Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 15, 2000.

DATES:

April 10, 2006.

FOR FURTHER INFORMATION CONTACT:

Pamela Pope, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of March 15, 2000 (65 FR 13982), FDA announced the availability of a guidance entitled “Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing.” This guidance described a pilot program in which biologics manufacturers could self-certify conformance to licensing criteria prescribed by FDA. This action was intended to reduce unnecessary burdens for industry without diminishing public health protection.

The guidance is being withdrawn because FDA has determined that there is a lack of industry interest in pursuing the pilot licensing program outlined in the guidance.