Formal Dispute Resolutions; Appeals Above the Division Level

OMB 0910-0430

This information collection approval request supports FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented.

The latest form for Formal Dispute Resolutions; Appeals Above the Division Level expires 2022-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0430 GFI Dispute Res SS 2019 Ext 2019.pdf Supporting Statement A
CDER - Requests for Formal Dispute Resolution Other-Agency Guidance
CBER - Requests for Formal Dispute Resolution Other-Agency Guidance

All Historical Document Collections

201902-0910-004 Approved without change	Revision of a currently approved collection	2019-02-27
201510-0910-005 Approved without change	Extension without change of a currently approved collection	2015-10-21
201207-0910-008 Approved without change	Revision of a currently approved collection	2012-07-20
200904-0910-011 Approved with change	Extension without change of a currently approved collection	2009-04-29
200602-0910-001 Approved without change	Extension without change of a currently approved collection	2006-02-06
200212-0910-003 Approved without change	Extension without change of a currently approved collection	2002-12-19
199910-0910-010 Approved without change	New collection (Request for a new OMB Control Number)	1999-10-28

OMB Details

CDER - Requests for Formal Dispute Resolution

Federal Enterprise Architecture: Health - Consumer Health and Safety