The U.S. Food and Drug Administration (FDA) intends to solicit a 5-year, sole source, firm-fixed-price type contract from BIOMEDICAL RESEARCH ALLIANCE OF NEW YORK LLC (“BRANY”), 1981 Marcus AVE STE 210, Lake Success, New York, 11042-1055, in accordance with the authority under Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii). This procurement will be conducted using FAR subpart 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services in accordance with 41 U.S. Code § 1901. The North American Industry Classification System (NAICS) code is 611430 - Professional and Management Development Training. The anticipated period of performance consists of one (1) 12-month base period and four (4) 12-month option periods. The FDA is responsible for ensuring that Human Subjects Research (HSR) complies with Federal regulations. The FDA is mandated by Federal regulations to give its employees the opportunity to acquire the skills and competencies necessary to carry out its mission. The FDA must provide the required trainings for FDA researchers in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, Good Clinical Practice, and general research ethics compliance. The objective of the proposed contract action is to provide mandated research ethics/compliance training to FDA authorized personnel as required to support FDA’s responsibilities including oversight and monitoring functions for research protections in FDA supported and regulated research. The Contractor shall develop and provide web-based trainings in the areas of research ethics, compliance, and best practices education, in all mandated areas. The trainings shall be accessible to FDA employees with 24/7 online access in twenty (20) geographic sites to meet the training needs of FDA researchers in FDA’s various geographic areas. The web-based training program shall contain subject matter content specifically addressing Human Subjects Research (“HSR”) ethics requirements under applicable Federal regulations, as well as Responsible Conduct of Research (RCR), Animal Care and Use (ACU), and Good Clinical Practice (GCP). BRANY has unique qualifications and experience performing this requirement for the FDA through BRANY’s Collaborative Institutional Training Initiative (CITI) Program. BRANY is the only known provider that is capable of providing all of the legally mandated training courses and certifications needed by FDA’s laboratory staff. The vendor utilizes a user-friendly online platform that allows FDA employees to access training materials 24/7 at their convenience, including a Single Sign On (SSO) feature that allows learners to sign in with the same credentials they use at the FDA, increasing security and facilitating FDA staff access. The vendor provides comprehensive reporting tools that allow FDA Centers to monitor researchers’ compliance with training requirements. It also offers a customizable training solution that allows FDA to tailor the content and modules according to agency’s specific requirements. This flexibility ensures that FDA employees receive training that is directly applicable to their roles and responsibilities, enhancing the effectiveness of the program. Training received is transferable to another agency should the employee transfer to another agency that is also serviced by BRANY. This helps save the Government time and money by not needing to have their employees re-certify every time they move to a new Federal Agency-operated research facility. Therefore, it would not be reasonable to compete this requirement. This notice is not a request for competitive proposals. 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 must be received by the response date and time set forth in this notice. Any response will undergo a review to determine if the respondent 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 and Time: 4:00 p.m. ET on July 21, 2023. Responses must be emailed to Melinda Kim at
[email protected], with a CC: to Nicholas Bisher at
[email protected].