[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Notices]
[Pages 8961-8962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5211]



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

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


Guidance for Industry, 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Treatment of Rheumatoid Arthritis; Availability of Draft Guidance; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Draft Guidance for 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 is also announcing a public workshop 
to discuss the draft guidance document. The draft guidance document was 
prepared by the Rheumatology Working Group comprised of members from: 
The Center for Drug Evaluation and Research, 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 rheumatoid arthritis (RA) and to discuss the types of 
claims that might be reasonably pursued and the data necessary to 
support such claims.

DATES: The public workshop will be held Wednesday, March 27, 1996, from 
8 a.m. to 6 p.m. There is no registration fee for the workshop, but 
advance registration is requested. 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 Written comments on the draft 
guidance for consideration at the workshop should be submitted by March 
22, 1996. The administrative docket will remain open until May 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views on the draft guidance or the workshop.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 DoubleTree Hotel, 
1750 Rockville Pike, Plaza 1 and 2, Rockville, MD 20852. Persons 
interested in attending should Fax their registration to Rose 
Cunningham at 301-594-5493. The Fax should include the participant's 
name and title; organization name, if any; address; and telephone 
number.
    A copy of the draft guidance document entitled ``Draft Guidance for 
Industry in Designing Clinical Programs for Developing Human Drugs, 
Medical Devices, or Biological Products Intended for the Treatment of 
Rheumatoid Arthritis'' is available through the Center for Drug 
Evaluation and Research's Fax-on-Demand, 301-827-0577 or 800-342-2722, 
under the index ``Guidance to industry,'' document no. 0806. The draft 
guidance is also available via Internet by connecting to the CDER file 
transfer protocol server (CDVS2.CDER.FDA.GOV). 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 10 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 Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5470.
SUPPLEMENTARY INFORMATION: A variety of new treatment modalities are 
being developed for RA, and many of these are anticipated to have 
beneficial effects that are different from traditional agents. However, 
uncertainty exists among experts in rheumatology clinical trials about 
the types of claims that might be reasonably pursued for these agents 
and what data would be necessary to support such claims. In addition, 
there is a need to identify appropriate outcome measures for RA, 
including composite indices, quality of life measures, and radiographic 
techniques. Parallel developments of treatment modalities for RA in the 
human drug, biological, and medical device communities have provided 
further impetus to the creation of this draft guidance document.
    FDA, through its Rheumatology Working Group, has developed a draft 
guidance document for industry that provides an overview of the kinds 
of design problems that are encountered in RA trials intended for 
product 

[[Page 8962]]
development, and offers a variety of suggested approaches that may be 
considered for improving the reliability, robustness, and clinical 
relevance of such trials. 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 RA as 
well as the types of claims that might be reasonably pursued and the 
data necessary to support such claims.
    After consideration of all data, information, or views submitted on 
the draft guidance and at the workshop, FDA will issue a final guidance 
document and announce its availability with a notice published in the 
Federal Register.

    Dated: February 29, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-5211 Filed 3-5-96; 8:45 am]
BILLING CODE 4160-01-F