SOLICITATION NOTICE
A -- Regulatory Policies Associated with Premarket Medical Device Submissions
- Notice Date
- 6/10/2005
- 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
- ZIP Code
- 20857-0001
- Solicitation Number
- 1000375
- Response Due
- 6/20/2005
- Archive Date
- 7/5/2005
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Request for Quote (RFQ) No. 1000375. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The North American Classification System (NAICS) Code is 541710. This is a small business set-aside. The FDA intends to issue a purchase order on a sole source basis to Joseph Sheehan for a professional service contract for the FDA?s Office of Device Evaluation (ODE) to assist on regulatory policies associated with premarket medical device submissions for the Center of Devices and Radiological Health (CDRH). The contractor shall provide the following services: 1) Provide a critical element of review in addressing many pressing regulatory policy issues, such as reclassification actions, transfer of ownership, limitations to exemption, and convenience kit policy associated with the premarket submission review; 2) Provide expertise to FDA staff on the application of various statutes, regulations, and Executive Orders on regulatory issues concerning medical devices and radiological health including the Federal Food, Drug, and Cosmetic Act, the Administrative Procedures Act, and the Paperwork Reduction Act among others; 3) Assist the Office with regulatory issues related to reclassification actions, transfer of ownership, limitations to exemption, among other regulatory issues associated with the premarket submission review; 4) Provide a regulatory counsel knowledge base that the office currently does not have on staff. This work will be done primarily through teleconferencing and meeting consults. In addition, the contractor shall help and assist with regulatory issues related to premarket submission processes that will have a great impact on the Office?s ability to properly administer many of the more complex, from a regulatory standpoint, premarket submissions. The contractor will also: 1) Serve as a consultant to the 510(k) Staff in the Office?s Program Operations Staff; 2) Provide expertise and input into regulatory policy issues, such as reclassification actions, transfer of ownership, and limitations to exemption, associated with the premarket submission review; 3) Attend meetings and teleconferences and he will participate in the development of regulations, guidance documents, and administrative policies and procedures for regulating medical devices. The following FAR Clauses shall apply to this solicitation: 52.212-1. 52.212-2, 52-212-4, 52-212-5 Instructions to Offerors-Commercial; 52.214-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award is being issued on a sole source basis because Mr. Sheehan is an expert in medical device regulation and CDRH regulatory policy. Mr. Sheehan is the only known source who has the background and experience in the medical device review process and regulatory matters to meet the FDA?s requirements. It would be most cost effective to use this contractor since he has extensive knowledge of CDER regulatory policy. All questions should be submitted in writing via e-mail to TONEILL@OC.FDA.GOV or fax to 301-827-7101. FAR provisions can be found at the following website: http://www/arnet.gov.
- Place of Performance
- Address: FDA/CDRH/ODE, 9200 Corporate Blvd., Rockville, MD
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN00827382-W 20050612/050612190239 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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