. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/653
5 November 2002
(02-6077)
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:   Food and Drug Ad ministration – FDA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable):   The products include drugs (or components), devices (or components or
accessory of a device or other article of a device requiring further processing, which is
ready or suitable for use for health-related purposes), food additives, color additives anddietary supplements.
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners
5. Title, language and number of pages of the notified document:  "Guidance for Food and
Drug Administration Field Offices on Regulatory Procedures Manual, Chapter 9,
Subchapter, 'Import for Export'".  (Available in English, 9 pages excluding Title Page)
6. Description of content:   This is to provide guidance to FDA field offices regarding the
handling of certain products that are offered for import under section 801 of the FederalFood, Drug, and Cosmetic Act (Act).  Those products are those that are offered as "imports
for export."  The provision of the Act that permits such imports, section 801(d)(3), is
referred to as the "import for export" provision.  This guidance is intended to provide
uniform procedures for handling such importations by all FDA offices.  This chapter
represents the Agency's current thinking on the application of the import for exportprovisions of the Act.
7. Objective and rationale:  [  X ] food safety, [   ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or  disease,  [   ]  protect territory from
other damage from pests
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:G/SPS/N/USA/653
Page 2
9. Relevant documents and language(s ) in which these are available:  Notice of Availability
was published  in Federal Register Vol. 67, Page 58810 (September 18, 2002): Docket
No. 02D-0402, OC 2002236.  Guidance for Food a nd Drug Administration Field Offices
on Regulatory Procedures Manual, Chapter 9, Subchapter, 'Import for Export'.
[FR Doc. 02-23759].  See internet address:
http://www.fda.gov/OHRMS/DOCKETS/98fr/091802b.pdf for Notice of Availability.
Available in English.
10. Proposed date of adoption:   Adopted 13 September 2002
11. Proposed date of entry into force:   In force 13 September 2002
12. Final date for comments:   No deadline.  Comments are always accepted on Guidance
Documents
Agency or authority designated to handle comments:  Food and Drug Administration
[   ] National notification authority, [ X ] National enquiry point, or address, fax
number and E-mail address (if available) of other body:   Submit written comments on
the document to the Dockets Manage ment Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, U.S.A.  It is possible
to submit electronic comments to:  http://www.fda.gov/dockets/ecomments .  Submit
comments by indicating DOCKET Number 02D-0402, Title of document. "Guidance for
Food and Drug Administration Field Offices on Regulatory Procedures Manual, Chapter 9,
Subchapter, 'Import for Export'".
13. Texts available from:  [   ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point / Notification Point
Mr. William Janis
U.S. Department of Agriculture
Stop 1027
Washington, DC 20250
Tel:  (202) 720-9047Fax:  (202) 720-0677
E-mail:  fstsd@usda.gov
Complete text can be also be found on the Internet
http://www.fda.gov/ohrms/dockets/default.htm  by looking under DOCKET No. 02D-0402