Federal Register: November 26, 2008 (Volume 73, Number 229)
DOCID: fr26no08-85 FR Doc E8-28169
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2008-N-0038]
DOCUMENT ACTION: Notice of public workshop.
Sex Differences in the Cardiovascular Device Trials; Public Workshop
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. NonU.S. citizens are subject to additional security screening and should register as soon as possible.
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Sex Differences in the Cardiovascular Device Trials.'' FDA is cosponsoring 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and analysis of sex and gender differences in cardiovascular medical device trials, in anticipation of issuance of draft guidance on this subject.
Sex Differences in the Cardiovascular Device Trials; Public Workshop,
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and analysis of sex and gender differences in cardiovascular medical device trials, in anticipation of issuance of draft guidance on this subject.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:
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
facility is spacious, registration will be on a firstcome, first served basis. NonU.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.fda.gov/cdrh/dsma/workshop.html.
Dated: November 19, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E828169 Filed 112508; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Kathryn O'Callaghan, Center for Devices and Radiological Health (HFZ450), Food and Drug
Administration, 9200 Corporate Blvd., rm. 230D, 2402764182, Rockville, MD 20850, firstname.lastname@example.org; or
Ashley Boam, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., rm. 230J, 240276 4188, Rockville, MD 20850, email@example.com.