To implement the GRAS (Generally
Recognized as Safe) provisions of section 201(s) of the Food, Drug,
and Cosmetic Act, FDA issued procedural regulations to establish a
process by which a person may obtain FDA concurrence with a GRAS
determination referred to as a GRAS affirmation. GRAS petitions are
reviewed by FDA to determine whether the available data establish
that the intended use of the substance is GRAS based upon either a
safe history of the safe use of the substance, or upon widely
available safety data.
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.