.  /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/126
24 June 1998
(98-2530)
Committee on Sanitary and Phytosanitary Measures
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 (tariff item number(s) as specified in national schedules deposited
with the WTO.  ICS numbers may be provided in addition, where applicable):   Export
of animal drugs, biologics, food additives as well as the importation of components for
incorporation or further processing into articles intended for export.
4. Title and number of pages of the notified document:   Draft Guidance for Industry:
Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.
5. Description of content:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled, FDA Draft Guidance for Industry on:
Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.  The
draft guidance document addresses issues pertaining to the exportation of human drugs,
animal drugs, biologics, food additives, and devices as well as the importation ofcomponents, parts, accessories, or other articles for incorporation or further processing into
articles intended for export.  (The draft guidance document is included in the full text of this
notification.)
6. Objective and rationale: The draft guidance document provides information on the
statutory requirements for exporting human drugs, animal drugs, biologics, and medical
devices, general requirements for products exported under Section 801 of the Act
(21 U.S.C. 381), labeling requirements for drugs and biologics exported under
Section 801(e) of the Act, export requirements for unapproved drugs, biologics, and devices
under Section 802(b) of the Act (21 U.S.C. 382(b)), exports of unapproved drugs anddevices for investigational use, exports of unapproved drugs and devices in anticipation of
foreign approval;  exports of drugs and devices for diagnosing, preventing, or treating a
tropical disease or a disease "not of significant prevalence in the United States," export
notifications to FDA, and "Import for export."
7. An international standard, guideline or recommendation does not exist [ X ].
If an international standard, guideline or  recommendation exists, whenever possible,
identify deviations:           
8. Relevant documents and language(s) in which these are available:  63 FR 32219,
12 June 1998 (Available in English – 16 pages).
9. Proposed date of adoption:  Proposed implementing regulations will be published in the
Federal Register later this year and notified to the WTO.G/SPS/N/USA/126
Page 2
10. Proposed date of entry into force: Proposed implementing regulations will be published in
the Federal Register later this year and notified to the WTO.
11. Final date for comments:  26 August 1998
Agency or authority designated to handle comments:  Food and Drug Administration
12. Texts available from:  National enquiry point [     ] or address, telefax number and
E-mail address (if available) of other body:   
United States SPS Enquiry Point
USDA/FAS/FSTSDATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov