Food Labeling: Revision of the Nutrition Facts Label and Supplement Facts Label

Forms and Documents

Document Name	Status
0813 SS Part A for NFL SS Final Rules 2016.pdf Supporting Statement A	2016-05-24
0813 Final RIA for rulemaking 2016.pdf Supplementary Document	2016-05-17

IC Document Collections

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

ICR Details

OMB Control No: 0910-0813	ICR Reference No: 201605-0910-006
Status: Historical Active	Previous ICR Reference No: 201602-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling: Revision of the Nutrition Facts Label and Supplement Facts Label
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/26/2016
	Date Received in OIRA: 05/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	36 Months From Approved
Responses	1,338,100	0	0
Time Burden (Hours)	2,488,258	0	0
Cost Burden (Dollars)	3,480,000,000	0	0

---

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 new 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.

---

Authorizing Statute(s): US Code: 21 USC 321; 343; 371 Name of Law: Food Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF22	Final or interim final rulemaking	81 FR 33742	05/27/2016

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

---

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

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

---

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	1,338,100	0	0	1,338,100	0	0
Annual Time Burden (Hours)	2,488,258	0	0	2,488,258	0	0
Annual Cost Burden (Dollars)	3,480,000,000	0	0	3,480,000,000	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection associated with rulemaking.

---

Annual Cost to Federal Government: $1,300,000

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

---

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: 05/27/2016

---