Food Labeling Regulations

Forms and Documents

Document	Type	Status	Availability
Form 3570 Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570	Form and Instruction	Modified	Repair queued
SS-0910-0381.doc	Supporting Statement A	Uploaded 2010-07-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6027	Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570	Form and Instruction	Modified
194090	Third Party Disclosure: Food Labeling Requirements		New
194089	Third Party Disclosure: food Labeling Regulations		New
194088	Third Party Disclosure: Food Labeling Regulations		New
194087	Third Party Disclosure: Food Labeling regulations		New
194086	Third Party Disclosure: Food Labeling Regulations		New
194085	Third Party Disclosure: Food Labeling regulations		New
194084	Third Party disclosure: Food Labeling Regulations		New
194083	Third Party Disclosure: Food Labeling Regulations		New
194082	Third Party Disclosure: Food Labeling Regulation		New
194081	Third Party Disclosure: Food Labeling Regulations		New
180373	Third Party Disclosure: Food Labeling Regulations		Modified
180372	Third Party Disclosure: Food Labeling Regulations		Modified
180371	Third Party Disclosure: Food Labeling Regulations		Modified
180370	Third Party Disclosure: Food Labeling Regulations		Modified
180369	Third Party Disclosure: Food Labeling Regulations		Modified
180368	Third Party Disclosure: Food Labeling Regulations		Modified
180367	Third Party Disclosure: Food Labeling Regulations		Modified
180366	Third Party Disclosure: Food Labeling Regulations		Modified
180365	Third Party Disclosure: Food Labeling Regulations		Modified
180364	Third Party Disclosure: Food Labeling Regulations		Modified
180363	Third Party Disclosure: Food Labeling Regulations		Modified
180362	Third Party Disclosure: Food Labeling Regulations		Modified
180361	Third Party Disclosure: Food Labeling Regulations		Modified
180360	Recordkeeping: Declaration of Net Quanty When Exempt - Requirement For Maintainance of Records in Which the Declaration of Net Quanity of Contents Does Not Accurately Reflect The Actual Quantity ...		Modified
180359	Recordkeeping:Exemptions From Food Labeling Requirements: Maintaince of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons		Modified
180358	Recordkeeping: Specifice Food Labeling Requirements - Maintainance of Certification Records by Flavor Suppliers		Modified
180357	Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records		Modified
180356	Recordkeeping: Nutrient Content Claim - Requirement That Restaurants Document ( maintain records) and Provide to Appropriate Regulatory Officials Upon Request.		Modified
180355	Recordkeeping- Reference Amounts- Specific Requirements for Maintainence of Records For a Food Modified by Incorporating Air ( aerated)		Modified
180354	Reporting: Written Proposal For Requesting Temporay Exemptions From Certain Requirements Under 21 CFR 101.9 & 105.66 For the Purposes of Conducting Food Labeling Experiments		Modified
180353	Reporting: Petitions for Health Claims		Modified
180352	Reporting: Petition for Nutrient Content Claims		Modified
180351	Reporting: Petition To Establish or Amend a Reference Amount		Modified

ICR Details

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

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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.

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

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 34353	07/15/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 41207	07/15/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 34

IC Title	Form No.	Form Name
Third Party Disclosure: Food Labeling Regulations
Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570	3570	Small Business Nutrition Labeling Exemption Notice Module Form
Reporting: Petition To Establish or Amend a Reference Amount
Reporting: Petition for Nutrient Content Claims
Reporting: Petitions for Health Claims
Recordkeeping: Specifice Food Labeling Requirements - Maintainance of Certification Records by Flavor Suppliers
Recordkeeping:Exemptions From Food Labeling Requirements: Maintaince of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons
Recordkeeping: Declaration of Net Quanty When Exempt - Requirement For Maintainance of Records in Which the Declaration of Net Quanity of Contents Does Not Accurately Reflect The Actual Quantity ...
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulation
Third Party Disclosure: Food Labeling Regulations
Reporting: Written Proposal For Requesting Temporay Exemptions From Certain Requirements Under 21 CFR 101.9 & 105.66 For the Purposes of Conducting Food Labeling Experiments
Recordkeeping- Reference Amounts- Specific Requirements for Maintainence of Records For a Food Modified by Incorporating Air ( aerated)
Recordkeeping: Nutrient Content Claim - Requirement That Restaurants Document ( maintain records) and Provide to Appropriate Regulatory Officials Upon Request.
Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records
Third Party disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: food Labeling Regulations
Third Party Disclosure: Food Labeling Requirements

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ICR Summary of Burden

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

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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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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 08/04/2010

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