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

OMB 0910-0052

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 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.

All Historical Document Collections
Extension without change of a currently approved collection 2024-06-28
Approved without change
Revision of a currently approved collection 2021-06-11
Approved without change
Extension without change of a currently approved collection 2018-04-17
Approved without change
Revision of a currently approved collection 2016-12-16
Approved with change
Extension without change of a currently approved collection 2015-02-09
Approved without change
Extension without change of a currently approved collection 2012-01-04
Approved without change
Extension without change of a currently approved collection 2008-12-17
Approved without change
Extension without change of a currently approved collection 2006-01-26
Approved with change
Extension without change of a currently approved collection 2002-12-23
Approved without change
Extension without change of a currently approved collection 1999-12-20
Approved without change
Reinstatement with change of a previously approved collection 1997-03-12
Approved without change
Reinstatement with change of a previously approved collection 1996-11-04
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 1992-12-07
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-05-27
Approved with change
No material or nonsubstantive change to a currently approved collection 1989-04-18
Approved without change
Reinstatement with change of a previously approved collection 1988-11-10
Approved without change
Reinstatement with change of a previously approved collection 1984-06-15
Approved without change
Revision of a currently approved collection 1981-02-11
Approved without change
Reinstatement with change of a previously approved collection 1978-03-31
Approved without change
Reinstatement without change of a previously approved collection 1978-03-14
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


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