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.
In accordance with the 5
CFR 1320.13, the use of normal clearance procedures will cause the
agency's guidance document to not be finalized in time for the
launch of the portal on September 8, 2009, which will cause a
statutory deadline to be missed. FDA is requesting OMB approval by
August 17, 2009.
This is a new collection. The
reporting and recordkeeping burdens reflect our estimate of the
number of reportable food events that FDA would require the
immediate previous source and immediate subsequent recipient of a
reportable food to be notified and that they also notify their
immediate previous source and immediate subsequent recipient; this
burden includes any mandatory notification and the associated
mandatory (and some voluntary) recordkeeping regarding the
event.
$350
No
No
Uncollected
Uncollected
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.
Reportable Food ss 08 11 2009 CLEAN.doc
Reporting and Recordkeeping Requirements for Reportable Food