[Federal Register Volume 61, Number 122 (Monday, June 24, 1996)]
[Notices]
[Pages 32447-32448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15991]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0067]


Guidance for Industry in Designing Clinical Programs for 
Developing Human Drugs, Medical Devices, or Biological Products 
Intended for the Treatment of Rheumatoid Arthritis; Availability of 
Draft Guidance; Notice of Public Workshop on Juvenile Rheumatoid 
Arthritis

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availability of a draft guidance document entitled ``Discussion for 
Designing Clinical Programs for Developing Drugs, Devices, or 
Biological Products Intended for the Treatment of Rheumatoid Arthritis 
(RA).'' On March 27, 1996, the agency held a public workshop to discuss 
the draft guidance. The agency is now announcing a second public 
workshop to discuss the draft guidance as it pertains to juvenile 
rheumatoid arthritis (JRA). The draft guidance was prepared by the 
Rheumatology Working Group comprised of members from: The Center for 
Drug Evaluation and Research (CDER), the Center for Biologics 
Evaluation and Research, and the Center for Devices and Radiological 
Health. The workshop will enable experts in rheumatology clinical 
trials and interested representatives of industry, academia, and the 
public to exchange ideas on developing and assessing new treatment 
modalities for JRA and to discuss the types of claims that might be 
reasonably pursued, and evidence necessary to support such claims.

DATES: The public workshop will be held Tuesday, July 23, 1996, from 8 
a.m. to 6 p.m. There is no registration fee for the workshop, but 
registration is requested before July 12, 1996. Interested parties are 
encouraged to register early because space is limited. Written comments 
on the draft guidance for consideration at the workshop should be 
submitted by July 12, 1996. The administrative docket will remain open 
until August 30, 1996, for the submission of written comments, data, 
information, or views on the draft guidance or the workshop.

ADDRESSES: The public workshop will be held at the Holiday Inn-- 
Bethesda, Versailles III and IV, 8120 Wisconsin Ave., Bethesda, MD 
20814. Persons interested in attending should Fax their registration to 
Rose E. Cunningham at 301-594-5493. The Fax should include the 
participant's name and title; organization name, if any; address; and 
telephone and Fax numbers.
    A copy of the draft guidance document entitled ``Discussion for 
Designing Clinical Programs for Developing Drugs, Devices, or 
Biological Products Intended for the Treatment of Rheumatoid Arthritis 
(RA)'' is available through CDER's Fax-on-Demand, 301-827-0577 or 800-
342-2722, under the index ``Guidance to industry,'' document no. 0806. 
The agenda for the workshop is available as document no. 0504. The 
draft guidance, agenda, and registration are also available on the CDER 
Home Page on the World Wide Web at <a href="http://www.fda.gov/cder/
jraworkshop.htm">http://www.fda.gov/cder/
jraworkshop.htm</a> (these must be lower case). A transcript of the 
workshop will be available from the Freedom of Information Office (HFI-
35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, approximately 15 business days after the workshop at a cost of 
10 cents per page.
    Written comments on the draft guidance or the workshop should be 
submitted to the Dockets Management Branch (HFA-305), 12420 Parklawn 
Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments are to 
be submitted, except that individuals may submit one copy. Comments are 
to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5470.


[[Page 32448]]


SUPPLEMENTARY INFORMATION: In the Federal Register of March 6, 1996 (61 
FR 8961), FDA announced the availability of a draft guidance document 
entitled ``Discussion for Designing Clinical Programs for Developing 
Drugs, Devices, or Biological Products Intended for the Treatment of 
Rheumatoid Arthritis (RA)'' also referred to as ``Draft Guidance for 
Industry in Designing Clinical Programs for Developing Human Drugs, 
Medical Devices, or Biological Products Intended for the Treatment of 
Rheumatoid Arthritis.'' The agency also announced that it was holding a 
public workshop on March 27, 1996, to discuss the draft guidance. The 
agency is now announcing a second public workshop to discuss the draft 
guidance as it pertains to JRA.
    New treatment modalities being developed for JRA may have 
beneficial effects that are different from traditional agents. However, 
uncertainty exists among experts in rheumatology clinical trials about 
the types of labeling claims that might be reasonably pursued for these 
agents and what evidence would be necessary to support such claims. In 
addition, there is a need to discuss endpoints for JRA trials, and 
whether functional/quality-of-life or radiographic claims are 
appropriate.
    FDA, through its Rheumatology Working Group, has developed a draft 
guidance document for industry that provides an overview of some design 
problems that are encountered in JRA trials intended for product 
development. FDA is sponsoring a public workshop to provide an 
opportunity for experts in rheumatology clinical trials and interested 
representatives of industry, academia, and the public to discuss the 
working draft of the guidance document and to exchange ideas on 
developing and assessing new treatment modalities for JRA as well as 
the types of claims that might be reasonably pursued and the evidence 
necessary to support such claims.
    After consideration of all data, information, or views submitted on 
the draft guidance at the workshop, FDA will issue a final guidance 
document and announce its availability with a notice published in the 
Federal Register.

    Dated: June 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-15991 Filed 6-21-96; 8:45 am]
BILLING CODE 4160-01-F