Manufactured Food Regulatory Program Standards

Forms and Documents

Document Name	Status
foodstandardsCM.doc Supplementary Document	0000-00-00
foodstandardsSupporting Statemen123.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
178727	Manufactured Food Regulatory Program Standards Other-Other	New
178726	Manufactured Food Regulatory Program Standards Other-Other	New

ICR Details

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
	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

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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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

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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

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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

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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

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Common Form ICR:  No

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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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