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Process Update: FDA Will Acknowledge and Retain Post-Approval Facility Withdrawal Notifications and Submissions to NDAs and ANDAs

FDA is updating its regulatory business processes for supplements seeking only to withdraw a facility from the application submitted under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

What Is Changing: Effective immediately, supplements seeking only to withdraw a facility from the application for NDAs and ANDAs will receive an "acknowledge and retain" letter instead of an action letter.

Please note the following:

• For submissions proposing multiple changes, including a facility withdrawal, FDA will acknowledge the facility withdrawal in the initial acknowledgement communication. The following language will be included:

“We acknowledge receipt of the facility(ies) withdrawal request included in this supplement. This 21 CFR 314.70 minor reportable change will be documented as withdrawn and maintained in our administrative records. No further regulatory action with respect to this change will be taken for this supplement.”

• The facility withdrawal will not be referenced in any subsequent action letter for that supplement.
• Future facility withdrawal notifications may continue to be submitted through an appropriate post-approval changes notification pathway under 21 CFR 314.70.
• For ANDA applicants only: To avoid the assessment of certain facility fees, submit facility withdrawal notifications prior to the fiscal year due date for facility fees.

No action is required from applicants at this time. If you have questions about this change, please contact the appropriate Regulatory Business Project Manager in the Office of Pharmaceutical Quality, Office of Program and Regulatory Operations, or CDER-OPQ-OPRO-PostMarketingActivities@fda.hhs.gov.

We appreciate your continued partnership as we work to improve efficiency and consistency in our regulatory procedures.

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