Document ID: FDA-2010-D-0249-0003
Agency: fda
Document Type: Notice
Title: Guidance for Industry;Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Notice of Withdrawal
Posted Date: 2012-06-27T04:00Z

[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guidance is being withdrawn because it does not reflect FDA's current 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]
BILLING CODE 4160-01-P