[Federal Register: April 24, 2008 (Volume 73, Number 80)]
[Page 22156-22157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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Draft Guidance for Industry on Developing Coronary Drug Eluting 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.


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discuss the draft guidance entitled ``Coronary Drug-Eluting Stents: 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comments on the issues and questions presented in the draft guidance 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.

    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, 


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    The purpose of the workshop is to discuss the draft guidance 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issues and questions presented in this draft guidance.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]