Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

OMB 0910-0563

Disputes about scientific and technical issues relating to current good manufacturing practice requirements (CGMP) may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements, or during FDA's assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures for raising such disputes to FDA's Office of Regulatory Affairs (ORA) and center levels and for requesting review by a dispute resolution (DR) Panel.

The latest form for Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice expires 2021-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Requests for Dispute Resolution (Tier One and Tier Two) Other-Guidance
Requests for Tier-Two Dispute Resolution Other-Guidance

All Historical Document Collections

202104-0910-008 Approved without change	Extension without change of a currently approved collection	2021-04-14
201804-0910-007 Approved without change	Extension without change of a currently approved collection	2018-04-12
201501-0910-001 Approved without change	Extension without change of a currently approved collection	2015-01-08
201109-0910-001 Approved without change	Extension without change of a currently approved collection	2011-09-08
200808-0910-001 Approved without change	Extension without change of a currently approved collection	2008-08-11
200503-0910-003 Approved with change	New collection (Request for a new OMB Control Number)	2005-03-07

OMB Details

Requests for Tier-One Dispute Resolution

Federal Enterprise Architecture: Health - Public Health Monitoring