UFI License and Validation Services

Pre-Solicitation Notice of Sole Source Intent: The Food and Drug Administration (FDA) intends to award a five (5)-year indefinite delivery-indefinite quantity (IDIQ) on a sole source basis to Dun and Bradstreet, Inc. (D&B), 11710 Plaza America Drive, Suite 900, Reston, VA 20190-4768, in accordance with the authority under FAR Part 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements. The NAICS code is 541519 - Other Computer Related Services. The 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. The 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; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The FDA's work and business is 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: - Safe Medical Devices Act of 1990 - Medical Device Amendments of 1992 - Mammography Quality Standards Act (MQSA) of 1992 - FDA Modernization Act of 1997 - Medical Device User Fee and Modernization Act (MDUFMA) of 2002 - Food and Drug Administration Amendments Act (FDAAA) of 2007 o Includes the second reauthorization of the Medical Device User Fee Act (a.k.a. MDUFA II) - Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) o Includes the third reauthorization of the Medical Device User Fee Act (a.k.a. MDUFA III) Under statutory requirements from the FDA Safety and Innovation Act of 2012 (FDASIA), 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 Dun & Bradstreet's D-U-N-S Number (DUNS), and FDA is evaluating the DUNS system for application to other regulatory activities and product-lines, including all imports. FDA has initiated a Master Data Management initiative to harmonize the data and identifiers for all business entities throughout the Agency. This requires integration with D&B data and services to identify and validate each DUNS, which will be used as a harmonizing identifier to link FDA, non-FDA, and D&B's information to the appropriate business entities. In addition, 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 to be used as keys for linking the information. FDA plans to utilize the D&B DUNS system, with its matching, validation, verification and business information services, to ensure that regulatory information from multiple diverse sources, including local, state, federal, and international regulatory government agencies, is properly linked to the correct business entities. D&B is the only source that can provide the requested services. A sources sought notice was posted to Federal Business Opportunities (FBO) on June 27, 2018. FDA reviewed all of the responses received and determined that Dun and Bradstreet (D&B) is the only vendor who meets FDA's needs/requirements. D&B has an existing Business Entity Data Services offering/capability and provides sufficient information for FDA to assess that their capability will satisfy our requirements. In order for FDA to obtain its goal of improving the completeness and accuracy of data in regards to business entities that interact with FDA, the use of a unique identifier system is required. The most practical identifier for this purpose is the DUNS number, which has been selected by FDA as a component of its statutorily-mandated Unique Facility Identifier system. D&B created the DUNS number and it is assigned and maintained solely by D&B; and once assigned, D&B tracks that entity through 20,000+ data sources to monitor its business activities and corporate relationships. The FDA has utilized the data and services of D&B for many years in various capacities to further the FDA regulatory mission. These data services include validation of entity information for contracting actions, user fees, ethics determinations, drug registration, food registration, medical device registration, investigations, audit assessments, and risk assessments for prioritization of inspections and other regulatory activities. Nearly every FDA component currently uses the data and services of D&B to incorporate the DUNS number and related information into their business processes. Since the DUNS number is an OMB-mandated standard, FDA has integrated many DUNS-related activities into its business processes; it would not be feasible or cost effective to integrate another solution at this time. Based on the above, Dun and Bradstreet is the only vendor who meets FDA's needs/requirements. D&B has an existing Business Entity Data Services offering/capability and provides sufficient information for FDA to assess that their capability will satisfy our requirements, and there is not another vendor capable of meeting our requirements in terms of coverage and depth of the data. This notice is not a request for competitive offers. However, any party that believes it is capable of meeting the requirements, as stated herein, may submit a written response (i.e., capability statement) which clearly supports and demonstrates its ability to perform the requirements. Any response must be received by the response due date and time of this notice. Any response received will undergo a review by FDA to determine whether the respondent can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government. Response Due Date: 10:00 p.m. ET on December 31, 2018. Responses must be emailed to Haritha Raja at haritha.raja@fda.hhs.gov and Michelle Creenan at michelle.creenan@fda.hhs.gov. The subject of line of the email must read: Response to Sole Source Pre-Solicitation Notice - 1207696.