Investigational New Drug Regulations

OMB 0910-0014

OMB 0910-0014

This information collection supports FDA regulations regarding investigational new drug applications. The IND requirements provide the means by which FDA can: (a) monitor the safety of ongoing clinical investigations; (b) determine whether the clinical testing of a drug should be authorized; (c) ensure production of reliable data on the metabolism and pharmacological action of the drug in humans; (d) obtain timely information on adverse reactions to the drug; (e) obtain information on side effects associated with increasing doses; (f) obtain information on the drug's effectiveness; (g) ensure the design of well-controlled, scientifically valid studies; and (h) obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects.

The latest form for Investigational New Drug Regulations expires 2022-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Form
Justification for No Material/Nonsubstantive Change
Supporting Statement A
All Historical Document Collections
No material or nonsubstantive change to a currently approved collection 2021-03-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-06-09
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 2019-02-28
Approved without change
No material or nonsubstantive change to a currently approved collection 2018-02-28
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-09-21
Approved with change
Extension without change of a currently approved collection 2015-03-11
Approved with change
Revision of a currently approved collection 2011-05-31
Approved with change
Extension without change of a currently approved collection 2009-05-28
Approved with change
Extension without change of a currently approved collection 2006-02-17
Approved without change
Extension without change of a currently approved collection 2002-11-27
Approved without change
Extension without change of a currently approved collection 1999-07-28
Approved without change
Reinstatement without change of a previously approved collection 1996-10-31
Approved without change
No material or nonsubstantive change to a currently approved collection 1995-09-30
Approved without change
Reinstatement with change of a previously approved collection 1992-09-14
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-06-05
Approved without change
Reinstatement with change of a previously approved collection 1988-01-04
Approved without change
Revision of a currently approved collection 1987-05-05
Approved without change
Reinstatement with change of a previously approved collection 1986-11-06
Approved without change
Reinstatement with change of a previously approved collection 1985-07-24
Approved without change
Extension without change of a currently approved collection 1984-01-19
Approved without change
Extension without change of a currently approved collection 1983-03-07
Approved without change
Reinstatement with change of a previously approved collection 1983-01-12
Approved without change
Revision of a currently approved collection 1982-05-13
Approved without change
Extension without change of a currently approved collection 1977-10-27
OMB Details

CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 1572Statement of InvestigatorFillable FileableForm
Form Form FDA 1571Investigational New Drug ApplicationFillable FileableForm

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


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