26 May 2011

2 minute read

North America

This draft policy guideline, including a concept paper, will also be available for review and comment.

APHIS developed the draft policy guideline concerning the wording of indications statements used in veterinary biologicals labelling in response to concerns expressed by stakeholders. The draft guideline differs from current guidance regarding label claims in that a single indications statement, e.g. 'This product has been shown to be effective for the vaccination of healthy animals X weeks of age or older against...', would replace current indications statements that may reflect any of four different levels of effectiveness.

In addition to a standardised indications statement, the concept paper also provides for the public disclosure of a summary (with confidential business information removed) of the efficacy and safety data submitted to APHIS in support of the issuance of the product licence.

APHIS is holding the public meeting to gather input and discuss any issues that are pertinent to the draft guideline and concept paper. The public meeting will be held on Thursday 16 June 2011 from 09:00 to 15:00 at APHIS's National Center for Animal Health, 1920 Dayton Avenue, Ames, Iowa. The public can comment on the concept paper at the meeting or by submitting them to the addresses listed below.

This notice is scheduled for publication in today's Federal Register. Consideration will be given to comments received on or before 25 July 2011. You may submit comments on the concept paper by either of the following methods:

• Federal eRulemaking Portal: click here to submit or view comments and to view the concept paper.
• Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS-2011-0049, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2011-0049.

Comments are posted on the web site [click here] and may also be reviewed at USDA, Room 1141, South Building, 14th Street and Independence Ave., S.W., Washington, DC, between 08:00 and 16:30, Monday through Friday, excluding holidays. To facilitate entry into the comment reading room, please call (202) 690-2817.