[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22033]


[[Page Unknown]]

[Federal Register: September 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0243]

 

Certification for Exports; Revised Compliance Policy Guide; 
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 and other acts that FDA 
administers. FDA has historically issued a number of different types of 
such certificates, e.g., Certificates of Free Sale, Certificates for 
Export, Certificates to Foreign Governments, and most recently the 
European Union Health Certificate for Fishery Products. With expanding 
world trade, ongoing international harmonization initiatives, and 
developing international agreements, pressures on FDA to issue more 
certificates for U.S. products are escalating. Therefore, FDA has 
revised the CPG to clarify that it is the responsibility of the 
certificate requestor to provide information that will allow FDA to 
issue a Certificate for Export and to provide guidance on the 
preparation of such certificates, including model forms. The revised 
guidance will improve agency uniformity and consistency in providing 
export certifications for FDA-regulated commodities.

ADDRESSES: CPG 7150.01 may be ordered from the National Technical 
Information Service (NTIS), U.S. Department of Commerce, 5285 Port 
Royal Rd., Springfield, VA 22161. Orders must reference NTIS order 
number PB94-204401 and include payment of $9 for each copy of the 
document plus $2 shipping and handling. Payment may be made by check, 
money order, charge card (American Express, Visa, or Mastercard), or 
billing arrangements made with NTIS. Charge card orders must include 
the charge card account number and expiration date. For telephone 
orders or further information on placing an order, call NTIS at 703-
487-4650. CPG 7150.01 is available for public examination in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, 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, 301-443-1500.

SUPPLEMENTARY INFORMATION: This revised CPG describes current agency 
views on certificates requested by U. S. firms to facilitate the 
exports of FDA regulated products to other countries. The agency 
recognizes the current importance of fulfilling requests for export 
certificates, however, FDA's long-term policy is to work towards the 
reduction or elimination of export certificates by finding other means 
to satisfy other countries' need for reassurance about imported 
products. The new guide replaces CPG 7150.01 entitled ``Certificates of 
Free Sale'' that was issued in 1989.
    The statements made in CPG 7150.01 are not intended to bind the 
courts, the public, or FDA or to create or confer any rights, 
privileges, immunities, or benefits on or for any private person, but 
are intended merely for internal FDA guidance.

    Dated: August 15, 1994.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-22033 Filed 9-6-94; 8:45 am]
BILLING CODE 4160-01-F