Sources Sought for Drug Product Database Access

This is a sources sought announcement, a market survey for written information only. This is not a solicitation, and no contract will be awarded from this announcement. The purpose of this sources sought synopsis is to gain industry input and knowledge of potential qualified sources and their size classifications (Service Disabled Veteran-Owned, Veteran-Owned Small Business, Women-Owned Small Business, HubZone 8(a), 8(a), HubZone, Small Business, Emerging Small Business, and Small Disadvantage Business (SDB)) relative to NAICS code 511120 (size standard of 500 employees). As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation. The decision to solicit for a contract shall be solely the Government's discretion. This sources sought notice is not to be construed as a commitment by the Government, nor will the Government pay for the information submitted in response. Respondents will not be notified of the results of any government assessments. The information received will be utilized to assist in formulating the strategy for competitive procurements. The Food and Drug Administration (FDA) is seeking to obtain access to a database containing general information about all drug products marketed in the United States, including currently marketed and discontinued products. Specific Minimum Technical Requirements: Data Elements: At a minimum, the database should contain the following elements: - NDC Code - FDA Application Number (a six-digit number used by FDA to identify New Drug Applications and Abbreviated New Drug Applications). - Established Name - Trade Name - Name of the company that produces/markets the drug - Active Ingredient(s) - Therapeutic Class - Strength - Dosage Form - Route of administration - First marketed date - Discontinued date (for discontinued drugs) - Database must be 508 Compliant Period of Performance: The period of performance shall consist of one (1) Base Year and Four (4) Option Years. Option years, if exercised by the Government, are 12-month periods that occurs consecutively following the base year. Time Period: The database should include data on products produced since at least 2000 and should be current as of July 1st, 2012 or later. If option years are exercised, the database shall at a minimum include data that is current for the calendar year in which the option is exercised. Delivery: The database may be delivered to FDA through physical storage media (e.g., compact disk) or electronically (e.g., digital download). The data should be made available to FDA in a relational database format and/or as a series of delimited text files (e.g., csv). Documentation: Documentation should be provided to FDA that provides the following information: - Descriptions of data elements in the database. - Diagrams and/or descriptions of the tables and relationships in the database. - Data dictionaries for terminology used in the database. Responses to this notice are due to the Contract Specialist no later 12:00 (noon) EST on Tuesday, August 28, 2012. In your response you must include (a) your small business status (b) a positive statement of your intention to submit a quote for this solicitation as a prime contractor; (c) evidence of experience in providing similar products; (d) past performance references with points of contact and telephone numbers; (e) confirmation that the product will be 508 compliant. At least two references are requested, but more are desirable. All of the above must be submitted in sufficient detail for a decision to be made. Failure to submit all information requested may result in an unrestricted acquisition. All correspondence shall be directed to the Contract Specialist. Email is the preferred method of communication. CONTACT INFORMATION Please submit response to Contract Specialist Tomeka Evans at Tomeka.Evans@fda.hhs.gov