Postmarketing Adverse Drug Experience Reporting

ICR 202105-0910-002

OMB: 0910-0230

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0230 202105-0910-002
Received in OIRA 202008-0910-004
HHS/FDA CDER
Postmarketing Adverse Drug Experience Reporting
No material or nonsubstantive change to a currently approved collection   No
Regular 05/26/2021
  Requested Previously Approved
12/31/2021 12/31/2021
1,139,100 1,132,600
14,922,297 14,660,297
25,000 25,000

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.

US Code: 21 USC 301 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 379 Name of Law: FFDCA; Adverse Event Reporting
   PL: Pub.L. 109 - 462 2(e)(3) Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 40520 08/15/2018
83 FR 55901 11/08/2018
No

  Total Request 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 1,139,100 1,132,600 0 0 6,500 0
Annual Time Burden (Hours) 14,922,297 14,660,297 0 0 262,000 0
Annual Cost Burden (Dollars) 25,000 25,000 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
No
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.
05/26/2021


© 2024 OMB.report | Privacy Policy