SOLICITATION NOTICE
A -- SUBMISSION REVIEW OF ANESTHESIA WORKSTATIONS
- Notice Date
- 2/15/2005
- Notice Type
- Solicitation Notice
- 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, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- R1302405
- Response Due
- 2/25/2005
- Archive Date
- 2/25/2005
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Dr. Eric T. Pierce to provide the overall clinical support needed for the project: ?Submission Review of Anesthesia Workstations.? The Center for Devices and Radiological Health (CDRH), Office of Device Evaluation?s Division of Anesthesia, General Hospital and Dental Devices is responsible for regulating anesthesia devices. Devices employed in the delivery of anesthetic gases are an important and major component of the Division?s workload. Developments in therapies directed at physiological closed-loop control of anesthesia delivery systems are escalating and expertise is needed to assist CDRH in the review and analyses of these submissions. The Agency will rely on clinical expertise provided by a part-time board certified anesthesiologist. The approval of this contract will greatly enhance the Office?s ability to review and evaluate these very complex anesthesia devices. The contractor shall be able to complete the following tasks: 1. Serve as one of the clinical reviewers of anesthesia drug-device delivery system applications. 2. Provide preclinical and clinical reviews of IDEs and PMAs. 3. Attend meetings and tele-conferences. 4. Participate in the development of guidance for clinical studies of anesthesiology devices. 5. Work as a medical officer, through telephone meetings, and assist in the medical device review process by providing clinical consults on the Investigational Device Exemption and Pre-market Approval Applications that are received in the Office because he/she shall be familiar with the design of the devices and his/her expertise will be used in rendering decisions. 6. Provide written formal consultative memoranda with the time constraints dictated by regulations. 7. Be available for telephone communication and verbal consultations with the staff of DAGID on an ad hoc basis. 8. Be committed to a regularly scheduled weekly telephone interaction with DAGID staff and participate telephonically at meetings and conferences as is necessary. 9. Participate at professional meetings as a representative of the FDA. 10. Have working knowledge of Agency regulations, procedures, and policy. An award will be made in ten (10) days from the date of this notice. This is not a request for quotes; however, sources may submit descriptive literature, which fully demonstrate their capabilities, which will be considered by the agency. This sole source procurement is being awarded as a simplified acquisition in accordance with FAR Subpart 13.5.
- Place of Performance
- Address: FDA/CDRH?Office of Evaluation (HFZ-405), 9200 Corporate Blvd., Rockville, MD
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN00751128-W 20050217/050215211711 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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