SOURCES SOUGHT
B -- Innovative Methodologies for Evidence Synthesis for Medical Devices Study - RFI
- Notice Date
- 8/20/2010
- Notice Type
- Sources Sought
- 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
- 1074629
- Archive Date
- 9/8/2010
- Point of Contact
- Christopher E. Cunningham, Phone: 301-827-7185, Doreen Williams, Phone: Contracting Officer
- 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
- This is a MS Word version of the RFI. General Information: Document Type: Request for Information (RFI) Release Date: August 20, 2010 Response Date: August 24, 2010 at 1:00pm EST via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration (FDA), Christopher E. Cunningham Contract Specialist Description: Innovative Methodologies for Evidence Synthesis for Medical Devices Study This is a RFI NOTICE to determine the availability and capability of small business (including certified 8(a), Small Disadvantage, HUB Zone one firms; veteran-owned small business, and women-owned small businesses), or other sources. This information is being sought for information and planning purposes only and shall not be construed as an invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items or services herein. This notice is NOT a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this RFI. If in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **NO QUESTIONS WILL BE ENTERTAINED AT THIS TIME** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities or prior experience in developing and illustrating innovative methodologies for evidence synthesis for medical devices. Draft Objectives: To provide expert services to develop and illustrate different methodological approaches to analyzing data from external post-market databases and integrating them into the Center for Devices & Radiological Health (CDRH) Post-approval decision making. Part A. Technical Capability - Please submit your ideas on how the following may be accomplished: 1. Work with FDA epidemiologists to select two approved medical devices based on the public health importance/need and the availability of existing data sources. 2. Work with FDA epidemiologists to develop the final study protocol for combining the evidence from diverse data sources involving the selected devices. 3. Identify and conduct detailed evaluation of available data sources in terms of the included population, duration of follow-up, linkability with other databases, advantages and disadvantages of the elements (e.g. Medicare and Medicaid data, hospital discharge data, hospital emergency room data, electronic medical record data, etc). 4. Work with FDA epidemiologists to identify and evaluate evidence from the published studies involving selected devices. 5. Develop and illustrate hierarchical model for combining the evidence from multiple external data sources for selected devices. (see below) External data sources: 1) ACC National Cardiovascular Data Registry - Hemostasis Study. 2) Society of Thoracic Surgeons (STS) National Database - Heart Valve Surgery Study. 4) American College of Surgeons (ACS) - Bariatric Surgery Study. 5) ACC Implantable Cardioverter Defibrillator (ICD) - Registry Study. Experience - Please indicate experience in the following areas: Methodological strategies and analytical skills involving simultaneous application of analytical methods such a as meta-analysis, cross design synthesis and network meta-analysis. Statistical models that combine these methodologies requires exceptional statistical background of a nationally recognized expert with appropriate infrastructure to integrate the data and work with the FDA on development of these models. Expertise and experience in the evidence synthesis is crucial to the success of this important initiative. Deliverables - Please indicate experience in providing deliverables similar to the following: DELIVERABLES • Develop study protocol and obtain IRB approval • Identifying data sources • Paper summarizing clinical data sources and potential uses, methods to model the various sources of data, and illustrating findings for some specific devices; and potential additional databases used to enhance post-market surveillance • Preliminary analyses of linking clinical data to predict device success; procedural success; and safety & effectiveness • Presentations at a scientific meeting (AHA/ACC, ENAR, ICPE) • Paper describing and illustrating methods to estimate differential effectiveness of new devices for women, minorities, and children in usual care setting Place of Performance - Contractors site Period of Performance - It is estimated that this study will take two years to complete. Part B. Size of Business - Please provide your business size and submit copies of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) - If any; provide disclosure of business activities of your company, your affiliates, and your team members. Part D. Cost Estimate - In accordance with FAR Part 10 Market Research Information, please provide a cost estimate for the prospective supplies/services to be provided. If applicable, cost should consist of labor, supplies, overhead costs, and travel expenditures.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1074629/listing.html)
- Record
- SN02248510-W 20100822/100820234910-39d658fb863681fcc740c708ca553ddf (fbodaily.com)
- Source
-
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