Voluntary National Retail Food Regulatory Program Standards

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
VNFR ss 12-14-2007.doc	Supporting Statement A	Uploaded 2007-12-14	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
183429	Voluntary National Retail Food Regulatory Program Standards	Other-Program Standards	New
183428	Voluntary National Retail Food Regulatory Program Standards	Other-Program Standards	New

ICR Details

OMB Control No: 0910-0621	ICR Reference No: 200801-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Voluntary National Retail 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 without change	Conclusion Date: 03/25/2008
	Date Received in OIRA: 01/18/2008
Terms of Clearance: OMB approves this previously unapproved collection. We appreciate FDA's efforts to identify and resolve previous violations of the PRA and ensure full compliance. Please report the resolution of this violation in the next ICB.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2011	36 Months From Approved
Responses	3,000	0	0
Time Burden (Hours)	78,800	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: While the responsibility for regulating retail and foodservice establishments lies primarily with state, local, and tribal jurisdictions, FDA provides assistance to these jurisdictions through multiple means including, but not limited to, training and technical assistance. Authority for providing such assistance is derived from section 311 of the Public Health Service Act (42 U.S.C. 243). In addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and sanitary, and section 903(b)(4) of the Act directs FDA to cooperate with food retailers, among others, in carrying out this part of its mission. The Centers for Disease Control and Prevention has identified the major contributing factors associated with foodborne illness outbreaks. Five of these contributing factors directly relate to retail and foodservice establishments and are called "foodborne illness risk factors" by FDA. In an effort to assist state, local, and tribal regulators and the retail and food service entities they regulate, FDA has developed a Program Standards document entitled, "Voluntary National Retail Food Regulatory Program Standards." The Program Standards were developed to address the need for national uniformity among retail food regulatory programs, to promote uniform application of the FDA Food Code, and to reduce the occurrence of foodborne illness risk factors. The Program Standards were developed with extensive input from state, tribal, and local regulatory authorities and are intended to help those authorities design and manage a retail food regulatory program that is focused on the reduction of foodborne illness risk factors. They are intended to capture the best management practices currently in use by state, tribal, and local regulatory authorities. The Program Standards initiative represents a comprehensive strategic approach that will help ensure the safety and security of the food supply at the retail level.

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Authorizing Statute(s): US Code: 42 USC 243 Name of Law: PHS Act
   US Code: 21 USC 393(b)(2)(A) Name of Law: FFDCA
   US Code: 21 USC 393(b)(4) Name of Law: FFDCA
  

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 66336	11/14/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 2500	01/15/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Voluntary National Retail Food Regulatory Program Standards
Voluntary National Retail Food Regulatory Program Standards

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ICR Summary of Burden

table that charts list 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	3,000	0	0	3,000	0	0
Annual Time Burden (Hours)	78,800	0	0	78,800	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 is a new collection of information. The new burden hours are caused when State, local, and tribal regulatory agencies voluntarily enroll in the Program Standards and seek listing in the FDA National Registry. The regulatory agencies follow recordkeeping recommendations and report to FDA on the completion of three management tasks outlined in the Program Standards.

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Annual Cost to Federal Government: $24,999

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]? 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: 01/18/2008

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