SOLICITATION NOTICE
R -- Medical Product Safety Network - Adverse Reporting Feedback Program (MedSun)
- Notice Date
- 5/16/2007
- Notice Type
- Solicitation Notice
- 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, UNITED STATES
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-07-00155
- Response Due
- 5/31/2007
- Point of Contact
- Jennifer Fagan , Contract Specialist , Phone 301-827-7183, Fax 301-827-7101, - Leonard Grant, Contracting Officer, Phone (301) 827-7173, Fax (301) 827-7101
- E-Mail Address
-
jennifer.fagan@fda.hhs.gov, leonard.grant@fda.hhs.gov
- Description
- The Food and Drug Administration intends to make a single award for professional services to support the MedSun program. MedSun is a medical device adverse event reporting network. It is comprised of a primary network and several sub-networks. The primary network collects information on radiological devices generally, while the sub-networks collect information about specific classes of devices. The program involves investigation of the adverse events reported and providing feedback to the clinical community about the events and possible remedies thereto. Currently 350 hospitals participate in the MedSun program, providing reports to both the primary network and sub-networks. The purpose of the intended contract is twofold: to obtain assistance in the continued development of the program, and to process incoming reports and to analyze the data. With respect to program development, the contractor shall recruit and train participating sites, develop incentives plans to retain participating sites, and increase participation in sub-networks. The contractor shall also maintain and market the MedSun websites, and administer, update and test the MedSun database. The development of communication plans, small scale compliance evaluations, and rapid response surveys is also required. Additionally, the contractor shall advise the FDA on program related issues. With respect to the processing of reports and data analysis, the contractor shall process incoming reports. Processing the reports is not solely a clerical function, but requires the expertise to understand the reported events from a clinical and biomedical perspective. The contractor shall also code the reports, analyze the reports, meet with the FDA to review reports, and perform follow-up to the reports as requested. Additionally, the contractor shall assist the FDA in evaluating the impact of the MedSun program and shall develop methods to link data received to the demographics of the participating hospitals. The contract is expected to consist of a one year base period, with four one year option periods. The deliverables called for under the contract shall be provided according to the schedule set forth therein. Some contractor employees will be required to work on-site at the FDA? facility located at 1350 Piccard Dr Rockville, MD 20850 ? others may work off-site. It is anticipated that a written solicitation will be released on or about June 4, 2007. Award will be made on or before September 21, 2007. All responsible sources may submit an offer, and the FDA will consider all offers submitted. All contractors doing business with the Federal Government must be registered in the Central Contractor Registration (CCR) database. The website for registration is www.ccr.gov. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (16-MAY-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 26-SEP-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-07-00155/listing.html)
- Place of Performance
- Address: 1350 Piccard Drive Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01422418-F 20070928/070926230453 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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