Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

OMB 0910-0119

OMB 0910-0119

The good laboratory practice (GLP) regulations are intended to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing. Respondents to the collection are those submitting applications to FDA for research or marketing permits.

The latest form for Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies expires 2021-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
Extension without change of a currently approved collection 2021-01-12
Approved without change
Extension without change of a currently approved collection 2017-12-21
Comment filed on proposed rule and continue
Revision of a currently approved collection 2017-02-02
Approved without change
Extension without change of a currently approved collection 2014-09-29
Approved without change
Extension without change of a currently approved collection 2011-07-19
Approved without change
Extension without change of a currently approved collection 2008-07-15
Approved without change
Extension without change of a currently approved collection 2004-12-29
Approved without change
Extension without change of a currently approved collection 2001-07-27
Approved without change
Extension without change of a currently approved collection 1998-09-01
Approved without change
Extension without change of a currently approved collection 1995-06-27
Approved with change
No material or nonsubstantive change to a currently approved collection 1993-05-19
Approved without change
Reinstatement with change of a previously approved collection 1992-07-16
Approved without change
Reinstatement with change of a previously approved collection 1988-05-19
Approved with change
No material or nonsubstantive change to a currently approved collection 1983-12-21
Approved without change
Revision of a currently approved collection 1983-08-22
Approved without change
Revision of a currently approved collection 1983-03-11
Approved with change
No material or nonsubstantive change to a currently approved collection 1982-07-16
Approved without change
New collection (Request for a new OMB Control Number) 1981-01-19

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