Applications for FDA Approval to Market a New Drug

OMB 0910-0001

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.

All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2021-04-05
Approved without change
Revision of a currently approved collection 2021-02-26
Approved with change
No material or nonsubstantive change to a currently approved collection 2020-02-20
Improperly submitted and continue
No material or nonsubstantive change to a currently approved collection 2020-01-27
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-07-25
Approved without change
Extension without change of a currently approved collection 2017-12-27
Approved without change
No material or nonsubstantive change to a currently approved collection 2016-01-22
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-02-26
Approved without change
No material or nonsubstantive change to a currently approved collection 2014-12-24
Approved with change
Extension without change of a currently approved collection 2014-09-18
Approved without change
No material or nonsubstantive change to a currently approved collection 2014-07-22
Approved without change
Extension without change of a currently approved collection 2011-04-15
Approved without change
Extension without change of a currently approved collection 2008-04-23
Approved without change
No material or nonsubstantive change to a currently approved collection 2006-08-28
Approved without change
Extension without change of a currently approved collection 2005-03-10
Approved without change
No material or nonsubstantive change to a currently approved collection 2002-08-27
Approved without change
Extension without change of a currently approved collection 2002-01-25
Approved without change
Reinstatement without change of a previously approved collection 1998-09-25
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-06-26
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-04-07
Approved with change
No material or nonsubstantive change to a currently approved collection 1986-08-28
Approved without change
Revision of a currently approved collection 1986-08-29
Approved with change
No material or nonsubstantive change to a currently approved collection 1985-06-28
Approved without change
Reinstatement with change of a previously approved collection 1984-11-21
Approved without change
Extension without change of a currently approved collection 1983-12-22
Approved without change
Extension without change of a currently approved collection 1983-05-26
Approved without change
Extension without change of a currently approved collection 1982-06-08
Approved without change
Revision of a currently approved collection 1982-04-12
Approved with change
No material or nonsubstantive change to a currently approved collection 1982-03-29
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 2252Transmittal of Annual Report for Drug and Biologics for Human UseFillable FileableForm
Form FDA 3331aNDA - Field Alert Reportwww.fda.gov/drugs/surveillance/field-alert-reportsForm and instruction
Form 356Application to Market a New or Abbreviated New Drug or Biologic for Human UseFillable FileableForm
Form 2253Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human UseFillable FileableForm

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


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