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 Spring, MD.

Faculty and researchers engaged in innovative medical device research as well as administrators and students are encouraged to attend. There is no fee to attend this workshop.

The agenda, schedule, and registration for the workshop are available at the following website: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/
ucm224407.htm. Please register early if interested in attending this workshop due to limited seating. Registration closes October 15, 2010.

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 lpenfield@jhmi.edu for any additional questions.

2011 NIH Loan Repayment Program

New Application Deadline is November 15, 2010

The 2011 application cycle for the National Institutes of Health's Loan Repayment Programs (LRPs) is now open, and applications can be found online. The LRPs repay the outstanding student loans of researchers who are or will be conducting nonprofit biomedical or behavioral research, and opportunities are available in five research areas - clinical, pediatric, health disparities, contraception and infertility and clinical research for individuals from disadvantaged backgrounds. Applications will be accepted until 8:00 p.m. Eastern time on November 15, 2010.

BENEFITS: New LRP contracts are awarded for a two-year period and repay up to $35,000 of qualified educational debt annually. Tax offsets also are provided as an additional benefit. Participants may apply for competitive renewals, which are issued for one or two years. Undergraduate, graduate, medical school, and other health professional school loans qualify for repayment. An NIH grant or other NIH funding is not required to apply for or participate in the LRPs.

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.

AWARDS: Each year, nearly 1,600 research scientists benefit from the more than $70 million NIH invests in their careers through the extramural LRPs. Twenty-six percent of awards are made to individuals within one to five years of receiving their doctoral degree. More than 75 percent of awards go to individuals within 10 years of receiving their doctoral degree. Approximately 40 percent of new applications and 70 percent of renewal applications are funded.

For guidance on the application process and NIH Institute and Center (IC) research priorities, potential applicants should review "Tips for Completing a Competitive Application" and contact an IC LRP liaison. The list of ICs and their liaisons can be found online.

QUESTIONS? Visit the LRP website for more information and to access the online application. For additional assistance, call or e-mail the LRP Information Center at (866) 849-4047 or lrp@nih.gov. Also, receive application cycle updates through Twitter @NIH_LRP or www.twitter.com/NIH_LRP.


Revised Policy on Applicant Institution Responsibilities for Ensuring Just-in-Time Submissions are Accurate and Current Up to the Time of Award

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 process.

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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-120.html

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