OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Formal Meetings with Sponsors and Applicants for PDUFA Products

OMB 0910-0429 · HHS/FDA.

OMB 0910-0429

This information collection supplements FDA regulations by providing recommendations to industry on what to include in formal meeting requests between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by FDA.

The latest form for Formal Meetings with Sponsors and Applicants for PDUFA Products expires 2023-05-31 and is listed under ICR 202002-0910-002.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
CDER - Meeting Requests Information collection
CBER - Information Packages Information collection
CDER - Information Packages Information collection
CBER- Meeting Requests Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202002-0910-002 Reinstatement with change of a previously approved collection 2020-02-13 Approved with change
201510-0910-004 Extension without change of a currently approved collection 2015-10-21 Approved without change
201207-0910-007 Revision of a currently approved collection 2012-07-20 Approved without change
200906-0910-004 Extension without change of a currently approved collection 2009-06-29 Approved with change
200903-0910-009 Revision of a currently approved collection 2009-03-31 Improperly submitted and continue
200601-0910-002 Extension without change of a currently approved collection 2006-01-26 Approved without change
200212-0910-004 Revision of a currently approved collection 2002-12-23 Approved without change
199910-0910-009 New collection (Request for a new OMB Control Number) 1999-10-28 Approved without change

OMB Details

CDER - Meeting Requests

Federal Enterprise Architecture: Health - Consumer Health and Safety