FDA Sends Secure Supply Chain Application to OMB, Will Accept Apps After Approval
The application form for the Food and Drug Administration’s Secure Supply Chain (SSC) pilot program was submitted for the Office of Management and Budget approval, it said, as well as forms for modification of the application, responses to terminations of participation in the program, and recordkeeping requirements. Comments on the proposed information collection are due to the Office of Management and Budget by July 20.
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(FDA said an SSC program, which would be available to sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs), would assist it in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing it to focus its resources on imported drugs outside the program that may pose such risks. The SSC program would also increase the likelihood of expedited entry for specific finished drug products and APIs imported into the U.S. that meet the criteria for selection under the program, it said. See ITT’s Online Archives 09011620 for summary of FDA’s announcement of the SSC pilot program.)
After OMB Approval, FDA to Accept Applications; Will Accept 100 Applicants
After OMB approval, FDA said it will accept applications to participate in the program and will select qualified applicants. FDA will announce in the Federal Register the date that applications may be submitted, and application submission procedures, it said. FDA said it intends to accept applications from no more than 100 qualified applicants and for no more than 5 drugs per applicant to participate in the program.
Proposed SSC pilot application form FDA 3676 available here.