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U.S. Department of Health and Human Services

Drugs

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Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry

On May 12-13, 2009, FDA's Center for Drug Evaluation and Research (CDER) will hold a public workshop to seek constructive input from key stakeholders in the pediatric rheumatology community, the pharmaceutical industry and the public to explore the value and feasibility of developing a consolidated pediatric rheumatology observational registry.  FDA is interested in obtaining public comment on issues relating to development of a consolidated pediatric rheumatology observational registry.

Dates:           May 12-13, 2009
Time:            8:30 a.m. to 5:00 p.m. on May 12 and 8:30 a.m. to Noon on May 13
Location:       Hilton, Downtown Silver Spring, The Ballrooms, 8727 Colesville Road,
                   Silver Spring, MD 20910 (Metro: Silver Spring Station on the Red Line)

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852. Submit electronic comments to Regulations.gov. Written or electronic comments will be accepted after the hearing until July 14, 2009.

Attendance and Registration to Speak:

There is no fee to attend the workshop, and attendees who do not wish to make an oral presentation do not need to register.

If you would like to make an oral presentation during the open public session on day one of the workshop, you must register and provide an abstract of your presentation by close of business on April 21, 2009. To speak, submit your name, title, business affiliation (if applicable), address, telephone and fax numbers, and e-mail address to Diane Ehrlich.  FDA has included questions for comment in section II of the Federal Register Notice. You should also identify by number each question you wish to address in your presentation, and the approximate time requested for your presentation. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Persons registered to make an oral presentation should check in before workshop.

Transcripts of the workshop will be available for review approximately 30 days after the hearing at the Division of Dockets Management and on the Internet at Regulations.gov

For further information, contact:

Diane Ehrlich
Center for Drug Evaluation and Research
Food and Drug Administration
Telephone: 301-796-3452
E-mail: diane.ehrlich@fda.hhs.gov