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OMB Control No: 0910-0643	ICR Reference No: 200906-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reporting and Recordkeeping Requirements for Reportable Food
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 08/17/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/21/2009
	Date Received in OIRA: 06/17/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2010	6 Months From Approved
Responses	6,000	0	0
Time Burden (Hours)	3,180	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Section 1005 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amends the Federal Food, Drug, and Cosmetic Act (the act) by creating a new section 417 (21 U.S.C. 350f), among other things. Section 417 of the act defines "reportable food" as an "article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." (Section 417(a)(2) of the act). Section 417 of the act requires FDA to establish an electronic portal (the Reportable Food electronic portal) by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. FDA made the decision that the most efficient and cost effective means to implement the requirements of section 417 of the act relating to the Registry was to utilize the business enterprise system currently under development within the agency: the MedWatchPlus Portal. In addition, Section 1005(f) of FDAAA required FDA to issue guidance to industry about submitting reports through the electronic portal of instances of reportable food and providing notifications to other persons in the supply chain of such article of food. FDA is issuing guidance containing questions and answers relating to the requirements under section 417 of the act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

Emergency Justfication: In accordance with the 5 CFR 1320.13, the use of normal clearance procedures will cause the agency's guidance document to not be finalized in time for the launch of the portal on September 8, 2009, which will cause a statutory deadline to be missed. FDA is requesting OMB approval by August 17, 2009.

Authorizing Statute(s): US Code: 21 USC 350f Name of Law: FFDCA

Citations for New Statutory Requirements: US Code: 21 USC 350f Name of Law: FFDCA

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

Federal Register Notices & Comments
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 28498	06/16/2009
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
Reporting and Recordkeeping Requirements for Reportable Food
Reporting and Recordkeeping Requirements for Reportable Food

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	6,000	6,000
Annual Time Burden (Hours)	3,180	3,180
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection. The reporting and recordkeeping burdens reflect our estimate of the number of reportable food events that FDA would require the immediate previous source and immediate subsequent recipient of a reportable food to be notified and that they also notify their immediate previous source and immediate subsequent recipient; this burden includes any mandatory notification and the associated mandatory (and some voluntary) recordkeeping regarding the event.

Annual Cost to Federal Government: $350

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)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Jonnalynn Capezzuto 3018274659

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