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

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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3542 Form FDA 3542 Form and Instruction
Form FDA 3542a Form FDA 3542a Form and Instruction
0513 Patent Declarations SSA 2019 Ext.pdf Supporting Statement A
Form FDA 3542 Form and Instruction
Form FDA 3542a Form and Instruction

All Historical Document Collections

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

OMB Details

Form FDA 3542

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3542

Patent Declaration After Filing NDA or Supplement

Fillable Fileable

Form and instruction

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