Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

OMB 0910-0116

OMB 0910-0116

This information collection supports FDA regulations. Current good manufacturing practice (CGMP) regulations for donor testing, donor notification, and "lookback" provide FDA with information necessary to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections and initiate recalls. The recordkeeping requirements serve preventative and remedial purposes. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease.

The latest form for Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" expires 2021-06-30 and can be found here.

All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-08-08
Approved without change
No material or nonsubstantive change to a currently approved collection 2018-12-11
Approved without change
Revision of a currently approved collection 2018-04-18
Approved without change
Extension without change of a currently approved collection 2015-03-11
Approved with change
Extension without change of a currently approved collection 2012-01-03
Approved with change
Revision of a currently approved collection 2008-11-20
Approved without change
Extension without change of a currently approved collection 2005-10-26
Approved without change
Extension without change of a currently approved collection 2002-10-10
Approved without change
Extension without change of a currently approved collection 2000-09-28
Approved without change
Reinstatement with change of a previously approved collection 1997-12-15
Approved without change
Reinstatement with change of a previously approved collection 1993-03-09
Approved without change
Reinstatement with change of a previously approved collection 1986-01-28
Approved without change
Revision of a currently approved collection 1984-08-28
Approved without change
Revision of a currently approved collection 1983-11-25
Approved without change
Revision of a currently approved collection 1983-03-09
Approved without change
New collection (Request for a new OMB Control Number) 1981-01-08
OMB Details

CGMP for Blood and Blood Components: Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety


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