Applications for FDA Approval to Market a New Drug

OMB 0910-0001

This information collection supports Food and Drug Administration regulations governing applications for FDA approval to market a new drug. Respondents to the collection are individuals or entities submitting such applications to the agency in accordance with the provisions found in the Code of Federal Regulations (CFR), Title 21, Part 314.

The latest form for Applications for FDA Approval to Market a New Drug expires 2021-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3331a Subpart B - Applications Form and Instruction
Form FDA 3938 PART 314: Subparts E through I Form
0001 NDAs SSA 2024 REV.docx Supporting Statement A
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change
Subpart B - Applications Form and Instruction
PART 314: Subparts E through I Form
Subpart D - FDA Action on Applications Other-Agency Guidance
Subpart C - Abbreviated Applications Other-Agency Guidance

All Historical Document Collections

202402-0910-003 Approved with change	Revision of a currently approved collection	2024-03-06
202310-0910-005 Comment filed on proposed rule and continue	Revision of a currently approved collection	2023-10-27
202209-0910-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-09-07
202109-0910-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-09-09
202104-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-04-05
202003-0910-010 Approved without change	Revision of a currently approved collection	2021-02-26
202002-0910-006 Approved with change	No material or nonsubstantive change to a currently approved collection	2020-02-20
202001-0910-012 Improperly submitted and continue	No material or nonsubstantive change to a currently approved collection	2020-01-27
201907-0910-022 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-07-25
201704-0910-006 Approved without change	Extension without change of a currently approved collection	2017-12-27
201601-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2016-01-22
201502-0910-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-02-26
201412-0910-015 Approved without change	No material or nonsubstantive change to a currently approved collection	2014-12-24
201409-0910-004 Approved with change	Extension without change of a currently approved collection	2014-09-18
201407-0910-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2014-07-22
201104-0910-006 Approved without change	Extension without change of a currently approved collection	2011-04-15
200804-0910-004 Approved without change	Extension without change of a currently approved collection	2008-04-23
200608-0910-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2006-08-28
200503-0910-004 Approved without change	Extension without change of a currently approved collection	2005-03-10
200208-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2002-08-27
200201-0910-011 Approved without change	Extension without change of a currently approved collection	2002-01-25
199809-0910-006 Approved without change	Reinstatement without change of a previously approved collection	1998-09-25
198906-0910-021 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-06-26
198904-0910-017 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-04-07
198608-0910-006 Approved with change	No material or nonsubstantive change to a currently approved collection	1986-08-28
198608-0910-005 Approved without change	Revision of a currently approved collection	1986-08-29
198506-0910-007 Approved with change	No material or nonsubstantive change to a currently approved collection	1985-06-28
198411-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1984-11-21
198312-0910-004 Approved without change	Extension without change of a currently approved collection	1983-12-22
198305-0910-001 Approved without change	Extension without change of a currently approved collection	1983-05-26
198206-0910-007 Approved without change	Extension without change of a currently approved collection	1982-06-08
198204-0910-006 Approved without change	Revision of a currently approved collection	1982-04-12
198203-0910-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1982-03-29
197705-0910-006 Approved without change	Extension without change of a currently approved collection	1977-05-23

OMB Details

Subpart B - Applications

Federal Enterprise Architecture: Health - Public Health Monitoring

Form 2252	Transmittal of Annual Report for Drug and Biologics for Human Use	Fillable Fileable	Form
Form FDA 3331a	NDA - Field Alert Report	www.fda.gov/drugs/surveillance/field-alert-reports	Form and instruction
Form 356	Application to Market a New or Abbreviated New Drug or Biologic for Human Use	Fillable Fileable	Form
Form 2253	Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use	Fillable Fileable	Form

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