[Federal Register: April 24, 2008 (Volume 73, Number 80)]
[Notices]
[Page 22156-22157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap08-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0180]
Draft Guidance for Industry on Developing Coronary Drug Eluting
Stents; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of a public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Coronary Drug-Eluting Stent (DES) Guidance Document
Workshop.'' FDA is cosponsoring the workshop with the Advanced Medical
Technology Association (AdvaMed). The purpose of the workshop is to
discuss the draft guidance entitled ``Coronary Drug-Eluting Stents:
Nonclinical and Clinical Studies'' announced in the Federal Register of
March 27, 2008, and its companion document entitled ``Coronary Drug-
Eluting Stents-Nonclinical and Clinical Studies (Companion Document)''
(the Companion Document). The workshop intends to solicit additional
comments on the issues and questions presented in the draft guidance
during the open comment period.
DATES: The public workshop will be held on April 29, 2008, from 8 a.m.
to 6 p.m. Participants are encouraged to arrive early to ensure time
for parking, security screening, and registration before the meeting.
Security screening will begin at 7 a.m., and registration will begin at
7:30 a.m. Please preregister by April 22, 2008, according to the
instructions in section I.C of this document.
ADDRESSES: The public conference will be held at the Food and Drug
Administration, White Oak Campus, Bldg. 2, located at 10903 New
Hampshire Ave., Silver Spring, MD 20993.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Devices and Radiological Health, 9200
Corporate Blvd. (HFZ-400), Rockville, MD 20850, 240-276-3983
ashley.boam@fda.hhs.gov or
Elizabeth Hillebrenner, Center for Devices and Radiological Health,
9200 Corporate Blvd. (HFZ-450), Rockville, MD, 20850, 240-276-4222,
elizabeth.hillebrenner@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
I. The Public Workshop
A. Why Are We Holding This Public Workshop?
The purpose of the workshop is to discuss the draft guidance
announced in the Federal Register of March 27, 2008 (73 FR 16311), and
any issues that it may raise, and to solicit additional input on the
issues and questions presented in this draft guidance. In addition, the
purpose of this workshop is to discuss the Companion Document.
B. What Are the Topics We Intend To Address at the Workshop?
We hope to discuss a large number of issues at the workshop,
including, but not limited to:
How to characterize the drug substance, including
chemistry, nonclinical systemic and local tissue pharmacology and
toxicology, and how to evaluate potential for and consequences of
systemic clinical exposure.
How to characterize the drug-device combination product,
including the chemical/physical/mechanical properties of the DES, the
nonclinical local vascular and regional myocardial toxicology, and the
clinical performance of the drug-stent combination.
Regulatory considerations that are unique to DES
combination products.
[[Page 22157]]
Other issues and questions raised by the workshop
attendees or others.
C. Is There a Fee and How Do I Register for the Workshop?
There is a modest fee to attend the workshop to defray the costs of
meals provided and other expenses. The fee for the meeting for
registrants from industry is $125, and the fee for government
registrants is $75. Fees will be waived for invited speakers and
panelists. The registration process will be handled by AdvaMed, which
has extensive experience in planning, executing, and organizing
educational meetings. Register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.AdvaMed.org. Although the
facility is spacious, registration will be on a first-come, first-
served basis. If you need special accommodations because of a
disability, please contact Elizabeth Hillebrenner at least 7 days
before the workshop.
D. Where Can I Find Out More About This Public Workshop?
Background information on the workshop, registration information,
the agenda, information about lodging, and other relevant information
will be posted, as it becomes available, on the Internet at:
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.AdvaMed.org and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/dsma/workshop.html.
II. Electronic Access
Persons with access to the Internet may obtain both the draft
guidance document entitled ``Coronary Drug-Eluting Stents: Nonclinical
and Clinical Studies''and the Companion Document at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ode/guidance/6255.pdf.
Dated: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8853 Filed 4-23-08; 8:45 am]
BILLING CODE 4160-01-S