Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

OMB 0910-0052

The information collection supports agency requirements regarding the registration of blood establishments and the listing of blood products. The information obtained through the registration and product listing of domestic and foreign blood establishments assists FDA in its inspections of facilities. This information is essential to the overall regulatory scheme designed to ensure the safety of the nation's blood supply.

The latest form for Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices expires 2021-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 2830 Waiver requests Form and Instruction
0052_Supporting Statement_2021.pdf Supporting Statement A
Initial registration Other-eSystem screen shots
Waiver requests Form and Instruction
Annual review and product listing update of registration Other-eSystem screen shots

All Historical Document Collections

202106-0910-001 Approved without change	Revision of a currently approved collection	2021-06-11
201804-0910-015 Approved without change	Extension without change of a currently approved collection	2018-04-17
201612-0910-006 Approved without change	Revision of a currently approved collection	2016-12-16
201501-0910-007 Approved with change	Extension without change of a currently approved collection	2015-02-09
201201-0910-002 Approved without change	Extension without change of a currently approved collection	2012-01-04
200812-0910-003 Approved without change	Extension without change of a currently approved collection	2008-12-17
200601-0910-004 Approved without change	Extension without change of a currently approved collection	2006-01-26
200212-0910-006 Approved with change	Extension without change of a currently approved collection	2002-12-23
199912-0910-005 Approved without change	Extension without change of a currently approved collection	1999-12-20
199703-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1997-03-12
199611-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1996-11-04
199509-0910-015 Approved without change	No material or nonsubstantive change to a currently approved collection	1995-09-30
199212-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1992-12-07
198905-0910-021 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-05-27
198904-0910-023 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-04-18
198811-0910-004 Approved without change	Reinstatement with change of a previously approved collection	1988-11-10
198406-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1984-06-15
198102-0910-001 Approved without change	Revision of a currently approved collection	1981-02-11
197803-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1978-03-31
197803-0910-001 Approved without change	Reinstatement without change of a previously approved collection	1978-03-14
197510-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1975-10-09

OMB Details

Initial registration

Federal Enterprise Architecture: Health - Consumer Health and Safety