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OMB Control No: 0910-0643	ICR Reference No: 201002-0910-004
Status: Historical Inactive	Previous ICR Reference No: 200906-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Third Party Disclosure and Recordkeeping Requirements For Reportable Food
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 05/05/2010
	Date Received in OIRA: 02/26/2010
Terms of Clearance: Withdrawn at the request of FDA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2010	36 Months From Approved	11/30/2010
Responses	6,000	0	6,000
Time Burden (Hours)	3,180	0	3,180
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.

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
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 53746	10/20/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8960	02/26/2009
Did the Agency receive public comments on this ICR? Yes

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: Program change increase for 150 hours due to maintenance of records for voluntary reports.

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

View ICR - OIRA Conclusion