For combination products for which the
constituent parts receive marketing authorization under separate
applications held by different entities, the Agency established a
requirement, specific to these “constituent part applicants,” that
they must share safety information they receive related to certain
events with the other constituent part applicant(s), and maintain
records of this information sharing.
The burden for this extension
request has decreased (an adjustment) because the burden for drug,
devices and biological products has been omitted from this ICR and
consolidated into the appropriate center ICRs referred to in
section 1 of this document.