FDA Workshop on Medical Devices 10/26/10
On Tuesday, October 26, 2010, the U.S. Food and
Drug Administration (FDA) Center for Devices and Radiological Health
(CDRH) is hosting a one-day workshop called, "Innovation, Technology
Transfer and Scientific Interchange: Leveraging Academic and FDA Collaborations
to Resolve Unmet Public Health Needs." This workshop, sponsored
by the FDA CDRH and the University of Virginia, is for mid-Atlantic
universities and is being held at the FDA's White Oak Campus in Silver
Full agenda details will be posted shortly.
Upon registration, please indicate your top two choices of the afternoon break-out track sessions from 1:30 PM-3:00 PM so that room allocations/assignments can be determined. Additional details will be available at the above website as updates are made, so please periodically check the website for additional information.
IIf attending, please allow additional time upon arrival at the FDA site on the morning of the workshop for the shuttle ride to Building 1 and Security checks. Please bring photo ID to facilitate the Security process. Please expect to receive a Security form from the FDA (via email). The form should be completed and immediately returned to the FDA for processing if you are not a US citizen.
Please contact Leigh Penfield at firstname.lastname@example.org for any additional questions.
New Application Deadline is November 15, 2010
ELIGIBILITY: Applicants must possess
a doctoral-level degree (with the exception of the contraception and
infertility research LRP); be a U.S. citizen, national or permanent
resident; devote 20 hours or more per week to conducting qualified research
funded by a domestic nonprofit, university or government entity; and
have qualified educational loan debt equal to or exceeding 20 percent
of their institutional base salary.
NIH has revised and clarified the responsibilities
of applicants and NIH staff to ensure that information submitted to
NIH is current and accurate at the time of award. NIH grant applicants
are responsible for verifying the accuracy and validity of all administrative,
fiscal, and programmatic information at the time of submission. This
notice extends that policy to information submitted through the Just-in-Time
As a reminder, several elements of a grant application
are not required at the time the application is submitted. Instead,
this information will be requested later in the review cycle (i.e.,
"just-in-time") to ensure that it is current. The information
eligible for just-in-time submission includes: current other support,
certifications, human embryonic stem cells, and other information requested
by the awarding IC.
Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of award. This includes items such as Other Support changes that could lead to budgetary overlap, scientific overlap, or commitment of effort greater than 12 person-months for the PD/PI(s) or any Senior/Key Personnel; or any changes in the use or approval of vertebrate animals or human subjects. Similar to the NIH public policy requirements, applicants are responsible for establishing and maintaining the necessary processes to monitor its compliance with this policy and informing NIH of any problems or concerns.
Recent changes to the eRA Commons Just-in-Time
Submission Module have improved the electronic process by allowing individual
submissions of each required element separate from other elements, and
by providing the new capability to submit updated information electronically
as many times as necessary. To read the complete policy, click here: