The Division proposes the rule amendment to set forth the biennial licensing fees for the restricted prescription drug blood establishment permit and medical device registrations.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:
61N-1.018Fees
PURPOSE AND EFFECT: The Division proposes the rule amendment to set forth the biennial licensing fees for the restricted prescription drug blood establishment permit and medical device registrations.
SUBJECT AREA TO BE ADDRESSED: Licensing and registration fees.
RULEMAKING AUTHORITY: 499.01, 499.04, 499.05 FS.
LAW IMPLEMENTED: 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: R. Kathleen Brown-Blake, 1940 North Monroe Street, Suite 42, Tallahassee, Florida 32399, [phone]

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

61N-1.018 Fees.

(1) though (2) No change.

(3) Biennial fees for OTHER permits are as follows:

		Biennial Fee
	Complimentary Drug Distributor	$500
	Veterinary Prescription Drug Retail Establishment	$600
	Medical Oxygen Retail Establishment Restricted Prescription Drug Distributor – Blood Establishment	$600 $600
	Restricted Prescription Drug Distributor – Health Care Entity	$600
	Restricted Prescription Drug Distributor – Charitable Organization	$600
	Restricted Prescription Drug Distributor – Reverse Distributor	$600
	Restricted Prescription Drug Distributor – Destruction	$600
	Restricted Prescription Drug Distributor – Government Programs	$600
	Restricted Prescription Drug Distributor – Institutional Research	$600
	Third Party Logistics Provider	$600
	Health Care Clinic Establishment	$255

(4) Miscellaneous OTHER fees are as follows:

(a) through (e) no change.

		Fee
	(f) Product Registration (for each drug, device or cosmetic product registered)	$30*
	* The registration fee for a prescription drug, device or cosmetic product being amended to an existing product registration that has 12 months or less until it expires is $15.
	(g) through (i) No change.

(5) No change.

Rulemaking Authority 499.01, 499.04, 499.05 FS. Law Implemented 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028 FS. History–New 7-1-96, Formerly 10D-45.0544, Amended 4-17-01, 7-6-03, 1-1-04, 9-13-04, 2-14-06, 9-5-07, 3-10-09, Formerly 64F-12.018, Amended_________.