View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0601
ICR Reference No:
200702-0910-002
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Manufactured Food Regulatory Program Standards
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 with change
Conclusion Date:
05/24/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/15/2007
Terms of Clearance:
Approved as amended by FDA's memo of 5/24.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2010
36 Months From Approved
Responses
60
0
0
Time Burden (Hours)
1,000
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
In June 2000, the Department of Health and Human Services, Office of Inspector General (OIG) recommended that FDA improve its oversight of food firm inspections conducted by States through contracts. Consequently, FDA developed the Manufactured Food Regulatory Program Standards (program standards), which establish a uniform foundation for the design and management of a State program that is responsible for the regulatory oversight of food plants that manufacture, process, pack, or hold foods in the United States. Achieving conformance with these program standards requires comprehensive self-assessment of the State program. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist the State programs in determining their level of conformance with the standard. The State program is not required to use the forms and worksheets for the standard; however, alternative forms should be equivalent to the forms and worksheets in the program standards. FDA needs the data from the forms and worksheets to assess the State program's conformance with the program standards and to improve contracts with State agencies. Ultimately, 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:
71 FR 41221
07/20/2006
30-day Notice:
Federal Register Citation:
Citation Date:
71 FR 75760
12/18/2006
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Manufactured Food Regulatory Program Standards
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
60
0
0
60
0
0
Annual Time Burden (Hours)
1,000
0
0
1,000
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:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This new program will cut redundancy, because the program standards will help both FDA and the State food inspection programs focus their oversight of food firms thereby significantly reducing overlap of inspection and compliance activities
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?
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
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:
02/15/2007
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