Postmarketing Adverse Drug Experience Reporting

ICR 202110-0910-003

OMB: 0910-0230

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0230 202110-0910-003
Received in OIRA 202105-0910-002
Postmarketing Adverse Drug Experience Reporting
Revision of a currently approved collection   No
Regular 11/22/2021
  Requested Previously Approved
36 Months From Approved 12/31/2021
1,136,229 1,139,100
14,703,589 14,922,297
0 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.

PL: Pub.L. 109 - 462 2(e)(3) Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
   US Code: 21 USC 321, 352, 355, 371, 379aa Name of Law: FFDCA; Adverse Event Reporting

Not associated with rulemaking

  86 FR 34759 06/30/2021
86 FR 61277 11/05/2021

  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 1,136,229 1,139,100 0 0 -2,871 0
Annual Time Burden (Hours) 14,703,589 14,922,297 0 0 -218,708 0
Annual Cost Burden (Dollars) 0 25,000 0 0 -25,000 0
The information collection reflects both program changes and adjustments. For efficiency of agency operations we have revised the ICR to include and account for burden we attribute to reporting and recordkeeping discussed in agency guidance documents and previously approved in separate ICRs; and we have adjusted estimates to reflect fewer reports for nonprescription drug products. We also removed costs reflected in burden summary as we include in these in 12b of our supporting statement

Domini Bean 301 796-5733 [email protected]


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.

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