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Notification Detail :: G/TBT/N/USA/2105/Add.1
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
Objective
Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of animal or plant life or health (TBT)
Product Covered
New animal drugs labeling; Veterinary medicine (ICS code(s): 11.220)
Document Notification
Link to ePing
HSCODE
ICSCODE
11.220 - Veterinary medicine; 11.220 - Veterinary medicine
Keywords
Animal health; Animal health
Specific Regions
Additional Data
Description
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs” published in the Federal Register of 12 March 2024, by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.FDA is extending the comment period on the proposed rule published 12 March 2024 (89 FR 18262), by 60 days. Either electronic or written comments must be submitted by 9 August 2024.Title 21 Code of Federal Regulations (CFR) Parts 201500501510514, and 516This extension of comment period and the proposed rule notified as G/TBT/N/USA/2105 are identified by Docket Number FDA-2023-N-5160. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2023-N-5160/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders by 4pmEastern Time on 9 August 2024 will be shared with FDA and will also be submitted to the Docket on Regulations.gov if received within the comment period.
Notified Document
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
Active
Inactive
Comment
No
#
Comment By
Title
Comment Date
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