. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/157
21 May 1999
(99-2080)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved:
2. Agency responsible:   US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO;  ICS numbers may be provided in addition, where applicable).
Regions or countries likely to be affected, to the extent relevant or practicable:  Animal
drugs, human drugs, biol ogical products, and devices
4. Title and number of pages of the notified document:  Foreign Establishment Registration
and Listing (15 pages)
5. Description of content:  The Food and Drug Administration (FDA) is proposing to amend
its regulations pertaining to the registration of foreign establishments and the listing of
human drugs, animal drugs (including animal f eed bearing or containing an animal drug for
non-investigational uses), biological products (will not affect veterinary biologics as they are
regulated by USDA), and devices.  The proposal would require foreign establishments
whose products are imported or offered for import into the United States to register with
FDA. The proposal would also require foreign establishments to identify a United States
agent and would describe some of the agent’s responsibilities.  The Agency is proposingthese changes to implement section 417 of the Food and Drug AdministrationModernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration.
6. Objective and rationale:  [  X ] food safety  [ X ] animal health [  ] plant protection
[  ] protect humans from animal/plant pest or disease  [  ]  protect territory from other 
damage from pests
7. An international standa rd, guideline or recommendati on does not exist [ X ].
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  64 FR 26330,
14 May 1999;  21 CFR Parts 207, 607 and 807 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  The date of adoption and entry into force will be
announced when the final rule is published in the Federal Register.G/SPS/N/USA/157
Page 2
11. Final date for comments:   Written comments by 28 July 1999.  Written comments on the
information collection requirements by 14 June 1999.
Agency or authority designated to handle comme nts:  [  ] National notification authority,
[  ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:   Food and Drug Administration
Detailed instruction on where and how to send commen ts is in the body of the full text – which
will be sent upon request to the address in paragraph 12.
12. Texts available from:  [ X ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
USDA/FAS/FSTD
Attn:  Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720 2239
Fax::  (202) 690 0677
E-mail address:  ofsts@fas.usda.gov