[Federal Register: March 5, 2004 (Volume 69, Number 44)]
[Notices]
[Page 10456-10457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr04-80]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
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]
BILLING CODE 4160-01-S