Guide for the preparation of applications for medical use programs



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STATE OF FLORIDA


DEPARTMENT OF HEALTH
BUREAU OF RADIATION CONTROL

REGULATORY GUIDE





Regulatory Guide 1.30
Revision 5

Issuance Date: 2014


GUIDE FOR THE PREPARATION

OF APPLICATIONS FOR

MEDICAL USE PROGRAMS



TABLE OF CONTENTS

Page

ENCLOSURE A – FEES 3

I. INTRODUCTION

PURPOSE OF GUIDE 5

TYPES OF LICENSES 5

1. GENERAL LICENSE 5

2. SPECIFIC LICENSE 5

3. SPECIFIC LICENSE OF BROAD SCOPE 6

APPENDICES, EXHIBITS, AND SUPPLEMENTS 6

APPLICABLE REGULATIONS 7

LICENSE REQUIREMENTS AND RESTRICTIONS 7

II. FILING AN APPLICATION 9

LICENSE FEES 10

III. CONTENTS OF AN APPLICATION 11

ITEM 1.a. NAME AND MAILING ADDRESS OF APPLICANT 11

ITEM 1.b. STREET ADDRESS WHERE RADIOACTIVE MATERIAL WILL BE USED 11

ITEM 2.a.&b. LICENSE CATEGORY AND FEE 11

ITEM 3. THIS IS AN APPLICATION FOR 11

ITEM 4. INDIVIDUAL USERS (AUTHORIZED USERS) 11

ITEM 5.a. RADIATION SAFETY OFFICER (RSO) 12

ITEM 5.b. ALTERNATE EMERGENCY CONTACT 12

ITEM 6.a. RADIOACTIVE MATERIAL FOR MEDICAL USE 12

ITEM 6.b. RADIOACTIVE MATERIAL FOR USES NOT LISTED IN 6.a. 13

ITEM 7. FACILITIES AND EQUIPMENT 13

ITEMS 8.THROUGH 34. MODEL PROCEDURES 13

ITEM 35. CERTIFICATE 13

IV. LICENSE AMENDMENTS 14

V. LICENSE RENEWAL 14

VI. LICENSE TERMINATION 14

EXHIBITS 1 AND 2 – FACILITY DIAGRAMS 15

REQUIRED APPENDICES 17

DELEGATION OF AUTHORITY TO MAKE LEGALLY BINDING STATEMENTS 18

APPENDICES A THROUGH Z 19-94

MEDICAL APPLICATION



Enclosure A

Fees*

The categories are:



Category



Description




Application Fee



Annual Fee



Reclamation Fee


Annual and Reclamation Fee

5A(I)

Teletherapy or gamma stereotactic radiosurgery including gamma knife devices

$1,838

$1,791

$89.55

$1,880.55

5A(II)

High dose rate remote afterloading devices

$1,697

$1,654

$82.70

$1,736.70

5A(III)

High dose rate remote afterloading devices and gamma stereotactic radiosurgery including gamma knife devices or teletherapy devices

$1,838

$1,791

$89.55

$1,880.55

5B

Medical Institutions, including hospitals, except categories
5A(I), 5A(II), 5A(III), 5E, 5F(I), and 5F(II)

$1,972

$2,290

$114.50

$2,404.50

5C

Private practice physicians except categories 5A(I), 5A(II), 5A(III), 5E, 5F(I), and 5F(II)

$1,421

$1,608

$80.40

$1,688.40

5D

Private practice physicians using only strontium 90 eye applications, materials authorized by
64E-5.631, F.A.C., and materials authorized by 64E-5.630, F.A.C.

$726

$898

$44.90

$942.90

5E

Nuclear powered pacemakers

$521

$319

$15.95

$334.95

5F(I)

Mobile Nuclear Medicine Services

$1,697

$1,950

$97.50

$2047.50

5F(II)

Mobile high dose rate remote afterloading therapy device when the treatment is only performed on the mobile vehicle

$2,970

$3,308

$165.40

$3473.40

*Fees are subject to change and may be found in section, 64E-5.204 F.A.C.

Effective August, 2007


Page Left Blank lntentionally



I. INTRODUCTION

The Department of Health (department), Bureau of Radiation Control, regulates the use of radioactive material administered to human beings. Medical use of radioactive materials requires a specific license. The regulations governing medical use are contained in Chapter 64E-5, Florida Administrative Code (F.A.C.), Part VI, “Use of Radionuclides in the Healing Arts.”

The department issues a single radioactive material license to cover an entire radionuclides program except for teletherapy, high dose rate remote afterloaders, gammaknifes, nuclear-powered pacemakers, and irradiators. A license is issued to one facility, though the license may cover different departments within the hospital or different individuals employed or contracted with the hospital.

PURPOSE OF GUIDE

This guide is designed to describe the type and extent of information needed by the department to evaluate an application for a medical use license. This regulatory guide identifies the information needed to complete Department of Health, Form DH-1322 when applying for a license for a medical use program. This guide does not apply to generally licensed material or academic programs that do not use radioactive material for medical use.



TYPES OF LICENSES

The department issues three types of licenses for the use of radioactive material in the practice of medicine, as described below. This guide is only for persons who want to apply for a specific medical use license. However, persons who are applying for other types of licenses may find the information in this guide useful in designing their radiation safety program.

1. General License

Subsection 64E-5.206(8), F.A.C., “General Licenses for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing” establishes a general license authorizing physicians, veterinarians, clinical laboratories, and hospitals to receive, acquire, possess, or use certain small quantities of radioactive material for in-vitro clinical or laboratory tests. This section explains the requirements for using these materials. If the general license alone meets the applicant’s needs, only Department of Health, Form DH-360, “ Certificate - In Vitro Testing With Radioactive Material Under General License,“ needs to be filed. Specific licensees do not need to file this form.

2. Specific License

Specific licenses issued to medical institutions authorize radioactive material for medical uses by physicians named on the license. The regulations require a medical institution licensee to have a radiation safety committee (RSC) to oversee the use of licensed material throughout the facility and to review the radiation safety program. The physicians named on the institution’s license conduct their use of radioactive materials with the approval of the RSC. Specific licenses issued to outpatient facilities or individual physicians in private practice are commonly limited to physicians who are located in private offices. A radiation safety committee may be required. Methods of use that require hospitalization of the patient are not permitted for outpatient facilities or private offices.

3. Specific License of Broad Scope

Some medical institutions provide patient care and conduct research programs that use radionuclides for in-vitro, animal, and medical procedures. The department may issue a specific license of broad scope as discussed in section 64E-5.209, F.A.C., “Specific Requirements for a Specific License of Broad Scope.” Specific licenses of broad scope for medical use may be issued to institutions that (1) have had previous experience operating under a specific institutional license of limited scope, and (2) are engaged in medical research as well as routine diagnosis and therapy using radionuclides. This type of license is not appropriate for most institutions performing routine procedures with radioactive materials.



Appendices, Exhibits and Supplements

Applicants must acquire and maintain appropriate facilities and equipment, have appropriately trained workers, and implement procedures that ensure compliance with regulatory requirements. This guide provides a set of appendices, exhibits and supplements to assist in the development of a radiation protection program.



  • Appendices are model procedures that may be used to address regulatory requirements.

  • Exhibits are samples of the types of documents or forms that must be submitted as part of the application, and in some cases, are model forms that may be used to satisfy regulatory requirements.

  • Supplements include resources for preparing the application and additional resources and reference material.

Model procedures and forms may be adopted by submitting them as part of the license application, or may be used as guides for developing equivalent procedures and forms. Carefully review the regulations, model procedures and forms before deciding if the models are appropriate for the activities being requested.

IMPORTANT NOTICE:
The information provided in a license application must demonstrate that proposed equipment, facilities, personnel and procedures are adequate to protect public health and property in accordance with regulatory requirements. Submission of incomplete or inadequate information will result in delays in the license approval process. Additional information will be requested when necessary to ensure that an adequate radiation protection program has been established. Such requests will delay completion of the application review, and may be minimized by a thorough study of the regulations and this guide prior to submitting the application.

While adoption of the attached model procedures and forms should provide for a radiation protection program that complies with regulatory requirements, applicants may need to consider additional equipment, procedures and training that may be appropriate for the scope of their operations.



APPLICABLE REGULATIONS

Florida is an Agreement State; it has an agreement with the U.S. Nuclear Regulatory Commission (NRC) to assume regulatory authority over most activities involving radioactive material within the state. With certain exceptions, the Department of Health (department), Bureau of Radiation Control (bureau) regulates the possession and use of radioactive material within Florida. Exceptions include nuclear power plants and federal agencies, and national security issues involving radioactive material, which remain under NRC jurisdiction.

Under authority of Chapter 404, Florida Statutes (the Florida Radiation Protection Act), the bureau issues licenses to users of radioactive material and performs inspections to ensure safe operations and compliance with Chapter 64E-5, Florida Administrative Code (F.A.C.), the department’s radiation control regulations. Chapter 64E-5, F.A.C., is available on the Internet at http://www.floridahealth.gov/prevention-safety-and-wellness/radiation-control/radmat/index.html. The bureau amends these regulations periodically. Licensees are notified of changes as they occur. When applicable, licensees will need to revise their safety programs to address changes in regulatory requirements.

The following portions of the regulations are applicable to the use of radioactive material in the form of sealed sources in portable devices and should be used in conjunction with these instructions:



Part I “General Provisions”

Part II “Licensing of Radioactive Materials”

Part III “Standards for Protection Against Radiation”

Part IX “Notices, Instructions and Reports to Workers; Inspections”

Part XIII “Radiation Safety Requirements for Possession and Use of Sealed or Unsealed Sources of Radioactive Materials”

Part XV “Transportation of Radioactive Materials”

Licensees engaging in transportation of radioactive materials or related activities are also subject to U.S. Department of Transportation (DOT) regulations, which are found in Title 49, Code of Federal Regulations (49 CFR), and are incorporated into Chapter 64E-5 by reference. DOT regulations are available on the Internet at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 and can be ordered from the U.S. Government Printing Office by calling (866) 512-1800 or writing P.O. Box 37954, Pittsburg, PA 15250-7954, Attn: Superintendent of Documents.



LICENSE REQUIREMENTS AND RESTRICTIONS

Licensees are required to confine use and possession of radioactive material to the locations and purposes authorized by the license. The license is divided into two sections: Items and Conditions, which are described on the following page. The first section of the license lists Items 1 - 9. The remainder of the document lists the license conditions, which may vary in number based on the authorizations provided by the license, but always begin with Condition 10.



License Items

Item No. and Title

Description

1. Name

Lists the legal name of the licensee (individual or business). If the license is issued to a business, Item 1 must list the company’s name as it is registered with the Florida Department of State, Division of Corporations; 850-245-6052 or http://www.sunbiz.org. If a business operates under another name, Item 1 must list both the registered name and the fictitious name it is doing business as (d/b/a).

2. Address

Lists the mailing address, which may be different from the physical address where records and material are used and stored. If the two addresses are different, the physical address must be listed in Condition 10; if they are the same, Condition 10 will reference the address listed in Item 2.

3. License Number

Lists the number assigned to the license by the bureau. The number should be referenced in all license-related correspondence.

4. Expiration Date

Lists the date the license is due to expire. A radioactive materials license is valid for 5 years from the date issued. A renewal application must be received by the bureau at least 30 days prior to the expiration date to ensure that the license remains valid. The bureau sends out reminder notices as the license nears its expiration date.

5. Category

Lists the license category: e.g. 5A (II), 5B, 5C. Activities involving possession and use of radioactive materials are divided into license categories. Organizations seeking to conduct more than one category of licensed activity must obtain separate licenses for each category of use. Refer to section 64E-5.204, F.A.C., or Regulatory Guide 6.20, Revision 5, for a complete listing of license types and fees at http://www.floridahealth.gov/prevention-safety-and-wellness/radiation-control/radmat/matform.html.

6. Radioactive
Material


Describes the type (element and mass number) of radioactive material the license authorizes for possession and use.

7. Form

Describes the form of radioactive material the license authorizes for possession and use.

8. Possession Limit

Lists the maximum possession limit for radioactive sources. In order to accommodate future business growth, a licensee may request authorization for a possession limit higher than the number of sources initially being obtained. Possession of more sources than authorized is a license violation and may result in enforcement actions.

9. Use

Describes the types of uses that are approved for the sources and devices listed in the previous items. Improper use of radioactive material is a license violation and may result in enforcement actions.

License conditions describe requirements and limitations applicable to the radioactive materials authorized by the license. Additional requirements and conditions may be incorporated as appropriate to protect public health and the environment. If a licensee seeks added authorizations, supplementary license conditions may be added.

II. FILING AN APPLICATION

Chapter 64E-5, F.A.C., this guide, forms, and other guidance documents are available on the bureau’s website: http://www.floridahealth.gov/prevention-safety-and-wellness/radiation-control/index.html.

Applicants for a materials license must complete Items 1 through 35 of the department’s form DH-1322, “Application for a Radioactive Materials License, Human Use.” Use supplemental sheets as necessary. For Items 7 through 34, be sure to check the appropriate box for each item. Each separate sheet or document submitted with the application should be identified and keyed to the item number on the application to which it refers. All typed pages, sketches, and if possible, drawings should be on 8.5 x 11 inch paper to facilitate handling and review.

All application items must be addressed in sufficient detail to demonstrate that equipment, facilities, personnel qualifications and procedures are adequate to protect public health and safety or property. Complete and submit the table provided as Supplement B to this guide to indicate whether model or equivalent procedures and forms have been included in the application.



Mail to:

If using an overnight delivery service, use:

Florida Department of Health
Bureau of Radiation Control
Radioactive Materials Program
4052 Bald Cypress Way, Bin C21
Tallahassee, FL 32399-1741

Florida Department of Health
Bureau of Radiation Control
Radioactive Materials Program
4042 Bald Cypress Way, Rm. 220.09
Tallahassee, FL 32399

With the exception of security-related information, all license applications and documents submitted to the bureau are available for review by the general public. Do not submit proprietary information unless it is absolutely necessary for evaluation of the application. Any request for withholding documents is subject to a determination by the department as to whether the document may actually be withheld in accordance with applicable laws and regulations.

Personal information about employees should not be submitted unless it is necessary. Home addresses, home telephone numbers, dates of birth, and social security numbers should not be submitted unless the bureau specifically requests it.

When issued, the license will require that radioactive material be possessed and used in accordance with statements, representations and procedures provided in the application and supporting documentation (which are incorporated by referenced into the license). Regulatory requirements specified in Chapter 64E-5, F.A.C., shall govern unless the statements, representations and procedures set forth in the license application and correspondence are more restrictive than the regulations.

LICENSE FEES

The following fees are assessed:



Application fee A non-refundable fee for processing the license application. The amount is dependent on the category of license the applicant is seeking; refer to section 64E-5.204, F.A.C., or Regulatory Guide 6.20 for a description of application fees. Review of the application will not begin until the proper fee is received by the department. An application fee is also required to process an application for a new license replacing an existing license due to a change of ownership.

Annual fee An annual fee covers department costs for administration of the materials licensing program. The amount is dependent on the license category. Refer to section 64E-5.204, F.A.C., or Regulatory Guide 6.20 for a description of annual fees. Annual fees are due within 60 days of issuance of the new license; an invoice for this fee is included with the cover letter accompanying a new license.

Reclamation fee In addition to the application and annual fees, a reclamation fee will be assessed for the Radiation Protection Trust Fund, established to pay department costs associated with a licensee’s abandonment of radioactive materials, default on lawful obligations, insolvency, or other inability to meet regulatory requirements, and to assure the protection of the public and environment. Reclamation fees are equal to 5% of the annual fee. Reclamation fees are due within 60 days of issuance of a new license; a fee invoice is included with the cover letter accompanying a new license.

Notes: 1. Annual and reclamation fees are assessed on the anniversary of the license issuance date. An invoice is sent to the licensee 60 days in advance of the due date.

2. Fees are not assessed for license renewals, amendment requests, licensing actions, inspections initiated by the department, license terminations, or requests for regulatory information (except for document copying costs).

III. CONTENTS OF AN APPLICATION

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