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.

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: [email protected]. Response Date: 10:00 p.m. ET on August 24, 2020. Please email Sharon Masciana at [email protected] and Anthony S. Wimbush; [email protected]. 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