Bar Code Label Requirements for Human Drug Products and Biological Products

ICR 201907-0910-019

OMB: 0910-0537

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-07-22
IC Document Collections
IC ID
Document
Title
Status
6254
Unchanged
ICR Details
0910-0537 201907-0910-019
Active 201607-0910-006
HHS/FDA CDER
Bar Code Label Requirements for Human Drug Products and Biological Products
Extension without change of a currently approved collection   No
Regular
Approved without change 08/22/2019
Retrieve Notice of Action (NOA) 07/22/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 09/30/2019
2 0 2
48 0 48
0 0 0

This ICR collects information regarding waiver requests or exemptions from bar code requirement regulations. A request that FDA waive the bar code requirement for a particular drug product must include the following information: (1) Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity, or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or (2) an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.

US Code: 21 USC 358, 360, 360b, 360j Name of Law: null
   US Code: 21 USC 331, 351-355 Name of Law: null
   US Code: 21 USC 360gg-360ss, 371, 374, 379e Name of Law: null
   US Code: 42 USC 216,241,262,263a,264 Name of Law: null
   US Code: 21 USC 321 Name of Law: FFDCA
  
None

Not associated with rulemaking

  83 FR 54930 11/01/2018
84 FR 35118 07/22/2019
No

1
IC Title Form No. Form Name
Exemption Request from Bar Code Label Requirements

  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 2 2 0 0 0 0
Annual Time Burden (Hours) 48 48 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$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.
07/22/2019


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