FDA Recall Regulations

ICR 201802-0910-013

OMB: 0910-0249

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0249 201802-0910-013
Active 201502-0910-005
FDA Recall Regulations
Revision of a currently approved collection   No
Approved with change 04/06/2018
Retrieve Notice of Action (NOA) 03/08/2018
  Inventory as of this Action Requested Previously Approved
04/30/2021 36 Months From Approved 04/30/2018
1,523,502 0 1,748,460
584,477 0 721,886
0 0 0

This information collection supports FDA regulations governing recalls. The information collection provisions apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.

US Code: 21 USC 701 Name of Law: FFDCA

Not associated with rulemaking

  82 FR 54359 11/17/2017
83 FR 8284 02/26/2018

  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 1,523,502 1,748,460 0 -225,915 -1,896 2,853
Annual Time Burden (Hours) 584,477 721,886 0 -147,024 -33,180 42,795
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
Miscellaneous Actions
The adjustment in burden is due to the decreased number of respondents from 3,801 to 2,853 (-948). FDA discovered that 21 CFR 7.59 (general industry guidance) contained information collection that was not previously approved and, therefore, added it to this ICR request for extension of OMB approval. Despite this addition the estimated total burden has decreased 137,409 hours.

Jonna Capezzuto 301 796-3794 [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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