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:
0910-0812
ICR Reference No:
202205-0910-001
Status:
Historical Active
Previous ICR Reference No:
201903-0910-019
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Mitigation Strategies to Protect Food Against Intentional Adulteration
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:
07/13/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/09/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2025
36 Months From Approved
07/31/2022
Responses
427,566
0
427,566
Time Burden (Hours)
2,525,522
0
2,524,298
Cost Burden (Dollars)
0
0
24,097,974
Abstract:
This information collection supports agency regulations that relate to the development of mitigation strategies to protect against the intentional adulteration of food. Respondents to the collection are food production facilities subject to agency regulations.
Authorizing Statute(s):
US Code:
21 USC 350g
Name of Law: Federal Food, Drug and Cosmetic Act
US Code:
21 USC 350i
Name of Law: Federal Food, Drug and Cosmetic Act
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:
86 FR 71646
12/17/2021
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 34879
06/08/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Exemptions for very small businesses
IA Mitigation Strategies
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
427,566
427,566
0
0
0
0
Annual Time Burden (Hours)
2,525,522
2,524,298
0
0
1,224
0
Annual Cost Burden (Dollars)
0
24,097,974
0
0
-24,097,974
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 no adjustments other than to increase the burden estimate by 1,224 hours due to a corrected calculation for the estimate related to training (§ 121.160). Also, burden costs were inadvertently entered into OMB’s ROCIS digital platform for this collection during the last approval. FDA requests OMB revise those costs from $24,097,974 to zero.
Annual Cost to Federal Government:
$161,500
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.
No
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:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.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:
06/09/2022
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