RFI. No basis for claims against the Government shall arise as a result of a response to this RFI or from the Government's use of such information.

While the Government anticipates establishing an IDIQ for the Business Data Enrichment Services which requires contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this RFI.

Response Due Date/Time: 4:00 PM EST on Friday, November 15, 2024.

Email responses to: Noah Padilla, Noah.Padilla@fds.hhs.gov

Please include the RFI number FDA-RFI-75F40125Q00020 Business Data Enrichment Services in the subject line. No phone calls will be accepted for this notice.

Attachments Attachment A - RFI Questionnaire Attachment B - SOW_102424 Appendix A – Enterprise Performance Life Cycle Framework