This rulemaking provides a process and application for those qualified individuals or entities under section 381.986(8)(a)2.b., Florida Statutes and those who wish to apply pursuant to section 381.986(8)(a)4., Florida Statutes, to apply for ...

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64-4.026Application for Registration of Pigford Class and Additional Medical Marijuana Treatment Centers

PURPOSE AND EFFECT: This rulemaking provides a process and application for those qualified individuals or entities under section 381.986(8)(a)2.b., Florida Statutes and those who wish to apply pursuant to section 381.986(8)(a)4., Florida Statutes, to apply for registration as a medical marijuana treatment center.

SUMMARY: Rule 64-4.026, F.A.C., provides the application requirements, forms, and process necessary to apply for registration as a medical marijuana treatment center under sections 381.986(a)2.b. and 381.986(8)(a)4.

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: As detailed in the SERC, the rulemaking will have an adverse impact or regulatory costs in excess of $1 million within five years as established in s. 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: 381.986(8)(b) FS

LAW IMPLEMENTED: 381.986(8)(a)2.b., 381.986(8)(a)4. FS

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: August 17, 2018, 9:00 a.m. – 11:00 a.m., or until the conclusion of the hearing, whichever occurs first.

PLACE: The Florida Department of Health, 4025 Bald Cypress Way, Room 301, Tallahassee, FL 32399

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 4 days before the workshop/meeting by contacting: Courtney Coppola at [e-mail].. 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 IS: Courtney Coppola at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64-4.026 Application for Registration of Pigford Class and Additional Medical Marijuana Treatment Centers.

Pursuant to section 381.986, F.S., all applicants seeking registration as a medical marijuana treatment center pursuant to sections 381.986(8)(a)2.b. and 381.986(8)(a)4., F.S., shall comply with the process detailed below.

(1) Each individual or entity that meets the requirements of section 381.986(8)(b), F.S., desiring to be registered as a medical marijuana treatment center pursuant to section 381.986 (8)(a)4. or 381.986(8)(a)2.b., F.S., shall submit an application to the department using Form DH8013-OMMU-04/2018, “Application for Medical Marijuana Treatment Center Registration,” incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. The application must comply with the page limits, blind grading, format, and organization instructions detailed in the application. The applicant must include with the application at the time of submission the following:

(a) A non-refundable application fee of $60,830.00.

(b) Written documentation from the Department of State or the Department of Revenue, as applicable under Florida law, demonstrating that the applicant has been registered to do business in Florida for the prior five (5) consecutive years. The name of the applicant as submitted to the department must match the name on any documents provided in accordance with this paragraph.

(c) Written documentation that the applicant possesses a valid certificate of registration issued by the Department of Agriculture and Consumer Services pursuant to section 581.131, F.S. The name of the applicant as submitted to the department must match the name on any documents provided in accordance with this paragraph.

(d) A list of all owners, officers, board members, and managers indicating the date of each individual’s most recent Level-2 background screening pursuant to section 381.986(9), F,S, within the calendar year prior to application. Each owner, officer, board member, and manager shall go to the Florida Department of Law Enforcement (FDLE) or one of its approved vendors for fingerprinting and, at such time, shall give to FDLE or the FDLE-approved vendor the entity ORI number FL924890Z (DOH – OFFICE OF MEDICAL MARIJUANA USE). The report will be sent directly to the Office of Medical Marijuana Use. The provision of this list is required as part of a complete application prior to review and scoring by the subject matter experts. The list does not indicate passage of any background screening and to be eligible for registration as a medical marijuana treatment center, all of the applicant’s owners, officers, board members, and managers must have successfully passed a Level-2 background screening.

(e) For applicants seeking registration as a medical marijuana treatment center pursuant to section 381.986(8)(a)2.b., F.S. (“Pigford Class applicant”), the applicant must provide evidence that it is an individual or an entity that is majority-owned by individual(s) who is a recognized class member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999) (“Pigford”) or In re Black Farmers Discrimination Litigation, 856 F. Supp. 2d 1 (D.D.C. 2011) (“BFDL”).

1. Examples of acceptable evidence include:

a. Documentation from Poorman-Douglass Corporation (now Epiq Systems Inc.) that the applicant received a consent decree case number in Pigford;

b. Documentation that the applicant was granted class status by the Pigford adjudicator;

c. Court documents or United States Department of Agriculture (USDA) documents showing that the applicant received judgment discharging debt, providing a cash payment, or providing injunctive relief in Pigford;

d. Documentation that the applicant was determined to be a class member by Epiq Systems Inc. in BFDL;

e. Documentation that the applicant received a settlement award in BFDL; or

f. Other court documents or USDA documents demonstrating that the applicant was granted class member status in either Pigford or BFDL.

2. Applicants seeking registration as a medical marijuana treatment center pursuant to section 381.986(8)(a)2.b., F.S., are exempt from the evidentiary requirements of paragraph (1)(c) above and, therefore, are also exempt from the provisions of paragraph (4)(c) below. However, if an applicant wishes to be considered under section 381.986(8)(a)4., F.S., the applicant must provide the documentation required in paragraph (1)(c).

(2) If the applicant intends to claim any exemption from public records disclosure under section 119.07, F.S., or any other exemption from public records disclosure provided by law for any part of its application, it shall indicate on the application the specific sections for which it claims an exemption and the statutory basis for the exemption. The applicant shall submit a redacted copy of the application redacting those items identified as exempt concurrent with the submission of the application under subsection (5) below. Failure to provide a redacted copy of the application at the time of submission or failure to identify and redact information claimed as trade secret will result in the release of all application information in response to a public records request, unless the information falls under another public records exemption. All identified trade secrets are subject to the department review in accordance with section 381.83, F.S.

(3) The department will conduct a preliminary review of the application in accordance with section 120.60, F.S., limited to the items in paragraphs (1)(a)-(1)(f) above within 15 days. An applicant will have five (5) business days following receipt of notice from the department to respond to correct or complete its application. Applications provided to subject matter experts for review and scoring will be considered complete. An applicant may not add, remove, or change information in its application once it is complete and has been provided to the subject matter experts for review.

(4) Failure to provide the following, after the notice and cure period set forth in subsection (3) above, shall result in the application being denied prior to any scoring as contemplated in subsection (6) of this rule:

(a) The $60,830.00 application fee;

(b) Documentation required under paragraph (1)(b);

(c) Documentation required under paragraph (1)(c); or

(d) The list of owners, officers, board members, and managers required under paragraph (1)(d).

(5) Applications and all required exhibits and supporting documents shall be hand delivered to the Department of Health, ATTN: Office of Medical Marijuana Use, at 4052 Bald Cypress Way, Tallahassee, Florida, during normal business hours, but no earlier than 10:00 a.m. (Eastern Time), 21 days after the effective date of this rule and no later than 5:00 p.m. (Eastern Time) 42 days after the effective date of this rule. Applications submitted after 5:00 p.m. Eastern Time on the final day of the application period will be denied.

(6) Subject matter experts will substantively and comparatively review, evaluate, and score applications using Form DH8014-OMMU-04/2018, “Scorecard for Medical Marijuana Treatment Center Selection,” incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

(a) The subject matter experts shall have the following qualifications:

1. Subject matter experts reviewing Sections 1-3 of the application, the cultivation components, shall have at least two (2) years of professional experience or advanced degree in one of the following areas: agriculture, horticulture, or agronomy, or comparable field.

2. Subject matter experts reviewing Sections 4-5 of the application, the processing components, shall have at least two (2) years of professional experience or advanced degree in chemistry, biology, or biochemistry.

3. Subject matter experts reviewing Sections 6-8 of the application, the dispensing components, shall have at least two (2) years of professional experience or advanced degree in industrial engineering, supply chain management, or strategic management.

4. Subject matter experts reviewing Sections 9, 10, 12, and 16 of the application, the compliance components, shall have at least two (2) years of professional experience or advanced degree related to operating a business in a highly regulated environment.

5. Subject matter experts reviewing Section 13 of the application shall have at least two (2) years of management experience within a business operating in a regulated industry or at least two (2) years of experience working in human resources.

6. Subject matter experts reviewing Section 11 of the application shall have at least two (2) years of management experience within a business operating in the health care industry or an active, unrestricted license as a medical doctor or doctor of osteopathic medicine.

7. Subject matter experts reviewing Sections 14-15 of the application, the legal and financial components, shall have an active CPA license or an active license to practice law and experience in business structuring.

8. Subject matter experts will certify that they do not have a conflict of interest and will evaluate and score each assigned section of the application according to the rubric set forth in DH8014-OMMU-04/2018.

(b) Scores for each section of the application will be combined to create an applicant’s total score. The department shall generate a final ranking of the applicants in order of highest to lowest scores. Any application which demonstrates a failure to pass background screening as required by section 381.986(8)(b)8., F.S., and to comply with the minimum statutory requirements for cultivation, processing, dispensing, security, or general operations, as identified in DH8014-OMMU-04/2018, shall be denied and will not be considered in the final ranking of applications.

(7) Registration pursuant to section 381.986(8)(a)2.b., F.S. will be awarded to the highest scoring applicant that is a recognized member of Pigford or BFDL.

(8) Registrations pursuant to section 381.986(8)(a)4., F.S., will be awarded to the highest scoring applicants, after the award of the registration set forth in subsection (7) above, as applicable. Eligibility for additional registrations pursuant to section 381.986(8)(a)4, F.S., shall be determined pursuant to the number of active qualified patients in the medical marijuana use registry as of the date the department announces the award of registrations.

(9) In the event of a tie that will determine the awarding of a registration, the following tiebreakers will be applied:

(a) The first tiebreaker shall be the score for Section 14 – Financials: Certified Financial Documents. The applicant with the highest score in Section 14 shall be awarded a registration. In the event that this does not resolve the tie, then

(b) The second tiebreaker shall be the score for Section 15 – Financials: Business Structure. The applicant with the highest score in Section 15 shall be awarded a registration. In the event that this does not resolve the tie, then

(c) The third tiebreaker shall be the score for Section 13 – Diversity Plan. The applicant with the highest score in Section 13 shall be awarded a registration. In the event that this does not resolve the tie, then

(d) The final tiebreaker shall be the score for Section 10 – Accountability: Operations.

(10) Following the registrations awarded under the application cycle set out in subsection (5), subsequent determination by the department that sufficient active qualified patients have been registered in the medical marijuana use registry to provide for additional registrations pursuant to section 381.986(8)(a)4., F.S. will activate a new application cycle.

(a) The department will publish in the Florida Administrative Register and on its website the date upon which the department will begin accepting applications and the deadline to receive all applications.

(b) Applications and all required exhibits and supporting documents shall be hand delivered to the Department of Health at 4052 Bald Cypress Way in Tallahassee, Florida, during normal business hours, but no earlier than 10:00 a.m. (Eastern Time), on the date the department begins accepting applications and no later than 5:00 p.m. (Eastern Time) on the last date upon which the applications are accepted.

(c) Registrations pursuant to this subsection will be awarded to the highest scoring applicants.

(11) Upon notification that it has been awarded registration as a medical marijuana treatment center, the applicant shall have 10 business days to:

(a) Post a performance bond, provide an irrevocable letter of credit payable to the department or provide cash to the department in the amount of $5 million (collectively “financial assurance”) pursuant to section 381.986(8)(b)7., F.S. If a bond is provided, the bond shall:

1. Be payable to the department in the event the medical marijuana treatment center’s registration is revoked;

2. Be written by an authorized surety company rated in one of the three (3) highest rating categories by a nationally recognized rating service; and

3. Be written so that the individual or entity name on the bond corresponds exactly with the applicant name.

4. The surety company can use any form it prefers for the performance bond as long as it complies with this rule. For convenience, the surety company may use Form DH8015-OMMU-04/2018, “Florida Medical Marijuana Performance Bond,” incorporated by reference herein and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX.

(b) Provide documentation supporting representations related to property ownership and/or leases made in the application.

(12) If a financial assurance is canceled or revoked in any manner and the medical marijuana treatment center fails to provide new financial assurance to the department in the required amount on or before the effective date of cancellation or revocation or the applicant fails to provide property ownership and/or use documents within the required timeframes, the medical marijuana treatment center’s registration shall be revoked.

(13) If a selected applicant fails to post the financial assurance or supporting property ownership and/or use documents within the required timeframe resulting in the revocation of its registration, the applicant with the next highest score shall be awarded a registration.

Rulemaking Authority 381.986(8)(b), FS. Law Implemented 381.986(8)(a)2.b., 381.986(8)(a)4.,FS. History–New   .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Courtney Coppola

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 8, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 16, 2018