Prescription Drug Product Labeling; Medication Guide Requirements

ICR 201908-0910-014

OMB: 0910-0393

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-09-09
ICR Details
0910-0393 201908-0910-014
Active 201510-0910-012
HHS/FDA CDER
Prescription Drug Product Labeling; Medication Guide Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 10/08/2019
Retrieve Notice of Action (NOA) 09/10/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
507,957,217 0 507,957,166
27,491,378 0 27,486,670
0 0 0

This information collection supports agency regulations pertaining to patient labeling for certain drug products. Specifically, regulations in 21 CFR part 208 describe requirements for Medications guides and enables the agency to determine whether the labeling for certain prescription drug products that pose a serious and significant public health concern comply with current safety regulations.

US Code: 21 USC 301 et seq. Name of Law: Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  83 FR 54110 10/26/2018
84 FR 43608 08/21/2019
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 507,957,217 507,957,166 0 0 51 0
Annual Time Burden (Hours) 27,491,378 27,486,670 0 0 4,708 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects an upward adjustment in the number of respondents, which we attribute to an increase in submissions we have received over the past few years. We have also corrected a calculation error in our annual third-party disclosure burden. These adjustments result in an overall increase of 51 annual responses and 4,708 annual hours.

$0
No
    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.
09/10/2019


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