Guidance for Industry (GFI): Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

OMB 0910-0675

OMB 0910-0675

The information collection supports agency recommendations for manufacturers regarding the development and maintenance of a plan for ensuring the availability of medically necessary drug products. In addition, the information collection supports recommendations that manufacturers include a procedure in their plan when the plan is activated and when returning to normal operations and that these notifications occur within one day of a plan's activation and within one day of a plan's deactivation.

The latest form for Guidance for Industry (GFI): Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products expires 2023-04-30 and can be found here.

OMB Details

Reporting; Notify FDA of Plan Activation and Deactivation

Federal Enterprise Architecture: Health - Consumer Health and Safety


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