D -- ACCESS TO LONGITUDINAL DRUG UTILIZATION DATA

Notice Date

June 6, 2001

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

223-01-5500

Response Due

July 6, 2001

Point of Contact

Leonard Grant, Contract Specialist, Phone (301) 827-7154, Fax = (301) 827-7151, Email lgrant@oc.fda.gov

Description

The Food and Drug Administration and the Center for Drug = Evaluation and Research intend to issue a solicitation for a contract = to gain access to data representing U.S. ambulatory or outpatient, = longitudinal prescription drug utilization on a patient-specific level. = The data shall provide a unique tool to evaluate prescription drug = utilization that is not currently available to the FDA. The objectives = of this contract are (1) to provide FDA personnel with immediate = automated access to a currently existing, outpatient longitudinal = prescription drug utilization data resource with the capability of = providing counts of uniquely identifiable patients (using encrypted = patient identifiers) utilizing drugs over time (either across or within = ambulatory health care plans) and to characterize the duration of their = exposures in the ambulatory care setting; (2) to provide FDA personnel = with the ability to use these data to describe national patterns of = prescription drug utilization in the outpatient setting through the use = of projection or other appropriate methodologies that are = scientifically sound and transparent to FDA personnel; and (3) to = provide FDA personnel with direct, unlimited access to data in a = multi-user environment and in real time. For the purpose of this = contract, the data shall meet the need of the FDA to access = patient-level data describing outpatient, longitudinal prescription = drug utilization. The size and characteristics of the population from = which the data are derived shall be provided to the FDA, since these = can affect the quality and usefulness of the data and the validity of = national projections from the data. Characteristics of the sample shall = minimally include: population size; geographic diversity; demographic = distribution of patients in the sample; representation of special = populations of interest (including children, women of childbearing age, = and elderly); enrollment data and turnover rate for participation in = health plans providing the majority of the data, if applicable; = description of coverage or inclusion policies of pharmaceutical = products under health care plans providing the majority of the data to = the database, if applicable; and information relating to criteria for = enrollment or selection of patients into the database. Age and gender = shall be provided for all patients. Prescription drug utilization data = shall be required for all drugs dispensed to all patients, and shall = include the generic and established name for the drug, strength, dosage = form, all dates dispensed, initial/refill indication, and quantity = dispensed. The FDA has no interest in knowing the identity of any = patient or provider included in the data resource. It shall be solely = the Offeror's responsibility to de-identify the data for FDA use. FDA = requires the ability to use these data to estimate drug utilization = patterns in the total U.S. ambulatory care population, or to a national = sub-population of interest (e.g., children, women of child-bearing age, = elderly). This shall require the use of projection methodology, which = shall be valid, reliable, and robust with regard to drug utilization = specifically, and the methods fully disclosed. If such methodology has = not been developed, a commitment in the form of a detailed development = plan, strategic outline, and timeline to collaborate with FDA investigat= ors to develop and implement it within 6 months is required. = Demographics and other relevant characteristics (e.g., projection = factors) for patients included in the sample to be used for projection, = as well as for the proposed universe, and information about the portion = of the universe population represented by the sample, shall be = included. In addition, the following information shall be provided to the FDA: = the number of years of valid data available overall and in real time to = FDA personnel; the ability and ease of accessing data that is no longer = on-line; the lag time between the date of service and on-line = availability of the data; and data collection and management = procedures. A live demonstration of the interface that FDA will use to = access the data will be required. This is an unrestricted solicitation = for a Commercial Item Acquisition. The competition is being conducted = under FAR Part 12 and 15. The period of service will be from September = 28, 2001 through September 27, 2002, with 2-option years. The = solicitation for this requirement will be available on or about June = 15, 2001, on FedBizOpps at http://www.fedbizopps.gov under Health and = Human Services, Food and Drug Administration. All responsible sources = may submit a proposal, or quotation which shall be considered.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/FDA/DCPM/223-01-5500/listing.html)

Record

Loren Data Corp. 20010608/DSOL001.HTM (D-157 SN50O1J0)