. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/214 
4 September 2006 
 (06-4207) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration (FDA) (221) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Human and animal drugs 
(HS Chapter 3004;  ICS:  11.120, 11.220). 
5. Title, number of pages and language(s) of the notified document:   Requirements for 
Foreign and Domestic Establishment Registra tion and Listing for Human Drugs, Including 
Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; 
Proposed Rule  (82 pages, in English). 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing drug establishment re gistration and drug listing.  The proposed 
revisions would reorganize, consolidate, clarif y, and modify current regulations concerning 
who must register establishments and list human  drugs, human drugs that are also biological 
products (including vaccines and allergenic products), and/or human cells, tissues, and 
cellular and tissue-based products (HCT/Ps), and animal drugs.  The proposal describes 
when and how to register and list and what information must be submitted for registration 
and listing.  In addition, the proposal would make certain changes to the National Drug 
Code (NDC) system and would require the appr opriate NDC number to appear on the labels 
for drugs subject to the listing requirements.  The proposed regulations generally would 
require the electronic submission of all regi stration and most listing information.  We 
(FDA) rely on establishment registration and drug listing information for administering many of our programs, such as postmarketi ng surveillance (including FDA inspections), 
bioterrorism, drug shortages and availability, a nd user fee assessments.  We are taking this 
action to use the latest technology to impr ove our registration and listing system, which 
would further our goal of protecting the public h ealth.  We also believe that the conversion 
to an electronic system would make the registration and listing processes more efficient and 
effective for industry and us.  We are also taking this action to support the implementation of, for example, the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, our rule making requiring a bar code on certain drug 
products, and the DailyMed initiative. G/TBT/N/USA/214 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:   : 
Protection of human life and health, protection of animal life and health 
8. Relevant documents:   71 Federal Register (FR) 51275 29 August 2006; Title 21 Code of 
Federal Regulations (CFR) Parts 20, 201, 207, 314, 330, 514, 515, 601, 607, 610, and 1271. 
Will appear in the Federal Register when adopted.. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   27 November 2006 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Internet URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/06-
7172.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20061800/edocket.access.gpo.gov/2006/pdf/
06-7172.pdf