[Federal Register Volume 75, Number 119 (Tuesday, June 22, 2010)]
[Notices]
[Pages 35492-35493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15081]


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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; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Lupus Nephritis 
Caused By Systemic Lupus Erythematosus--Developing Medical Products for 
Treatment.'' This guidance provides recommendations for industry on 
developing human drugs, therapeutic biological products, and medical 
devices for the treatment of lupus nephritis (LN) caused by systemic 
lupus erythematosus (SLE). This guidance finalizes the parts of the 
draft guidance entitled ``Systemic Lupus Erythematosus--Developing 
Drugs for Treatment'' (the draft guidance) regarding LN. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the guidance entitled ``Systemic Lupus Erythematosus--Developing 
Medical Products for Treatment,'' which finalizes the draft guidance. 
Additional organ-specific guidances will be developed in the future.

DATES:  Submit either electronic or written comments on agency 
guidances at any time.

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002; the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448; or the Division 
of Small Manufacturers, International, and Consumer Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist the offices in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jeffrey Siegel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 3154, Silver Spring, MD 20993-0002, 301-
796-2280; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210; or
    Sahar M. Dawisha, Office of In Vitro Diagnostic Devices, Center for 
Devices

[[Page 35493]]

and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., rm. 374, Rockville, MD 20850, 240-276-0717.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus--
Developing Medical Products for Treatment.'' This guidance is intended 
to assist sponsors in the clinical development of medical products for 
the treatment of LN caused by SLE. Specifically, the guidance addresses 
study population enrollment and efficacy endpoints for LN trials.
    In the Federal Register of March 29, 2005 (70 FR 15868), FDA 
announced the availability of a draft guidance entitled ``Systemic 
Lupus Erythematosus--Developing Drugs for Treatment,'' which included 
recommendations regarding medical product development for the treatment 
of LN caused by SLE. The recommendations specific to LN were removed 
from the draft guidance and are being finalized in this separate 
guidance. However, sponsors also should become familiar with the 
information regarding the overall development program and clinical 
trial designs for general SLE disease. The guidance entitled ``Systemic 
Lupus Erythematosus--Developing Medical Products for Treatment,'' the 
availabity of which is announced elsewhere in this issue of the Federal 
Register, provides general information on clinical trial considerations 
that may assist sponsors in studying LN, as well as providing specific 
information on trial design, trial duration, efficacy endpoints, and 
response criteria in SLE.
    FDA received a number of comments on the draft guidance. The 
comments specific to LN were considered and incorporated, as 
appropriate, when finalizing this separate guidance. Other changes that 
were made include the addition of more specific examples of trial 
design and study endpoints, updating the science, and minor editorial 
changes to clarify specific issues. In addition, input was obtained 
from the Center for Biologics Evaluation and Research and the Center 
for Devices and Radiological Health.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on developing medical products for the 
treatment of LN caused by SLE. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
OMB Control No. 0910-0014; the collections of information in 21 CFR 
part 314 have been approved under OMB Control No. 0910-0001; the 
collections of information in 21 CFR part 601 have been approved under 
OMB Control No. 0910-0338; and the collections of information in 21 CFR 
part 812 have been approved under OMB Control No. 0910-0078.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15081 Filed 6-21-10; 8:45 am]
BILLING CODE 4160-01-S