Additional Information for RFA-HL-06-001: Cardiovascular Cell Therapy Research Network

RFA HL-06-001 Pre-Submission Meeting

All prospective applicants are invited to a pre-submission meeting at 8:00 AM on Wednesday, October 12, 2005.

The meeting will be held at the Bethesda Marriott Suites Hotel (http://marriott.com/property/downloadfactsheet/wassb) located at:
6711 Democracy Boulevard,
Bethesda, MD 20817.

NHLBI Program staff from the Division of Heart and Vascular Diseases, the Division of Blood Diseases and Resources, and the Division of Extramural Activities will make presentations that explain their goals and objectives for the Network and will answer questions from the attendees.

The meeting will cover organizational aspects for Cardiovascular Cell Therapy Research Network Clinical Centers, the Data and Coordinating Center, and the Clinical Research Skills Development Core plus budget issues and review issues. Attendees will have the opportunity to ask questions concerning the program. Issues addressed during the meeting will be posted on this website in the form of Frequently Asked Questions (FAQs).

The meeting will begin at 8:00 AM and will end by 1:00 PM. A limited number of rooms at the Marriott Suites Hotel have been reserved for attendees for the meeting. If you wish to book a room, please call the Marriott reservations at 1 (800) 228-9290 and request a reservation under the NHLBI RFA Pre-Application Meeting. Reservations for attendees must be received on or before Tuesday, September 30, 2005. Please note: travel to this meeting and associated costs such as ground transportation and lodging will be the responsibility of attendees and will not be provided by the NHLBI.

New NHLBI Initiative for Cardiovascular Cell Therapy Research Network

Objective: The purpose of the Cardiovascular Cell Therapy Research Network is to accelerate research in the use of cell-based therapies for the management of cardiovascular diseases in order to improve outcomes through the development and application of cell-based therapies and evaluation of these novel therapies. The network will provide the necessary infrastructure to develop, coordinate, and conduct multiple collaborative clinical protocols to facilitate application of emerging scientific discoveries into clinical investigations. Results of Network studies are expected to be widely disseminated and to improve the scientific basis of care for affected individuals.

RFA HL-06-001 "Cardiovascular Cell Therapy Research Network "

• A maximum of five awards will be made for Clinical Centers and one award for a Data Coordinating Center. Approximately $33.7 million (total costs) over 5 years will be awarded. It is anticipated that the annual award for the Data Coordinating Center will be approximately $1,000,000 direct costs in the first year and $1,750,000 each year for years two through five. An additional budget of $8,600,000 for protocols and patient care costs for the entire five year study period is anticipated. The maximum annual amount for each Clinical Center will be $300,000 direct costs. A maximum of two Clinical Skills Development Core awards will be made for up to $100,000 per year (direct costs).
• The cooperative agreement (U01) administrative and funding mechanism of support will be used.
• Eligible organizations include domestic, Canadian, Mexican, for profit and non-profit, public and private institutions such as universities, colleges, hospitals, laboratories, faith-based or community-based organizations, units of state and local governments, and eligible agencies of the federal government.
• Eligible principal investigators include those with the experience and expertise to conduct clinical studies in heart disease. The disciplines and expertise that may be appropriate for this program are cardiology, cardiovascular surgery, cardiovascular imaging, cardiovascular nursing, cardiovascular physiology, stem cell biology, clinical trials management, and biostatistics.
• Awards for a Clinical Center and a Data Coordinating Center will not be made to the same principal investigator to ensure that data analysis is performed independently of data acquisition. The same institution may apply for both a Clinical Center and Data Coordinating Center award, but the applications for each must be from different individuals and must be submitted as separate applications.
• Application receipt date is March 10, 2006.

For further information contact:

Sonia Skarlatos, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II Centre, Room 9158
6701 Rockledge Drive, Mail Stop 7940
Bethesda, MD 20892
Phone 301-435-0477
FAX 301-480-1454
Email: skarlats@mail.nih.gov

Denis Buxton , Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II Centre, Room 9188
6701 Rockledge Drive, Mail Stop 7940
Bethesda, MD 20892
Phone 301-435-0516
FAX 301-480-1454
Email: buxtond@mail.nih.gov

Last updated: July 27, 2005