To update the concentration percentage of a topical ocular pharmaceutical agent.

Notice of Proposed Rule

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NO.:RULE TITLE:

64B13-18.002Formulary of Topical Ocular Pharmaceutical Agents

PURPOSE AND EFFECT: To update the concentration percentage of a topical ocular pharmaceutical agent.

SUMMARY: Update the concentration percentage of a topical ocular pharmaceutical agent.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST 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: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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: 463.005, 463.0055(2)(a) FS.

LAW IMPLEMENTED: 463.0055 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE ANNOUNCED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joseph Lesho, Program Operations Administrator, Board of Optometry, 4052 Bald Cypress Way, Bin #C07, Tallahassee, Florida 32399-3257, [phone]

 

THE TEXT OF THE PROPOSED RULE IS:

 

64B13-18.002 Formulary of Topical Ocular Pharmaceutical Agents.

Introductory paragraph: No change.

(1) through (6)(b) No change.

(c) Olopatadine HCl – 0.7 0.2%;

(d) through (9)(f) No change.

Rulemaking Authority 463.005, 463.0055(2)(a) FS. Law Implemented 463.0055 FS. History–New 3-30-87, Amended 4-5-88, 5-7-90, Formerly 21-18.002, Amended 5-10-92, 1-29-93, Formerly 21Q-18.002, Amended 8-31-93, 7-30-94, Formerly 61F8-18.002, Amended 2-11-96, 4-21-96, 1-12-97, 6-8-97, Formerly 59V-18.002, Amended 6-15-00, 6-7-05, 6-10-06, 6-26-08, 10-16-08, 3-23-09, 6-28-09, 10-18-09, 4-21-10, 12-26-10, 7-21-11, 11-11-12, 11-29-13, 12-9-13, 4-10-14,          .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Optometry

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Optometry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 27, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 25, 2015