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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.

	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

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.

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

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 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

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

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	3,000	3,000
Annual Time Burden (Hours)	78,800	78,800
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Jonnalynn Capezzuto 3018274659

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