Manufactured Food Regulatory Program Standards

ICR 201308-0910-003

OMB: 0910-0601

Federal Form Document

Forms and Documents
Supporting Statement B
Supporting Statement A
ICR Details
0910-0601 201308-0910-003
Historical Active 201008-0910-008
HHS/FDA 20305
Manufactured Food Regulatory Program Standards
Extension without change of a currently approved collection   No
Approved without change 09/27/2013
Retrieve Notice of Action (NOA) 08/15/2013
  Inventory as of this Action Requested Previously Approved
09/30/2016 36 Months From Approved 09/30/2013
44 0 62
13,332 0 8,160
0 0 0

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.


Not associated with rulemaking

  78 FR 11651 02/19/2013
78 FR 41802 07/11/2013

  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
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.

Yes Part B of Supporting Statement
ILa Mizrachi 301 796-7726 [email protected]


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:
    (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;
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.

© 2021 | Privacy Policy