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

ICR 200904-0910-009

OMB: 0910-0641

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2009-03-26
Supporting Statement A
2009-03-26
ICR Details
0910-0641 200904-0910-009
Historical Inactive
HHS/FDA
Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers
New collection (Request for a new OMB Control Number)   No
Regular
Preapproved 07/24/2009
Retrieve Notice of Action (NOA) 04/17/2009
This ICR is preapproved, consistent with changes to the classification of burden as "third party disclosures." FDA is reminded to accurately classify burdens in future submissions.
  Inventory as of this Action Requested Previously Approved
07/31/2012 36 Months From Approved
100,000 0 0
400,000 0 0
0 0 0

The guidance provides information on: (1) The meaning of "domestic address" for purposes of the labeling requirements of section 502(x) of the 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 act. Public Law 109-462 also requires certain postmarketing safety reports for dietary supplements.

PL: Pub.L. 109 - 462 760 Name of Law: DSNDCPA
  
PL: Pub.L. 109 - 462 760 Name of Law: DSNDCPA

0910-AF96 Proposed rulemaking 63 FR 59746 11/05/1998

  73 FR 196 01/02/2008
74 FR 8264 02/24/2009
Yes

  Total Request 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 100,000 0 100,000 0 0 0
Annual Time Burden (Hours) 400,000 0 400,000 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new collection.

$0
No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
04/17/2009


© 2024 OMB.report | Privacy Policy