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