Notice of Intent to Sole Source 1228943 V1.pdf

Notice ID: FDA 1228943

Notice of Intent to Sole Source with the Biomedical Research Alliance of New York, LLC (BRANY) Training Program

Title: 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.

Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS)/Food and Drug Administration (FDA) on behalf of OC/OSPD intends to sole source to:

Biomedical Research Alliance of New York, LLC (BRANY), 1981 Marcus Ave, Ste 210, Lake Success, NY 11042-1055

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 is 611430 – Professional and Management Development Training.

and/or 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.

It is anticipated that an award will be issued to the BRANY, within approximately 15 days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 10:00 p.m. ET on August 24, 2020. Please email Sharon Masciana at Sharon.Masciana@fda.hhs.gov. All responses are due by the response date noted above. A mailto:Sharon.Masciana@fda.hhs.gov 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

Contact Information:

Primary point of contact:

Sharon Masciana Sharon.Masciana@fda.hhs.gov 240-402-7631

Secondary point of contact:

Anthony Wimbush Anthony.Wimbush@fda.hhs.gov 240-402-7628 mailto:Anthony.Wimbush@fda.hhs.gov mailto:Anthony.Wimbush@fda.hhs.gov