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View ICR - OIRA Conclusion

OMB Control No: 0910-0381	ICR Reference No: 201008-0910-001
Status: Historical Active	Previous ICR Reference No: 200705-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Labeling Regulations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/05/2010
	Date Received in OIRA: 08/04/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved	12/31/2010
Responses	2,401,288	0	1,042,632
Time Burden (Hours)	1,786,023	0	1,786,022
Cost Burden (Dollars)	0	0	942,932

Abstract: 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 or labeling of their food products. Related regulations require that food producers retain records establishing the basis for the information contained in the label or labeling of their products and provide those records to regulatory officials. Finally, certain regulations provide for the submission of food labeling petitions. FDAs food labeling 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. The disclosure requirements and other collections of information in the regulations in parts 101,102,104, and 105 are necessary to ensure that food products produced or sold in the United states are in compliance with labeling provisions of the act and the FPLA.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,401,288	1,042,632	1,358,656
Annual Time Burden (Hours)	1,786,023	1,786,022	1
Annual Cost Burden (Dollars)	0	942,932	-942,932

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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