Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance

OMB 0910-0701

This information collection supports agency guidance that includes FDA recommendations on adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The purpose of the information collection is to help support global preparedness in the event of such a pandemic and help offset associated threats and risks to the public health.

The latest form for Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance expires 2021-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0701 AER pandemic Non sub request June 2020.pdf Justification for No Material/Nonsubstantive Change
0701 SSA GFI AER for Flu Pandemic 2018 Ext.pdf Supporting Statement A
Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored Other-Agency Guidance
Maintain Documentation of Influenze Pandemic Conditions and Resultant High Absenteeism Other-Agency Guidance
Add Adverse Event Reporting Plan to COOP Other-Agency Guidance
Notify FDA When Normal Reporting is Not Feasible Other-Agency Guidance

All Historical Document Collections

202006-0910-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-06-24
201804-0910-004 Approved without change	Extension without change of a currently approved collection	2018-04-12
201412-0910-017 Approved without change	Extension without change of a currently approved collection	2015-01-08
201107-0910-010 Approved without change	New collection (Request for a new OMB Control Number)	2011-07-25

OMB Details

Notify FDA When Normal Reporting is Not Feasible

Federal Enterprise Architecture: Health - Public Health Monitoring