SOLICITATION NOTICE
A -- MedPool Project
- Notice Date
- 7/14/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- 1043256
- Archive Date
- 8/7/2008
- Point of Contact
- Thomas M Dumas,, Phone: 404-253-1253, Marcia O Park,, Phone: (870) 543-7405
- E-Mail Address
-
thomas.dumas@fda.hhs.gov, marcia.park@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, as applicable, and as supplemented with additional information include in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a 100% small business set-aside. The solicitation number is 1043256. This solicitation is issued as a Request for Quote (RFQ). Quotations are due (7) days from the publication date of this synopsis or 23 July 2008, by 2:00 p.m. Eastern Standard Time, local prevailing time in Atlanta, GA: at Food and Drug Administration, OC/OSS/OFFAS, Attention: Thomas Dumas, 60 8th Street, NE, Atlanta, GA 30309. The quotation must reference solicitation number 1043256. The Offers are due in person, by mail or fax. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26, June 12, 2008. The associated North American Industry Classification System (NAICS) code is 541990 – All Other Professional, Scientific, and Technical Services, and the Small Business Size Standard is 500 employees. The Food and Drug Administration is soliciting for the following services in support of the RSR Project, Title: MedDRA Term Pooling for Adverse Event Analysis (MedPool). (1) OBJECTIVES • Improve the ability of medical officers to detect safety signals in an adverse event dataset by pooling similar MedDRA terms • Improve the consistency among medical officers with respect to how adverse events are combined • Eliminate the time spent by medical officers manually combining MedDRA terms (2) SCOPE Create an application for internal use by FDA CDER medical officers that allows pooling of similar MedDRA terms. The pooling of terms should be configurable by the end user of the application. (3) REQUIREMENTS The specific goals for this project are to develop, test, and implement a system that achieves the program objectives. The MedPool functionality shall be developed using the FDA Software Development Life-Cycle (SDLC) as a primary reference. (4) TASKS The project is intended to develop functionality that will support processing and managing of large adverse event datasets submitted by pharmaceutical companies. The functionality will provide a tool for researchers to pool similar adverse event terms and perform additional analyses with the resulting dataset(s). (5) PROJECT MANAGEMENT The contractor shall comply with proven project management methodologies and techniques in the performance of this task order. The contractor shall develop and document all plans, processes, and phases of work including SDLC deliverables in the Project Management Plan (PMP). This PMP shall be the complete documentation for all phases and decisions during the performance of this task order, and shall be the reference location for any other documents, plans, or schedules required in performance of the task order. The contractor shall apply earned value processes and reporting throughout the performance of this task order. All reporting shall be included in the PMP. (6) PARTICIPATE IN A PROJECT KICKOFF MEETING The contractor shall participate in a post-award project kickoff meeting. The Government will schedule the kickoff meeting and all contractors Key Personnel shall attend. The agenda will include, at a minimum, an overview of project tasks, security requirements, and other logistics issues. The contractor shall provide briefing material or other appropriate information, such as high level work schedules and project management strategies, as requested by the Government to support the meeting. (7) PROVIDE PROJECT MANAGEMENT SUPPORT The contractor shall provide project management support to FDA to ensure that Task Order requirements are met, and the Task Order is managed efficiently. The contractor shall employ best practices to include knowledge management and total quality management to ensure effective project management and communications. In the absence of formal written delegations of authority, the primary point-of contact will be the contractor’s PM. These PM shall ensure effective project management, direction, administration, quality assurance, and financial control of the task order. (8) MEDPOOL PROGRAM DEVELOPMENT The contractor shall include development and/or integrating supporting technology into the MedDRA project. The contractor shall create an application for internal use by FDA medical officers that allows pooling of similar MedDRA terms within an adverse event dataset. The mapping of terms will be configurable by the end user of the application. The Government expects the system to be capable of supporting non-concurrent FDA users. The contractor shall size the system to be capable of importing and exporting datasets with a file size of up to 500 MB. (9) FINAL RELEASE ALL SDLC PHASES All phases of the MedPool project shall be completed in accordance with the FDA SDLC and include the functions and steps as listed in 10 - 16 of this solicitation. (10) PLANNING The contractor shall create the plans in accordance with the SDLC. In the Planning Phase, the contractor shall further develop the concept to describe how the system will operate once the approved system is implemented. All the deliverables within this phase and other SDLC phases will be reviewed and approve by the Government. (11) REQUIREMENTS VALIDATION During Requirements Validation the contractor shall: • Further define and refine the functional and data requirements and document them in the Systems Requirement Specification • Use coding standards and naming conventions established by Enterprise Architecture • Use database standards and naming conventions established by Enterprise Architecture • Develop the test and evaluation parameters to determine acceptable system performance. At completion of this phase, the contractor shall install a prototype. (12) SYSTEM DESIGN The contractor shall design the physical characteristics of the system during this phase. The contractor shall establish the operating environment, define system inputs and outputs, and allocate processes to resources. Everything requiring user input or approval must be documented and reviewed by the user. The contractor shall specify the physical characteristics of the system and prepare a detailed design. The contractor shall created a detailed structure of the subsystems and the system. The contractor shall partition each subsystem into one or more design units or modules. The contractor shall prepare detailed logic specifications for each software module. (13) SYSTEM DEVELOPMENT The contractor shall develop a system in a custom manner. Customization involves the selection of options or the testing or parameters which activate desired features within the software. (14) INTEGRATION AND TESTING The contractor shall integrate and systematically test the various components of the system. The user tests the system to ensure that the functional requirements, as defined in functional requirements document, are satisfied by the developed or modified system. Prior to installing and operating the system in a production environment, the system must be security credited and certified. (15) IMPLEMENTATION The contractor shall install and make operational the system or system modifications in a production like environment. The phase is initiated after the system has been tested and accepted by the user. (16) CERTIFICATION AND ACCREDITATION The contractor shall prepare and submit certification and accreditation (C&A) documentation following the National Institute of Systems and Technology (NIST) C&A guidelines to ensure a fully certified and accredited SPL system. The contractor shall work cooperatively with the FDA Independent Security Testing and Evaluation (ST&E) team to achieve a deployable system that is fully certified and accredited to operate. The verification and completion of a final C&A package and the issuance of an “Authorization to Operate” is the signal that the product is ready for deployment. (17) TASK ORDER SCHEDULE AND MILESTONE DATES All deliverable must meet professional standards and the requirements set forth in contractual documentation. The contractor shall be responsible for delivering all end items specified. Acceptance criteria will include an assessment of whether the deliverables meets the Statement of Work (SOW) requirements; whether it employs approved standards, regulations, tools, and methods; and whether it is useful. Deliverables will be addressed to the FDA Project Officer. (1) Project Start - Time of Award (2) Kickoff Meeting - NLT 5 workdays after award (3) Post-Award Orientation - On-going during first 22 workdays after award (4) Bi-Weekly Status Report - COB the 15th and 30th workday of each month (5) Initial Operational Capability (IOC) Prototype - 2 months after award (6) Full Operational Capability - 3 Months after award. Contract Type: Commercial-Item Firm Fixed Price. FOB Point: Destination. Delivery for equipment and services provided is Food and Drug Administration, 10903 New Hampshire Ave, Silver Springs, MD 20993. The technical quotations will receive paramount consideration over cost and past performance; however, cost will be evaluated for price reasonableness. The Government reserves the right to make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offeror’s best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offerors equipment. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Offerors must include a complete copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications – Commercial Items with its offer. Applicability of FAR PROVISIONS: THE FOLLOWING FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS AND CLAUSES APPLY TO THIS REQUEST FOR QUOTES AND ARE INCORPORATED BY REFERENCES: 52.212-4 CONTRACT TERMS AND CONDITIONS---COMMERCIAL ITEMS (FEB 2007). 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS---COMMERCIAL ITEMS (JUNE 2008); THE FOLLOWING CLAUSES ARE APPLICABLE: 52.203-6; 52.219-6; 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-35; 52.222-36; 52.222-37; 52.222-50; 52.225-1; 52.225-3; 52-225-13, AND 52.232.33. FULL TEXT OF CLAUSES AND PROVISIONS CAN BE OBTAINED AT http://www.acquisition.gov CCR Requirement – Offeror’s must be registered in the Central Contractor Registration (CCR) before an award can be made. If offeror’s are not registered in CCR, they may do so by accessing the CCR web site at: http://www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocation System (DPAS) and assigned are not applicable to this solicitation notice.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=b90c34cb058eb3c71b08a103a5df117d&tab=core&_cview=1)
- Place of Performance
- Address: FOOD AND DRUG ADMINISTRATION, 10903 New Hampshire Ave, Silver Springs, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01613271-W 20080716/080714222314-b90c34cb058eb3c71b08a103a5df117d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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