WORLD TRADE
ORGANIZATIONG/TBT/Notif.98.269
27 May 1998
(98-2200)
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  (14)
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 appl icable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):  Human cellular and tissue-
based products  
5. Title, number of pages and language(s) of the notified document:  Establishment
Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products
(12 pages, English)
6. Description of content:  The Administration is  proposing to require manufacturers of certain
human cellular and tissue-based products to register with the agency and list their products.
In addition, the agency is proposing to amend the registration and listing regulations that
currently apply to human cellular and tissue-based products regulated as drugs, devices,
and/or biological products.
7. Objective and rationale, including the nature of urgent problems where applicable:  To
establish a unified registration and listing program for human cellular and tissue-based
products.
8. Relevant documents:  63 FR 26744, 14 May  1998; 21  CFR Parts 207, 807 and 1271.  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:  12 August 1998
11. Texts available from:  National enquiry point [X] or address, e-mail and telefax number of
other body: