Web-Based Training System for FDA Personnel in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, and Good Clinical Practice.
Closed Pre-Solicitation Posted
- Solicitation number
- 1228943
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Place of performance
- Silver Spring MD 20993 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This pre-solicitation notice seeks capability statements for a sole source contract to provide a web-based training system for FDA personnel in the areas of human subjects research, responsible conduct of research, animal care and use, biosafety and biosecurity, good clinical practice, and good laboratory practice. The Food and Drug Administration requires the training to ensure compliance with federal regulations. Capability statements must demonstrate the offeror can provide the required courses through a web-based system and will be evaluated to determine if the capability exists to fulfill the scope of work. Capability statements are due by August 24, 2020.
The NAICS code listed is 541990 for all other professional, scientific and technical services and the PSC code is U010. Biomedical Research Alliance of New York, LLC is identified as the only known provider that can currently meet these training requirements. The statement of work outlines the required tasks, deliverables, and contractor responsibilities to provide the web-based training system and courses on an ongoing basis. An award is anticipated to be made to Biomedical Research Alliance of New York, LLC within 15 days of the response deadline unless another source is found that can fulfill the requirement.
Notice text
ID: 1228943 – Web-based Training for FDA Personnel – Human Subjects Research (Sole Source)
The Food and Drug Administration (FDA) is responsible for ensuring that Human Subjects Research (HSR)
complies with Federal regulations. FDA is mandated by federal regulations to give its employees the opportunity to acquire the skills and competencies necessary to carry out its mission. FDA must provide the required trainings for FDA researchers in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, Biosafety and Biosecurity, Good Clinical Practice, and Good Laboratory Practice and, the general research ethics compliance.
The contractor shall provide a Web-Based Training System for FDA Personnel in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, Biosafety and Biosecurity, Good Clinical Practice, and Good Laboratory Practice. BRANY is the only known provider of the Web- Based Training for FDA Personnel in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, Biosafety and Biosecurity, Good Clinical Practice, and Good Laboratory Practice.
NAICS Code: 541990 All Other Professional, Scientific, and Technical Services
PSC Code: U010 Certifications/Accreditations
This notice is not a request for competitive proposals. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Contact Information: Sharon.Masciana@fda.hhs.gov.
Response Date: 10:00 p.m. ET on August 24, 2020. Please email Sharon Masciana at Sharon.Masciana@fda.hhs.gov and Anthony S. Wimbush; Anthony.Wimbush@fda.hhs.gov. All responses are due by the response date noted above. A determination not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.
Attachments/Links: Statement of Work
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent to Sole Source 1228943 V1.pdf | ||
| Statement of Work 1228943.pdf |
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