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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
FDA issued a notice in the Federal Register last week requesting comments on the automated collection of four additional pieces of information that are not available in the US Customs and Border Protection's (CBP) data set.
The US Food and Drug Administration issued a notice in the Federal Register last week requesting comments on the automated collection of four additional pieces of information that are not available in the US Customs and Border Protection’s (CBP) data set. FDA is requesting that the Office of Management and Budget approve the automated collection for this information.
These four elements are the FDA product code, FDA country of production, FDA manufacturer/shipper, and ultimate consignee. This information is now allowed to be collected via different media such as paper, and the agency wants to extend this approval to include automated collection.
The automated system allows entry data to pass through a screening criteria program. At each US port of entry where foreign-origin FDA-regulated products are offered for import, FDA is notified through CBP’s automated commercial system by the importer of the arrival of the entry. Following this notification, FDA reviews relevant data to ensure the imported product meets the standards as are required for domestic products, makes an admissibility decision, and informs the importer and CBP of its decision.
Comments on the notice are requested by Apr. 27, 2009.
FDA also issued a notice in the Federal Register this week that would allow FDA to continue to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States as well as for those same products that are not legally marketed but are acceptable to the importing country.
FDA has developed five types of certificates (1) certificates of foreign governments, (2) certificates of exportability, (3) certificates of a pharmaceutical product, (4) nonclinical-research-use-only certificates, and (5) certificates of free sale. As specified in the notice, FDA will continue to rely on self-certification by manufactures for certificates to foreign governments, certificates of exportability, and certificates of a pharmaceutical product.
FDA must issue certification within 20 days of receipt of the request for self-certification and charge firms up to $175 for the certification.
FDA estimates that it receives an average of 7046 export requests from the Center for Drug Evaluation and Research and an average of 1501 requests from the Center for Biologics Evaluation and Research.
Comments on the notice are requested by Apr. 2, 2009.