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