OMB is filing
comment on this ICR which is associated with a proposed rule.
Approval is not granted at this time. FDA should resubmit this ICR
in conjunction with the final rule. At that time, FDA will consider
public comments and estimate the number of respondents who will
avail themselves of the streamlined reporting requirements proposed
in the rule for combination products. Accordingly, FDA will revise
its estimates of the consequent reduction in reporting and
recordkeeping burden currently allocated to separate information
collection requests (i.e. OMB control numbers 0910-0001, 0910-0230,
0910-0291, 0910-0308, 0910-0116, and 0910-0437).
Inventory as of this Action
36 Months From Approved
To ensure appropriate ongoing
postmarketing surveillance of risks, to ensure the consistency of
the agency's postmarketing regulation of combination products, to
streamline requirements for reporters by avoiding duplicative
reporting requirements, FDA proposes to create 21 CFR part 4,
subpart B to clarify postmarketing safety reporting requirements
for combination products.