Manufactured Food Regulatory Program Standards

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT PART B FINAL 8-13-13.doc Supporting Statement B	2013-08-13
SUPPORTING STATEMENT PART A FINAL 8-13-13.doc Supporting Statement A	2013-08-13

IC Document Collections

IC ID	Document Title	Status
178727	Manufactured Food Regulatory Program Standards Instruction	Removed
178726	Manufactured Food Regulatory Program Standards - State Departments of Agriculture or Health Instruction	Modified

ICR Details

OMB Control No: 0910-0601	ICR Reference No: 201308-0910-003
Status: Historical Active	Previous ICR Reference No: 201008-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: 20305
Title: Manufactured Food Regulatory Program Standards
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: 09/27/2013
	Date Received in OIRA: 08/15/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	09/30/2013
Responses	44	0	62
Time Burden (Hours)	13,332	0	8,160
Cost Burden (Dollars)	0	0	0

---

Abstract: The elements of the manufactured food regulatory program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The ten standards describe the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the State program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 11651	02/19/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 41802	07/11/2013
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Manufactured Food Regulatory Program Standards - State Departments of Agriculture or Health
Manufactured Food Regulatory Program Standards

---

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	44	62	0	0	-18	0
Annual Time Burden (Hours)	13,332	8,160	0	0	5,172	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: This adjustment between current burden and requested burden is a result increase in the number of hours needed to compile records. The current burden was based on FDA's understanding that State agencies maintained records of the usual and customary activites required by their inspection programs. The requested burden of the states for their implementation of the standards has been addressed and funding opportunities have been given to the states as an option for significant conformance of the ten standards.

---

Annual Cost to Federal Government: $39,125,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 08/15/2013

---