SPECIAL NOTICE
B -- Epidemiologic Studies of Adverse Effects of Marketed Drugs
- Notice Date
- 4/29/2011
- Notice Type
- Special 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1083478
- Archive Date
- 5/28/2011
- Point of Contact
- Christopher E. Cunningham, Phone: 301-827-7185, Doreen Williams, Phone: 301-827-3366
- E-Mail Address
-
christopher.cunningham@fda.hhs.gov, doreen.williams@fda.hhs.gov
(christopher.cunningham@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) intends to execute a modification to add additional funds to an existing contract on a sole-source basis pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1) awarded to Ingenix on September 22, 2005 competitive basis. The purpose of this follow-on work is a continuation of the work conducted under the 2005 multiple award contracts entitled, "The Epidemiologic Studies of Adverse Effects of Marketed Drugs" with Ingenix (HHSF223200510006C). The purpose of this work is to evaluate a drug product deemed to have in effect an approved Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks of the drug. FDA is interested in determining whether the conditions of safe use are being met. To evaluate adherence to the risk management program process elements, FDA funded Phase I of a descriptive study to Ingenix to (1) describe and characterize patient use of the drug and a comparator and (2) to describe important patient events in the short time following program initiation (e.g. repeat hospitalization, mortality). This contractor conducted Phase I of the descriptive study, consisting of an analysis of outpatient use of the drug and comparator. During this initial phase of the study, the contractor completed the outpatient analysis and submitted outpatient descriptive analysis tables. The purpose of this modification is to conduct a follow-on study, Phase II of the descriptive study. The proposed work will use the data from Phase I of the descriptive study and link the outpatient data from the Phase I outpatient descriptive study with inpatient data. This linkage would enable completion of Phase II of the evaluation of the risk management program. FDA will leverage Ingenix's capability to link Ingenix's outpatient data with inpatient data from Premier. Premier inpatient data are cross-matched to the i3/Ingenix Invision Datamart outpatient data. Ingenix is uniquely qualified to collaborate and conduct the follow-on study and perform analyses of data in that they 1) conducted the outpatient descriptive analysis and hold the data from this analysis; 2) the results from Phase I of the study are proprietary and no other source has completed this portion of the study; 3) using another contractor would be cost prohibitive as Phase I portion of the work would need to be performed again; 4) they have a unique and established relationship with Premier and the capability to link Ingenix's outpatient data from Phase I of the study with inpatient hospital data from Premier; and 5) that they have the expertise required since they participated in Phase I of the study awarded in the 2005 contract, "The Epidemiologic Studies of Adverse Effects of Marketed Drugs." This is not a Request for Proposals. No Solicitations will be issued. However, sources interested in this requirement must provide statement of capabilities in sufficient detail to determine if the requirement of this synopsis can be met. A determination by the Government to compete this procurement based on responses from this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A modification to the contract will be executed on or after May 13, 2011.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1083478/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN02436537-W 20110501/110429234347-6ad288470e46a78fba6fcf31063d83f2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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