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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
PC Animal food PRIA.pdf	Supplementary Document	Uploaded 2015-03-27	Available
PC for Animal Food Supporting Statement for Proposed Rule.pdf	Supporting Statement A	Uploaded 2015-03-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
215409	Change of address on labeling		New
215408	Change of product labels		New
215407	3rd PARTY: Labeling for finished animal food product		New
215370	Records documenting training for qualified individual		New
215369	Verification records		New
215368	Monitoring records		New
215367	Corrective action records		New
215366	Food safety plan		New
215365	Labels of containers holding animal food		New
215364	Records demonstrating "qualified" facility		New
215363	Submission of appeal, including request for informal hearing (507.67, 507.69, 507.71)		New
215362	Exemption under 21 CFR 507.7		New

ICR Details

OMB Control No: 0910-0789	ICR Reference No: 201502-0910-011
Status: Historical Inactive	Previous ICR Reference No:
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: Comment filed on proposed rule	Conclusion Date: 05/27/2015
	Date Received in OIRA: 03/27/2015
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG10	Proposed rulemaking	79 FR 58476	09/29/2014

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
Change of address on labeling
Food safety plan
Verification records
Exemption under 21 CFR 507.7
Submission of appeal, including request for informal hearing (507.67, 507.69, 507.71)
Records demonstrating "qualified" facility
Records documenting training for qualified individual
3rd PARTY: Labeling for finished animal food product
Change of product labels
Labels of containers holding animal food
Corrective action records
Monitoring records

---

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 to support rulemaking.

---

Annual Cost to Federal Government: $3,630,000

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

---

Common Form ICR:  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:

(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: 03/27/2015

---