[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draft guidance entitled ``Systemic Lupus Erythematosus--Developing
Drugs for Treatment'' (the draft guidance) regarding LN.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Medical Products for Treatment,'' which finalizes the draft guidance.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]
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