; (2) overseeing initial cell collection and the development and maintenance of qualified cell banks; (3) overseeing proliferation and differentiation of cells up to the time of harvest; (4) ensuring that the appropriate entities comply with applicable requirements of the Food and Drug Administration, including facility registration, the current good manufacturing practices and preventive controls regulation, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food; (5) developing additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe; or (6) conducting appropriate inspections and follow-up activities, including taking enforcement action if necessary, to ensure that cell bank and cell culturing facilities are in compliance with applicable laws (including regulations).