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FBO DAILY ISSUE OF DECEMBER 25, 2004 FBO #1125
MODIFICATION

B -- Access to Outpatient and Longitudinal Drug Utilization Data

Notice Date
12/22/2004
 
Notice Type
Modification
 
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
 
ZIP Code
20857-0001
 
Solicitation Number
223-05-3000
 
Response Due
1/7/2005
 
Archive Date
1/22/2005
 
Description
AMENDMENT 2 TO SOLICITATION 223-05-3000 (FOR ORIGINAL SOLICITATION, PLEASE SEARCH UNDER BOTH ACTIVE AND ARCHIVED DOCUMENTS.) THE DUE DATE FOR RECEIPT OF PROPOSALS IS EXTENDED TO JANUARY 14, 2005 AT 4:00 PM Solicitation 223-05-3000 is amended as follows: 1. In Paragraph III. SCOPE OF WORK, Subparagraph 4., Glossary, the following definitions are added: Continuous: Uninterrupted in time, sequence, substance, or extent. In the case of an enrollment ? or eligibility-based products, this would translate to the cohort of individuals with uninterrupted enrollment for a two-year period. In the case of a non-enrollment- or non-eligibility-based data resources, the Offeror would be expected to provide an estimate of individuals with continuous pharmacy activity over a two year period. FDA realizes that due to the nature of the source of data for these resources, this may be an approximation, and not as precise as the results for eligibility- or enrollment-based information. FDA expects the Offeror to described in detail how this value is calculated, including assumptions and limitations of the result, and to cite appropriate references from the literature where necessary. Churn rate: This is the term used to describe the same concept as a turnover rate, but in a system that is not eligibility-based. If the offeror's data resource is not eligibility-based (e.g., if it is pharmacy-based), the Offeror is expected to estimate the ratio of the number of individuals who no longer are actively filling prescriptions to the total number of individuals who are actively filling prescriptions over the course of a calendar year. FDA recognizes that due to the nature of the data resource, this will be an approximation. FDA expects the Offeror to describe in detail how this rate was calculated, including assumptions and limitations of the result, and to cite appropriate references from the literature where necessary. Turnover rate: This is a way to describe the yearly inflow and outflow of individuals within an eligibility-based data resource. Generally, calculation of the turnover rate requires knowledge of the total number of eligible individuals (i.e., those covered by insurance) in the data resource over the course of a defined period of time. 2. Paragraph VII. DELIVERY INSTRUCTIONS, the date for receipt of technical and business proposals is changed to January 14, 2005 at 4:00 PM. 3. The following additional information is provided: Question 1: Is the purpose of the sample data test period to: 1) become familiar with the data (i.e., to assess and become familiar with data variables within a market), or 2) to identify the longitudinal nature of the data (more data months over time) Response: FDA requests access to the full, commercially available database to get a realistic idea of what will be involved in integrating the Offeror?s data resource into the current FDA functions. Our goal is to understand how to use and interpret the data through running some sample queries. Question 2: For the purposes of the providing unlimited access to data, can it be assumed that the number of users at any given time will be ten? Or is this an underestimation of the possible activity level? Response: As stated in the RFP, FDA requires a site license, or a licensing agreement that is not dependent on a specific number of users. If the Offeror?s data resource is configured in such a way that there are limitations on the number of simultaneous or total users, the Offeror should clearly explain how this configuration is implemented ant the nature of these limitations. The Offeror should also describe in detail FDA?s options for adding or reducing the total number of users during the contract period. Question 3: Can data access be approached in a variety of ways (i.e., Microstrategy tool, SAS datasets, etc.)? Response: FDA currently uses the Microsoft Office Suite of tools as well as SAS as part of our standard desktop. If access to the data resource requires additional front-end software (such as Microstrategy) or hardware this should be clearly explained in the Offeror?s response. FDA is willing to consider multiple access options as long as they conform to the technical requirements listed in the RFP. Question 4: How many markets are required of the RFP? All? Top 25? Other? Response: FDA will require access to the entire data resource. If the data resource is in the form of ?cubes? or ?markets?, FDA will require access to all of them. Question 5: How often are the database updates required? Monthly Other? Response: FDA expects the Offeror to explain in their technical proposal how often the database is updated. Question 6: Regarding Paragraph III.2.9 ? would FDA be willing to execute a non-disclosure agreement before release of an offeror?s data dictionary. Response: Due to the time constraints associated with this procurement, FDA would need to hold off signing a non-disclosure agreement. However, after award FDA would be agreeable to submitting the non-disclosure agreement to our legal department for review and approval prior to signing. Question 7: (A) Regarding Paragraph VI.1.B. ? Short term trial subscription at no cost. What are the criteria for choosing vendors for this trial? (B) Would a single, best and final vendor be chosen or would a number of vendors provide this trail subscription? (C) Because of the complexity of the data and the potential queries that FDA might want to perform, training and support will be required. Would the FDA consider less expensive options such as access to a smaller, representative sample of the data? (D) Prior to the trial training session, would the FDA be willing to submit the sample queries that they would like to obtain? This would allow more focused training. Response: (A) The minimum mandatory requirements are the criteria for choosing vendors for the trial subscription. (B) Those vendors who meet the minimum mandatory requirements will be selected to provide a trial subscription. This could be a number of vendors. (C) As stated in the RFP, FDA is only interested in accessing the full, currently existing, commercially available, HIPAA-compliant, out-patient and patient level prescription data via secure Internet or network-based methods to a maximum of four FDA researchers for the trial subscription for evaluation purposes. (D) The training should address how to access, navigate, and retrieve reports and/or downloads from the product. Offerors should be prepared to demonstrate during training how the product can be used to address queries concerning trend and volume in drug utilization, and how to characterize that information by demographic factors.? NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (22-DEC-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 23-DEC-2004. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 
Record
SN00726138-W 20041225/041223212502 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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