From: no-reply@erulemaking.net
Sent: Thursday, November 16, 2006 8:04 PM
To: Dockets, FDA
Subject: Public Submission

Please Do Not Reply This Email. 

Public Comments on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs:========

Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
FR Document Number: 06-07172
Legacy Document ID: 
RIN: 0910-AA49
Publish Date: 08/29/2006 00:00:00
Submitter Info:


First Name: Jing
Last Name: Zhang
Category: Drug Industry - C0020
Organization Name: Becton, Dickinson and Company (BD)

Comment Info: =================

General Comment:"for commercial distribution" shall be added to the end of the first sentence under 
Section 207.21 as the following:

Domestic manufacturers, ... must register each establishment no later than 5 calendar 
days after beginning to manufacture, ...or salvage a drug for commercial distribution.

This is probably an oversight. If this clarification is not added, establishments that have 
drugs only in IND phase will have to register as well.  I do not believe that is the intent 
of this requirement.