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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:
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
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/16/2017
Terms of Clearance:
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
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).
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
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:
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
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Food Labeling Regulations: 3rd PARTY DISCLOSURE
Food Labeling Regulations: RECORDKEEPING
Food Labeling Regulations: REPORTING
3570
Small Business Nutrition Labeling Exemption Notice
Recordkeeping : Health Claims- Specific Requirements for Maintaince of Records
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: 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 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
2,424,463
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.
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
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@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:
06/16/2017
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