15868 Federal Register / Vol. 70, No.

59 / Tuesday, March 29, 2005 / Notices

DEPARTMENT OF HEALTH AND Administration, 9201 Corporate on this topic. It does not create or confer
HUMAN SERVICES Blvd., suite N316, Rockville, MD any rights for or on any person and does
20850, 301–827–2090; or not operate to bind FDA or the public.
Food and Drug Administration Jeffrey N. Siegel, Center for Drug An alternative approach may be used if
Evaluation and Research (HFD– such approach satisfies the
[Docket No. 2005D–0106]
108), Food and Drug requirements of the applicable statutes
Draft Guidance for Industry on Administration, 5600 Fishers Lane, and regulations.
Systemic Lupus Erythematosus— Rockville, MD 20857, 301–594–
5667. II. Comments
Developing Drugs for Treatment;
Availability SUPPLEMENTARY INFORMATION: Interested persons may submit to the
Division of Dockets Management (see
AGENCY: Food and Drug Administration, I. Background ADDRESSES) written or electronic
HHS. FDA is announcing the availability of comments on the draft guidance. Two
ACTION: Notice. a draft guidance for industry entitled copies of any mailed comments are to be
‘‘Systemic Lupus Erythematosus— submitted, except that individuals may
SUMMARY: The Food and Drug Developing Drugs for Treatment.’’ SLE submit one copy. Comments are to be
Administration (FDA) is announcing the is a chronic disease characterized by identified with the docket number
availability of a draft guidance entitled protean manifestations often found in brackets in the heading of this
‘‘Systemic Lupus Erythematosus— demonstrating a waxing and waning document. The draft guidance and
Developing Drugs for Treatment.’’ The course. In the past, a diagnosis of SLE received comments may be seen in the
draft guidance is intended to provide often implied a decreased life span due Division of Dockets Management
recommendations for industry on to internal organ system involvement or between 9 a.m. and 4 p.m., Monday
developing drugs for the treatment of to toxic effects of therapy. However, through Friday.
systemic lupus erythematosus (SLE). recent improvements in care have
Specific topics include measurement of III. Electronic Access
dramatically enhanced the survival of
lupus disease activity and clinical SLE patients with the most severe and Persons with access to the Internet
outcomes, reduction in disease activity life-threatening manifestations. may obtain the document at http://
and flares, treatment of organ-specific Unfortunately, current treatments for www.fda.gov/ohrms/dockets/
disease, trial design issues and analysis, SLE remain inadequate as many patients default.htm or http://www.fda.gov/cder/
surrogate markers as endpoints, and have incompletely controlled the guidance/index.htm.
risk-benefit assessment. disease, progression to end-stage organ Dated: March 22, 2005.
DATES: Submit written or electronic involvement continues, and current Jeffrey Shuren,
comments on the draft guidance by June therapies carry potential risks of
Assistant Commissioner for Policy.
27, 2005. General comments on agency debilitating side effects. Therefore, it is
important to clearly describe acceptable [FR Doc. 05–6085 Filed 3–28–05; 8:45 am]
guidance documents are welcome at any
time. endpoints for approval to facilitate the BILLING CODE 4160–01–S

ADDRESSES: Submit written requests for development of novel therapeutic agents

single copies of the draft guidance to the which have the potential to be more
Division of Drug Information (HFD– effective and/or less toxic.
This draft guidance provides a general DEPARTMENT OF HOMELAND
240), Center for Drug Evaluation and SECURITY
Research, Food and Drug discussion of outcomes and
measurements of lupus disease activity
Administration, 5600 Fishers Lane, Bureau of Customs and Border
including the use of disease activity
Rockville, MD 20857. Submit written Protection
indices, flares, and organ-specific
comments on the draft guidance to the
outcomes. It presents the indications Cancellation of Customs Broker
Division of Dockets Management (HFA–
that the agency may be willing to License Due to Death of the License
305), Food and Drug Administration,
approve at present for new drug Holder
5630 Fishers Lane, rm. 1061, Rockville,
therapies for lupus. It also presents
MD 20852. Submit electronic comments
general trial design issues, discusses the AGENCY: Bureau of Customs and Border
to http://www.fda.gov/dockets/
use of surrogate endpoints in relation to Protection, Department of Homeland
ecomments. Send one self-addressed
lupus, presents the overall risk-benefit Security.
adhesive label to assist the office in
assessment that should be addressed for ACTION: General notice.
processing your requests. See the
any new therapy of lupus, and presents
SUPPLEMENTARY INFORMATION section for
some issues related to lupus and SUMMARY: Notice is hereby given that,
electronic access to the draft guidance pursuant to Title 19 of the Code of
pharmacokinetics.
document. This draft guidance is being issued Federal Regulations § 111.51(a), the
FOR FURTHER INFORMATION CONTACT: consistent with FDA’s good guidance following individual Customs broker
Joel Schiffenbauer, Center for Drug practices regulation (21 CFR 10.115). licenses and any and all permits have
Evaluation and Research (HFD– The draft guidance, when finalized, will been cancelled due to the death of the
550), Food and Drug represent the agency’s current thinking broker:

Name License No. Port name

Enoch Van Hoesen ..................................................................................................................................................... 2528 New York.

Manuel A. Gonzalez ................................................................................................................................................... 05742 Miami.
Sherry A. Ireland ......................................................................................................................................................... 22657 Detroit.
Joan P. Shindledecker ................................................................................................................................................ 9808 Baltimore.
Robert E. Finley, Sr. ................................................................................................................................................... 3448 Mobile.
Gabe S. Fountain ....................................................................................................................................................... 9170 Mobile.

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