Food Labeling Regulations

Forms and Documents

Document Name	Status
Form 3570 Food Labeling Regulations: REPORTING Form	Modified
0381 Food labeling - add gluten SSA 2023.docx Supporting Statement A	2023-08-16
Guidance-Labeling-Certain-Beers-04032023.pdf Supplementary Document	2023-08-16
0374 GFI Notification of Health Claim.pdf Supplementary Document	2017-12-04
0626 GFI Substantiation for Dietary Supp Claims.pdf Supplementary Document	2017-12-04
GFI Labeling Required by DSNDCPA.pdf Supplementary Document	2017-12-04

IC Document Collections

IC ID	Document Title	Status
6027	Food Labeling Regulations: REPORTING Form	Modified
180361	Food Labeling Regulations: 3rd PARTY DISCLOSURE	Modified
180355	Food Labeling Regulations: RECORDKEEPING	Modified

ICR Details

OMB Control No: 0910-0381	ICR Reference No: 202308-0910-014
Status: Received in OIRA	Previous ICR Reference No: 202001-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/17/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2023
Responses	2,892,913	2,612,905
Time Burden (Hours)	2,100,957	1,974,605
Cost Burden (Dollars)	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). The information collection also supports agency guidance developed to assist repondents regarding food lableing regulations.

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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:
	88 FR 22045	04/12/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 54326	08/10/2023
Did the Agency receive public comments on this ICR? No

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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

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ICR Summary of Burden

	Total Request	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	2,892,913	2,612,905	0	0	280,008	0
Annual Time Burden (Hours)	2,100,957	1,974,605	0	0	126,352	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: The information collection reflects changes and adjustments since last approved by OMB. Specifically we have reduced our estimate of the number of reports under 101.12 (RACC); we have added burden to account for recordkeeping associated with 101.91 (gluten); and we have added burden for disclosures recommended for beer subject to FDA jurisdiction as denoted in the referenced agency guidance.

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Annual Cost to Federal Government: $6,542,114

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 08/17/2023

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