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Import Procedures - Draft Proposal 5

View PDF of the Import Procedures Section (31 KB)


Background

Summary of Public Comments

Considerations

View All Import Procedures Draft Proposals

View Comments for this Proposal


Average Rating for this proposal (Based on 5 Ratings):
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Draft Proposal
FDA should disclose the outcome of the filer evaluation for importers or third parties working on behalf of importers.

Reasoning: Importers, or third parties working on behalf of importers, file information about the product offered for import.  FDA conducts evaluations of the filers who submit information electronically to FDA to determine if they are submitting accurate information about products being presented for import into the U.S.  Given their role in the import process, disclosing the results of these evaluations may increase the accuracy of the information submitted to FDA and decrease the number of potentially violative products firms try to import into the United States.  It is important for other federal agencies with jurisdiction over FDA-regulated products imported into the U.S., as well as for other companies in the supply chain, to have information about the compliance history of these entities.  To the extent that other regulatory entities conduct inspections using a risk-based approach, this information also may be helpful for setting priorities.

Disclosing the outcome of filer evaluations will likely increase accountability among actors in the supply chain.  Filers will have an incentive to provide accurate information about imported products, which will allow FDA, CBP, and other federal agencies to more effectively protect the public from potentially harmful products.  To the extent importers use third parties to file on their behalf, they will be armed with information that will allow them to select filers that have a track record of providing accurate information about imported products. 


Comments for this proposal 

(Total Received: 4)

Comment: This is a critical issue because many times when there is a problem with a drug, especially like a vitamin supplements or weight reduction drug, the manufacturer is in another country. many times a developing country, where the controls on testing and manufacturing are not as strong as they are here. But people in any event should know the medicines they take are as effective and manufactured as safely as is possible to be.
Date Submitted: 5/22/2010
Comment: I concur with this proposal in that it will allow importers to evaluate third parties that file on their behalf. It will allow importers to hire filers that have proven track records in providing accurate information about products offer for importation. jehamilton&associates
Date Submitted: 6/17/2010
Comment: CRN supports disclosing additional information about the outcome of the filer evaluations for importers or third parties working on behalf of importers along with the current information the agency makes available on refused import product. CRN assumes the agency intends to provide the outcomes of ALL filer evaluations (refused product and imported product) so that companies in the supply chain have information about the compliance history of these entities. Disclosing the outcome of filer evaluations will likely increase accountability amongst filers and discourage potentially violative firms from attempting to import illegal substances. FDA currently discloses the name of the foreign manufacturer responsible for the refused product, the date of refusal, and the description of the refused product. Making available all FDA filer evaluations will increase supply chain transparency and provide valuable information for all firms in the supply chain and to other federal agencies with j
Date Submitted: 7/19/2010
Comment: FDA currently discloses the name of the foreign manufacturer responsible for the refused product, the date of refusal, and the description of the refused product. Making available all FDA filer evaluations will increase supply chain transparency and provide valuable information for all firms in the supply chain and to other federal agencies with jurisdiction over FDA-regulated products imported into the U.S.
Date Submitted: 7/19/2010