+--------------------------------------------------+-------------------+
| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
|                                                  | *                 |
|                                                  | *G/TBT/N/USA/71** |
|                                                  |                   |
|                                                  | 5 August 2004     |
+--------------------------------------------------+-------------------+
|                                                  | (04-3334)         |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
| **Committee on Technical Barriers to Trade**     | Original: English |
+--------------------------------------------------+-------------------+

NOTIFICATION

The following notification is being circulated in accordance with
Article 10.6.

+----+---------------------------+---+---------------------------------+
| ** | **Member to Agreement     |   |                                 |
| 1. | notifying:** [UNITED      |   |                                 |
| ** | STATES]{.underline}       |   |                                 |
|    |                           |   |                                 |
|    | **If applicable, name of  |   |                                 |
|    | local government involved |   |                                 |
|    | (Articles 3.2 and 7.2):** |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Agency responsible:**   |   |                                 |
| 2. | 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:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Notified under Article  |   |                                 |
| 3. | 2.9.2 \[**X**\], 2.10.1   |   |                                 |
| ** | \[ **  **\], 5.6.2        |   |                                 |
|    | \[ **  **\], 5.7.1        |   |                                 |
|    | \[ **  **\], other:**     |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Products covered (HS or |   |                                 |
| 4. | 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 )           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Title, number of pages  |   |                                 |
| 5. | and language(s) of the    |   |                                 |
| ** | notified document:**      |   |                                 |
|    | Cold, Cough, Allergy,     |   |                                 |
|    | Bronchodilator, and       |   |                                 |
|    | Antiasthmatic Drug        |   |                                 |
|    | Products for              |   |                                 |
|    | Over-the-Counter Human    |   |                                 |
|    | Use; Proposed Amendment   |   |                                 |
|    | of Final Monograph for    |   |                                 |
|    | Over-the-Counter Nasal    |   |                                 |
|    | Decongestant Drug         |   |                                 |
|    | Products (4 pages, in     |   |                                 |
|    | English)                  |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Description of          |   |                                 |
| 6. | 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 terms |   |                                 |
|    | \"sinusitis\'\' and       |   |                                 |
|    | \"associated with         |   |                                 |
|    | sinusitis\'\' elsewhere   |   |                                 |
|    | on the labelling. This    |   |                                 |
|    | proposal is part of       |   |                                 |
|    | FDA\'s ongoing review of  |   |                                 |
|    | OTC drug products.        |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Objective and           |   |                                 |
| 7. | rationale, including the  |   |                                 |
| ** | nature of urgent problems |   |                                 |
|    | where applicable:**       |   |                                 |
|    | Protection of human       |   |                                 |
|    | health                    |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Relevant documents:**   |   |                                 |
| 8. | 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.             |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Proposed date of        | } | To be determined                |
| 9. | adoption:**               |   |                                 |
| ** |                           |   |                                 |
|    | **Proposed date of entry  |   |                                 |
|    | into force:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Final date for          |   |                                 |
| *1 | comments:** 1 November    |   |                                 |
| 0. | 2004                      |   |                                 |
| ** |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Texts available from:   |   |                                 |
| *1 | National enquiry point    |   |                                 |
| 1. | \[**X**\] 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.akamai     |   |                                 |
|    | tech.net/7/257/2422/06jun |   |                                 |
|    | 20041800/edocket.access.g |   |                                 |
|    | po.gov/2004/04-17445.htm> |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamaitech |   |                                 |
|    | .net/7/257/2422/06jun2004 |   |                                 |
|    | 1800/edocket.access.gpo.g |   |                                 |
|    | ov/2004/pdf/04-17543.pdf> |   |                                 |
+----+---------------------------+---+---------------------------------+