OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Abbreviated New Drug Applications and 505(b)(2) Applications

OMB 0910-0786 · HHS/FDA.

OMB 0910-0786

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form Form FDA 3542a Patent Information Submitted With the Filing of an NDA, Amendment, or SupplementForm and Instruction
Form Form FDA 3542 Patent Information Submitted Upon and After Approval of an NDA or SupplementForm and Instruction
0786 FRIA 6 OCT 2016 FR.pdf Supplementary Document
0786 SS for FR Oct 2016.pdfSupporting Statement A
Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act Information collection
Supplements and other changes to an approved abbreviated application Information collection
Supplements and other changes to an approved abbreviated application Information collection
Amendments to an unapproved abbreviated application Information collection
Amendments to an unapproved abbreviated application Information collection
Notice of certification of invalidity or noninfringement of a patent Information collection
Content and format of an abbreviated application Information collection
Supplements and other changes to an approved application Information collection
Amendments to an unapproved application, supplement, or resubmission Information collection
Submission of patent information Information collection
Notice of certification of invalidity or infringement of a patent Information collection
Notice of certification of invalidity or infringement of a patent Information collection
Content and format of an application Information collection
Abbreviated New Drug Applications and 505(b)(2) Applications Form and Instruction
Abbreviated New Drug Applications and 505(b)(2) Applications Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
201610-0910-001 New collection (Request for a new OMB Control Number) 2016-10-06 Approved without change
201501-0910-016 New collection (Request for a new OMB Control Number) 2015-02-12 Comment filed on proposed rule