Color additive petitions are reviewed
by the Food and Drug Administration (FDA) scientific personnel to
assure the identity of the substance, its use in or on drugs,
medical devices, food, or cosmetics, and that the intended use is
safe. The color additive petitions provide the only method for
premarket review and approval of color additives, without which
there would be no legal way to bring new products to market. The
labeling requirements require that color additives used in drugs,
devices, food, or cosmetics be labeled with sufficient information
to ensure their safe use.
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.