. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/71 
5 August 2004 
 (04-3334) 
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  (75)  
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 Drug Products 
(HS Chapter 3003) (ICS  11.1.20 )   
5. Title, number of pages and langua ge(s) of the notified document:   Cold, Cough, Allergy, 
Bronchodilator, and Antiasthmatic Drug Prod ucts for Over-the-Counter Human Use; 
Proposed Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug 
Products  (4 pages, in English) 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
the final monograph for over-the-counter (OTC ) nasal decongestant drug products (drug 
products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory 
allergies) to remove the indication "for the temporary relief of nasal congestion associated 
with sinusitis'' and to prohibit use of the term s "sinusitis'' and "associated with sinusitis'' 
elsewhere on the labelling. This proposal is  part of FDA's ongoing review of OTC drug 
products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   69 Federal Register (FR) 46119 2 August 2004; Title 21 Code of 
Federal Regulations (CFR) Parts 310, and 341.  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:   1 November 2004 G/TBT/N/USA/71 
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 22/06jun20041800/edocket.access.gpo.gov/2004/04-
17445.htm  
http://a257.g.akamaitech.net/7/257/24 22/06jun20041800/edocket.access.gpo.gov/2004/pdf/
04-17543.pdf  
 