[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Notices]
[Pages 57444-57445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0390]


Exports: Certificates and Other Assurance that Products Meet FDA 
Requirements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised Compliance Policy Guide (CPG) 7150.01 
entitled ``Certification for Exports.'' 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 acts FDA 
administers. FDA has historically issued a number of different types of 
certificates, e.g., Certificates of Free Sale, Certificates for Export, 
Certificates to Foreign Governments, and the European Union (EU) Health 
Certificate for Fishery Products. Therefore, FDA has revised CPG 
7150.01 to provide guidance on the preparation of certificates, 
including model forms, and to clarify that it is the responsibility of 
the certificate requester to provide certain information that will be 
used by FDA to determine whether a certificate may be issued. The 
revised guidance is intended to improve agency uniformity and 
consistency in providing export certifications for FDA-regulated 
products.

DATES: Effective November 6, 1996. Written comments by February 4, 
1997.

ADDRESSES: Send written requests for single copies of CPG 7150.01 
``Certification for Exports'' (CPG 7150.01) to the Director, Division 
of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send a self-
addressed adhesive label to assist that office in processing your 
requests. Submit written comments on revised CPG 7150.01 to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm 1-23, Rockville, MD 20857. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. A copy of revised CPG 7150.01 and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Steven M. Solomon, Office of 
Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0423.

SUPPLEMENTARY INFORMATION: Under the FDA Export Reform and Enhancement 
Act of 1996, FDA is required to issue certificates for the export of 
drugs and biologics, animal drugs, and devices that meet the applicable 
requirements of the act within 20 days of receipt of a request for such 
a certificate. A fee of up to $175 may be charged for each certificate 
issued. While FDA is not

[[Page 57445]]

required to issue certificates for foods, feed additives, nonmedicated 
feeds, pet foods, and cosmetics, the agency intends to continue to 
provide this service. In addition to issuing export certificates for 
products that are approved, licensed, or otherwise in compliance with 
the applicable requirements of the act, FDA will issue export 
certificates for products that meet the requirements for export of 
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 
interstate commerce.
    Revised CPG 7150.01 ``Certification for Exports'' describes current 
agency views on issuing certificates requested by firms to facilitate 
the export of FDA-regulated products to other countries. While the 
agency recognizes the current importance of fulfilling requests for 
export certificates, FDA's long-term goal is to reduce or eliminate 
export certificates by finding other means to satisfy other countries' 
needs for reassurance about imported products. The new CPG replaces CPG 
7150.01, entitled ``Certificates for Export'' that was issued in 1994.
Although this CPG does not create or confer any rights or benefits for 
or on any person and does not operated to bind FDA or industry, it does 
represent the agency's current thinking on issuing export certificates.

    Dated: October 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28528 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F