. /. WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/55 
5 May 2004 
 (04-2015) 
Committee on Technical Barriers to Trade  
   
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  (59)  
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 app licable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Human Drug Products 
(HS Chapter  3003) (ICS 11.120)   
5. Title, number of pages and langu age(s) of the notified document:   Toll-Free Number for 
Reporting Adverse Events on Labeling for Huma n Drug Products (19 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing the format and cont ent of labeling for human drug products for 
which an application is approved under section 505 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355). The pr oposed rule would require the addition of a 
statement that includes a toll-free number and advises that the number is to be used only for 
reporting side effects and is not intended for medical advice (the side effects statement). 
When finalized, this rule will bring FDA regula tions into compliance with provisions of the 
Best Pharmaceuticals for Children Act (the BPCA). 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   69 Federal Register (FR) 21778 22  April 2004;  Title 21 Code of 
Federal Regulations (CFR) Part s 201, 208, and 209.  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:   21 July 2004 G/TBT/N/USA/55 
Page 2  
 
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:   
Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/14mar20010800/edocket.access.gpo.gov/2004/04-
9069.htm  
http://a257.g.akamaitech.net/7/257/2422/ 14mar20010800/edocket.access.gpo.gov/2004/pdf/
04-9069.pdf  
 