SOLICITATION NOTICE
B -- Sole Source for Epidemiological Studies of Advrese Effects of Markets
- Notice Date
- 7/29/2008
- Notice Type
- Presolicitation
- 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
- FDA1046212
- Archive Date
- 8/28/2008
- Point of Contact
- Patricia Wright,, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA), Center for Drug Evaluation and Research 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 modification is to increase the level of funding in the Ingenix, Inc. contract to allow the contractor to increase their level of effort to perform the increasing numbers of drug safety studies needed within the original scope of work. The following studies have been identified as serious drug safety issues requiring additional funds for studying expeditiously: Study 1. For the Medications for ADHD and Risk of Serious Cardiovascular Disease in Adults: Addition of Stroke Endpoint, Ingenix completed an FDA-sponsored feasibility study in which they were determined to have an appropriate number of drug users and outcomes to allow for pooling of their data with other sites (also completing feasibility studies) to conduct an in-depth study. Phase I of the in-depth study included the analysis of automated data. Ingenix shall complete the work associated with Phase II which includes visiting sites, pulling records and adjudicating events. All electronically identified strokes in adults shall require confirmation. Reviewers shall confirm the diagnosis from the medical record, and will identify potential exclusions due to other diagnoses. An Events Adjudication Committee (AEC) will be established to make final Study 2. Ingenix completed an FDA-sponsored feasibility study in which they were determined to have an appropriate number of ADHD drug users and cardiovascular outcomes to allow for pooling of their data with other sites (also completing feasibility studies) to conduct an in-depth study. Ingenix shall complete Phase II, which included retrieval and review of medical charts, National Death Index search, and retrieval and review of death certificates. The volume of studies that need to be conducted through this contract has greatly increased since award, due to an increased awareness within FDA of potential drug safety issues that can be studied. There has also been increasing awareness of these types of resources and their value by those outside of FDA, such as the Institute of Medicine and Congress. Recent legislation, Section 905(A)(4) of the Food and Drug Administration Amendments Act (FDAAA), mandates expansion of these resources for the purpose of providing timely assessments of drug safety data. Therefore, CDER must continue to work with the Ingenix to conduct study analyses to the benefit of the public’s health; respond expeditiously to urgent public safety concerns; 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. 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 August 13, 2008.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=756860608cbdf80040b58d32001c9799&tab=core&_cview=1)
- Record
- SN01625837-W 20080731/080729225217-756860608cbdf80040b58d32001c9799 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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