Approved
consistent with clarification in FDA memos of 10-22 and 10-30
including acknowledgememt of the annual costs of testing.
Inventory as of this Action
Requested
Previously Approved
12/31/2005
12/31/2005
1,216
0
0
35,700
0
0
38,875,000
0
0
The Food and Drug Administration is
codifying regulations to implement the premarket notification
process for food contact substances (FCS) established by section
309 of Food and Drug Administration Modernization Act. Once
implemented, the notification process will be the primary method
for authorizing new uses of food additives that are FCSs. FDA is
proposing regulations that 1) identify the circumstances under
which a food additive petition will be required to authorize the
use of an FCS, 2) specify the information required in a
notification for an FCS, 3) describe the administration of the
notification...
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.