WORLD TRADE
ORGANIZATIONG/TBT/Notif.99/564
17 November 1999
(99-5009)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated 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 (41)
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):   Hearing Aids
(HS Chapter 9021)
5. Title, number of pages and language(s) of the notified document:   Medical Devices;
Hearing Aids;  Technical Data Amendments (3 pages, in English)
6. Description of content:   The Administration is proposing to amend its regulations governing
hearing aid labelling to reference the most r ecent version of the consensus standard used to
determine the technical data to be included in la belling for hearing aids.  This proposed rule is
a companion document to the direct final rule published elsewhere in this issue of the Federal
Register.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To ensure that manufacturers may use state-of-t he art methods to address technical data in
hearing aid labelling.
8. Relevant documents:   64 FR 59695, 3 November 1999; 21 CFR Part 801.  Will appear in
the Federal Register when adopted.
9. Proposed date of adoption:  To be determined
Proposed date of entry into force:
10. Final date for comments:   18 January 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:   The text is also available on the Internet at:
http://www.access.gpo.gov/nara/index.html