From: becky.armfield@ah.novartis.com
Sent: Tuesday, January 21, 2003 1:57 PM
To: fdadockets@oc.fda.gov
Subject: Docket # 02D-0449

Comments regarding Docket # 02D-0449 The Administrative New Animal Drug
Application Process:
From: Novartis Animal Health US, Inc.
3200 Northline Ave. Suite 300
Greensboro, NC 27408
Becky Armfield, Regulatory Affairs Support Specialist

Page 3 - Definition - Can an administrative NADA be submitted after
receiving verbal or a faxed approval from CVM for the labeling and FOI
component, or must we have an approval letter in hand prior to submission?

Page 3 C.  - This is a new street address for Document Control.  When does
this go into effect?

Page 4 C(4)  -  Is this meant to include telephone conversation reports?

Page 5 (6) - Does 'container labels' include secondary corrugated shippers?

General comments:
   Is a component complete letter issued for packages submitted under the
   'other' category?
   Please clarify that information eligible to be submitted under 'other
   info', especially publications, can continue to be submitted with their
   relevant phased component.   CVM has indicated in the past that they
   prefer to review this information with the component.
   Please clarify, if a drug is approved in another country during the
   phased review process with CVM, can the marketing information on the
   drug be included with a component?  Can it be included in a labeling
   component?
   Is an Administrative NADA required for a supplemental application?  (We
   have been asked to do one in the past.)