[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]
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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.
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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medical device trials, in anticipation of issuance of draft guidance on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anticipation of issuance of draft guidance on this subject.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