OMB control number
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance
OMB 0910-0701 · HHS/FDA.
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 is listed under ICR 202006-0910-014.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 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All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202006-0910-014 | No material or nonsubstantive change to a currently approved collection | 2020-06-24 | Approved without change | |
| 201804-0910-004 | Extension without change of a currently approved collection | 2018-04-12 | Approved without change | |
| 201412-0910-017 | Extension without change of a currently approved collection | 2015-01-08 | Approved without change | |
| 201107-0910-010 | New collection (Request for a new OMB Control Number) | 2011-07-25 | Approved without change |
OMB Details
Notify FDA When Normal Reporting is Not Feasible
Federal Enterprise Architecture: Health - Public Health Monitoring