[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38305-38306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15716]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0249]
Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus
Erythematosus--Developing Medical Products for Treatment; 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 published in the Federal Register of June 22,
2010.
DATES: June 27, 2012.
FOR FURTHER INFORMATION CONTACT: Leila P. Hann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, rm. 3143, Silver Spring, MD 20993-0002, 301-
796-3367;
or
Philip Desjardins, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 5437,
Silver Spring, MD 20993-0002, 301-796-5678;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
[[Page 38306]]
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 June 22, 2010 (75 FR 35492), FDA announced the availability
of a guidance entitled ``Lupus Nephritis Caused By Systemic Lupus
Erythematosus--Developing Medical Products for Treatment.'' This
guidance is being withdrawn because it does not reflect FDA's current
thinking on the development of medical products for the treatment of
lupus nephritis.
Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15716 Filed 6-26-12; 8:45 am]
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