64H-1.002: Biomedical Research Grant Applications
PURPOSE AND EFFECT: The purpose of this rule is to provide information to apply for a Biomedical Research Grant, pursuant to the provisions of Sections 215.5602 and 381.922, Florida Statutes.
SUBJECT AREA TO BE ADDRESSED: Biomedical Research Grant Applications.
SPECIFIC AUTHORITY: 215.5602(9) FS.
LAW IMPLEMENTED: 215.5602(5), 381.922(3)(a) FS.
A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: Tuesday, January 26, 2010, 9:30 a.m. – 10:30 a.m. (EST)
PLACE: Department of Health, 4030 Esplanade Way, 2nd Floor, Room 280N, Tallahassee, FL
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Sylvia McDaniel, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin #A24, Tallahassee, FL 32399, (850)245-4585. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Sylvia McDaniel, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin #A24, Tallahassee, FL 32399, (850)245-4585
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
64H-1.002 Biomedical Research Grant Applications.
(1) Grant Applications.
(a) The Florida Department of Health (Department) will accept grant applications for research initiatives into the prevention, diagnosis, treatment, and cure of tobacco-related diseases to be funded by the James and Esther King Biomedical Research Program (Program) and for research initiatives into the prevention, diagnosis, treatment, and cure of cancer to be funded by the Bankhead-Coley Cancer Research Program (Program) in response to Calls for Grant Applications (Calls).
(b) The Calls will be announced and available at the Program's website (www.floridabiomed.com) and applications will be submitted through a web-based electronic system in a format determined by the Department.
(c) The Department may modify the format and content requirements for the Calls at any time. Notice of the modification will be announced at the Program's website.
(d) Applicants shall not initiate contact with Biomedical Research Advisory Council members regarding the status, substance, or preparation of a grant application.
(2) Advisory Council.
(a) Biomedical Research Advisory Council members are prohibited from attempting to use their council position to influence a decision to approve or award a grant or contract to the council member’s employer or any other entity in which the council member has an interest.
(b) Biomedical Research Advisory Council members will report conflicts of interest in writing to the Program Administrator and will recuse himself or herself from the Council’s deliberations and actions on the matter and shall not participate in the Council’s decision on the matter.
(c) Nothing in this rule prohibits the Department or the Biomedical Research Advisory Council from adopting additional standards and reporting requirements relating to prohibited conflicts of interest that may be more rigorous than set forth in Florida Statute. Council members must comply with additional standards upon adoption.
(3) Peer Review Process.
(a) The Department will endeavor to ensure that projects representing the best science are funded. This will be accomplished through a rigorous scientific peer review process of grant applications in coordination with the Biomedical Research Advisory Council and the State Surgeon General.
(b) Scientific peer reviewers will be located outside of Florida, must disclose all conflicts of interest, and will receive an honorarium.
(c) In addition to scientific merit scores, peer reviewers will assign a tobacco-relatedness score for the James and Esther King Biomedical Research Program and a cancer-relatedness score the Bankhead-Coley Cancer Research Program. To the extent possible, priority for funding grant applications will be given to proposals with better relatedness scores.
(4) Grant Terms and Conditions.
(a) Grant recipients must sign a Grant Terms and Conditions document. A sample document is included with each Call.
(b) Grant recipients are under a continuing obligation to notify the Program of any adverse conditions that materially impact milestones and objectives included in the research proposal and Grant Terms and Conditions.
(c) Grant funds may not be used for purposes other than those for which the grant was awarded.
(5) Termination of Grants.
(a) The Program may terminate grants prior to the expiration of the terms and conditions.
(b) The Program will notify the grant recipient in writing of the intent to terminate funding.
Rulemaking Authority 215.5602(9) FS. Law Implemented 215.5602(5), 381.922(3)(a) FS. History–New________.