Food Labeling Regulations

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3570 Food Labeling Regulations: REPORTING	Form	Modified	Available
0381 ss 6-15-2017.pdf	Supporting Statement A	Uploaded 2017-06-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6027	Food Labeling Regulations: REPORTING	Form	Modified
194090	Third Party Disclosure: Food Labeling Requirements		Removed
194089	Third Party Disclosure: food Labeling Regulations		Removed
194088	Third Party Disclosure: Food Labeling Regulations		Removed
194087	Third Party Disclosure: Food Labeling regulations		Removed
194086	Third Party Disclosure: Food Labeling Regulations		Removed
194085	Third Party Disclosure: Food Labeling regulations		Removed
194084	Third Party disclosure: Food Labeling Regulations		Removed
194083	Third Party Disclosure: Food Labeling Regulations		Removed
194082	Third Party Disclosure: Food Labeling Regulation		Removed
194081	Third Party Disclosure: Food Labeling Regulations		Removed
180373	Third Party Disclosure: Food Labeling Regulations		Removed
180372	Third Party Disclosure: Food Labeling Regulations		Removed
180371	Third Party Disclosure: Food Labeling Regulations		Removed
180370	Third Party Disclosure: Food Labeling Regulations		Removed
180369	Third Party Disclosure: Food Labeling Regulations		Removed
180368	Third Party Disclosure: Food Labeling Regulations		Removed
180367	Third Party Disclosure: Food Labeling Regulations		Removed
180366	Third Party Disclosure: Food Labeling Regulations		Removed
180365	Third Party Disclosure: Food Labeling Regulations		Removed
180364	Third Party Disclosure: Food Labeling Regulations		Removed
180363	Third Party Disclosure: Food Labeling Regulations		Removed
180362	Third Party Disclosure: Food Labeling Regulations		Removed
180361	Food Labeling Regulations: 3rd PARTY DISCLOSURE		Modified
180360	Recordkeeping: Declaration of Net Quanty When Exempt - Requirement For Maintenance of Records in Which the Declaration of Net Quanity of Contents Does Not Accurately Reflect The Actual Quantity		Removed
180359	Recordkeeping: Exemptions From Food Labeling Requirements; Maintenance of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons		Removed
180358	Recordkeeping: Specific Food Labeling Requirements; Maintenance of Certification Records by Flavor Suppliers		Removed
180357	Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records		Removed
180356	Recordkeeping: Nutrient Content Claim - Requirement That Restaurants Document (maintain records) and Provide to Appropriate Regulatory Officials Upon Request.		Removed
180355	Food Labeling Regulations: RECORDKEEPING		Modified
180354	Reporting: Written Proposal For Requesting Temporary Exemptions From Certain Requirements Under 21 CFR 101.9 & 105.66 For the Purposes of Conducting Food Labeling Experiments		Removed
180353	Reporting: Petitions for Health Claims		Removed
180352	Reporting: Petition for Nutrient Content Claims		Removed
180351	Reporting: Petition To Establish or Amend a Reference Amount		Removed

ICR Details

OMB Control No: 0910-0381	ICR Reference No: 201705-0910-002
Status: Historical Active	Previous ICR Reference No: 201312-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: 07/18/2017
	Date Received in OIRA: 06/16/2017
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	07/31/2017
Responses	2,424,463	0	2,424,463
Time Burden (Hours)	1,786,323	0	1,786,323
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports food labeling regulations issued under the Fair Packaging and Labeling Act and the Federal Food, Drug, and Cosmetic Act. Respondents to this information collection are manufacturers, packers, and distributors of food products and include the private sector (including for-profit businesses, not-for-profit institutions and farms).

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	81 FR 96462	12/30/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 27504	06/15/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling Regulations
Third Party Disclosure: Food Labeling regulations
Food Labeling Regulations: REPORTING	3570	Small Business Nutrition Labeling Exemption Notice
Food Labeling Regulations: RECORDKEEPING
Food Labeling Regulations: 3rd PARTY DISCLOSURE
Reporting: Petition To Establish or Amend a Reference Amount
Reporting: Petition for Nutrient Content Claims
Reporting: Petitions for Health Claims
Reporting: Written Proposal For Requesting Temporary Exemptions From Certain Requirements Under 21 CFR 101.9 & 105.66 For the Purposes of Conducting Food Labeling Experiments
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
Recordkeeping: Specific Food Labeling Requirements; Maintenance of Certification Records by Flavor Suppliers
Recordkeeping: Declaration of Net Quanty When Exempt - Requirement For Maintenance 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 Regulation
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
Recordkeeping: Exemptions From Food Labeling Requirements; Maintenance of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons

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ICR Summary of Burden

table that charts list 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	2,424,463	2,424,463	0	0	0	0
Annual Time Burden (Hours)	1,786,323	1,786,323	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: This ICR reflects editorial adjustments only.

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Annual Cost to Federal Government: $6,206,964

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: 06/16/2017

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