Food Labeling: Nutrition Facts and Supplement Facts labels

Forms and Documents

Document Name	Status
0813 NFL SSA 2019 Ext.pdf Supporting Statement A	2019-07-22

IC Document Collections

IC ID	Document Title	Status
221566	3rd PARTY Disclosures to Consumers	Modified
221565	New products entering market	Modified
221564	REPORTING Filing of petition to amend declaration of dietary fiber claim	Modified
221563	Declaration of folate/folic acid	Unchanged
221562	Declaration of Vitamin E	Unchanged
221561	Declaration of insoluble fiber	Unchanged
221560	Declaration of soluble fiber	Unchanged
221559	Declaration of dietary fiber	Unchanged
220335	Declaration of added sugars	Unchanged

ICR Details

OMB Control No: 0910-0813	ICR Reference No: 201907-0910-001
Status: Historical Active	Previous ICR Reference No: 201605-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling: Nutrition Facts and Supplement Facts labels
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: 08/22/2019
	Date Received in OIRA: 07/22/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	08/31/2019
Responses	188,442	0	1,338,100
Time Burden (Hours)	188,942	0	2,488,258
Cost Burden (Dollars)	22,434,973	0	3,480,000,000

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Abstract: FDA has issued regulations revising the Nutrition Facts and Supplement Facts labels and amended certain other food labeling requirements. The information collection supports these requirements, which the agency believes will serve to promote and protect public health. Respondents to the collection of information are manufacturers of food products sold in the United States.

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Authorizing Statute(s): US Code: 21 USC 321; 343; 371 Name of Law: 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:
	84 FR 16513	04/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35119	07/22/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
REPORTING Filing of petition to amend declaration of dietary fiber claim
New products entering market
Declaration of dietary fiber
Declaration of soluble fiber
Declaration of insoluble fiber
Declaration of Vitamin E
Declaration of folate/folic acid
3rd PARTY Disclosures to Consumers
Declaration of added sugars

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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	188,442	1,338,100	0	0	-1,149,658	0
Annual Time Burden (Hours)	188,942	2,488,258	0	0	-2,299,316	0
Annual Cost Burden (Dollars)	22,434,973	3,480,000,000	0	0	-3,457,565,027	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 information collection reflects adjustments resulting from regulations that have become effective since last OMB review (RIN 0910-AF22). Accordingly, we have lowered our third-party disclosure estimate to reflect that burden associated with changes in labeling resulting from the new requirements has since been realized by respondents. This results in a decrease of 1,149,158 annual disclosures and 2,299,816 burden hours attributable to those labeling changes. We have also made corresponding cost adjustments.

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Annual Cost to Federal Government: $199,000

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? 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: 07/22/2019

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