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:
201008-0910-008
Status:
Historical Active
Previous ICR Reference No:
200702-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Manufactured Food Regulatory Program Standards
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/15/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/26/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2013
36 Months From Approved
Responses
62
0
0
Time Burden (Hours)
8,160
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):
US Code:
42 USC 241.301
Name of Law: PHS Act
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:
74 FR 63154
12/02/2009
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 9605
03/03/2010
Did the Agency receive public comments on this ICR?
No
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
62
0
0
2
0
60
Annual Time Burden (Hours)
8,160
0
0
7,160
0
1,000
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The hours per response increased because the Baseline Self-Assessment includes developing a strategic plan to fully implement the standards. FDA reduced the estimated first-year baseline self-assessment burden when it replaced the verification audit performed by the State with a program assessment validation audit that would be done by FDA. However, the burden was increased because States needed additional time to obtain the documents needed to conduct their self-assessment. Additionally, in the past FDA had always beleived that the recordkeeping was usual and customary. We learned from the program assessment validation audits of 15 states that the States were not keeping records on a usual and customary basis.
Annual Cost to Federal Government:
$1,100,000
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]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
08/26/2010
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