SOLICITATION NOTICE
D -- Knowledge Management Tool for Creating Cross-Disciplinary Multiple-NDA Disease Database
- Notice Date
- 4/25/2008
- Notice Type
- Modification/Amendment
- NAICS
- 541511
— Custom Computer Programming 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-08-1041469
- Response Due
- 4/25/2008
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227, Leonard D Grant,, Phone: (301) 827-7173
- E-Mail Address
-
dominique.malone@fda.hhs.gov, leonard.grant@fda.hhs.gov
- Description
- THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6, STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS, AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES. THIS SOLICITATION IS A REQUEST FOR QUOTATION (RFQ). THE ASSOCIATED NORTH AMERICAN INDUSTRIAL CLASSIFICATION SYSTEM (NAICS) CODE FOR THIS PROCUREMENT IS 541511. Food and Drug Administration intends to award a competitive purchase order for a Project Entitled: Knowledge Management Tool for Creating Cross-Disciplinary Multiple-NDA Disease Database. The contractor shall modify, implement, and maintain the current knowledge management tool, DMerge, to include additional modules and create disease databases. A) Project Background: Currently, the Office of Clinical Pharmacology has developed a knowledge management tool, DMerge, that is capable of combining large scale (NDA level) efficacy, safety, pharmacokinetic, pharmacogenomic, demographic, laboratory and other clinical trial information for quantitative analyses. The current version has many powerful functions to efficiently handle a variety of data in different therapeutic areas. It has been successfully piloted and improved against more than 10 NDA/BLA/VGDS submissions. The major challenge of creating cross-disciplinary multiple-NDA disease databases is the compatibility of data format between datasets (e.g. PG vs PK vs clinical), among clinical studies, and across NDAs. In addition, there are a wide range of statistical tools for analyzing the disease databases, each has different data requirements. The ease of accessing and retrieving information from the databases by the researchers is also essential. B) Project Objectives: The specific goal of this project is to continue modify the current knowledge management tool to include additional modules that will 1.handle a wider variety of disease data from different therapeutic areas 2.integrate with more standard statistical tools for data analyses 3.efficiently retrieve and organize key information from the large databases 4.be implemented in selected areas, including pharmacogenomic, biologics, gastroenterology, reproductive, and QT. C) Tasks and Deliverable Items: The contractor shall modify, implement, and maintain the current knowledge management tool, DMerge, to include additional modules and create disease databases. Milestones: Time after starting the contractMilestones Within 4 monthsDevelop new modules in DMerge according to the needs of disease databases and research objectives in 2 selected therapeutic areas. Within 10 monthsComplete at least 2 development cycles of enhancement-implementation of DMerge for each therapeutic area. Within 12 monthsProvide training of the tool to user group. The milestones can be completed before the specified timeline. D) Contractor Qualifications: Programmer: A M.S. in computer science, information system, or related areas. Individual should have a demonstrated ability in programming languages commonly used in database and biological research, including S-plus, SAS, NONMEM, Visual Basics, C++, and Oracle. Prior programming experience in database and biological areas will be desirable. Experience with FDA computer system and database structure will be a plus. 1.A M.S. in computer science, information system, or related areas. 2.Demonstrated ability in programming languages commonly used in database and biological research, such as Visual Basics, C++, Oracle, S-plus, SAS, and NONMEM. 3.Prior programming experience in database and biological areas. E) Place and Period of Performance: Contractors for the project are needed for one year from date of award. The estimated total amount of hours for the effort is 2200 hours. Contractor shall conduct research in space provided by FDA. FDA will also provide appropriate equipment. Contractor shall work at the FDA facility at least 30 hours per week, during the contract period. The milestones can be completed before the specified timeline if the contractor works additional hours per week. F) Additional Requirements: The Contractor shall obtain FDA security clearance prior to beginning work. Contractor shall sign a confidentiality agreement prior to beginning work under this contract. G) Additional Requirements/ Instructions for Submitting Quotation Responses to FDA: 1.Business Information -- a.DUNS: b.Company Name c.Company Address d.Type of Company (i.e., large/small business, 8(a), woman owned, veteran owned, etc.) as validated via the CCR. All Offeror’s must register on the Central Contractor Registration located at http://www.ccr.gov/index.asp. Note: To receive an award under this Request for Quotation, all Offerors must be CCR registered, referencing the NAICS of 541511. e.Company Point of Contact, Phone and Email address f.GSA Schedule Contract Number (if applicable) 2.Email your Quotes to the Contract Specialist, Dominique.Malone@fda.hhs.gov on or before MAY 2, 2008 by 2:00 PM eastern standard time. NOT WITHSTANDING, ANY FIRM THAT BELIEVES IT IS CAPABLE OF PROVIDING THE REQUIRED SERVICE AS STATED HEREIN MAY SUBMIT A QUOTE AND A CAPABILITY STATEMENT TO Dominique.Malone@fda.hhs.gov. ALL RESPONSES OR QUESTIONS REGARDING THIS POSTING MUST BE IN WRITING AND MUST BE SENT VIA EMAIL. NO PHONE CALLS WILL BE ACCEPTED. SUBMISSION MUST BE RECEIVED BY 2:00 P.M. EST ON, MAY 2, 2008. THIS ANNOUCEMENT HAS BEEN MODIFIED TO REFLECT AN EXTENSION TO THE RESPONSE DATE. ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=d5efe8a2bfa6529b33e3406b6081099e&tab=core&_cview=1)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01561673-W 20080427/080425220032-d5efe8a2bfa6529b33e3406b6081099e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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