0701 Nonsubstantive Change Request

UNITED STATES FOOD & DRUG ADMINISTRATION
Postmarketing Adverse Event Reporting for Medical Products
and Dietary Supplements During a Pandemic
OMB Control No. 0910-0701
JUSTIFICATION MEMORANDUM FOR NON-SUBSTANTIVE CHANGE
REQUEST
The Food and Drug Administration (FDA, the agency) is requesting a nonmaterial/nonsubstantive change to OMB control number 0910-0701. We have revised the currently
approved collection instrument to apply to any pandemic and not specifically an
influenza pandemic. The revised final guidance document is entitled, “Guidance for
Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary
Supplements During a Pandemic.” The guidance discusses our recommendations on
adverse event reporting requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic. Because of the potential for high employee
absenteeism during an influenza pandemic and because responsibility to report adverse
events during such a pandemic remained in effect, the guidance is intended to help firms
meet adverse event reporting requirements under these circumstances.
Specifically, the guidance document provides our recommendations on focusing limited
resources to certain types of reports, including planning, notification, and documentation
of postmarketing adverse events and on each firm’s pandemic influenza continuity of
operations plan (COOP) include instructions for reporting adverse events, including a
plan for the submission of stored reports that were not submitted within regulatory
timeframes.
In response to the Coronavirus Disease 2019 (COVID-19) public health emergency
(PHE), we updated the Final Guidance in March 2020. The primary revision was to
remove the word “influenza” so that the recommendations apply to any pandemic.
Dated: June 2020