SOLICITATION NOTICE
B -- HHSF223200510010C
- Notice Date
- 4/8/2005
- Notice Type
- Solicitation Notice
- 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
- HHSF223200510010C
- Response Due
- 5/31/2005
- Point of Contact
- John Speer, Contract Specialist, Phone (301) 827-7162, Fax (301) 827-7103, - Elizabeth Osinski, Contracting Officer , Phone 301-827-7043, Fax 301-827-7101,
- E-Mail Address
-
jspeer@oc.fda.gov, elizabeth.osinski@fda.hhs.gov
- Description
- The Center for Drug Evaluation and Research of the Food and Drug Administration has a requirement to gain access to data resources that can be used to (1) conduct drug safety analyses to the benefit of the public’s health; (2) respond expeditiously to urgent public safety concerns; (3) provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactions reported to FDA and enable rapid access to U.S. population-based data sources to ensure public safety when necessary. The Contractor shall provide US health encounter data for pharmacoepidemiology studies through collaboration with FDA; availability of a computerized system for linking each patient to all relevant medical care data including enrollment status, drug exposure data, coded medical outcomes, vital records (desired, but not required), cancer registries (desired, but not required), and birth defect registries (desired, but not required); capability of providing a patient population with low turnover, thereby permitting long-term longitudinal follow-up of most patients for acute or delayed adverse effects from drugs or other medical products; ability to capture all outpatient prescription drug exposures and health provider encounters, linked longitudinally to each patient; ability to capture all health provider encounters whether in the ambulatory, emergency, chronic care, or acute care setting in sufficient detail so that FDA has the ability to estimate the contribution of various risk factors (e.g., age, gender, dose, co-existing disease, disease severity, concomitant medications) associated with the occurrence of medical events of interest; demonstrated (post HIPAA) ability to access and retrieve complete, primary medical records as required for completion and validation of studies; ability to provide exposure data on new molecular entities (those approved within the last 5 years in the United States) and identify adverse drug events that occur infrequently (i.e., at rates lower than can be detected in clinical trials); ability to provide data and preliminary analyses to determine the feasibility of formal studies within 4 weeks of a data request; capability to form groups (i.e., cohorts) of patients exposed to one or more drug or biologic products and to follow them for the occurrence of one or more medical outcomes; full disclosure of data collection, coding, and configuration methods to allow FDA to appropriately interpret findings; and it shall be solely the Offeror’s responsibility to de-identify the data for FDA use. FDA will require no patient-, provider-, or health plan-specific identifiers. In providing access to longitudinal, population-based data, the Offeror shall ensure that the following criteria are met. At a minimum, the database description shall include: number of people (active and inactive) in the database, distribution of person time by calendar year in the database, extent of geographic diversity, demographics, size of special populations of interest (including children, women of childbearing age, and elderly patients); turnover rate, and enrollment data (if applicable) for participating individuals. In addition, the following information shall be provided to FDA: the number of years of data available overall; the lag time between the health encounter date and availability of the data; the mean, median, and range of observation time for patients in the database; and data collection and management procedures. These longitudinal data shall have the capability to follow uniquely identifiable individuals (using encrypted patient identifiers). Demographic information including but not limited to age and gender, health history, diagnoses and procedures, and hospitalizations shall be provided. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of this information. In addition, for each patient these data shall contain prescription drug and biologic utilization information, including the generic and brand name of the product, strength, dosage form, days supply, all dates dispensed, initial/continuing therapy indicator, quantity dispensed, instructions for use (if available), and prescriber specialty. A one (1) year base contract with four (4), one (1) year options is intended. This RFP Number HHSF223200510010C will be available on or about April 25, 2005. Any responsible offeror may submit a proposal for consideration by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. Point of Contact John Speer, Contracting Officer, Phone - 301-827-7162; Fax 301-827-7101, Email: John.Speer@oc.fda.gov – or Elizabeth Osinski, Contracting Officer, Phone 301-827-7043 Fax 301-827-7101, Email: Elizabeth.Osinski@fda.hhs.gov NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (08-APR-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 15-JUN-2005, 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/HHSF223200510010C/listing.html)
- Record
- SN00830762-F 20050617/050615212823 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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