DOCUMENT
R -- Regulatory and Quality Assistance Service - Attachment
- Notice Date
- 6/28/2016
- Notice Type
- Attachment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
- ZIP Code
- 15212-5319
- Solicitation Number
- VA26816R0114
- Response Due
- 6/30/2016
- Archive Date
- 8/29/2016
- Point of Contact
- Michael.haydo@va.gov
- E-Mail Address
-
Michael.Haydo@va.gov
(Michael.Haydo@va.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Veteran's Administration Office of Research and Development, Program Contracting Office - East in Pittsburgh, PA intends to negotiate on a sole source basis with Regulatory And Quality Solutions, LLC located in Monroeville, PA. The requirement is for a contractor to provide regulatory and quality assistance professional services. The contractor shall assist the VA in filing multiple medical study findings with federal regulatory agencies. Current plans are to file through the Integrated Development Environment (IDE) of the US Food And Drug Administration (FDA) for approval. All work shall be performed at the Advanced Platform Technology Center of the Louis Stokes VA Medical Center in Cleveland, OH. The contractor will be responsible for project management, patient education, program customization, training, program reviews, and data analysis. The sole source is pursuant to Federal Acquisition Regulation Part 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per Federal Acquisition Regulation. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Thursday, June 30, 2016, (10:00AM, EST). Interest/capability statements may be sent by email to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/8ab1675a4ca52b058ca6ca081d04fed8)
- Document(s)
- Attachment
- File Name: VA268-16-R-0114 VA268-16-R-0114_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2836010&FileName=VA268-16-R-0114-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2836010&FileName=VA268-16-R-0114-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA268-16-R-0114 VA268-16-R-0114_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2836010&FileName=VA268-16-R-0114-000.docx)
- Place of Performance
- Address: Cleveland, OH
- Zip Code: 44106
- Zip Code: 44106
- Record
- SN04164479-W 20160630/160628234755-8ab1675a4ca52b058ca6ca081d04fed8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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