SOLICITATION NOTICE
A -- Vaccine Surveillance: Preparing for a Pandemic
- Notice Date
- 8/1/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- FDASOL0700342
- Response Due
- 8/15/2007
- Archive Date
- 8/30/2007
- Description
- The Food and Drug Administration (FDA) intends to award a contract on a sole-source basis to the Harvard Pilgrim Health Care. The Government intends to solicit and negotiate with one source under the authority of FAR 6.302. It is anticipated that the period of performance of the award will be one year. The main objectives of this contract are: a) Collaborate with FDA on implementation of sequential analytic methods for active flu safety surveillance. b) Expand understanding of the benefits and limitations of comparison group selection and event definitions for active flu safety surveillance. c) Evaluation of claims patterns for selected events (e.g., vaccines, drugs, procedures, labs, diagnostic studies) of interest. Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, and facilities, and otherwise do all things necessary for or incident to the performance of the work described in the statement as follows: DESCRIPTION OF WORK: The primary goal of this project is to build upon and expand on activities undertaken as part of a previous FDA and CDC collaborative pandemic flu study and other FDA sponsored flu activities, including evaluating adverse events after influenza vaccination among the elderly using Medicare data. The following describe in greater detail the activities and deliverables for each of the above objectives of the study. d) Task 1. Collaborate with FDA on implementation of sequential analytic methods for active flu safety surveillance. This task will involve collaboration with Harvard on the use of sequential analytic methods for active flu vaccine safety surveillance, specifically use of the maximized sequential probability ratio test (maxSPRT). The maxSPRT was developed by the Vaccine Safety Datalink project researchers, including Dr. Martin Kulldorffi, as a refinement of the sequential probability ratio test developed by Wald in 1945. This new statistical method involves periodic statistical analysis of data as they are collected. The FDA is currently working with CMS to conduct flu vaccine safety surveillance using weekly data extracts from CMS, and FDA intends to continue this work with CMS during the 2007-08 flu season. Harvard will work closely with FDA to develop and describe the data structures necessary to analyze the weekly CMS data using the maxSPRT, collaborate with FDA on implementation of the statistical testing, and assist with interpretation of the findings and comparison to findings generated using the analytic methods currently employed by FDA. Harvard will help FDA understand the data needs, benefits, and limitations of sequential analysis using the maxSPRT. The goal will be achieved through a series of face-to-face meetings and/or teleconferences to describe the methodology and by working closely with FDA on implementation of the methodology using the CMS data during the 2007-08 flu season. A series of teleconferences and written communications between Harvard and FDA will describe the new sequential methodology and active collaboration will provide the opportunity for potential implementation of the methodology using the CMS data stream. Deliverables will include draft and final data structures necessary to analyze CMS data using the maxSPRT. e) Task 2. Expand understanding of the benefits and limitations of comparison group selection and event definitions for active flu safety surveillance. This task will involve two main activities. The first activity will be to describe the benefits, limitations, and considerations of various potential comparison groups and event definitions when conducting real-time flu vaccine safety surveillance. The selection of a comparison group is complex in any safety surveillance study, but is heightened in flu vaccine safety due to factors that include the potential for widespread exposure to the vaccine, the need for real-time information, seasonality, differences in vaccines across years, and variability in flu severity. Selection of an appropriate comparison group or groups is essential for interpretation of the real-time safety data. Potential comparison groups include concurrent exposed or unexposed individuals, historical exposed or unexposed individuals, and population based estimates. The second activity for this task will be to use the previously generated summary data from i3. These data include a single definition for each event (e.g., inpatient GBS claim) and a single comparison group (exposed individuals during the prior flu season). However, we collected data that will allow evaluation of alternative event definitions (e.g., inpatient versus physician office diagnoses), various time windows for comparison (e.g., 1-42 days and 43-84 day before vaccination), and comparator groups, and we will assess how these alternative specifications affect study findings. Harvard will work with FDA to compare findings with a similar assessment tentatively planned by FDA using the CMS data. The deliverable for this task is a report that describes the key benefits, limitations, and considerations of various potential comparison groups and event measures when conducting real-time flu vaccine safety surveillance in both databases when feasible. The report will include the findings of new analyses using the data developed during the prior flu vaccine safety study. f) Task 3. Evaluation of claims patterns for selected events (e.g., vaccines, drugs, procedures, labs, diagnostic studies) of interest. For this task, Harvard will work with FDA to select a set of 3 to 5 key outcomes (e.g., seizure, ataxia, anaphylaxis/allergic reaction, and paralytic syndrome) for flu safety surveillance and conduct a retrospective review of the automated claims associated with those outcomes. Harvard Pilgrim Health Care automated claims data will be used to describe the claims patterns of members with selected events to help improve our understanding of the expected patterns of care for those events within a managed care plan. Harvard will work with FDA to compare findings with a similar assessment tentatively planned by FDA using the CMS data. The goal of this task is to better understand the expected patterns of care for selected events, thereby improving our ability to define those events more precisely using claims data. This task will employ only automated data; chart abstraction will not be possible within the scope of work. The deliverable for this task will be a report describing the patterns of care for health plan members with selected events and suggestions for improving event definitions based on automated claims data. The deliverables called for under the contract shall be provided according to the schedule set forth therein. NO REQUEST FOR PROPOSAL (RFP) IS AVAILABLE. This notice of intent is not a request for competitive proposals. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services no later than 3pm eastern standard time on August 15, 2007 to Dominique.Malone @fda.hhs.gov. A determination to compete this procurement based on responses to this notice is solely within the discretion of the Government. NOTE: Contractors must be registered in the Central Contractor Registration (CCR). Information on registration and annual confirmation requirements may be obtained by calling 1-888-227-2423, or by accessing the CCR web site at http://www.ccr.gov/. Respondents will not be notified of the government?s decision. This announcement does not bind the government to a particular acquisition method. All responses or questions regarding this posting must be in writing and can be sent via email to Dominique.Malone@fda.hhs.gov. No phone calls will be accepted.
- Place of Performance
- Address: 1401 Rockville Pike, Rockville, MD
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01358566-W 20070803/070801220641 (fbodaily.com)
- Source
-
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