; (C) in a new patient population for which the contrast agent is determined by the Secretary to pose an increased risk; or (D) in an imaging modality (such as an ultrasonic, ionizing radiation, or magnetic resonance imagine modality) that is different from those described in the approved labeling of the contrast agent. (2) The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application or notification described in paragraph (1). In conducting such review, such agency center may— (A) consult with the agency center charged with the premarket review of drugs and biological products