The Department of Health and Human Services, Food and Drug Administration has a requirement for business data enrichment services.

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.

FDA’s data strategy goal is 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.

Tier 1: Operational Data Enrichment Services:

• Establishing the Validation and Verification Services to verify the identity and business status of each domestic and foreign business entity that interacts with FDA using Name, Address, Geocode location, and unique entity identifier numbers (e.g. Dun and Bradstreet “DUNS,” GS1, LEI, SAM.gov or other industry/international unique entity identifier)
• Using business entity matching, validation, and verification services to verify the identity and business status of each domestic and foreign business entity that interacts with FDA
• Providing a unique indexing key for integrating all information FDA has, receives, or shares on each specific business entity
• Accessing additional business information to enrich the existing data (e.g., industry, line of business, entity size, classifications details, employee contact and other details, local/country/region identification numbers, NAIC Code, SIC Code or any other related data elements
• Accessing additional corporate family tree(s) and associated entities (e.g., parents, subsidiaries, headquarters, and branch offices of a corporate family, legal ownership, franchise, subsidiary, outsourcing, other connection type)

Tier 1A: FDA Objectives Include:

• Verification of business identity and operational status, identification of potential duplicate records, and notification of entities that are no longer in business, have moved, or have never registered with FDA
• Assistance in identifying, matching, merging (when needed), and linking FDA and other source records relating to business entities that interact with FDA (past, present, and future)
• Utilization of manual resolution processes (including human lookup, telephone contact, web searches, and on-site visits) to verify business entity identification, business information (including operational status), and to reconcile data inconsistencies
• Access to additional business intelligence information acquired through data collection activities or special investigations, to include corporate family relationships, trade activity, and financial and other potential risk information that can supplement FDA risk assessments
• Utilization of software, systems, and consulting support
• Access to online subscription services that allow FDA staff to obtain detailed business intelligence information relating to specific business entities on an ad-hoc basis

Tier 2: Analytics Data Enrichment Services:

• Enabling secure and convenient access to the following information:
  • Company/Entity financial data; including bankruptcy filings, suits, employee details, and other pertinent data.
  • Company/Entity contact details.
  • Company/Entity insights obtained through data collection and special investigation.
• Enabling secure and consistent access to obtaining the third-party data:
  • Product sales data perspective, both foreign and domestic
  • Tracking and tracing products through supply chain data
  • Market profiling related to industry insights.

Tier 3: Social Media-based Data Enrichment Services

• The Contractor shall provide FDA social media data (e.g., text from original posts, text from comments on posts, and images or additional media, when available) to provide FDA with real-time and historic insight into the public discourse on matters regulated by or impacting FDA. Social media data is defined herein as content originating from commonly used social media applications in the U.S. (e.g., Reddit, X). Coverage shall include access to social media data in topics directly relevant to product areas regulated by FDA (e.g., food, drugs, tobacco products, biologics, medical devices, veterinary products, cosmetics, and radiation-emitting electronic products) and topics that affect FDA policy or otherwise inform FDA about U.S. public health (e.g., general medical health, pregnancy, weight loss, illegal and recreational drug use)

Tier 4:  Access to National Brand Sales Data

• Enterprise Access is the ability of authorized FDA users to run queries, reports and analysis on products, time periods, geographies, measures, and syndicated attributes, and to publicize aggregate data in support of public health issues. The external collaborators will have access to the data for the sole purpose of conducting FDA-approved projects. Similar security standards as those used for the FDA’s own confidential and sensitive data will be used to provide access to the external collaborators. Contractor must approve all external collaborators directly accessing the data, and a Third-Party Agreement (TPA) will be put in place. The resulting findings will be disseminated through multiple media, including but not limited to professional economics journals, FDA publications, the FDA website, and presentations at meetings of professional economics associations.

Tier 5:  Supply Chain Related Data Enrichment Services

• The scope of this IDIQ is to obtain data licenses, software licenses, subscription(s), IT hosting services, matching, validation, and manual resolution and verification services, and/or various professional, technical, and consulting services.  This may include related to data science, data analytics and data engineering, to fulfill FDA’s project objectives as specified at the time of award of specific IDIQ Task orders. Emphasis is on business entity identification and verification, data cleaning and linking, business intelligence, and risk assessment in relation to FDA-regulated products, as well as providing support in making FDA’s regulatory activities more efficient and effective.