+--------------------------------------------------+-------------------+
| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
|                                                  | **                |
|                                                  | G/TBT/N/USA/162** |
|                                                  |                   |
|                                                  | 15 December 2005  |
+--------------------------------------------------+-------------------+
|                                                  | (05-5986)         |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
| **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 (FDA)      |   |                                 |
|    | (167)                     |   |                                 |
|    |                           |   |                                 |
|    | **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)    |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Title, number of pages  |   |                                 |
| 5. | and language(s) of the    |   |                                 |
| ** | notified document:**      |   |                                 |
|    | Dandruff, Seborrheic      |   |                                 |
|    | Dermatitis, and Psoriasis |   |                                 |
|    | Drug Products Containing  |   |                                 |
|    | Coal Tar and Menthol for  |   |                                 |
|    | Over‑the‑Counter Human    |   |                                 |
|    | Use; Proposed Amendment   |   |                                 |
|    | to the Monograph (4       |   |                                 |
|    | pages, in English)        |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Description of          |   |                                 |
| 6. | content:** The Food and   |   |                                 |
| ** | Drug Administration (FDA) |   |                                 |
|    | is issuing a proposed     |   |                                 |
|    | rule to amend the final   |   |                                 |
|    | monograph (FM) for        |   |                                 |
|    | over-the-counter (OTC)    |   |                                 |
|    | dandruff, seborrheic      |   |                                 |
|    | dermatitis, and psoriasis |   |                                 |
|    | drug products to include  |   |                                 |
|    | the combination of 1.8    |   |                                 |
|    | percent coal tar solution |   |                                 |
|    | and 1.5 percent menthol   |   |                                 |
|    | in a shampoo drug product |   |                                 |
|    | to control dandruff. FDA  |   |                                 |
|    | is issuing this proposed  |   |                                 |
|    | rule after considering    |   |                                 |
|    | information submitted in  |   |                                 |
|    | a citizen petition. 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. | 70 Federal Register (FR)  |   |                                 |
| ** | 73178 9 December 2005;    |   |                                 |
|    | Title 21 Code of Federal  |   |                                 |
|    | Regulations (CFR) Parts   |   |                                 |
|    | 310 and 358. 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:** 9 March 2006  |   |                                 |
| 0. |                           |   |                                 |
| ** |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **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:**                   |   |                                 |
|    |                           |   |                                 |
|    | Full text of this         |   |                                 |
|    | Notification is now       |   |                                 |
|    | available on the Internet |   |                                 |
|    | at URLs:                  |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamai     |   |                                 |
|    | tech.net/7/257/2422/01jan |   |                                 |
|    | 20051800/edocket.access.g |   |                                 |
|    | po.gov/2005/05-23839.htm> |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamaitech |   |                                 |
|    | .net/7/257/2422/01jan2005 |   |                                 |
|    | 1800/edocket.access.gpo.g |   |                                 |
|    | ov/2005/pdf/05-23839.pdf> |   |                                 |
+----+---------------------------+---+---------------------------------+