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

Forms and Documents

Document Name	Status
0789 PC for Animal Food Supporting Statement for Final Rule.pdf Supporting Statement A	2015-09-17
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	New
215409	3rd Party Disclosure: Identifying ingredientsand other raw materials	Modified
215408	3rd Party Disclosure: Change of address on labeling for qualified facilities	Modified
215407	3rd PARTY: change labels	Modified
215370	3rd Party Disclosure; specific information and instruction	Modified
215369	Reporting: requests for reinstatement of exemption	Modified
215368	Recordkeeping: Subpart F; Requirements applying to records	Modified
215367	Recordkeeping: Subpart E; Supply Chain Program	Modified
215366	Recordkeeping: Subpart C; Hazard Analysis and Risk-Based Preventive Controls	Modified
215365	Recordkeeping: Animal food safety and hygiene training	Modified
215364	Recordkeeping: Records demonstrating "qualified" facility	Modified
215363	Reporting: Submission of appeal, including request for informal hearing (507.67, 507.69, 507.71)	Modified
215362	Reporting: Exemption of qualified facility	Modified

ICR Details

OMB Control No: 0910-0789	ICR Reference No: 201509-0910-005
Status: Historical Active	Previous ICR Reference No: 201502-0910-011
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/26/2015
	Date Received in OIRA: 09/18/2015
Terms of Clearance:

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

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Abstract: This information collection supports rulemaking that establishes and implements 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 rule will apply to domestic and imported animal food (including raw materials and ingredients) and is intended to build an animal food safety system for the future 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:
0910-AG10	Final or interim final rulemaking	80 FR 56169	09/17/2015

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Federal Register Notices & Comments

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	0	0	11,831,223	0	0
Annual Time Burden (Hours)	1,193,231	0	0	1,193,231	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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 request in support of agency rulemaking.

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Annual Cost to Federal Government: $0

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: 09/18/2015

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