[Federal Register Volume 72, Number 156 (Tuesday, August 14, 2007)]
[Notices]
[Pages 45433-45434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0077 (formerly 98D-0077)]


Clinical Development Programs for Human Drugs, Biological 
Products, and Medical Devices for the Treatment and Prevention of 
Osteoarthritis; Request for Assistance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) seeks additional 
information on issues related to clinical development programs for 
human drugs, biological products, and medical devices for the treatment 
and prevention of osteoarthritis (OA). We will take such information 
into account as we work to finalize our draft guidance issued in July 
1999. Once finalized, the guidance will aid sponsors and other 
interested parties in developing new products to treat OA.
    Before the agency can issue such guidance, a critical appraisal of 
certain fundamentals of the science related to OA is needed. FDA is 
inviting any interested party, or parties, to conduct and manage the 
coordination of this critical appraisal. FDA believes that the party, 
or parties', first step in conducting the critical appraisal would be 
to hold a public meeting to discuss issues related to OA assessment and 
trial design. FDA intends to submit to the docket all the information 
received in response to this notice so that interested parties may be 
fully informed and to facilitate participation in and coordination of 
these activities.

[[Page 45434]]


DATES: Submit written or electronic comments on this notice by October 
15, 2007.

ADDRESSES: Submit written comments on this notice to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of the 
Commissioner (HF-18), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7864.

SUPPLEMENTARY INFORMATION: Because of the positive response to the 
agency's guidance on rheumatoid arthritis, the agency has recognized 
the need for more information on the development of human drugs, 
biological products, and medical devices for the treatment and 
prevention of OA. FDA is requesting assistance from the public in 
conducting scientific analyses for the purpose of finalizing the 
agency's current draft OA guidance.
    Specifically, the agency is inviting any interested group or 
consortium of interested groups from academia, industry, practitioners, 
and patients and their representatives to conduct and manage the 
coordination of a critical appraisal of certain fundamentals of the 
science related to OA. Initially, the party or parties would organize 
and hold a public meeting to discuss relevant questions related to OA 
assessment and trial design (a number of which are suggested in this 
notice). FDA believes a public meeting will lead to conceptual advances 
not now present, and the expression of such advances in a series of 
concept papers. These concept papers would then be discussed at 
subsequent workshops, soliciting feedback from all parties including 
regulators from the United States and elsewhere. Such discussion would 
emphasize the rationale for various approaches to key issues.
    FDA welcomes other suggestions of activities that could be 
undertaken as part of this guidance development effort. To provide a 
starting point for discussion, FDA has developed a list of some key 
concepts that the interested parties may want to consider for 
discussion at the meeting.
    1. Should the scope of the guidance apply to OA alone? Are there 
particular clinical subgroups of OA that need to be explicitly 
considered and addressed?
    2. For a claim of symptomatic relief in OA, what are the optimal 
outcome measures and trial designs? Currently, withdrawal and flare 
designs are commonly used. These designs, while believed to be 
predictive, may lack generalizability. It is also difficult to 
understand the actual size of the treatment effect based on a flare 
design. If withdrawal and flare designs are not optimal, what 
alternative designs could be used to support a symptomatic relief 
claim? What should the size and duration of exposure of the safety 
database be for symptomatic relief?
    3. Is a claim of decreased rate of progression useful and, if so, 
what would be the appropriate outcome measure(s) to establish the 
claim? What is the desirable duration of a trial for this claim? What 
comparator arms might be used?
    4. For a claim of prevention or risk reduction for the development 
of OA, what are potential outcome measures? If biomarkers are used, 
what is their state of qualification? What is the desirable duration of 
a trial for such a claim? What is an appropriate safety database for a 
prevention of OA claim?
    5. Are there additional claims that should be considered? If so, 
what outcome measures and trial designs should be used?
    6. In any long term studies, what are the best statistical 
comparisons for inference testing (is, for instance, a comparison of 
mean changes from baseline suitable or should responses be graded 
according to points on established scales)? Because longer trials 
inevitably have substantial dropouts, what imputation methods for 
dropouts are most appropriate or should the trial results be based on a 
survival analysis or a time to event (for treatment failure) analysis?
    Interested persons should submit comments and expressions of 
interest in conducting and managing a critical appraisal to the 
Division of Dockets Management (see ADDRESSES). 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 are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15844 Filed 8-13-07; 8:45 am]
BILLING CODE 4160-01-S