OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB 0910-0765 · HHS/FDA.

OMB 0910-0765

This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation. Respondents to the collection are manufacturers or sponsors of drug and/or biologic products.

The latest form for Expedited Programs for Serious Conditions-Drugs and Biologics expires 2028-03-31 and is listed under ICR 202408-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Clean_0765_Supporting Statement_2024-8-1.docxSupporting Statement A
Premeeting Packages - CBER Other-Agency Guidance
Fast Track Designation Requests - CBER Other-Agency Guidance
Breakthrough Therapy Designation Requests - CBER Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER Other-Agency Guidance
Accelerated Approval Designation - CDER Other-Agency Guidance
RMAT Designation Requests - CBER Other-Agency Guidance
Premeeting packages - CDER Other-Agency Guidance
Fast Track Designation Requests - CDER Other-Agency Guidance
Breakthrough Therapy Designation Requests - CDER Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER Other-Agency Guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202408-0910-006 Revision of a currently approved collection 2024-08-23
202407-0910-004 Extension without change of a currently approved collection 2024-07-22 Withdrawn and continue
202309-0910-011 Revision of a currently approved collection 2024-04-18 Withdrawn and continue
202102-0910-008 Extension without change of a currently approved collection 2021-03-26 Approved without change
201809-0910-004 No material or nonsubstantive change to a currently approved collection 2018-09-25 Approved without change
201802-0910-008 Revision of a currently approved collection 2018-02-13 Approved without change
201703-0910-010 Extension without change of a currently approved collection 2017-03-15 Approved without change
201312-0910-015 New collection (Request for a new OMB Control Number) 2013-12-31 Approved without change

OMB Details

Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER

Federal Enterprise Architecture: Health - Consumer Health and Safety