Respondents to the information
collection are manufacturers of foods that are fermented,
hydrolyzed, or contain fermented or hydrolyzed ingredients and bear
the claim “gluten-free,” “no gluten,” “free of gluten,” or “without
gluten.” It imposes recordkeeping that FDA believes will provide a
reasonable assurance that food so labeled is gluten-free before
fermentation or hydrolysis; that the manufacturer has evaluated the
potential for cross-contact with gluten during the manufacturing
process; and that measures have been taken to prevent the
introduction of gluten into the food during the manufacturing
process.
This is a new information
collection. We have not adjusted estimates from our proposed
rulemaking. As discussed at Question 8, we have addressed comments
(no. 13) regarding potential concers pertaining to electronic
records.
$2,257,884
No
No
No
No
No
No
No
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.