[Federal Register: September 15, 2004 (Volume 69, Number 178)]
[Notices]
[Page 55637-55638]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se04-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0404]
Novel Formulations of Dialysis Solutions; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to gain input from interested persons on how solutions used in
hemodialysis or peritoneal dialysis should be evaluated for safety and
efficacy. More specifically, the agency is interested in collecting
comments on the development of formulations containing novel
concentrations of electrolytes and simple sugars, but no new molecular
entities.
DATES: The public meeting will be held on September 27, 2004, from 9
a.m. to 4 p.m. Written or electronic comments on dialysis solutions are
welcome at any time.
ADDRESSES: The public meeting will be held at the Doubletree Hotel,
1750 Rockville Pike, Rockville, MD. Public parking is available at the
hotel. The Doubletree Hotel is also accessible by Metro at the
Twinbrook 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 http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Norman Stockbridge, Center for Drug
Evaluation and Research (HFD-110), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5365, e-mail:
Norman.Stockbridge@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is holding a public meeting to discuss the nature of
development programs for solutions used in hemodialysis or peritoneal
dialysis. The discussion will be limited to solutions containing only
simple sugars and the electrolytes and other small molecules normally
found in plasma. Solutions containing novel oncotic or osmotic agents
more clearly resemble conventional drugs and are subject to
conventional drug development programs, with the usual characterization
of safety and effectiveness through clinical studies. The discussion
will focus on the following questions:
For solutions with no novel constituents, what clinical
studies are necessary?
[[Page 55638]]
Are there acceptable ranges of individual sugars and
electrolytes that can be established in clinical studies so that a
novel product would not need to demonstrate its ability to act as a
dialysate?
Are there additional constraints for combinations of
ingredients, for example, to constrain the overall osmolarity?
In the absence of clinical studies to show safety and
effectiveness, how would appropriate instructions for use be
established?
If you need special accomodations due to a disability, please
contact Norman Stockbridge at least 7 days in advance.
II. Comments and Transcripts
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on dialysates. Two paper
copies of any mailed comments are to be submitted, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Comments are available for public examination in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
There will be no transcript of this meeting.
Dated: September 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-20809 Filed 9-10-04; 3:49 pm]
BILLING CODE 4160-01-S