SOLICITATION NOTICE
B -- Continuous Development of Health Level 7 (HL7) Individual Case Safety Report (ICSR) Message
- Notice Date
- 12/11/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDA-SOL-07-00127
- Response Due
- 1/25/2007
- Archive Date
- 2/9/2007
- Description
- This is a synopsis which announces the Food and Drug Administration?s intent to issue solicitation FDA-SOL-07-00127 and award a sole-source contract to Mead Walker Consulting1199 Hopewell Road, Downingtown, PA 19335-1206 for the continuous development of Health Level 7 (HL7) Individual Case Safety Report (ICSR) Message for federal government public health surveillance activities. (Numbered Note #22 applies.) The upcoming contract will be Year 4 of the study/development; further, 33% of the study/development has already been completed. The services will include further expansion of FDA and CDC?s HL7 Normative Standards for federal government public health surveillance activities. There will also be data collection and analysis for FDA?s drug and biologic Adverse Event Reporting System (AERS), Center for Devices and Radiological Health (CDRH)?s Manufacturer and User Facility Device Experience Database (MAUDE), FDA/CDC Vaccine Adverse Event Reporting System (VAERS), and CDC?s National Disease Surveillance System. Additionally, services will require involvement when the DSC AE Workgroup will engage in extensive planning and system development to implement the ICSR message, including a comprehensive FDA implementation guide, which will be used to support the agency?s new consolidated adverse event reporting portal MedWatchPlus The FDA has worked exclusively with the contractor for past three years to develop the Health Level 7 (HL7) Individual Case Safety Report (ICSR) Message. The contractor has extensive experience with HL7, and is one of two experienced modelers in HL7 that has direct, relevant experience as an HL7 Modeling Facilitator that has successfully developed messages for the HL7 Public Health Reporting Domain. The contractor has worked extensively over the past four years with FDA and CDC to develop HL7 Normative Standards for federal government public health surveillance activities. The contractor is uniquely qualified, in that he already has thorough knowledge and experience with both FDA and CDC regulatory and public health surveillance program requirements. The contractor has developed standards that support data collection and analysis for FDA?s drug and biologic Adverse Event Reporting System (AERS), Center for Devices and Radiological Health (CDRH)?s Manufacturer and User Facility Device Experience Database (MAUDE), FDA/CDC Vaccine Adverse Event Reporting System (VAERS), and CDC?s National Disease Surveillance System. The contractor understands FDA?s business processes and analysis requirements for adverse event data reported to the agency, and well as other pre-market regulatory submission requirements that support new drug applications and biologics license applications. Examples include: Structured Product Labeling, Stability Data and the International Conference on Harmonisation?s (ICH) Electronic Common Technical Document (eCTD). Additionally, the contractor has been facilitating the development of a new HL7 standard, the Regulated Product Submissions (RPS) message, which is designed to support all new FDA regulated product submissions. The contractor produces excellent work products, as has successfully coordinated HL7 and American National Standards Institute (ANSI) approval of public health standards: Case Notification (used by CDC for disease surveillance) and ICSR Release 1 (used by FDA CDRH for piloting electronic submission of device adverse events). Mead?s ability to translate FDA requirements into HL7 modeling language is exceptional, and has contributed to the overall success of our work over the past three years. The learning curve for a new contractor to understand all FDA adverse event requirements, based upon several FDA data collection systems and forms, international requirements (ICH and Veterinary ICH), and the HL7 modeling, software tools and balloting process is substantial. The FDA Data Standards Council (DSC) would like to minimize the amount of ballot preparation and review fatigue and resource commitments necessary to orient and train a new contractor. The DSC AE Workgroup will also be engaged in extensive planning and system development to implement the ICSR message, including a comprehensive FDA implementation guide, which will be used to support the agency?s new consolidated adverse event reporting portal MedWatchPlus. This concurrent work will greatly reduce the amount of time and assistance that can be devoted to bringing a new contractor up to speed on the standard, and facilitate our goal to consolidate AE reporting formats within the agency. The 2006 contract agreement with the contractor already included data requirements gathering and analysis for the FDA Center for Veterinary Medicine (CVM), the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Combination Products (OCP). These new requirements will be used to develop Release 2 of the ICSR message, which FDA intends to implement for MedWatchPlus. The contractor?s understanding of how AERS, VAERS, and MAUDE accepts, processes and archives data will contribute greatly to his efforts to migrate CVM, CFSAN and OCP data into the existing model structure (ICSR Release 1), and provide the design basis for release 2. Given the contractor?s exceptional performance on previous FDA and CDC contracts and experience with HL7, the DSC is confident that the contractor will continue to do an outstanding job, and is better positioned to work more independently to develop the necessary requirements analysis documents, HL7 project descriptions, Refined Message Information Models (RMIMs), data artifacts and ballot materials for successful acceptance and approval of the ICSR Release 2 message.
- Place of Performance
- Address: 5600 Fishers Lane, Rockville, MD
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01194230-W 20061213/061211220125 (fbodaily.com)
- Source
-
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