SOLICITATION NOTICE
B -- Study of Comparison Rates of MI between patients treated with COX-2 Inhibitors and Traditional NSAIDs survey
- Notice Date
- 9/4/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-D78033
- Point of Contact
- Stephanie Hawk, Buyer, Phone 301-827-7886, Fax 301-594-2127,
- E-Mail Address
-
hawks@cder.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. D78033. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code for this acquisition is 8999 and the North American Classification System (NAICS) Code is 541710. The FDA intends to issue a purchase order on a sole source basis to Kaiser Permanente for the following service: Design of Survey Questionnaire to be used in the Study of Comparison Rates of Myocardial Infarction (MI) between Patients Treated with Cyclo-Oxygenase-2 Inhibitors (COX-2) and Traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The Contractor will expand the current study window to increase the time period covered and incorporate the additional data covering a total of 2.5 years. The contractor will provide a completed survey questionnaire of 1000 randomly selected plan members who have been treated with COX-2 inhibitors, traditional NSAIDs or neither class of prescription drugs and provide a brief report describing the plans developed for conducting the survey. The following FAR Clauses shall apply to this solicitation: 52.212-1 Instructions to Offerors-Commercial; 52.212-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award is being issued on a sole source basis because: 1. Kaiser Permanente already has a study of COX-2 and NSAID use and MI risk under way. 2. It is not possible for any organization or persons to access and use KP data; 3. To initiate a new study would result in extensive time delay and marked cost increases; 4. The KP database is very large; 5. Healthcare utilization data within the KP database are longitudinal at the plan member level; 6. Accurate patient enrollment files are available; 7. KP has the ability to link out-patient drug prescriptions and in[patient laboratory results data to individual plan members; 8. KP has well-established linkage to California mortality data and death certificates of plan members; 9. KP has the capacity to conduct voluntary surveys of plan members to investigate specific behaviors and other factors that may increase the risk of MI; and 10. KP has the ability to rapidly and completely obtain medical records for their review, when needed. FAR provisions can be found on the following website: http://www/arnet.gov.
- Place of Performance
- Address: FDA/CDER/OPaSS/ODS, 5600 Fishers Lane, Room 15B-32, HFD-400, Rockville, Maryland
- Zip Code: 20857
- Country: USA
- Zip Code: 20857
- Record
- SN00157315-W 20020906/020904213354 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |