SOLICITATION NOTICE
T -- Medical Drug Database
- Notice Date
- 3/24/2009
- Notice Type
- Presolicitation
- NAICS
- 511130
— Book Publishers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1055161
- Archive Date
- 4/22/2009
- Point of Contact
- David - Kordel,
- E-Mail Address
-
david.kordel@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Requisition Number: FDA1054781 The Food and Drug Administration (FDA) seeks a 100% small business set-aside for access to a medical drug database. Award will be a firm-fixed price purchase order. Background: The FDA requires the procurement of a Medi-Span Master Drug Database v2.5 (MDDB®) with 5 user licenses within one of our laboratories located in Rockville, MD. The FDA will use MDDB® to insure accuracy of data entry, completeness of drug product data, reconciliation of drug product status and in identification of drug products not known to the FDA. Through a process of coding, safeguards shall be in place that insure integrity and preservation of data entered to satisfy 21 CFR 207. FDA requires access to relevant data for purposes of identifying marketed drug products in support of multiple agency programs and activities, expressly including use of such data to prepare reports, lists, or other information identifying marketed drug products to respond to inquiries from, or that may otherwise be shared with other governmental entities or the public. Requirements: 1. The Contractor and product must support the following: a. On-line searchable, sortable prescription drug product file. b. Ten or more years plus in compiling drug product related data for those drug products in the commercial marketplace. c. Ability to obtain new drug product listings and discontinue drug product listings that are no longer on the marketplace on a timely basis using a monitored process. d. Adds all newly approved FDA products. e. Coded method of identifying which drugs are FDA approved (NDAs and ANDAs), pre-1962, etc. and which are not. f. Comprehensive, complete, and accurately identified compiling of prescription drug products on the commercial marketplace, referenced by NDC# and manufacturer, distributer, re-labeler or re-packager name and address plus other value added descriptors. g. Combines a comprehensive set of drug data base elements, drug pricing and clinical information with multiple types of unique drug identifiers to provide flexibility in representing drug products, enhancing drug product identity and tracking drug related information. h. Product must be an accurate and comprehensive drug products file which includes at least 95% of all prescription drug products on the commercial marketplace. i. Must include all variations of a drug product’s packaging (package codes) and updates all on-line files with 30 days of FDA approval. j. Reliable data regarding manufacturers, distributors, relabelers, and repackagers and their contact information so that DRLS has an accurate, up to date list of the industry involved in all facets of the drug product supply chain. k. Provides means to determine new drug products which have been added since the previous update. l. Includes an Over-the-Counter Drug List option. m. Identification of both FDA approved and unapproved prescription drug products. On June 19, 2006, the FDA Commissioner appointed an Unapproved Drug Coordinator to help firms identify the steps they must take to obtain approval of their marketed unapproved drugs. With this stepped-up focus, in June 2006, demands for expertise in the unapproved drugs and DESI area increased significantly. 2. Contractor Tasks / Requirements. a. Provide monthly updates of company’s sortable database (MDDB®) with 5 user license. Updates will be by internet downloads. 3. Period of Performance. a. Base: 5/1/2009-4/30/2010 b. Option year 1: 5/1/2010-4/30/2011 c. Option year 2: 5/1/2011-4/30/2012 d. Option year 3: 5/1/2012-4/30/2013 4. Section 508 Compliance a. Contractor must meet Section 508 requirements, specifically Access Board Final Rule (36 CFR Part 1194.21 (c), (d), and (f). 5. Deliverables. RefDeliverable 3.0Monthly updates of Medi-Span® Master Drug Database v2.5 (MDDB®) downloaded from the vendor site on Web. Due Date Deliver To Monthly (same day each month)Project Officer Silver Spring, MD 20993-0002 Ref Deliverable 3.05 user license to Medi-Span® Master Drug Database v2.5 (MDDB®) Due Date Deliver To Date of award Project Officer Silver Spring, MD 20993-0002 6. Performance Requirements Summary. PERFORMANCE REQUIREMENTS SUMMARY a. Performance Requirement Monthly updates of Medi-Span® Master Drug Database v2.5 (MDDB®) downloaded from the vendor site on Web. b. Performance Indicator Medi-Span® Master Drug Database v2.5 (MDDB®) updated database made available same day each month. c. Standard Medi-Span® Master Drug Database v2.5 (MDDB®) that is accessible at a minimum monthly with new updates d. Acceptable Quality Level Updated Medi-Span® Master Drug Database v2.5 (MDDB®) online updates made available on time each month. e. Surveillance Method Check that Medi-Span® Master Drug Database v2.5 (MDDB®) online data contains updated monthly data. Sources intending to provide quotes must provide detailed information indicating their ability to meet the Government’s requirements. This announcement constitutes the only solicitation and a written solicitation will not be issued. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov under NAICS code 511130 to be considered. This procurement is a 100% small business set-aside. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 PM (1630) EST on 30 March 2009. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 7 April 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described has "Meet or Exceeded the Requirement," and 2) Price. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
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