FDA Business Entity Services

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to Dun & Bradstreet, under the authority 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1. This acquisition is in support of the FDA Business Entity Data Services Program. The Federal Food, Drug, and Cosmetic Act requires most manufacturers and processors of FDA-regulated products to register their facilities with FDA, and in many cases also to provide FDA with a listing of their products in commercial distribution. Due to various factors, the FDA registration data quality and completeness has declined and is inaccurate, especially in relation to foreign manufacturers. The Business Entity Data Services Program improves the completeness and accuracy of existing and incoming data regarding all business entities that interact with FDA, both directly and indirectly, by 1) utilizing D&B's DUNS number as the unique identifier system for each business entity interacting with FDA and/or involved in the import supply chain, 2) utilizing D&B data matching and validation/verification services to verify the identity of each domestic or foreign business entity that interacts with FDA, 3) accessing additional business information collected through D&B's routine data collection activities, and 4) providing a unique indexing key (DUNS number) for integrating all information FDA has, receives, or shares on each specific business entity. Under statutory requirements from the FDA Safety and Innovation Act of 2012, FDA must specify a Unique Facility Identifier system for use by drug manufacturers to accurately identify their establishments and importers in registration with FDA and potentially in their drug imports. FDA has determined that its Unique Facility Identifier system for drug establishment registration will include D&B's DUNS number, and FDA is evaluating the DUNS number for application to other activities and product-lines. In order to continue the Business Entity Data Services Program the FDA will need to acquire the following data and services through D&B: - Perpetual license to use D&B's DUNS number for business entity identification as a Unique Facility Identifier system. - Verification of business entity identity and validation of their DUNS numbers. - Tracking of firms and facilities for operational status, line of business, corporate family relationships, and other business intelligence information. Basic business information (including identity information, line of business (including SIC/NAICS codes), general business and operational data, corporate family relationships, and business executives) shall be readily available to FDA staff for up to two million business entities. Enhanced business intelligence information, such as business information report products shall also be available on an as-needed basis. Access to on-line business report products and database information shall be provided on a 24/7 basis. - Provision of business intelligence and specific risk information for FDA use, both for individual businesses and in risk assessment models/algorithms, including historical and individual (business executives) data. - Matching of FDA or externally-submitted records to D&B's global database of 230+ million business entities and providing or validating their DUNS numbers. This will include matching diagnostics and may include cleansing (standardization) of the name/address information and provision of address type (e.g., residential, business, multi-unit), move history and geospatial coordinates. - Resolution of matching and business entity verification and information gathering processes through automation, human lookup processes, telephone interviews, and/or on-site visits, as necessary. This includes assistance with D&B and FDA processes of matching FDA records to D&B records, education on understanding the matching components and interpreting matching results, developing viewers for potential matches, and conducting specialized batch matches, analyzing the matching processes, and reporting results. - Investigative services to verify a business entity and its operational status, find or assign an associated DUNS number, or collect specific FDA related information (e.g. operational hours, products marketed in the US, regulatory status, risk indicators). These activities may include specific data collection, data retrieval, data integration, and data analysis activities. - Establishment and hosting of global data sharing networks utilizing DUNS number matching and validation for entity identification and record linkage. - Consultation for data management, matching processes and analysis, customized data searches and reports, risk assessment and analysis, and integration of D&B data and services into FDA information systems. - Development of customized interfaces for FDA use in accessing D&B business intelligence information and matching of records or validation of DUNS numbers, including integration of D&B lookup, validation, and matching capabilities into FDA systems. - Training FDA on implementation and use of D&B and related products, and on analysis, interpretation, and use of the data provided. The period of performance for the services is one year with up to 4 one-year option periods. The NAICS code is 518210. This notice is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Danielle Pena at the email address below by 8:00 AM Eastern Time on March 17, 2014. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. No calls will be accepted. If you have any questions regarding this announcement, please contact Danielle Pe'a at danielle.pena@fda.hhs.gov.