Justification Submitted as General Correspondent and in the Annual Report

Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

OMB: 0910-0638

IC ID: 188042

Documents and Forms
Document Name
Document Type
Other-Final Guidance
Information Collection (IC) Details

View Information Collection (IC)

Justification Submitted as General Correspondent and in the Annual Report CDER
 
No Modified
 
Voluntary
 
21 CFR 201.57(c)(2)(i)(C)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Final Guidance GUIDANCE 11-3-14.pdf Yes No Paper Only

Health Public Health Monitoring

 

2 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 2 0 0 0 0 2
Annual IC Time Burden (Hours) 32 0 0 0 0 32
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

© 2024 OMB.report | Privacy Policy