Registration of Food Facilities

ICR 202509-0910-007

OMB: 0910-0502

Federal Form Document

ICR Details
0910-0502 202509-0910-007
Received in OIRA 202205-0910-011
HHS/FDA HFP
Registration of Food Facilities
Extension without change of a currently approved collection   No
Regular 09/30/2025
  Requested Previously Approved
36 Months From Approved 09/30/2025
260,805 279,927
361,775 278,382
0 0

Respondents to the information collection are manufacturers, processors, holders, and distributors of foods who must register with the agency. Through this registration program and the information provided under the regulations, the agency is able to identify firms in the event of food-related emergencies as well as ensure that contaminated food products are quickly and efficiently removed from the marketplace.

US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  90 FR 27619 06/27/2025
90 FR 46222 09/25/2025
Yes

  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 260,805 279,927 0 0 -19,122 0
Annual Time Burden (Hours) 361,775 278,382 0 0 83,393 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 83,393 hours (from 278,382 to 361,775), although the number of responses decreased by 19,122 (from 279,927 to 260,805). Among other considerations, we attribute this adjustment primarily due to a significant increase in the number of foreign facility registrations and updates submitted coupled with a drastic decrease in the number of cancellations and third-party registration and U.S. Agent verifications submitted.

$2,387,558
No
    Yes
    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.
09/30/2025


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