Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 35 No. 25, June 26, 2009 issue of the Florida Administrative Weekly.

(Substantial rewording of Rule 64H-2.002 follows. See Florida Administrative Code for present text.)

64H-2.002 Institutional Review Board Applications.

(1) Requests for Institutional Review Board review shall be submitted electronically using the Department’s electronic system. Payment shall be remitted to the Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399, (850)245-4585.

(2) Fees are waived for any student who is a candidate for a degree at a university located in Florida.

(3) Fees do not apply to Department of Health employees, including contracted employees, or investigators conducting research involving human subjects at the request of the Department under a contract, memorandum of understanding, or similar agreement, unless the study is industry sponsored, or sponsored by a for-profit organization. If so, then the fees listed in subsection (5) shall apply.

(4) Requests for review of studies involving Department electronic databases (such as, but not limited to Vital Statistics, Florida Cancer Data System) shall be charged according to the following schedule:

(a) Initial Requests $250.

(b) Amendments $100.

(d) Studies that expire will be assessed an additional $250.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(5) Requests for review of studies that are industry sponsored, or sponsored by a for-profit organization, shall be charged according to the following schedule:

(a) Initial Requests $2,000.

(b) Amendments $100.

(d) Studies that expire will be assessed an additional $2,000 fee.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(6) Requests for review of all other studies shall be charged according to the following schedule:

(a) Initial Requests $500.

(b) Amendments $100.

(d) Studies that expire will be assessed an additional $500 fee.

(e) Requests for study closure shall not be charged a fee.

(f) Requests for Continuing Review are due 60 days prior to study expiration.

(7) Fees do not apply for non-research determinations or studies that are exempt per 45 CFR 46.101 (b).

(8) Fees are due at the time a request for review is made. IRB determinations will not be granted until payment is received by the Department.

(9) Fees do not apply to studies that are requesting continuing review during the grants no-cost extension period or afterward when the study remains with no funding.

(9) Fees are nonrefundable, except if a fee is paid when none is due.

Specific Authority 381.86 FS. Law Implemented 381.86(5) FS. History–New 9-2-08, Amended_______.