Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment; Availability, 35493-35494 [2010-15080]

Download as PDF Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Notices such approach satisfies the requirements of the applicable statutes and regulations. srobinson on DSKHWCL6B1PROD with NOTICES 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 In the Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance entitled ‘‘Systemic Lupus Erythematosus— Developing Drugs for Treatment,’’ which included recommendations regarding medical product development for the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 The recommendations specific to LN were removed from the draft guidance and are being finalized in this separate guidance.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 FDA received a number of comments on the draft guidance.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 VerDate Mar<15>2010 16:17 Jun 21, 2010 Jkt 220001 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 https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, or https://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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 35493 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0224] (formerly Docket No. 2005D–0106) Guidance for Industry on Systemic Lupus Erythematosus—Developing Medical Products for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘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 systemic lupus erythematosus (SLE). This guidance finalizes the draft guidance entitled ‘‘Systemic Lupus Erythematosus—Developing Drugs for Treatment’’ (the draft guidance). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance entitled ‘‘Lupus Nephritis Caused by Systemic Lupus Erythematosus—Developing Medical Products for Treatment,’’ which finalizes the parts of the draft guidance regarding lupus nephritis. 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. E:\FR\FM\22JNN1.SGM 22JNN1 35494 Federal Register / Vol. 75, No. 119 / Tuesday, June 22, 2010 / Notices srobinson on DSKHWCL6B1PROD with NOTICES Submit electronic comments on the guidance to https://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 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 ‘‘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 SLE. The guidance addresses the overall development program and clinical trial designs as well as specific information on claims, study design, study duration, efficacy endpoints, and response criteria. 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.’’ FDA received a number of comments on the draft guidance, which were considered and incorporated, as appropriate, when finalizing the guidance. The recommendations regarding medical product development for lupus nephritis were removed from this guidance and placed into a separate guidance, the availability of which is announced elsewhere in this issue of the Federal Register. Additional organspecific guidances will be developed in the future. 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 VerDate Mar<15>2010 16:17 Jun 21, 2010 Jkt 220001 practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on developing medical products for the treatment of 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 https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, or https://www.regulations.gov. Dated: June 11, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–15080 Filed 6–21–10; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–N–2010–0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 26, 2010, from 8 a.m. to approximately 5:30 p.m. and July 27, 2010, from 8 a.m. to approximately 1 p.m. Location: Hilton Washington DC/ North, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Bryan Emery or Pearline Muckelvene, Center for Biologics and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On July 26, 2010, in the morning session, the committee will hear updates on the following topics: June 10 and 11, 2010, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; December 14 and 15, 2009, FDA workshop on emerging arboviruses; May 11 and 12, 2010, FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus. In the E:\FR\FM\22JNN1.SGM 22JNN1

Agencies

[Federal Register Volume 75, Number 119 (Tuesday, June 22, 2010)]
[Notices]
[Pages 35493-35494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15080]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0224] (formerly Docket No. 2005D-0106)


Guidance for Industry on Systemic Lupus Erythematosus--Developing 
Medical Products for Treatment; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``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 systemic lupus erythematosus (SLE). This guidance 
finalizes the draft guidance entitled ``Systemic Lupus Erythematosus--
Developing Drugs for Treatment'' (the draft guidance). Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of the guidance entitled ``Lupus Nephritis Caused by Systemic Lupus 
Erythematosus--Developing Medical Products for Treatment,'' which 
finalizes the parts of the draft guidance regarding lupus nephritis.

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.

[[Page 35494]]

    Submit electronic comments on the guidance to https://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 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 ``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 SLE. The 
guidance addresses the overall development program and clinical trial 
designs as well as specific information on claims, study design, study 
duration, efficacy endpoints, and response criteria.
    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.'' FDA received a 
number of comments on the draft guidance, which were considered and 
incorporated, as appropriate, when finalizing the guidance. The 
recommendations regarding medical product development for lupus 
nephritis were removed from this guidance and placed into a separate 
guidance, the availability of which is announced elsewhere in this 
issue of the Federal Register. Additional organ-specific guidances will 
be developed in the future. 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 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 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15080 Filed 6-21-10; 8:45 am]
BILLING CODE 4160-01-S
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