[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Draft Guidance for Industry: Center for Biologics and Evaluation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withdrawal of a draft guidance that was issued on July 11, 2001.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of a draft guidance entitled ``Guidance for Industry: CBER Pilot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draft guidance described a pilot program in which biologics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The draft guidance is being withdrawn because FDA has determined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licensing program outlined in the draft guidance.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