Food Labeling: Notification Procedures for Statements on Dietary Supplements

Forms and Documents

Document Name	Status
Form FDA 3955 Certain Types of Statements for Dietary Supplements Form	Modified
0331 Diet Supps SSA 2019 Rev.pdf Supporting Statement A	2019-06-01

IC Document Collections

IC ID	Document Title	Status
5918	Certain Types of Statements for Dietary Supplements Form	Modified

ICR Details

OMB Control No: 0910-0331	ICR Reference No: 201906-0910-002
Status: Active	Previous ICR Reference No: 201605-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling: Notification Procedures for Statements on Dietary Supplements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/01/2019
	Date Received in OIRA: 06/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	06/30/2019
Responses	3,690	0	2,200
Time Burden (Hours)	2,768	0	1,650
Cost Burden (Dollars)	196,825	0	0

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Abstract: The reporting requirements of this regulation implement the Dietary Supplement Health and Education Act. The subject regulation establishes reporting procedures necessary to inform FDA when dietary supplement manufacturers are making statements of nutritional support on their labels or in their labeling. FDA is seeking OMB approval of an electronic submission method for this collection.

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Authorizing Statute(s): US Code: 21 USC 343(r)(6) Name of Law: Federal Food, Drug, and Cosmetic Act; Misbranding
  

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 2528	02/07/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 25282	05/31/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Certain Types of Statements for Dietary Supplements	FDA 3955	Notification Procedures for Statements on Dietary Supplements

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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	3,690	2,200	0	0	1,490	0
Annual Time Burden (Hours)	2,768	1,650	0	0	1,118	0
Annual Cost Burden (Dollars)	196,825	0	0	0	196,825	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 a revision to the collection mechanism. Specifically, we are implementing an updated IT system, FARM, that improves our operational efficiency by interfacing with other agency systems. As explained in Question 1, no new information is collected, however we characterize the change as a revision. We have also adjusted our estimates to reflect an increase in submissions. Specifically, our estimated burden for the information collection reflects an overall increase of 1,117.5 hours (from 1650 to 2767.5 hours) and a corresponding increase of 1,490 responses (from 2,200 to 3,690 responses).

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Annual Cost to Federal Government: $39,536

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: 06/04/2019

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