Mitigation Strategies to Protect Food Against Intentional Adulteration

Forms and Documents

Document Name	Status
0812 Supporting Statement 5.20.22.docx Supporting Statement A	2022-05-20

IC Document Collections

IC ID	Document Title	Status
221716	Exemptions for very small businesses	Unchanged
220350	IA Mitigation Strategies	Modified

ICR Details

OMB Control No: 0910-0812	ICR Reference No: 202205-0910-001
Status: Received in OIRA	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	Date Submitted to OIRA: 06/09/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2022
Responses	427,566	427,566
Time Burden (Hours)	2,525,522	2,524,298
Cost Burden (Dollars)	0	24,097,974

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 2

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

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ICR Summary of Burden

	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

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.

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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

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Common Form ICR:  No

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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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