Changes to Reportable Food Registry Reports Under the FDA Food Safety Modernization Act

ICR 201205-0910-005

OMB: 0910-0709

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-05-22
Supplementary Document
2012-05-16
Supplementary Document
2012-05-16
Supporting Statement A
2012-05-22
ICR Details
0910-0709 201205-0910-005
Historical Active
HHS/FDA
Changes to Reportable Food Registry Reports Under the FDA Food Safety Modernization Act
New collection (Request for a new OMB Control Number)   No
Emergency 05/28/2012
Approved with change 05/25/2012
Retrieve Notice of Action (NOA) 05/16/2012
  Inventory as of this Action Requested Previously Approved
11/30/2012 6 Months From Approved
1,877 0 0
375 0 0
0 0 0

The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085) (FDAAA) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section 417 (21 U.S.C. 350f), Reportable Food Registry (RFR or the Registry). 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). The Secretary has delegated to the Commissioner of the Food and Drug Administration (FDA) the responsibility for administering the FD&C Act, including section 417. To further the development of the RFR, section 417 of the FD&C Act required FDA to establish an electronic portal by which instances of reportable food ("RFR reports") must be submitted to FDA by responsible parties and may be submitted by public health officials. The portal was established in 2009. RFR reports are submitted electronically using the FDA Safety Reporting Portal (approved under OMB control number 0910-0645).
In accordance with the 5 CFR 1320.13, the use of normal clearance procedures will cause the agency's revisions to RFR reports not to be finalized and also cause the agency to be unable to generate one page notices by June 4, 2012, which will cause a statutory deadline to be missed. More importantly, however, FDA believes that public harm will occur if normal PRA clearance procedures are followed. In the six months or more it can take to obtain a full PRA clearance to authorize the new data elements and the new one page notice, a significant number of consumers could be exposed to serious adverse health consequences or death. FDA believes that these circumstances can be mitigated or prevented through prompt FDA generation of one-page notices based on the information provided by responsible parties. In the absence of immediate approval of the new data elements, the Agency will not be able to issue one-page notices. If consumers are not notified that the grocery store has sold a reportable food, they will be at risk of consuming hazardous food products that pose a risk of serious adverse health consequences or death. The Agency will be at risk of not fulfilling its FSMA mandate and public harm is reasonably likely to occur. FDA is requesting OMB approval by May 14, 2012.

PL: Pub.L. 110 - 85 417 Name of Law: FDAA
  
PL: Pub.L. 110 - 85 417 Name of Law: FDAA

Not associated with rulemaking

No

1
IC Title Form No. Form Name
Submission of additional data elements required by section 417 of the FD&C Act

  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 1,877 0 1,877 0 0 0
Annual Time Burden (Hours) 375 0 375 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new collection of information.

$900,000
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
05/16/2012


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