Food Labeling: Notification Procedures for Statements on Dietary Supplements

ICR 201605-0910-005

OMB: 0910-0331

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-05-11
IC Document Collections
ICR Details
0910-0331 201605-0910-005
Historical Active 201303-0910-006
HHS/FDA CFSAN
Food Labeling: Notification Procedures for Statements on Dietary Supplements
Extension without change of a currently approved collection   No
Regular
Approved without change 06/13/2016
Retrieve Notice of Action (NOA) 05/13/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 06/30/2016
2,200 0 2,200
1,650 0 1,650
0 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
  
None

Not associated with rulemaking

  81 FR 12910 03/11/2016
81 FR 29867 05/13/2016
Yes

1
IC Title Form No. Form Name
Certain Types of Statements for 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 2,200 2,200 0 0 0 0
Annual Time Burden (Hours) 1,650 1,650 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$36,732
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
05/13/2016


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