Document ID: FDA-2008-N-0038-0089
Agency: fda
Document Type: Notice
Title: Sex Differences in the Cardiovascular Device Trials; Public Workshop
Posted Date: 2008-11-26T05:00Z

[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]               
[Page 72063-72064]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no08-85]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Sex Differences in the Cardiovascular Device Trials; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Sex Differences in the Cardiovascular Device 
Trials.'' FDA is co-sponsoring the conference with the Advanced Medical 
Technology Association (AdvaMed). The purpose of the workshop is to 
facilitate discussion between FDA and other interested parties on the 
study and analysis of sex and gender differences in cardiovascular 
medical device trials, in anticipation of issuance of draft guidance on 
this subject.

DATES: The workshop will be held on December 9, 2008, from 9 a.m. to 5 
p.m. Participants are encouraged to arrive early to ensure time for 
parking and security screening before the meeting. Security screening 
will begin at 8 a.m. and reception will begin at 8:30 a.m. Please 
register by December 2, 2008, using the instructions in this document. 
Non-U.S. citizens are subject to additional security screening and 
should register as soon as possible.

ADDRESSES: The workshop will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., rm. 230D, 240-276-4182, 
Rockville, MD 20850, kathryn.ocallaghan@fda.hhs.gov; or
    Ashley Boam, Center for Devices and Radiological Health (HFZ-450), 
Food and Drug Administration, 9200 Corporate Blvd., rm. 230J, 240-276-
4188, Rockville, MD 20850, ashley.boam@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion 
between FDA and other interested parties on the study and analysis of 
sex and gender differences in cardiovascular medical device trials, in 
anticipation of issuance of draft guidance on this subject.

II. What Are the Topics We Intend to Address at the Public Workshop?

    We hope to discuss a large number of issues at the public workshop, 
including, but not limited to:
     Current FDA perspective on sex/gender differences in 
pharmaceutical and medical device evaluation.
     Medical device development in the U.S. regulatory 
environment.
     Sex/gender-specific considerations in product design and 
clinical study design.
     The current state of cardiovascular treatment for women.
     Referral biases for women at risk for cardiovascular 
disease.
     The Clinical Research Organization and Institutional 
Review Board perspectives on inclusion, exclusion, recruitment, and 
retention issues related to women in clinical trials.
     The investigator/clinician perspective on the impact of 
sex/gender-specific issues on study design and conduct and available 
treatment options and limitations of use in women.
     The female patient perspective on enrollment and 
participation in clinical trials.
     The biostatistician perspective on statistical approaches 
and subgroup analysis in significant subpopulations.
     Case studies on gender-specific trials.

III. Is There a Fee and How Do I Register for the Public Workshop?

    There is a modest fee to attend the conference to defray the costs 
of meals provided and other expenses. The fee for the meeting for 
registrants from industry is $125.00, and the fee for government 
registrants is $75.00. 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://www.AdvaMed.org. 
Although the

[[Page 72064]]

facility is spacious, registration will be on a first-come, first-
served basis. Non-U.S. citizens are subject to additional security 
screening, and should register as soon as possible.
    If you need special accommodations because of a disability, please 
contact Kathryn O'Callaghan at least 7 days before the public workshop.

IV. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted, as it becomes available, on the Internet at 
http://www.AdvaMed.org and http://www.fda.gov/cdrh/dsma/workshop.html.

    Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28169 Filed 11-25-08; 8:45 am]

BILLING CODE 4160-01-S