WORLD TRADE
ORGANIZATIONG/SPS/N/USA/691/Add.4
23 December 2003
(03-6715)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 19 December 2003, is being circulated at the request of
the Delegation of the United States.
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Small Entity Compliance Guide on Registration of Food Facilities
On 12 December 2003, the US Food and Drug Administration (FDA) announced the
availability of small entity compliance guide (SECG) for the interim final rule on Registration of Food
Facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002(the Bioterrorism Act).  The interim final rule published in the Federal Register of 10 October 2003.
This SECG is intended to help small businesses better understand the registration regulation.
The Federal Register Notice 68 FR 69408-69409 can be found under at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-30738.pdf .  The guidance for can be found at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-gdl0001.pdf.pdf .  The Interim Final Rule on
Registration of Food Facilities issued under the Bioterrorism Act can be found at:
http://www.cfsan.fda.gov/~furls/ffregfr.html .
Written or electronic comments on SECGs can be submitted at any time.  Submit written
comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Submit electronic comments tohttp://www.fda.gov/dockets/ecomments .  Submit comments by indicating Docket No.2002N-0276.
For further information contact:  Deborah Ralston, Office of Regulatory Affairs, Office of
Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
(301) 443-6230.
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