Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

ICR 201210-0910-005

OMB: 0910-0642

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-02-14
ICR Details
0910-0642 201210-0910-005
Historical Active 200903-0910-001
HHS/FDA
Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Extension without change of a currently approved collection   No
Regular
Approved with change 02/18/2013
Retrieve Notice of Action (NOA) 10/31/2012
  Inventory as of this Action Requested Previously Approved
02/29/2016 36 Months From Approved 02/28/2013
11,120 0 111,200
2,224 0 444,800
0 0 0

This ICR collects information from dietary supplement and non-prescription drug manufacturers and distributers seeking to introduce these products into interstate commerce under the FFDCA. Respondents provide the agency with proposed labeling for their products as required under the applicable statutes and FDA clears the labeling to ensure compliance so the products can be marketed. Products that do not comply with the applicable labeling regulations may be misbranded and subject to enforcement action.

PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
  
None

Not associated with rulemaking

  77 FR 35687 06/14/2012
77 FR 50699 08/22/2012
No

  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 11,120 111,200 0 0 -100,080 0
Annual Time Burden (Hours) 2,224 444,800 0 0 -442,576 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
FDA is requesting to extend approval of the ICR, for which there is a decrease in burden. The burden change is due to an adjustment based on the agency's determination that the number of disclosures per respondent, the total annual number of disclosures, the average burden per disclosure, and the total annual hour burden have decreased.

$0
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.
10/31/2012


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