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.
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.
RFR Emergency Justification memo.pdf
RFR proposed SRP modifications_12April12.doc
Submission of additional data elements required by section 417 of the FD&C Act