Mitigation Strategies to Protect Food Against Intentional Adulteration

ICR 202205-0910-001

OMB: 0910-0812

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-05-20
IC Document Collections
IC ID
Document
Title
Status
221716
Unchanged
220350
Modified
ICR Details
0910-0812 202205-0910-001
Received in OIRA 201903-0910-019
HHS/FDA CFSAN
Mitigation Strategies to Protect Food Against Intentional Adulteration
Extension without change of a currently approved collection   No
Regular 06/09/2022
  Requested Previously Approved
36 Months From Approved 07/31/2022
427,566 427,566
2,525,522 2,524,298
0 24,097,974

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.

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
  
None

Not associated with rulemaking

  86 FR 71646 12/17/2021
87 FR 34879 06/08/2022
No

2
IC Title Form No. Form Name
Exemptions for very small businesses
IA Mitigation Strategies

  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 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
No
No
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.

$161,500
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 [email protected]

  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.
06/09/2022


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