Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

Forms and Documents

Document Name	Status
FSMA Intentional Adulteration FRIA.pdf Supplementary Document	2016-05-25
Intentional Adulteration Supporting Statement for Final Rule rev 1.doc Supporting Statement A	2016-06-28

IC Document Collections

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

ICR Details

OMB Control No: 0910-0812	ICR Reference No: 201605-0910-012
Status: Historical Active	Previous ICR Reference No: 201511-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/28/2016
	Date Received in OIRA: 05/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	427,566	0	0
Time Burden (Hours)	2,524,298	0	0
Cost Burden (Dollars)	24,097,974	0	0

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Abstract: This information collection supports agency regulations that relate to 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 350h Name of Law: 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:
0910-AG63	Final or interim final rulemaking	81 FR 34000	05/27/2016

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Federal Register Notices & Comments

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 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	0	0	427,566	0	0
Annual Time Burden (Hours)	2,524,298	0	0	2,524,298	0	0
Annual Cost Burden (Dollars)	24,097,974	0	0	24,097,974	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection in support of agency rulemaking.

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Annual Cost to Federal Government: $134,625

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 05/27/2016

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