This information collection supports
FDA regulations that implement minimum standards for produce
offered for human consumption. The regulations set forth
procedures, processes, and practices that minimize the risk of
serious adverse health consequences or death, including those
reasonably necessary to prevent the introduction of known or
reasonably foreseeable biological hazards into or onto produce and
to provide reasonable assurances that the produce is not
adulterated because of such hazards.
The information collection
reflects program changes and adjustments. Although we have removed
one-time burden and costs associated with implementation of the new
regulations, we have added burden for recommendations included in
agency guidance regarding testing for sprouts. This results in an
overall reduction in responses of 92,322, but an increase in burden
hours by 8,515. We also note a nominal cost increase of $104, which
we attribute to calculation adjustments in rounding to whole
numbers.
$0
No
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.
Recommendations in GFI (Sprouts Guidance)