SOLICITATION NOTICE
R -- Provision of Clinical Expertise Necessary for the Regulatory Review of Clinical Trial Design and for Assessment of Safety and Effectiveness of Vascular System Devices
- Notice Date
- 8/16/2007
- Notice Type
- Solicitation Notice
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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
- Reference-Number-1033659
- Response Due
- 8/15/2007
- Archive Date
- 8/30/2007
- Description
- The Food and Drug Administration intends to award a follow on purchase order to Case Western Reserve University of Cleveland, OH. This is NOT a request for competitive quotes. The Purchase Order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures for the following services to be performed both at 9200 Corporate Boulevard, Rockville, MD 20850, and 10900 Euclid Avenue, Cleveland, OH under the simplified acquisition procedures. INTRODUCTION: The Office of Device Evaluation?s Division of Cardiovascular Devices (DCD) at the FDA is responsible for regulating cardiovascular devices and in doing so is responsible for reviewing about 40% of the Pre-market Approval (PMA) submissions received by ODE annually. The reviews are undertaken by DCD scientists who make up approximately one quarter of the ODE review staff. Devices employed for correction of heart failure is a major component of the Division?s workload. This workload is rapidly increasing due to technologic developments expanding the application of complex new heart failure technologies. This new technology has not only significantly increased the population of candidates for treatments previously demonstrated as effective in open-operations, but has also introduced new modalities to correct eh defects in a less invasive, percutaneous manner. This is illustrated in the astronomical number of submission-ns related to heart failure treatment submitted to the Division for review. A total of over 1000 such submissions were reviewed during the past year which included 720 IDE applications; requiring a 30-day decision, 69 PMAs, and 720 510(k)s. Case Western University has the experienced staff that are experts in the field of heart failure, are board certified in cardiology and have experience in clinical pharmacology. Additionally, the experts at Case Western have been found to have participated in many of the changes in the conduct of heart failure and are familiar with the clinical trials conducted for the associated new technology. All of these characteristics give Case Western the credentials and experience to be able to perform the work requested. WORK TO BE PERFORMED: A) Objective: To assist the Office of Device Evaluation?s Division of Cardiovascular Devices (DCD) in reviewing and regulating cardiovascular devices. Devices employed for correction of heart failure is a major component of the division?s workload. The new technology has not only significantly increased the population of candidates for treatments previously demonstrated as effective in open-operations, but ahs also introduced new modalities to correct the defects in a less invasive, percutaneous manner. B) Scope of Work: Independently and not as an agent of the Government, the consultant shall serve as an expert clinical reviewer for heart failure device applications, provide expert preclinical and clinical reviews, provide scientific and technical leadership and guidance in the area of heart failure medical devices used in both diagnosis and treatment of all types of heart failure pathology. PERIOD OF PERFORMANCE: October 1, 2007 ? March 31, 2008. PAYMENT: This action is proposed on a sole source basis. Interested parties may identify their interest by responding to this requirement within 7 calendar days after the date of publication of this notice. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your DUN and Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Ronald.Banzon@fda.hhs.gov no later than August 22, 2007, 2:00pm EST. ANTICIPATED AWARD DATE: The anticipated award date is September 20, 2007; however, all dates in this announcement are subject to change. PROVISIONS and CLAUSES: The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), 52.217-9 Option to Extend the Term of the Contract (Mar 2000). All information received by 2:00pm EST on August 22, 2007 will be considered by the Government. Responses to this notice must be sent via email to ronald.banzon@fda.hhs.gov. No phone calls will be accepted.
- Place of Performance
- Address: 9200 Corporate Blvd Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01374676-W 20070818/070816220620 (fbodaily.com)
- Source
-
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