OMB control number

Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

OMB 0910-0119 · HHS/FDA.

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 2027-01-31 and is listed under ICR 202312-0910-006.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
0119 GLP SSA 2023 EXT.docx	Supporting Statement A
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies	Information collection

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202312-0910-006	Extension without change of a currently approved collection	2023-12-19	Approved without change
202011-0910-010	Extension without change of a currently approved collection	2021-01-12	Approved without change
201711-0910-004	Extension without change of a currently approved collection	2017-12-21	Approved without change
201610-0910-010	Revision of a currently approved collection	2017-02-02	Comment filed on proposed rule and continue
201409-0910-010	Extension without change of a currently approved collection	2014-09-29	Approved without change
201107-0910-008	Extension without change of a currently approved collection	2011-07-19	Approved without change
200807-0910-004	Extension without change of a currently approved collection	2008-07-15	Approved without change
200412-0910-004	Extension without change of a currently approved collection	2004-12-29	Approved without change
200107-0910-007	Extension without change of a currently approved collection	2001-07-27	Approved without change
199809-0910-004	Extension without change of a currently approved collection	1998-09-01	Approved without change
199506-0910-003	Extension without change of a currently approved collection	1995-06-27	Approved without change
199305-0910-007	No material or nonsubstantive change to a currently approved collection	1993-05-19	Approved with change
199207-0910-002	Reinstatement with change of a previously approved collection	1992-07-16	Approved without change
198805-0910-005	Reinstatement with change of a previously approved collection	1988-05-19	Approved without change
198312-0910-005	No material or nonsubstantive change to a currently approved collection	1983-12-21	Approved with change
198308-0910-002	Revision of a currently approved collection	1983-08-22	Approved without change
198303-0910-010	Revision of a currently approved collection	1983-03-11	Approved without change
198207-0910-003	No material or nonsubstantive change to a currently approved collection	1982-07-16	Approved with change
198101-0910-004	New collection (Request for a new OMB Control Number)	1981-01-19	Approved without change