Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

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 Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products expires 2023-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0675 Planning for high absenteeism SSA 2020 EXT.pdf Supporting Statement A
Recordkeeping; developing and updating plan Other-Agency Guidance
Reporting; Notify FDA of Plan Activation and Deactivation Other-Agency Guidance

All Historical Document Collections

202004-0910-005 Approved without change	Extension without change of a currently approved collection	2020-04-27
201703-0910-008 Approved without change	Extension without change of a currently approved collection	2017-03-15
201401-0910-002 Approved without change	Extension without change of a currently approved collection	2014-01-10
201011-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	2010-11-02

OMB Details

Reporting; Notify FDA of Plan Activation and Deactivation

Federal Enterprise Architecture: Health - Consumer Health and Safety