The purpose and effect of the proposed rule is to repeal rules identified during the comprehensive rule review required by Executive Order 11-01 as duplicative, unnecessarily burdensome, or no longer necessary.

DEPARTMENT OF HEALTH
Office of Statewide Research

RULE NO.: RULE TITLE:
64H-2.001: Institutional Review Board
PURPOSE AND EFFECT: The purpose and effect of the proposed rule is to repeal rules identified during the comprehensive rule review required by Executive Order 11-01 as duplicative, unnecessarily burdensome, or no longer necessary.
SUMMARY: Rule 64H-2.001, F.A.C., was identified during the comprehensive rule review as containing requirements that are unnecessary based on statutory language, and thus appropriate for repeal. There are no other rules incorporating this rule.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The department does not anticipate the need for ratification as the repeal of this rule will not have the adverse impact or regulatory costs established in Section 120.541(2)(a), F.S.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 381.86 FS.
LAW IMPLEMENTED: 381.86 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Meghan Kennedy, Institutional Review Board Administrator, 4052 Bald Cypress Way, Bin #A-24, Tallahassee, Florida 32399-1708, Telephone: [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

64H-2.001 Institutional Review Board.

Rulemaking Specific Authority 381.86 FS. Law Implemented 381.86(1) FS. History–New 1-24-06, Repealed_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Meghan Kennedy, Institutional Review Board Administrator
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P., State Surgeon General
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 13, 2011