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.
table that charts list comparision
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
Reginfo record details
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