This extension
is approved for 3 years. Please note that the burden table was
amended to reflect that the burden changes were due to adjustments
rather than program changes.
Inventory as of this Action
Requested
Previously Approved
08/31/2010
36 Months From Approved
08/31/2007
1,042,632
0
509,579
1,786,022
0
1,594,269
942,932
0
16,800,000
Section 403 (21 U.S.C. 343) of the
Federal Food, Drug, and Cosmetic Act (the act) establishes
requirements that the label or labeling of a food product must meet
so that it is not misbranded and subject to regulatory action.
Certain of the provisions of section 403 require that food
producers disclose information about themselves or their products
on the labels or labeling of their products. FDA has issued various
regulations in parts 101, 102, 104, and 105 (21 CFR parts 101, 102,
104, and 105) that also require food producers to disclose certain
information on the labels of their food products. Failure of a food
producer to comply with the provisions of section 403 of the act or
of parts 101, 102, 104, or 105 would result in the specific product
and the producer being subject to regulatory action. FDA
regulations in parts 101, 102, 104, and 105 (21 CFR parts 101, 102,
104, and 105) require food producers to disclose to consumers and
others specific information about themselves or their products on
the label or labeling of their products. These regulations were
issued under the authority of sections 4, 5, and 6 of the Fair
Packaging and Labeling Act (the FPLA) (15 U.S.C. 1453, 1454, and
1455) and of sections 201, 301, 402, 403, 409, and 701 of the act
(21 U.S.C. 321, 331, 342, 348, and 371). Most of the regulations in
Parts 101, 102, 104, and 105 derive from the requirements of
section 403 of the act, which provides that a food product shall be
misbranded if, among other things, its label or labeling fails to
bear certain required information concerning the food product, is
false or misleading in any particular, or bears certain types of
unauthorized claims. Additionally, FDA has issued regulations among
parts 101, 102, 104, and 105 that require that food producers
retain records relative to the information contained in the label
or labeling of their products and provide those records to
regulatory officials. Finally, certain of the regulations issued by
the agency provide for the submission of petitions to FDA.
The increase in hour burden is
due to an increase in the number of respondents and
recordkeepers.
$6,016,400
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
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.
0381 21 CFR Part 101 link.doc
Food Labeling Regulations