OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Administrative Practices and Procedures; Formal Hearings

OMB 0910-0191 · HHS/FDA.

OMB 0910-0191

This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations found in 21 CFR Part 10, 21 CFR Parts 12 through 16, and 21 CFR Part 19 (21 CFR §§ 10, 12-16, and 19). These regulations are established in accordance with the Administrative Procedures Act and implement administrative practice and procedures to give instructions to those conducting business with FDA.

The latest form for Administrative Practices and Procedures; Formal Hearings expires 2026-08-31 and is listed under ICR 202309-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
FDA-2026-N-2431 2025-527 Comment.pdfPublic Comments
0910-0191 Supporting Statement.docxSupporting Statement A
Notice of participation Information collection
Internal Agency Review of Decisions Other-Agency Guidance
Requests for FDA speakers at external events Other-Screenshot of Web Forms
Meetings and correspondence Information collection
Guidance submissions for proposed development and/or withdraw Information collection
Request for waiver, suspection, or modification of requirements Information collection
Filing Objections and Requests for a Hearing on a Regulation or Order Information collection
Advisory Opinions Information collection
Administrative Stay of Action Information collection
Administrative Reconsideration of Action Information collection
Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs Other-Agency Guidance Document

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202607-0910-002 Extension without change of a currently approved collection 2026-07-08
202309-0910-006 No material or nonsubstantive change to a currently approved collection 2023-09-06 Approved without change
202305-0910-007 Revision of a currently approved collection 2023-06-30 Approved without change
202005-0910-003 Revision of a currently approved collection 2020-06-01 Approved without change
201805-0910-009 Extension without change of a currently approved collection 2018-07-05 Approved without change
201504-0910-007 Revision of a currently approved collection 2015-05-12 Approved without change
201203-0910-008 Extension without change of a currently approved collection 2012-03-28 Approved without change
200904-0910-005 Extension without change of a currently approved collection 2009-04-06 Approved without change
200603-0910-006 Extension without change of a currently approved collection 2006-03-22 Approved without change
200302-0910-003 Extension without change of a currently approved collection 2003-02-21 Approved without change
200001-0910-002 Extension without change of a currently approved collection 2000-01-10 Approved without change
199708-0910-006 Reinstatement without change of a previously approved collection 1997-08-11 Approved without change
199307-0910-003 Revision of a currently approved collection 1993-07-06 Approved without change
199006-0910-003 Revision of a currently approved collection 1990-06-25 Approved without change
198906-0910-036 No material or nonsubstantive change to a currently approved collection 1989-06-27 Approved with change
198906-0910-006 No material or nonsubstantive change to a currently approved collection 1989-06-01 Approved with change
198904-0910-030 No material or nonsubstantive change to a currently approved collection 1989-04-25 Approved with change
198904-0910-024 No material or nonsubstantive change to a currently approved collection 1989-04-18 Approved with change
198703-0910-009 Revision of a currently approved collection 1987-03-30 Approved without change
198403-0910-004 New collection (Request for a new OMB Control Number) 1984-03-26 Approved without change

OMB Details

Notice of participation

Federal Enterprise Architecture: Health - Consumer Health and Safety