[Federal Register Volume 63, Number 239 (Monday, December 14, 1998)]
[Notices]
[Pages 68774-68775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33052]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-1063]


Announcement of a New Format for Export Certificates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a new 
format for export certificates. The new format features the use of 
several security measures in the paper used to print export 
certificates to deter falsification of or tampering with FDA-

[[Page 68775]]

issued export certificates. The new format may also help authenticate 
export certificates.

DATES: The agency will begin issuing export certificates using the new 
format after January 1, 1999.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: Firms exporting products from the United 
States are often asked by foreign customers or foreign governments to 
supply a certification relating to products subject to the Federal 
Food, Drug, and Cosmetic Act (the act) and other FDA-administered acts. 
Certification is the process by which a formal or official attestation 
is made concerning a product's regulatory status or the system by which 
a commodity is manufactured. Certification does not show that FDA has 
``approved'' the product for export; however, some certificates reflect 
that the product has been approved for marketing in the United States.
    FDA currently issues several types of certificates. In brief, the 
principal certificates are:
    1. Certificates to Foreign Government--used for products that may 
be legally marketed, sold, offered for sale, or distributed in the 
United States. For food products, these are commonly known as 
``certificates of free sale'' or ``certificates of export.''
    2. Certificates of Exportability--used for products that meet the 
requirements for export under section 801(e) or 802 of the act (21 
U.S.C. 381(e) or 382)) but may not otherwise be marketed, sold, offered 
for sale, or distributed in the United States.
    3. Certificates of a Pharmaceutical Product--used for 
pharmaceutical products and conform to the format in the World Health 
Organization's ``Certification Scheme on the Quality of Pharmaceutical 
Products Moving in International Commerce.''
    FDA's Center for Biologics Evaluation and Research, Center for Drug 
Evaluation and Research, Center for Devices and Radiological Health, 
Center for Food Safety and Applied Nutrition, and Center for Veterinary 
Medicine receive and process requests for export certificates for 
products subject to their respective authorities.
    Recently, there has been an increasing demand for export 
certificates, as well as requests from foreign governments to 
authenticate certificates and instances where FDA has found counterfeit 
or falsified certificates. Consequently, to facilitate the issuance and 
tracking of export certificates, deter unscrupulous persons from making 
counterfeit or false certificates or otherwise tampering with export 
certificates, and to help foreign governments identify authentic, FDA-
issued export certificates more readily, FDA has adopted a new format 
for its export certificates. The new format features the use of several 
security measures in the paper used for export certificates.
    FDA will begin using the new format on certificates issued after 
January 1, 1999. The procedures for requesting and issuing export 
certificates, as well as the text of the certificates themselves, will 
remain unchanged.
    However, FDA will not use the new format on European Union (EU) 
Export Health Certificates. These certificates are for fishery products 
intended for import into the EU and are not considered to be FDA 
certificates.
    FDA is notifying foreign embassies and its counterpart government 
agencies of the new format and also advising them that otherwise valid 
export certificates issued before January 1, 1999, remain valid. 
Consequently, persons whose export certificates were issued before 
January 1, 1999, but expire after that date, should not need to replace 
those certificates.

    Dated: December 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-33052 Filed 12-11-98; 8:45 am]
BILLING CODE 4160-01-F