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OMB Control No: 0910-0381	ICR Reference No: 200705-0910-005
Status: Historical Active	Previous ICR Reference No: 200402-0910-004
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 with change	Conclusion Date: 08/17/2007
	Date Received in OIRA: 05/30/2007
Terms of Clearance: 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
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	1,042,632	0	509,579
Time Burden (Hours)	1,786,022	0	1,594,269
Cost Burden (Dollars)	942,932	0	16,800,000

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 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.

Authorizing Statute(s): US Code: 21 USC 343 Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 8744	02/27/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 27135	05/14/2007
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,042,632	509,579	1,016,882	-483,829
Annual Time Burden (Hours)	1,786,022	1,594,269	1,760,272	-1,568,519
Annual Cost Burden (Dollars)	942,932	16,800,000	942,932	-16,800,000

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The increase in hour burden is due to an increase in the number of respondents and recordkeepers.

Annual Cost to Federal Government: $6,016,400

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Saleda Perryman

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