View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0502
ICR Reference No:
202509-0910-007
Status:
Active
Previous ICR Reference No:
202205-0910-011
Agency/Subagency:
HHS/FDA
Agency Tracking No:
HFP
Title:
Registration of Food Facilities
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/14/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2028
36 Months From Approved
11/30/2025
Responses
260,805
0
279,927
Time Burden (Hours)
361,775
0
278,382
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 301 et seq.
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 27619
06/27/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 46222
09/25/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Biennial renewal of registration
FDA 3537
Food Facility Registration
New domestic facility registration
FDA 3537
Food Facility Registration
New foreign facility registration
FDA 3537
Food Facility Registration
Registration cancellations
FDA 3537a
Cancellation of Food Facility Registration
Registration updates
FDA 3537
Food Facility Registration
Third party registration verification
U.S. Agency verification
ICR Summary of Burden
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
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$2,387,558
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/30/2025
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