Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers

ICR 201301-0910-008

OMB: 0910-0641

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-01-25
ICR Details
0910-0641 201301-0910-008
Historical Inactive 201207-0910-009
HHS/FDA 18618
Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers
Reinstatement with change of a previously approved collection   No
Regular
Withdrawn 03/04/2013
Retrieve Notice of Action (NOA) 01/30/2013
In accordance with 5 CFR 1320, this collection has been withdrawn at the request of the agency.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

The guidance document contains questions and answers relating to this labeling requirement and provides information on the following topics: (1) The meaning of "domestic address" for purposes of the labeling requirements of section 502(x) of the FD&C Act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or telephone number that is required to appear on the product label under section 502(x) of the act; and (3) FDA's intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act. Public Law 109-462 also requires certain postmarketing safety reports for dietary supplements.

PL: Pub.L. 109 - 462 760 Name of Law: DSNDCPA
  
None

Not associated with rulemaking

  77 FR 28604 05/15/2012
77 FR 43841 07/26/2012
No

1
IC Title Form No. Form Name
Domestic Address or Phone Number Labeling Requirement & Recommendation to Clarify Its Purpose (21 U.S.C. 502(x)

No
No

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 [email protected]

  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.
01/30/2013


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