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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:
200905-0910-002
Status:
Historical Inactive
Previous ICR Reference No:
200705-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Food Labeling Regulations
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Improperly submitted and continue
Conclusion Date:
05/21/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/12/2009
Terms of Clearance:
OMB notes that this action invloves a substantive change to the collection and should thus be resubmitted as a revision.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2010
08/31/2010
12/31/2010
Responses
1,042,632
0
1,042,632
Time Burden (Hours)
1,786,022
0
1,786,022
Cost Burden (Dollars)
942,932
0
942,932
Abstract:
Section 403 (21 U.S.C. 343) of the FFDCA 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 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 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) and of sections 201, 301, 402, 403, 409, and 701 of the FFDCA. Most of the regulations in Parts 101, 102, 104, and 105 derive from the requirements of section 403 of the FFDCA, 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
Number of Information Collection (IC) in this ICR:
24
IC Title
Form No.
Form Name
Food Labeling Regulations
Food Labeling Regulations
FDA 3570
MODEL SMALL BUSINESS NUTRITION LABELING EXEMPTION NOTICE
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
Food Labeling Regulations
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]?
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)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
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:
05/12/2009
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