[Federal Register Volume 71, Number 68 (Monday, April 10, 2006)]
[Notices]
[Pages 18106-18107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-1218]


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.

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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

[[Page 18107]]

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    The guidance is being withdrawn because FDA has determined that 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.

    Dated: March 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5204 Filed 4-7-06; 8:45 am]
BILLING CODE 4160-01-S