SOURCES SOUGHT
B -- Veterinary Informatics Project
- Notice Date
- 1/6/2005
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-HHSF223200510009C
- Response Due
- 1/21/2005
- Archive Date
- 2/5/2005
- Description
- It is the intent of the FDA's Center for Veterinary Medicine (CVM) to award a contract on a sole-source basis pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1) to the Drug Information Lab at the Virginia-Maryland Regional College of Veterinary Medicine, Virginia Polytechnic Institute and State University (Virginia Tech). CVM intends to contract with Virginia Tech to develop a standard dictionary of terms for use in drug labeling for species, claims, dosage, warnings, cautions, Adverse Drug Reactions, etc. This dictionary will help the Center to use consistent terminology for all aspects of the animal drug regulatory process. This will become even more important in the future when CVM begins to implement Structured Product Labeling (SPL). One premise of SPL is that all terms are drawn from a common dictionary so computers can communicate medical information without a need for human interpretation of the meaning of the text. Virginia Tech will establish informatically-useful standardized veterinary dictionary of terms to be used by CVM for: Submission Tracking and Reporting System (STARS), Greenbook, FOI Summaries/FR Approvals of NADAs, Drug Listing, Developing/Standardizing a List of Product Label Indications/Claims, Developing/Standardizing ADEs (clinical terms and adverse event reporting), Developing/Standardizing a List of Animal Production Classes, Developing/Standardizing a List of Species, Developing/Standardizing a List of Warnings, Cautions, Contraindications Statements, Developing/Standardizing a List of Dosage Forms, Developing/Standardizing a List of others lists. Tasks might include the following: Determine how much of the list of terms that appears in the STARS database, Drug Listing, CVM Adverse Event Reporting Dictionaries, the Greenbook, etc. is not currently available in the existing dictionaries (VEDRA and SNOMED) and work with CVM to better define these lists of terms. Suggest options that could provide future NADA applicants electronic access to a list that includes all of the terms from all of these sources. Work with HL7 or other bodies in accrediting these lists for use in SPL. This list (or group of lists), including definitions, would comprise the universe of terms acceptable for specific sections of drug labeling when CVM initiates SPL. The list would include species, animal production classes, indications/claims, dosage, warnings, cautions, ADEs, et cetera. Determine the ideal way of creating a list of terms that would efficiently allow search capabilities to select all sources with different terminology but the same concept, e.g., weight gain, rate of weight gain, gain are different terminologies for the concept weight gain. CVM has an existing contract with Dr. Jeff Wilcke, a professor of veterinary medical informatics and clinical pharmacology in the Drug Information Lab at the Virginia-Maryland Regional College of Veterinary Medicine, Virginia Polytechnic Institute and State University to work on the Green Book. Virginia Tech is uniquely qualified to perform this work because they have developed and maintain the animal drug database of CVM-approved drugs and are familiar with the terminology used by FDA in the areas identified and the inconsistencies that exist. The FDA is unaware of any other institution of similar academic or scientific stature being able to meet the requirements of the work described above. Virginia Tech has already compared CVM??s Adverse Drug Experience dictionary with VEDRA and so have the background no other institution would have in accomplishing this project. The new project is an expansion of this work to cover terminology used in other CVM regulatory functions. In addition, Dr. Wilcke is one of the pioneers of veterinary informatics. He has the unique expertise to tell FDA what standardized dictionaries are available and advise us whether they might have relevant use for regulatory purposes. Dr. Wilcke developed an internet browser for SNOMED, the Systemized Nomenclature of Human and Veterinary Medicine. He is the AVMA liaison to the SNOMED editorial board, and currently is the administrator for the SNOMED Veterinary Forum. The Government intends to solicit and negotiate with Virginia Tech as the only one source under the authority of FAR 6.302. This is not a Request for Quotations (RFQ). Sources interested in this requirement must be able to provide convincing evidence that they possess the requisite expertise and experience to successfully perform the services as specified above. Responses must be in writing and must be received at hbrown@oc.fda.gov within fifteen (15) calendar days from the publication date of this notice. Proposals must include pricing information. All responses received in a timely manner will be considered by the Government.
- Place of Performance
- Address: Contractor site
- Record
- SN00730848-W 20050108/050106211803 (fbodaily.com)
- Source
-
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