[Federal Register Volume 64, Number 135 (Thursday, July 15, 1999)]
[Notices]
[Pages 38201-38202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0077]


 Draft Guidance for Industry: Clinical Development Programs for 
Drugs, Devices, and Biological Products Intended for the Treatment of 
Osteoarthritis (OA); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Clinical 
Development Programs for Drugs, Devices, and Biological Products 
Intended for the Treatment of Osteoarthritis (OA).'' The draft guidance 
is intended to stimulate discussion about designing clinical programs 
for the development of drugs, devices, and biological products intended 
for the treatment of osteoarthritis (OA). This draft guidance reflects 
comments received in response to a previous draft version of the 
guidance available in February 1998.

DATES: Written comments on the draft guidance document may be submitted 
by September 13, 1999. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of the draft guidance and appended questions are 
available on the Internet at ``http://www.fda.gov/cder/guidance/
index.htm'' or ``http://www.fda.gov/cber/guidelines.htm''. Submit 
written requests for single copies of the draft guidance and appended 
questions to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Office of Communication, Training 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448; FAX: 1-888-CBERFAX or 301-827-3844, mail: the 
Voice Information System at 800-835-4709 or 301-827-1800. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFD-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra N. Cook, Center for Drug 
Evaluation and Research (HFD-550), 9201 Corporate Blvd., Rockville, MD 
20850, 301-827-2090.

SUPPLEMENTARY INFORMATION: Currently, treatment for OA is fundamentally 
symptomatic, with no data available on long-term outcomes. Clinical 
trial experience with OA has been limited to short-term studies in 
patients with knee or hip OA and generalized OA normally has not been 
appropriate for assessing OA agents. A number of novel approaches are 
under study for the treatment of OA, as companies, clinicians, and 
patients search for more

[[Page 38202]]

effective treatments. The design of clinical programs for developing 
drugs, devices, or biological products intended for the treatment of OA 
was the subject of a previous draft guidance issued in February 1998 
(63 FR 8208, February 18, 1998). The February 1998 draft guidance 
generated several comments and was the subject of discussion at the 
Arthritis Advisory Committee meeting held on February 20, 1998.
     The agency found the comments and the discussion at the advisory 
committee meeting very helpful in developing the recommendations to 
industry, contained in the guidance, on the design of clinical programs 
for developing drugs, devices, or biological products intended for the 
treatment of OA. However, the agency believes that more public input 
would be beneficial in preparing a final version of the guidance. 
Accordingly, the agency has decided to issue this revised version of 
the guidance as a draft.
     This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on developing drugs, 
devices, or biological products intended for the treatment of OA. 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 statute, 
regulations, or both.
     Interested persons may, on or before September 13, 1999, submit to 
the Dockets Management Branch (address above) written comments on the 
draft document. 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. The draft document, appended questions, and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 8, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-18031 Filed 7-14-99; 8:45 am]
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