OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

OMB 0910-0513 · HHS/FDA.

OMB 0910-0513

The information collection supports Form FDA 3542 and 3542a as used by new drug application (NDA) holders to submit patent declarations as prescribed by agency regulations. The information collected is required by statue and used by the agency for listing such information in the "Orange Book."

The latest form for Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That... expires 2022-10-31 and is listed under ICR 201908-0910-017.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 3542 Form FDA 3542Form and Instruction
Form FDA 3542a Form FDA 3542aForm and Instruction
0513 Patent Declarations SSA 2019 Ext.pdfSupporting Statement A
Form FDA 3542 Form and Instruction
Form FDA 3542a Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
201908-0910-017 Extension without change of a currently approved collection 2019-09-10 Approved without change
201611-0910-004 No material or nonsubstantive change to a currently approved collection 2016-11-22 Approved without change
201608-0910-016 Extension without change of a currently approved collection 2016-08-25 Approved with change
201309-0910-011 Extension without change of a currently approved collection 2013-09-20 Approved without change
201007-0910-003 Extension without change of a currently approved collection 2010-07-23 Approved without change
200704-0910-004 Extension without change of a currently approved collection 2007-04-30 Approved without change
200306-0910-003 New collection (Request for a new OMB Control Number) 2003-06-19 Approved without change

OMB Details

Form FDA 3542

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 3542Patent Declaration After Filing NDA or SupplementFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.