96-5211. 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Drugs, Medical Devices, or Biological Products Intended for the Treatment of Rheumatoid Arthritis; Availability of Draft Guidance; Notice of Public Workshop  

  • [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]
    
    
    
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    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    Treatment of Rheumatoid Arthritis; Availability of Draft Guidance; 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.
    
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    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    availability of a draft guidance document entitled ``Draft Guidance for 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    to discuss the draft guidance document. The draft guidance document was 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 Written comments on the draft 
    guidance for consideration at the workshop should be submitted by March 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 
    
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    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