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.
This information collection
incorporates a revision to include the guidance for industry
regarding electronic submission of adverse event reports and
adjustments. The information collection also includes the
consolidation of burden from OMB control number 0910-0834
(previously added to this collection in March 2023). The total
burden hours of the information collection have increased by
61,614,921 hours and 2,546,112 responses as compared to the
previous renewal.
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.
83-C for 0230 to add Combo Product AER disclosure MARCH 2023.docx
Reporting - AER Rx products not subject of marketing application