Reporting and Recordkeeping Requirements for Reportable Food

ICR 201408-0910-002

OMB: 0910-0643

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-08-27
IC Document Collections
IC ID
Document
Title
Status
197085 Modified
197084 Modified
197083 Modified
197082 Modified
189627 Modified
189626 Modified
ICR Details
0910-0643 201408-0910-002
Historical Active 201103-0910-009
HHS/FDA CFSAN
Reporting and Recordkeeping Requirements for Reportable Food
Extension without change of a currently approved collection   No
Regular
Approved without change 09/30/2014
Retrieve Notice of Action (NOA) 08/27/2014
  Inventory as of this Action Requested Previously Approved
09/30/2017 36 Months From Approved 09/30/2014
6,600 0 6,600
3,330 0 3,330
0 0 0
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.
US Code: 21 USC 350f Name of Law: FFDCA
  
None
Not associated with rulemaking
  79 FR 31946 06/03/2014
79 FR 50656 08/25/2014
No
  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 6,600 6,600 0 0 0 0
Annual Time Burden (Hours) 3,330 3,330 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$362
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/27/2014
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