[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
