[Federal Register: March 5, 2004 (Volume 69, Number 44)]
[Page 10456-10457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0086]

Diabetes: Targeting Safe and Effective Prevention and Treatment; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
following public meeting: FDA/National Institutes of Health (NIH) Joint 
Symposium on Diabetes: Targeting Safe and Effective Prevention and 
Treatment. The purpose of the public meeting is to define the current 
state of the prevention and management of diabetes and to identify and 
discuss therapeutic gaps and hurdles to safe and effective prevention 
and treatment of type 1 and type 2 diabetes mellitus. The public 
meeting is intended to provide assistance to FDA, clinical and basic 
scientists, and the interested pharmaceutical industry in their efforts 
to reduce the burden of diabetes and improve the health of all people 
with diabetes.

DATES:  The public meeting will be held on May 13, 2004, from 8:30 a.m. 
to 4:30 p.m. and on May 14, 2004, from 8 a.m. to 12 noon. Registration 
is required to attend the public meeting and must be received by April 
30, 2004, at 3 p.m.

ADDRESSES:  The public meeting will be held at the Natcher Conference 
Center, Bldg. 45, National Institutes of Health, 9000 Rockville Pike, 
Bethesda, MD. Important information about transportation and directions 
to the NIH campus, parking, and security procedures is available on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.

    Visitors must show two forms of identification, one of which must 
be a government-issued photo identification such as a Federal employee 
badge, driver's license, passport, green card, etc. If you are planning 
to drive to and park on the NIH campus, you must enter at the South Dr. 
entrance of the campus which is located on Wisconsin Ave. (the Medical 
Center Metro entrance), and allow extra time for vehicle inspection. 
Detailed information about security procedures is located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm.
 Due to the limited available 

parking, visitors are encouraged to use public transportation.

    For General Information: James Cross, Center for Drug Evaluation 
and Research, Food and Drug Administration (HFD-020), 5515 Security 
Lane, Rockville, MD 20852, 301-443-5355, FAX: 301-480-8329, e-mail: 
james.cross@fda.hhs.gov, or

    Sanford Garfield, National Institute for Diabetes and Digestive and 
Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., 
rm. 685, Bethesda, MD 20892-5460, e-mail: garfields@ep.niddk.nih.gov.
    For Registration Information: Iain MacKenzie, The Hill Group, 6903 
Rockledge Dr., suite 540, Bethesda, MD 20817, 301-897-2789, FAX 301-
897-9587, e-mail: imackenzie@thehillgroup.com


I. Background

    Diabetes mellitus constitutes a significant and growing threat to 
the U.S. public health, largely through its comorbid clinical features 
and long-term complications, including blindness, kidney disease, 
amputations, and cardiovascular disease. On January 31, 2003, FDA 
launched an initiative to improve the development and availability of 
innovative medical products by creating clearer guidance on priority 
therapeutic areas, including diabetes. Information about the initiative 
is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/bbs/topics/news/2003/beyond2002/report.html

    As outlined in the initiative, FDA intends to develop regulatory 
guidance on diabetes in collaboration with scientists and relevant 
parties through public meetings such as the FDA/NIH Joint Symposium on 
Diabetes: Targeting Safe and Effective Prevention and Treatment. This 
public meeting also relates to a recent initiative of the National 
Institute for Diabetes and Digestive and Kidney Diseases (NIDDKD) 
entitled ``Bench to Bedside, Research on Type 1 Diabetes and Its 
Complications,'' which aims to translate molecular understanding of 
type 1 diabetes into novel therapies.
    The public meeting will provide a forum for discussion of diabetes-
related topics, including the following topics:
     Important disease outcomes that are or should be 
targeted in the development of drugs, devices, and cell-based therapies 
for type 1 and/or type 2 diabetes;
     Issues surrounding the use of surrogate or 
intermediate measures of clinical effect in assessments of novel 
therapeutic approaches to prevention and treatment; and
     Clinical, scientific, and regulatory issues 
surrounding development of new medical technologies for the treatment 
of metabolic syndrome and for the prevention of type 2 diabetes.
    Participants include FDA and NIH staff, academic experts from the 
United States and abroad, members of trade associations representing 
commercial industry, and representatives of the major diabetes patient 
advocacy groups.
    FDA and NIH are currently developing a web page where interested 
persons can register to attend the public meeting, submit comments, and 
to obtain related information. Information about the public meeting 
will be posted at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.niddk.nih.gov/fund/other/conferences.htm.

II. Registration

    If you would like to attend the public meeting, you must register 
with Iain MacKenzie (see FOR FURTHER INFORMATION CONTACT) by April 30, 
2004, at 3 p.m. by providing your name, title, organizational 
affiliation, address, telephone, fax number (optional), and e-mail 
address (optional). Registration will be conducted on a first-come, 
first-served basis, and seating will be limited. To expedite 
processing, this registration information may also be faxed or e-mailed 
to Iain MacKenzie. If you need special accommodations due to a 
disability, please contact Iain MacKenzie at least 7 days in advance.
    The public meeting will include morning and afternoon sessions 
during which a discussion of diabetes and related issues associated 
with diabetes prevention and treatment will be presented. FDA and NIH 
are asking experts to provide presentations on specific issues, with 
discussion time following each presentation.

[[Page 10457]]

III. Comments

    The administrative record of this public meeting will remain open 
for 30 days after the public meeting. Interested persons may submit to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
written or electronic comments by June 11, 2004. You may also send 
comments to the Division of Dockets Management via e-mail to 
FDADockets@oc.fda.gov. Submit two paper copies of comments, identified 

with the docket number found in brackets in the heading of this 
document. Individuals may submit one paper copy. Received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday. Comments may be placed on the Internet 
and, if so, will be available for public viewing.

IV. Meeting Notes

    You may request a copy of the notes of the public meeting in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public meeting, at a cost of 10 
cents per page. You may examine the notes of the public meeting after 
June 11, 2004, at the Division of Dockets Management between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: February 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4888 Filed 3-4-04; 8:45 am]