Prescription Drug Product Labeling; Medication Guide Requirements

ICR 201510-0910-012

OMB: 0910-0393

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-09-23
ICR Details
0910-0393 201510-0910-012
Historical Active 201204-0910-003
HHS/FDA CDER
Prescription Drug Product Labeling; Medication Guide Requirements
Extension without change of a currently approved collection   No
Regular
Approved with change 09/30/2016
Retrieve Notice of Action (NOA) 11/12/2015
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
507,957,166 0 296,719,031
27,486,670 0 16,907,114
0 0 0

This information collection enables the agency to determine whether the labeling for certain prescription drug products that FDA has designated as posing a serious and significant public health concern requiring distribution of FDA-approved patient medication information include Medication Guides that are acceptable to FDA.

None
None

Not associated with rulemaking

  80 FR 30688 05/29/2015
80 FR 67762 11/03/2015
Yes

  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 507,957,166 296,719,031 0 0 211,238,135 0
Annual Time Burden (Hours) 27,486,670 16,907,114 0 0 10,579,556 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Significant burden estimate increase reflected in IC 5. This change due to adjustment in agency estimate is explained more fully at Q 15 of the agency supporting statement.

$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.
11/12/2015


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