FDA regulations require the reporting
to FDA of important adverse drug experience information associated
with the use of unapproved-marketed prescription drug product. This
information is used by FDA to determine at the earliest possible
time whether to request a manufacturer, packer, or distributor to
recall a product from the market or to recommend a seizure or
injunction action to halt the marketing of the product and to
remove it from the market. Such action, initiated promptly, may
avert further adverse effects that may be associated with the use
of the product.
The information collection
reflects both program changes and adjustments. For efficiency of
agency operations we have revised the ICR to include and account
for burden we attribute to reporting and recordkeeping discussed in
agency guidance documents and previously approved in separate ICRs;
and we have adjusted estimates to reflect fewer reports for
nonprescription drug products. We also removed costs reflected in
burden summary as we include in these in 12b of our supporting
statement
$0
No
No
No
No
No
No
No
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0230 AER for Drugs SSA 2021 REV.docx
AER Rx products not subject of marketing application