Notice of Intent to Sole Source - BRANY Training Program

Notice of Intent to Sole Source - Biomedical Research Alliance of New York, LLC (BRANY) Training Program The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Biomedical Research Alliance of New York, LLC (BRANY), 1981 Marcus Ave, Ste 210, Lake Success, NY 11042-1055, in accordance with the authority under FAR Part 13.501(a). This procurement is being conducted under simplified acquisition procedures in accordance with FAR Parts 12 and 13, including subpart 13.5. The NAICS code is 611430 - Professional and Management Development Training. 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. shall provide 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. Since their acquisition of BRANY is the only known and shall provide 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. This notice is not a request for competitive quotes. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response, i.e. capability statement, which clearly supports and demonstrates its ability to perform the requirements. Any response shall be received by the response date and time of this notice. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government. Response Date: 12:00 p.m. ET on September 11, 2019. Responses must be emailed to Pierre Smith at Pierre.smith@fda.hhs.gov.