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OMB Control No: 0910-0643	ICR Reference No: 201408-0910-002
Status: Historical Active	Previous ICR Reference No: 201103-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Reporting 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: Approved without change	Conclusion Date: 09/30/2014
	Date Received in OIRA: 08/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	09/30/2014
Responses	6,600	0	6,600
Time Burden (Hours)	3,330	0	3,330
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: 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:
	79 FR 31946	06/03/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 50656	08/25/2014
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	6,600	6,600
Annual Time Burden (Hours)	3,330	3,330
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:

Annual Cost to Federal Government: $362

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

View ICR - OIRA Conclusion