OMB control number

Formal Dispute Resolutions; Appeals Above the Division Level

OMB 0910-0430 · HHS/FDA.

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 is listed under ICR 201902-0910-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
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All Historical Document Collections

Historical document collections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

OMB Details

CDER - Requests for Formal Dispute Resolution

Federal Enterprise Architecture: Health - Consumer Health and Safety