Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Forms and Documents

Document Name	Status
0789 PCAF SSA 2018 Ext.pdf Supporting Statement A	2018-08-29
FRIA for PC for Animal Food.pdf Supplementary Document	2015-09-17

IC Document Collections

IC ID	Document Title	Status
218210	3rd Party Disclosure: labeling identifying product by common or usual name	Unchanged
215409	3rd Party Disclosure: Identifying ingredientsand other raw materials	Unchanged
215408	3rd Party Disclosure: Change of address on labeling for qualified facilities	Unchanged
215407	3rd PARTY: change labels	Unchanged
215370	3rd Party Disclosure; specific information and instruction	Unchanged
215369	Reporting: requests for reinstatement of exemption	Unchanged
215368	Recordkeeping: Subpart F; Requirements applying to records	Unchanged
215367	Recordkeeping: Subpart E; Supply Chain Program	Unchanged
215366	Recordkeeping: Subpart C; Hazard Analysis and Risk-Based Preventive Controls	Unchanged
215365	Recordkeeping: Animal food safety and hygiene training	Unchanged
215364	Recordkeeping: Records demonstrating "qualified" facility	Unchanged
215363	Reporting: Submission of appeal, including request for informal hearing (507.67, 507.69, 507.71)	Unchanged
215362	Reporting: Exemption of qualified facility	Unchanged

ICR Details

OMB Control No: 0910-0789	ICR Reference No: 201808-0910-014
Status: Active	Previous ICR Reference No: 201509-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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: 10/15/2018
	Date Received in OIRA: 09/13/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	36 Months From Approved	10/31/2018
Responses	11,831,223	0	11,831,223
Time Burden (Hours)	1,193,231	0	1,193,231
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports regulations establishing and implementing hazard analysis and risk-based preventive controls for food for animals, in addition to current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. The regulations apply to domestic and imported animal food (including raw materials and ingredients) and are intended to build an animal food safety system across all sectors of the animal food system.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 103, et al. Name of Law: Food Safety Modernization Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 103, et al. Name of Law: FSMA

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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:
	83 FR 24124	05/24/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 46496	09/13/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
3rd Party Disclosure: Identifying ingredientsand other raw materials
Recordkeeping: Subpart C; Hazard Analysis and Risk-Based Preventive Controls
Recordkeeping: Animal food safety and hygiene training
Recordkeeping: Subpart E; Supply Chain Program
Recordkeeping: Subpart F; Requirements applying to records
Reporting: requests for reinstatement of exemption
Reporting: Exemption of qualified facility
Reporting: Submission of appeal, including request for informal hearing (507.67, 507.69, 507.71)
Recordkeeping: Records demonstrating "qualified" facility
3rd Party Disclosure; specific information and instruction
3rd PARTY: change labels
3rd Party Disclosure: Change of address on labeling for qualified facilities
3rd Party Disclosure: labeling identifying product by common or usual name

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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	11,831,223	11,831,223	0	0	0	0
Annual Time Burden (Hours)	1,193,231	1,193,231	0	0	0	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:

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Annual Cost to Federal Government: $0

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? 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: 09/13/2018

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