SOURCES SOUGHT
B -- Access to Outpatient and Longitudinal Drug Utilization Data
- Notice Date
- 10/14/2004
- Notice Type
- Sources Sought
- 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
- Reference-Number-223-05-3000
- Response Due
- 11/1/2004
- Point of Contact
- Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101, - Megan Gnall, Contract Specialist, Phone (301) 827-7167, Fax (301) 827-7103,
- E-Mail Address
-
hbrown@oc.fda.gov, mgnall@oc.fda.gov
- Description
- This announcement is a Sources Sought Synopsis. Its purpose is to generate responses from qualified 8(a), HUBZONE, veteran owned, woman owned, or small business concerns, which have the interest and ability to provide FDA with access to outpatient and longitudinal drug utilization data. FDA is not interested in developing a database and expects any qualified organization to own the data as well as the means to access the data. The NAICS code for this procurement is 541990. Contractors interested in this requirement must submit a capability statement. A one (1) year base contract with two (2), one (1) year options is intended. The objectives are: (1) to provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level counts of outpatient prescriptions over time; (2) to provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing national-level counts of unique patients utilizing prescription drug products in an outpatient setting over time; (3) to provide patient- and prescription-level information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their prescription data; (4) to provide FDA personnel with the ability to use these data to characterize the duration of exposure to prescription drug products at a patient level and to examine concomitant use of multiple drug products at a patient level over the same time period; (5) to provide FDA personnel with the ability to use these data to describe national patterns of drug utilization in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel; (6) to provide FDA personnel with direct, unlimited, Internet or network-based access to all HIPAA-compliant longitudinal data in a multi-user environment and in real time; and (7) to provide FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies. These data shall meet the need of the FDA to access patient-level data describing outpatient prescription drug use in individuals over time, i.e., longitudinally. The longitudinal data shall include information at both the patient and prescription level. Offerors shall also provide data that will meet FDA¡¯s need for nationally-based, prescription-level outpatient information. The data shall include historic prescription information at a national level for trend analyses. The size and characteristics of the population of patients or covered lives from which the patient-level data are derived shall be provided to FDA, since these can affect the quality and usefulness of the data provided and the validity of national projections from the data. Characteristics shall minimally include: number of individual patients or covered lives; number and percent of patients or covered lives with at least two years of continuous activity; number and percent of patients or covered lives with corresponding enrollment information (if applicable); availability to FDA of enrollment/eligibility/participant inclusion information for use in data analyses; number and percentage of active patients or covered lives in populations of special interest to FDA (including children (ages ¡Ü 17 years) , women of child-bearing age, and elderly (ages ¡Ý 65 years)); turnover or churn rate for participation in the data resource; geographic diversity; demographics; coverage or inclusion policies relevant to pharmaceutical products under health care plans providing the majority of the data (if applicable); and availability to FDA of clinical or medical data (desired, but not required). If clinical or medical data are available, the number and percent of the total population for whom these data are accessible and detailed information describing how this information is linked to the pharmacy data is required. In addition, information that will allow FDA to describe and quantify the administration of drug- or biologic products in the outpatient setting by healthcare professionals (e.g., administration of chemotherapy to cancer patients, administration of drugs in conjunction with dialysis) is also desired, if available. These longitudinal data shall follow uniquely identifiable individuals (using encrypted patient identifiers) over time either across or within ambulatory health care plans. Age and gender shall be provided. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of this information. Prescription drug utilization data shall be provided and shall include the generic/established name of the drug, strength, dosage form and all dates dispensed (including initial/refill indication), quantity dispensed, days supply and prescriber specialty. Directions for use and method of payment shall also be included, if available. Current and historical national-level prescription information shall include counts of prescriptions at both the generic and established name level, as well as information on strength, dosage form, initial/refill indicator, and date (month/year) dispensed. Current data shall include patient-level demographic information. Aggregate demographic information related to historical prescription drug use is desired, but not required. To determine whether the data meet the needs of the FDA for making timely regulatory decisions based on the most current, scientifically valid information available, the following information shall be provided to FDA: the total number of years of data available overall and in real time to FDA personnel; the ability and ease of accessing data that is no longer on-line; and the lag time between the date of service for the patient prescription and on-line availability of the data. Offerors shall also provide a description of the offeror¡¯s data acquisition process for both the patient- and prescription- level drug utilization data. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, data de-identification procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, methods for coding data, percentage of missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates. A current and complete data dictionary shall be included. FDA requires the ability to use both the patient- and prescription-level data to estimate drug utilization patterns in the total U.S. outpatient population, or in a national sub-population of interest (e.g., children (¡Ü 17 years), women of child-bearing age, elderly (¡Ý 65 years)). This shall require the use of projection or other appropriate methodologies, 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 investigators to develop and implement it within 6 months is required. Demographics and other relevant characteristics for patients included in the sample to be used for projection or other appropriate methodologies, as well as for the proposed universe, shall be included. Interested offerrs shall provide (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel should be included; (3) any other specific and pertinent information as pertains to this Sources Sought Notice that would enhance FDA¡¯s consideration and evaluation of the information submitted. Responses must reference Request for Information (RFI) number 223-05-3000 and include the following: (1) name and address of firm, (2) type of business (i.e.: small business, small disadvantaged 8(a) certified, HUBZONE, woman-owned small business, small disadvantaged business (not 8(a) certified), veteran-owned small business, disabled veteran owned business, etc.) (3) two points of contact: name, title, phone, fax and e-mail, (4) DUNS number, (5) NAICS codes, (6) contractor¡¯s capabilities statement which provides the information stated above, (7) list of customers covering the past 5 years including a summary of animal husbandry work performed, contract number, contract type, dollar value for each customer, reference and customer point of contact with phone number, and identify your role as either the Prime or Subcontractor. THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS MARCH 8, 2004. RESPONSES SHALL BE SUBMITTED BY EMAIL, COURIER, OR U.S. POSTAL SERVICE TO: Hamilton Brown, Contracting Officer ¨C Phone 301-827-7043, Food and Drug Administration, OSS/OAGS/DCGM/CO, 5630 Fishers Lane, Room 2101, HFA-531 Rockville, Maryland 20857-0001. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (14-OCT-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 22-DEC-2004, 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.eps.gov/spg/HHS/FDA/DCASC/Reference-Number-223-05-3000/listing.html)
- Place of Performance
- Address: Contractor site
- Record
- SN00725550-F 20041224/041222213036 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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