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FBO DAILY ISSUE OF AUGUST 17, 2002 FBO #0258
SOLICITATION NOTICE

A -- Longitudinal Data Analysis on the use of Meridia and Xenical

Notice Date

8/15/2002
 

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-D78023
 

Response Due

8/30/2002
 

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. D78023. 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 7389 and the North American Classification System (NAICS) Code is 541990. The FDA intends to issue a purchase order for the following project titled: Longitudinal Data Analysis on the Use of Meridia (sibutramine) and Xenical (orlistat). The Contractor shall provide the necessary personnel, materials, services, and facilities and otherwise do all things necessary for or incident to the performance of work. Longitudinal data analysis shall consist of two parts and include the study time period for which data would be available for this analysis and include costs and timeframes associated with each part. Part One: All analyses shall be stratified by cash payers vs. third party payers (this can be broken down by private vs. government if convenient): 1. Total distribution of Merida and Xenical users by payment type. 2. Demographics (age and gender) of all patients with at least one prescription for Meridia or Xenical. 3. How long these patients have been in the database ? that is the time from their first evidence of utilization to the most recent prescription. 4. The length of time the patients stay on therapy with these agents ? a survival analysis model is ideal for our purposes. Patients new to therapy each month shall be defined and followed for the length of time they continue to receive prescriptions ? discontinuation would be defined a priori. 5. How many patients have had prescriptions for both Meridia and Xenical during the defined study period. 6. The prescriber specialty for prescriptions dispensed for each drug. Part Two: All analyses shall be stratified by cash payers vs. third party payers (this can be broken down by private vs. government if convenient): 1. How many patients also had prescriptions for antihypertensives, antihyperglycemics or antihypercholesterolemics during the study period (agents to be included in these classes will be mutually defined), for Meridia and Xenical users. 2. For antihypertensive drugs specifically, we would like to know the timing of use of these agents in reference to initiating therapy with Meridia or Xenical ? that is did the use of antihypertensive therapy precede, follow or begin at the same time as the diet drug therapy. Tasks and Deliverable Items: 1. Meet or teleconference with FDA Office of drug Safety, Division of Surveillance, Research and Communication Support (DSCRS) personnel within one month of award to discuss and agree upon all operational study definitions, to include data elements and NDC codes. Analysis Definition Report. 2. Part 1 study report. 3. Part 2 final study report. Period of Performance: September 30, 2002 through January 31, 2003. 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 will be issued to the contractor offering the best value to the government. FAR provisions can be found at the following website: http://www/arnet.gov.
 

Place of Performance

Address: FDA/CDER/OPaSS/ODS/DSCRS, 5600 Fishers Lane, room 15B-32, Rockville, Maryland

Zip Code: 20857

Country: USA
 

Record

SN00141384-W 20020817/020815213257 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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