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:
0910-0744
ICR Reference No:
202401-0910-002
Status:
Active
Previous ICR Reference No:
202106-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
ORA
Title:
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/01/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/30/2024
Terms of Clearance:
Previous terms continue: OMB continues to encourage FDA to work with CDC to find opportunities to minimize burden and combine collections when possible.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2027
36 Months From Approved
09/30/2024
Responses
824
0
1,616
Time Burden (Hours)
1,602
0
1,637
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information on the occurrence of foodborne illness risk factors in full service and fast food restaurants. Foodborne illness risk factors are defined as the preparation practices and employee behaviors most commonly reported to the Centers for Disease Control and Prevention (CDC) as contributing factors to foodborne illness outbreaks at the retail level.
Authorizing Statute(s):
US Code:
42 USC 243
Name of Law: Public Health Service Act
US Code:
21 USC 301
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
31 USC 1535
Name of Law: The Economy Act of 1932
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:
89 FR 15996
03/06/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 70652
08/30/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
2021-2022 - Fast Food Restaurants - Completion of Sections 1 and 3
2021-2022 - Full Service Restaurants - Completion of Sections 1 and 3
Fast-Food and Full-Service Restaurants--Form FDA 3966
FDA 3966
Restaurant Data Collection Record
Refusal
FDA 3967, FDA 3966
Retail Food Store Data Collection Form
,
Restaurant Data Collection Record
Retail Food Stores - Form FDA 3967
FDA 3967
Retail Food Store Data Collection Form
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
824
1,616
0
0
-792
0
Annual Time Burden (Hours)
1,602
1,637
0
0
-35
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 made adjustments to our burden estimate. On our own initiative, however, and for efficiency of Agency operations, we are revising the information collection to include and consolidate related information collection found in 0910-0799. Our estimated burden for the information collection reflects a decrease of 35 total burden hours and a corresponding decrease of 792 total annual responses.
Annual Cost to Federal Government:
$531,776
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
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:
Amber Sanford 301 796-8867 amber.sanford@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:
08/30/2024
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