Section 216-RICR-40-20-7.6 - Specific Licenses7.6.1Application for Specific LicensesA. Applications for specific licenses shall be filed in duplicate on a form prescribed by the Agency, and shall include a designated e-mail address for receipt of official Agency correspondence in electronic format.B. The Agency may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Agency to determine whether the application should be granted or denied or whether a license should be modified or revoked.C. Each application shall be signed by the applicant or licensee or a person duly authorized to act on their behalf.D. An application for a license may include a request for a license authorizing one (1) or more activities.E. In the application, the applicant shall submit the required information to the Agency without reference to previously submitted documents unless permission has been obtained from the Agency, in advance, to incorporate by reference information contained in previous applications, statements, or reports filed with the Agency. All references shall be clear and specific and shall contain all of the information needed for a particular item on the application.F. Applications and documents submitted to the Agency may be made available for public inspection except that the Agency may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.G. Specific License to Use Radioactive Material in the Form of a Sealed Source or in a Device That Contains the Sealed Source. For the purposes of this Part, requirements for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source are defined by 10 C.F.R. § 30.32(g).H. Consideration of the Need for an Emergency Plan for Responding to a Release of Radioactive Materials. For the purpose of this Part, requirements for consideration of the need for an emergency plan for responding to a release of radioactive materials are defined by 10 C.F.R. § 30.32(i).I. Production of PET Radioactive Drugs for Noncommercial Transfer. An application from a medical facility or educational institution to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part 9 of this Subchapter shall include: 1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Part, or equivalent Regulations of the U.S. Nuclear Regulatory Commission or another Agreement State, for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.2. Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one (1) of the criteria in §7.6.16(B) of this Part.3. Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an Authorized Nuclear Pharmacist as specified in 10 C.F.R. § 32.72(b)(2) and §7.6.16(C) of this Part.4. Information identified in 10 C.F.R. § 32.72(a)(3) on the PET drugs to be noncommercially transferred to members of its consortium.7.6.2General Requirements for Issuance of Specific LicensesA. For the purposes of this Part, general requirements for issuance of specific licenses are defined by 10 C.F.R. §§ 30.33, 40.32 and 70.31.B. Use of Radioactive Material at Property Not Owned by Applicant. In addition to the requirements set forth in §7.6.2(A) of this Part and/or Part 9 of this Subchapter, a specific license for use of radioactive material where the proposed location of use is not owned by the applicant will be issued under the following conditions: 1. Each initial application shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use. 2. Each amendment request for an additional location of use shall include a letter signed by the property owner (or authorized representative) that permits the use of licensed radioactive material at the proposed location of use.7.6.3Terms and Conditions of LicensesFor the purpose of this Part, terms and conditions of licenses are defined by 10 C.F.R. §§ 30.34 [excluding §§30.34(d), (e)(1), & (e)(3)], 40.41 [excluding §§40.41(d), (e)(1) and (3) and (g) ] and §70.32 [excluding §§70.32(a)(1), (4), (5), (6) and (7) and (b)(1), (3) and (4) and (c), (d), (e), (f), (g), (h), (i), (j) and (k) ].
7.6.4Financial Assurance and Recordkeeping for DecommissioningA. For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for a specific license authorizing the possession and use of unsealed radioactive material are defined by 10 C.F.R. § 30.35.B. For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for licenses authorizing the receipt, possession and use of source material are defined by 10 C.F.R. §§ 40.36(a), (b), (d) and (f).C. For the purpose of this Part, requirements for financial assurance and recordkeeping for decommissioning for licenses authorizing the receipt, possession and use of special nuclear material in quantities not sufficient to form a critical mass are defined by 10 C.F.R. §§ 70.25(a)(2), (b), (e) and (g).7.6.5Expiration and Termination of Licenses and Decommissioning of Sites andSeparate Buildings or Outdoor AreasFor the purpose of this Part, requirements for expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas are defined by 10 C.F.R. §§ 30.36, 40.42 and 70.38.
7.6.6Renewal of Specific LicensesA. Applications for renewal of specific licenses shall be filed in accordance with §7.6.1 of this Part.B. In any case in which a licensee, not less than thirty (30) days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the Agency.7.6.7Amendment of LicensesA. For the purpose of this Part, requirements for amendment of licenses are defined by 10 C.F.R. §§ 30.38, 40.44 and 70.34.B. A licensee shall notify the Agency by letter no later than thirty (30) days after: 1. An Authorized User or Radiation Safety Officer permanently discontinues performance of duties under the license or has a name change; or2. The licensee's mailing address changes; or3. The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in §7.6.3 of this Part; or4. The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used.7.6.8Agency Action on Applications to Renew or AmendIn considering an application to renew or amend a license, the Agency will apply the criteria set forth in §§ 7.5 or 7.6 of this Part as applicable.
7.6.9Transfer of Radioactive MaterialFor the purpose of this Part, requirements for transfer of radioactive material are defined by 10 C.F.R. §§ 30.41 [excluding §30.41(b)(6) ], 40.51 [excluding §40.51(b)(6) ] and 70.42 [excluding §70.42(b)(6) ].
7.6.10Requirements for a Specific License of Broad ScopeA. A person may file an application for specific license of broad scope in accordance with the provisions of §7.6.1 of this Part.B. For the purpose of this Part, requirements for the issuance of a Type A specific license of broad scope are defined by 10 C.F.R. § 32.13.C. For the purpose of this Part, requirements for the issuance of a Type B specific license of broad scope are defined by 10 C.F.R. § 32.14.D. For the purpose of this Part, requirements for the issuance of a Type C specific license of broad scope are defined by 10 C.F.R. § 32.15.E. An application filed pursuant to this Part for a specific license other than one of broad scope will be considered by the Agency as an application for a specific license of broad scope under this Part if the requirements of the applicable sections of this Part are satisfied.7.6.11Requirements for License to Manufacture or Initially Transfer Devices to Persons Generally Licensed Under §7.7.1 A. For the purpose of this Part, requirements for a license to manufacture or initially transfer devices to persons generally licensed under §7.7.1 of this Part are defined by 10 C.F.R. § 32.51.B. For the purpose of this Part, license conditions for a person licensed under §7.6.11(A) of this Part are defined by 10 C.F.R. § 32.51(a).C. For the purpose of this Part, requirements for material transfer reports and records for a person licensed under §7.6.11(A) of this Part are defined by 10 C.F.R. § 32.52.7.6.12Requirements for License to Manufacture, Assemble, Repair or Initially Transfer Luminous Safety Devices for Use in AircraftA. For the purpose of this Part, requirements for a license to manufacture, assemble, repair or initially transfer luminous safety devices for use in aircraft are defined by 10 C.F.R. § 32.53.B. For the purpose of this Part, requirements for labeling of devices licensed under §7.6.12(A) of this Part are defined by 10 C.F.R. § 32.54.C. For the purpose of this Part, requirements for quality assurance and prohibition of transfer of devices licensed under §7.6.12(A) of this Part are defined by 10 C.F.R. § 32.55.D. For the purpose of this Part, requirements for material transfer reports for persons licensed under §7.6.12(A) of this Part are defined by 10 C.F.R. § 32.56.7.6.13Requirements for License to Manufacture or Initially Transfer Calibration or Reference Sources Containing Americium-241, Plutonium or Radium-226A. For the purpose of this Part, requirements for a license to manufacture or initially transfer calibration or reference sources containing Americium-241 or Radium-226 are defined by 10 C.F.R. § 32.57.B. For the purpose of this Part, requirements for labeling of devices licensed under §7.6.13(A) of this Part are defined by 10 C.F.R. § 32.58.C. For the purpose of this Part, requirements for leak testing of each source licensed under §7.6.13(A) of this Part are defined by 10 C.F.R. § 32.59.D. For the purpose of this Part, requirements for a license to manufacture or initially transfer calibration or reference sources containing plutonium are defined by 10 C.F.R. § 70.39.7.6.14Requirements for License to Manufacture or Initially Transfer Ice Detection Devices Containing Strontium-90A. For the purpose of this Part, requirements for a license to manufacture or initially transfer ice detection devices containing Strontium-90 are defined by 10 C.F.R. § 32.61.B. For the purpose of this Part, requirements for quality assurance and prohibition of transfer of devices licensed under §7.6.14(A) of this Part are defined by 10 C.F.R. § 32.62.7.6.15Requirements for License to Manufacture and Distribute Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General LicenseFor the purpose of this Part, requirements for a license to manufacture and distribute radioactive material for certain in vitro clinical or laboratory testing under general license are defined by 10 C.F.R. § 32.71.
7.6.16Requirements for License to Manufacture, Prepare, or Transfer for Commercial Distribution of Radioactive Drugs Containing Radioactive Material for Medical Use Under Part 9A. For the purpose of this Part, requirements for a license to manufacture, prepare, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use under Part 9 of this Subchapter are defined by 10 C.F.R. § 32.72.B. In addition to the requirements in §7.6.16(A) of this Part, the applicant shall submit evidence that the applicant is at least one (1) of the following: 1. Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. § 207.20(a);2. Licensed as a drug manufacturer and/or pharmacy in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors; or3. Licensed as a positron emission tomography (PET) drug production facility pursuant to this Part.C. In addition to the provisions of 10 C.F.R. § 32.72(b)(4), an individual may function as an authorized nuclear pharmacist only if they are licensed as a pharmacist in accordance with Subchapter 15 Part 1 of this Chapter, Pharmacists, Pharmacies and Manufacturers, Wholesalers and Distributors.7.6.17Requirements for License to Manufacture and Distribute Sources or Devices Containing Radioactive Material for Medical UseFor the purpose of this Part, requirements for a license to manufacture and distribute sources or devices containing radioactive material for medical use are defined by 10 C.F.R. § 32.74.
7.6.18Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume ApplicationsA. For the purpose of this Part, requirements for a license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications are defined by 10 C.F.R. § 40.34.B. For the purpose of this Part, conditions of specific licenses issued pursuant to §7.6.18(A) of this Part are defined by 10 C.F.R. § 40.35.7.6.19Requirements for License to Initially Transfer Source Material for Use Under The 'Small Quantities of Source Material' General LicenseA. For the purpose of this Part, requirements for a license to initially transfer source material for use under the "small quantities of source material" general license are defined by 10 C.F.R. § 40.54.B. For the purpose of this Part, requirements for quality control, labeling, safety instructions, and records and reports for licenses issued pursuant to §7.6.19(A) of this Part are defined by 10 C.F.R. § 40.55.216 R.I. Code R. § 216-RICR-40-20-7.6
Adopted effective 1/1/2019
Amended effective 5/25/2022