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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0381
ICR Reference No:
201312-0910-014
Status:
Historical Active
Previous ICR Reference No:
201008-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
21222
Title:
Food Labeling Regulations
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
06/13/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/31/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2017
36 Months From Approved
06/30/2014
Responses
2,424,463
0
2,401,288
Time Burden (Hours)
1,786,323
0
1,786,023
Cost Burden (Dollars)
0
0
0
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.
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:
78 FR 65663
10/31/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 79461
12/31/2013
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
34
IC Title
Form No.
Form Name
Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records
Recordkeeping: Reference Amounts; Specific Requirements for Maintenence of Records For a Food Modified by Incorporating Air (aerated)
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
Recordkeeping: Exemptions From Food Labeling Requirements; Maintenance of Agreement Records that Forms the Basis For an Exemption From Labeling Requirements by Operator / Persons
Recordkeeping: Nutrient Content Claim - Requirement That Restaurants Document (maintain records) and Provide to Appropriate Regulatory Officials Upon Request.
Recordkeeping: Specific Food Labeling Requirements; Maintenance of Certification Records by Flavor Suppliers
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
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
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 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 Requirements
Third Party Disclosure: Food Labeling regulations
Third Party Disclosure: Food Labeling regulations
Third Party Disclosure: food Labeling Regulations
Third Party disclosure: Food Labeling Regulations
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
2,424,463
2,401,288
0
0
0
23,175
Annual Time Burden (Hours)
1,786,323
1,786,023
0
0
0
300
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:
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
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(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:
12/31/2013