Prescription Drug Product Labeling - Medication Guide Requirement

ICR 200201-0910-004

OMB: 0910-0393

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0393 200201-0910-004
Historical Active 199812-0910-002
HHS/FDA
Prescription Drug Product Labeling - Medication Guide Requirement
Extension without change of a currently approved collection   No
Regular
Approved without change 03/25/2002
Retrieve Notice of Action (NOA) 01/25/2002
Approved consistent with clarifications and changes in FDA memos of 3-15-02, 3-19-02, and 3-25-02.
  Inventory as of this Action Requested Previously Approved
03/31/2005 03/31/2005 03/31/2002
460,012 0 150,011
2,651 0 2,200
0 0 0

FDA regulations require the distribution of patient labeling, called Medications Guides, for certain prescription human drugs and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication guides inform patients about the most important they should know about these products in order to use them safely and effectively.

None
None


No

1
IC Title Form No. Form Name
Prescription Drug Product Labeling - Medication Guide Requirement

  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 460,012 150,011 0 0 310,001 0
Annual Time Burden (Hours) 2,651 2,200 0 0 451 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
01/25/2002


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