[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]               
[Page 18341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap06-108]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-1341]

 
Draft Guidance for Industry: Center for Biologics and Evaluation 
Pilot Licensing Program for Immunization of Source Plasma Donors Using 
Immunogen Red Blood Cells Obtained from an Outside Supplier; 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withdrawal of a draft guidance that was issued on July 11, 2001.

DATES: April 11, 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 July 11, 2001 (66 FR 36287), FDA announced the availability 
of a draft guidance entitled ``Guidance for Industry: CBER Pilot 
Licensing Program for Immunization of Source Plasma Donors Using 
Immunogen Red Blood Cells Obtained from an Outside Supplier.'' This 
draft guidance described a pilot program in which biologics 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    The draft guidance is being withdrawn because FDA has determined 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licensing program outlined in the draft guidance.

    Dated: March 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5220 Filed 4-10-06; 8:45 am]

BILLING CODE 4160-01-S