SOLICITATION NOTICE
B -- Sole Source - Epidemiological Studies of Adverse Effects of Marketed Drugs
- 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
- FDA1046214
- Archive Date
- 8/15/2008
- 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 Vanderbilt University on September 23, 2005 on a competitive basis. The purpose of this modification is to increase the level of funding in the Vanderbilt University 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. Medications for ADHD and Risk of Serious Cardiovascular Disease in Adults: Addition of Stroke Endpoint: For the Medications for ADHD and Risk of Serious Cardiovascular Disease in Adults: Addition of Stroke Endpoint, Vanderbilt University 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. Phase II of the study was initiated with the Agency for Healthcare Research and Quality (AHRQ) as a co-sponsor. The adult portion of the study was launched in this phase to investigate risk of myocardial infarction and sudden cardiac death associated with drugs used to treat ADHD. Vanderbilt University 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 will 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 decisions. Study 2. Combined Hormonal Contraceptives (CHC) and Risk of Thromboembolic Events: The objective of the CHC Study is to evaluate use of contraceptive products in a population of new and prevalent users to assess the public health impact and patterns of use that could place a woman at greater risk for a thromboembolic event and/or death. The large number of Ortho Evra users available for study at Vanderbilt University, as well as the large number of contraceptive users identified in the feasibility study, provide us with a valuable opportunity to assess this important public health concern. The initial phase (Phase I) of this study will consist of an incidence analysis of thrombotic and thromboembolic events (TTE) and death for all qualifying members based on claims data confirmed with medical record review. Study 3. Medication Use in Pregnancy Study, Vanderbilt University shall develop and maintain an integrated dataset that shall be used to study medication use from conception through delivery (pregnancy) and associated birth outcomes. Vanderbilt University is well equipped to fulfill the five main tasks of the study: 1. Maternal-infant record linkage of all women delivering an infant between 2001 and 2007 (or the most recent date available); 2. Linkage to birth certificate data, infants delivered between 2001 and 2007 (or the most recent date available); 3. Validation of data elements in datasets; 4. Linkage to other databases; 5. Annual update of maternal-infant files / linkage to birth certificate data. Vanderbilt University investigators have extensive experience in the use of automated databases to evaluate patient safety issues, including medication use during pregnancy, studies of birth outcomes related to prenatal exposure to medications, and other research using automated data. 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 Vanderbilt University 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.
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