SOURCES SOUGHT
B -- Evaluation of the Safety of Cardiovascular Devices - RFI document
- Notice Date
- 7/1/2010
- Notice Type
- Sources Sought
- NAICS
- 611699
— All Other Miscellaneous Schools and Instruction
- 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
- FDA1071298
- Archive Date
- 7/22/2010
- Point of Contact
- Ariana Nijaradze, Phone: 3018277161
- E-Mail Address
-
ariana.nijaradze@fda.hhs.gov
(ariana.nijaradze@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI full document. General Information: Document Type: Request for Information (RFI) Release Date: June 30, 2010 Response Date: July 7, 2010 at 4:30pm EST via e-mail to Contracting Specialist Contracting Office Address: Food and Drug Administration (FDA), Ariana Nijaradze Contract Specialist Description: Evaluation of the Safety of Cardiovascular Devices 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. 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 the evaluation of safety of cardiovascular devices in adult and pediatric populations. Draft Objective One: Risk of Adverse Events Following Cardiac Catheterization by Hemostasis Device The primary purposes of the proposed study are to evaluate the safety of hemostasis devices on national level. This should involve the use of data contained in a current data repository and the collection of new data as needed. The project should be able to: 1. Compare the relative safety of currently used hemostasis devices used for the prevention of femoral artery bleeding following cardiac catheterization, with each other and with manual compression controls, especially with regard to local vascular complications. 2. Assess the relative risk by gender of local vascular complications associated with the use of hemostasis devices. Draft Objective Two: Development of a Congenital Heart Disease Registry 1. To develop a relevant pediatric congenital heart disease registry, that will be able to assess the prevalence, demographics, management, and outcomes of patients with congenital heart disease who are undergoing diagnostic catheterization and catheter-based interventions across the United States. 2. To provide FDA with the ability to capture imaging and clinical outcomes when patients return for care for related or unrelated issues can provide critical information without exposing patients to unnecessary radiation. Draft Technical Requirement One: 1. Develop data collection form. 2. Train approximately 30 clinical sites that perform cardiac catheterization to collect the required data. 3. Collect data on approximately 14,000 patients over a period of about six months. 4. Assess comparative univariate risks of local vascular complications following the use of hemostasis devices 5. Assess risks of local vascular complications following the use of hemostasis devices for the various hemostasis devices by gender 6. Assess the role of sheath size on risks of local vascular complications following the use of hemostasis devices, and how that interacts with gender 7. Assess the effects of several confounding variables on risk by type of hemostasis device and gender, including: a. Race b. Diagnostic vs. therapeutic cardiac catheterization c. Body mass index (BMI) d. NYHA classification e. Diabetes f. Hypertension g. Peripheral vascular disease h. Left main coronary artery stenosis i. Shock j. History of congestive heart failure k. History of renal failure l. History of recent interventional cardiac catheterization m. Emergency vs. elective status n. Sheath size o. Institutional catheterization volume 8. Adverse events to be evaluated include: a. Entry site bleeding b. Hematoma c. Retroperitoneal bleeding d. Dissection e. Pseudoaneurysm f. Surgical device removal g. Entry site infection h. Occlusion i. Pulse loss j. Fistula Draft Technical Requirement Two: 1. Provide a summary of any data collected or lessons learned from a pilot phase of data collection from a pediatric registry. 2. Based on experience from the pilot phase, collaborate with FDA to refine the data elements to ensure that the registry will collect information relevant for FDA's premarket and postmarket objectives. 3. Based on experience from the pilot phase, continue work with FDA and other relevant professional societies to refine standardized definitions to ensure consistency, which will make more efficient use of other registry data. 4. Collaborate with device manufacturers and health care institutions to obtain widespread clinical site participation. 5. Provide FDA access to specific data including demographic data, adverse outcomes, results, and other endpoints of interest. 6. Provide FDA with sets of data or certain data analyses to address particular questions posed by FDA. 7. Provide FDA with regular updates on the progress of the registry. 8. Must have an in-depth knowledge, appropriate infrastructure and have initiated the development of such a large registry, which is sufficiently user-friendly such that participation will be high, and yet also addresses all appropriate patient privacy issues. The registry must also incorporate an infrastructure that will allow capture of data on pediatric patients regardless of location and how often they move (within the US). 9. Must have relevant experience and have established additional collaborative relationships in place to facilitate and expedite the development of uniform definitions and appropriate data elements. The contractor must have access to appropriate statistical expertise to compile datasets or conduct analyses as requested by FDA. 10. Must also have the ability to nationally audit the data collected in a confidential and secure manner. Part A. Capability and Technical Experience - Interested parties should submit capability statement describing relevant experience to the above requirement. Part B. Size of Business - 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 activates of your company, your affiliates, your team members and affiliates of your team member which create either a conflict of interest or the appearance of a conflict of interest. Part D. Cost Estimate - In accordance with FAR PART 10, provide a cost/price estimate for the prospective services to be conducted under the potential requirement. Cost should consist of the type of personnel required, hourly rates/days and material, etc.
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