. /.WORLD TRADE
ORGANIZATIONG/TBT/N/USA/50
6 August 2003
(03-4130)
Committee on Technical Barriers to Trade Original:  English
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  (49)
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):   Blood and blood
components, including source plasma, labeling and storage requirements
(HS Chapter 3002) (ICS 11)
5. Title, number of pages and language(s) of the notified document:   Revisions to Labeling
and Storage Requirements for Blood and Blood Components, Including Source Plasma
(11 pages, in English)
6. Description of content:   The FDA is proposing to revise the labeling and storage
requirements for certain human blood and blood components, including Source Plasma, bycombining, simplifying, and  updating specific regulations applicable to container labeling
and instruction circulars, and the shipping and storage temperatures for frozen noncellular
blood components.  This proposed rule would facilitate the use of a labeling system using
machine-readable information that would be acceptable as a replacement for the
"ABC Codabar'' system for labeling blood and blood components.  FDA is taking this action
as part of its "Blood Initiative'' to comprehensively review and, as necessary, revise its
regulations, policies, guidances, and procedures related to the licensing and regulation ofblood products.  This proposed rule is intended to help ensure the continued safety of the
blood supply, and to help ensure consistency in container labeling and storage temperatures.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human life and health           
8. Relevant documents:   68 Federal Register (FR) 44678 30 July 2003;  Title 21 Code of
Federal Regulations (CFR) Parts 600, 606, 610, and 640.  Will appear in the
Federal Register when adopted.           
9. Proposed date of adoption:
Proposed date of entry into force: }To be determinedG/TBT/N/USA/50
Page 2
10. Final date for comments:   28 October 2003
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:
http://www.access.gpo.gov/nara/index.html