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

ICR 202006-0910-014

OMB: 0910-0701

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-06-24
Supporting Statement A
2018-04-05
ICR Details
0910-0701 202006-0910-014
Active 201804-0910-004
HHS/FDA CDER
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/26/2020
Retrieve Notice of Action (NOA) 06/24/2020
  Inventory as of this Action Requested Previously Approved
05/31/2021 05/31/2021 05/31/2021
6,500 0 6,500
262,000 0 262,000
0 0 0

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.

US Code: 21 USC 301 et. seq. Name of Law: FD&C Act
  
None

Not associated with rulemaking

  82 FR 50431 10/31/2017
83 FR 15153 04/09/2018
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 6,500 6,500 0 0 0 0
Annual Time Burden (Hours) 262,000 262,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$12,000
No
    No
    No
No
No
No
Yes
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  No

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.
06/24/2020


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