[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]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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