Food Labeling: Notification Procedures for Statements on Dietary Supplements

ICR 201906-0910-002

OMB: 0910-0331

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
5918 Modified
ICR Details
0910-0331 201906-0910-002
Active 201605-0910-005
HHS/FDA CFSAN
Food Labeling: Notification Procedures for Statements on Dietary Supplements
Revision of a currently approved collection   No
Regular
Approved without change 07/01/2019
Retrieve Notice of Action (NOA) 06/04/2019
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 06/30/2019
3,690 0 2,200
2,768 0 1,650
196,825 0 0

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.

US Code: 21 USC 343(r)(6) Name of Law: Federal Food, Drug, and Cosmetic Act; Misbranding
  
None

Not associated with rulemaking

  84 FR 2528 02/07/2019
84 FR 25282 05/31/2019
No

1
IC Title Form No. Form Name
Certain Types of Statements for Dietary Supplements FDA 3955 Notification Procedures for Statements on Dietary Supplements

  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
No
No
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).

$39,536
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/04/2019


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