ML19317E657

Nebraska Cross Reference 2018-1

ML19317E657
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Issue date:	11/05/2019
From:	Office of Nuclear Material Safety and Safeguards
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Beardsley M
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ML19317E418	List: ML19317E656 ML19317E657 ML19317E659 ML19317E661 ML19317E662 ML19317E663 ML19317E665 ML19317E666 ML19324D839
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Enclosure 2 Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments 10 CFR Parts 30, 32, and 35 (83 FR 33046, Published July 16, 2018)

RATS ID: 2018-1 Effective Date: January 14, 2019 Date Due for State Adoption: January 14, 2022 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 30.34(g)

Terms and conditions of licenses B

In § 30.34, add a third sentence to paragraph (g) to read as follows:

(g)

• The licensee shall report the results of any test that exceeds the permissible concentration listed in § 35.204(a) of this chapter at the time of generator elution, in accordance with

§ 35.3204 of this chapter.

180 NAC 3-014.10(E) 3-014.10(E)

ELUATE CONTAMINATION TESTING. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with according to 180 NAC 7-045. The licensee must record the results of each test and retain each record for 3 years after the record is made.

The licensee must report the results of any test that exceeds the permissible concentration listed in 180 NAC 7-045 at the time of generator elution, in accordance with 180 NAC 7-120.

§ 32.72:

(a)(4) revised; (b)(5)(i) revised; (d) new Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for B

In § 32.72:

(a)

Revise the introductory text of (a)(4);

(b)

Revise (b)(5)(i);

(c)

Redesignate paragraph (d) as paragraph (e); and (d)

Add new paragraph (d). to read as follows:

(a) 180 NAC 3-014.10(A),

(iv),

180 NAC 3-014.10(B),

(vi)(1) 014.10(G) -

NEW 3-014.10(A) * * * *

(iv) The applicant satisfies the following labeling requirements:

(iv)

Commit to the following labeling requirements:

3-014.10(B), (vi)(1)

Must provide to the Department a copy of each individuals: (1) Certification by a specialty

2 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska medical use under part 35.

(4) The applicant commits to the following labeling requirements:

(b)

(5)

(i) A copy of each individuals certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in § 35.55(a) of this chapter; or (d) A licensee shall satisfy the labeling requirements in paragraph (a)(4) of this section.

board whose certification process has been recognized by the Department, U.S. Nuclear Regulatory Commission (NRC),

or any Agreement State as specified in 7- 024.01 with the written attestation signed by a preceptor as required by 7-024.03; or 3-014.10(G) LABELING. A licensee must satisfy the labeling requirements in 180 NAC 3-014.10(A)(iv).

§ 35.2:

New definition s for Associat e

Radiatio n Safety Officer and Ophthal mic physicist; Definitions B: for Associ ate Radiati on Safety Officer and Ophtha lmic physici st; In § 35.2, add, in alphabetical order, the definitions for Associate Radiation Safety Officer and Ophthalmic physicist, and revise the definition for Preceptor to read as follows:

§ 35.2 Definitions.

Associate Radiation Safety Officer means an individual who (1) Meets the requirements in §§ 35.50 and 35.59; and (2) Is currently identified as an Associate Radiation Safety Officer 180 NAC 7-002 7-002.04 ASSOCIATE RADIATION SAFETY OFFICER. An associate radiation safety officer is an individual who:

(A) Meets the requirements in 180 NAC 7-022 and 7-027; and (B) Is currently identified as an associate radiation safety officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer on:

(i) A specific medical use license issued by the Department, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State; or

3 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Revised definition for Precepto r

D: for Precep tor for the types of use of byproduct material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on (i) A specific medical use license issued by the Commission or an Agreement State; or (ii) A medical use permit issued by a Commission master material licensee.

Ophthalmic physicist means an individual who (1)

Meets the requirements in § 35.433(a)(2) and § 35.59; and (2)

Is identified as an ophthalmic physicist on a (i)

Specific medical use license issued by the Commission or an Agreement State; (ii)

Permit issued by a Commission or Agreement State broad scope medical use licensee; (iii)

Medical use permit issued by a Commission master material licensee; or (iv)

Permit issued by a Commission master material licensee broad scope medical use permittee.

Preceptor means an individual who provides, directs, or verifies training (ii) A medical use permit issued by a Department or U.S. Nuclear Regulatory Commission (NRC) master material licensee.

7-002.23 OPHTHALMIC PHYSICIST. An ophthalmic physicist is an individual who:

(A) Meets the requirements in 180 NAC 7-060.05 and 180 NAC 7-027; and (B) Is identified as an ophthalmic physicist on a:

(i) Specific medical use license issued by the Department, the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State; (ii) Permit issued by a Department, the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State broad scope medical use licensee; (iii) Medical use permit issued by a Department or U.S. Nuclear Regulatory Commission (NRC) master material licensee; or (iv) Permit issued by a Department or U.S. Nuclear Regulatory Commission (NRC) master material licensee broad scope medical use permittee.

4 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate Radiation Safety Officer.

§ 35.12 Application for license, amendment, or renewal D

In § 35.12, revise paragraphs (b)(1), (c)(1), (c)(1)(ii) and (d) to read as follows:

§ 35.12 Application for license, amendment, or renewal.

(b)

(1) Filing an original NRC Form 313, Application for Material License, that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, Associate Radiation Safety Officer(s), authorized user(s),

authorized medical physicist(s),

physicist(s), and authorized nuclear pharmacist(s); and (c) *

(1) Submitting an original of either (i) *

(ii) A letter containing all information required by NRC Form 313; and 180 NAC 7-008 N/A

5 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (d) In addition to the requirements in paragraphs (b) and (c) of this section, an application for a license or amendment for medical use of byproduct material as described in § 35.1000 must also include:

(1) Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, subparts A through C, L, and M of this part; (2) Identification of and commitment to follow the applicable radiation safety program requirements in subparts D through H of this part that are appropriate for the specific § 35.1000 medical use; (3) Any additional specific information on--

(i) Radiation safety precautions and instructions; (ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and (4) Any other information requested by the Commission in its review of the application.

6 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 35.13 License amendments D

In § 35.13:

(a)

Revise paragraph (b);

(b)

Redesignate paragraphs (d) through (g) as paragraphs (e) through (h);

(c)

Revise newly redesignated paragraphs (g) and (h); and (d)

Add new paragraphs (d) and (i) to read as follows:

§ 35.13 License amendments.

(b) Before it permits anyone to work as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist under the license, except (1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a),

35.392(a), 35.394(a), 35.490(a),

35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) and 35.59; (3) For an authorized medical physicist, an individual who meets 180 NAC 07-010 7-010.02 AUTHORIZED INDIVIDUALS. A licensee must apply for and receive a license amendment before permitting anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except other than an individual who is:

(D) Identified as an authorized user, authorized nuclear pharmacist or authorized medical physicist, or an ophthalmic physicist, on a U.S. Nuclear Regulatory Commission or Agreement State or other equivalent permit or license recognized by the Department that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively;

7 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska the requirements in §§ 35.51(a) and 35.59; (4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist (d) Before it permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license; (g) Before it changes the address(es) of use identified in the application or on the license; (h) Before it revises procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety; and (i) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is

8 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska in a quantity and for an isotope authorized by the license.

§ 35.14 Notifications D

In § 35.14, revise paragraphs (a) and (b) to read as follows:

(a) A licensee shall provide the Commission, no later than 30 days after the date that the licensee permits an individual to work under the provisions of § 35.13(b) as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist (1) A copy of the board certification and, as appropriate, verification of completion of:

(i) Training for the authorized medical physicist under § 35.51(c);

(ii) Any additional case experience required in § 35.390(b)(1)(ii)(G) for an authorized user under § 35.300; or (iii) Device specific training in § 35.690(c) for the authorized user under § 35.600; or (2) A copy of the Commission or Agreement State license, the permit issued by a Commission master material licensee, the permit issued by a Commission or Agreement State licensee of broad scope, the permit issued by a Commission master material license broad scope 180 NAC 07-011 7-011.01 DOCUMENTATION. A licensee must provide to the Department a copy of the board certification and the written attestation(s),

signed by a preceptor, -----

7-011.02 NOTIFICATION. A licensee must notify the Department by letter no later than thirty days after:

(A) An authorized user, an authorized nuclear pharmacist, radiation safety

officer, associate radiation safety

officer, ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change; or * *

• 9 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC for each individual whom the licensee permits to work under the provisions of this section.

(b) A licensee shall notify the Commission no later than 30 days after:

(1) An authorized user, an authorized nuclear pharmacist, a Radiation Safety Officer, an Associate Radiation Safety Officer, an authorized medical physicist, or ophthalmic physicist permanently discontinues performance of duties under the license or has a name change; (2) The licensee permits an individual qualified to be a Radiation Safety Officer under §§ 35.50 and 35.59 to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation

10 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Safety Officer in accordance with § 35.24(c);

(3) The licensees mailing address changes; (4) The licensees name changes, but the name change does not constitute a transfer of control of the license as described in § 30.34(b) of this chapter; (5) The licensee has added to or changed the areas of use identified in the application or on the license where byproduct material is used in accordance with either § 35.100 or § 35.200 if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area; or (6) The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in § 35.13(i). The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

11 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 35.15 Exemptions regarding Type A specific licenses of broad scope D

In § 35.15, revise paragraphs (c) and (e) to read as follows:

(c) The provisions of § 35.13(f) regarding additions to or changes in the areas of use at the addresses identified in the application or on the license; (e) The provisions of § 35.14(b)(1) for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist; 180 NAC 07-012 7-012.04 NOTIFICATION. The provisions of A licensee possessing a Type A specific license of broad scope for medical use, issued under 180 NAC 7-011.01 regarding notification to the Department for new authorized users, new authorized nuclear pharmacists, new ophthalmic physicists, and new authorized medical physicists.

§ 35.24 (b) and (c)

Authority and responsibilitie s for the radiation protection program.

H&S:

35.24(b

)

D:

35.24(c

)

In § 35.24, revise paragraphs (b) and (c) to read as follows:

(b) A licensee's management shall appoint a Radiation Safety Officer who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with 180 NAC 07-015.04 7-015.04 RADIATION SAFETY OFFICER. A licensees management must appoint a

Radiation Safety Officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the Radiation Safety Officer, must ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensees management may appoint, in writing, one or more Associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement

12 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska licensee-approved procedures and regulatory requirements.

A licensees management may appoint, in writing, one or more Associate Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written agreement of the licensees management, must assign the specific duties and tasks to each Associate Radiation Safety Officer.

These duties and tasks are restricted to the types of use for which the Associate Radiation Safety Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

(c) For up to 60 days each year, a licensee may permit an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as provided in paragraph (g) of this section, if the licensee takes the actions required in paragraphs (b), (e), (g), and (h) of this section of the licensees management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but may not delegate the authority or responsibilities for implementing the radiation protection program.

13 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska and notifies the Commission in accordance with § 35.14(b).

§ 35.40 Written directives H&S In § 35.40, (a)

Revise paragraph (b)(5);

(b)

Redesignate paragraph (b)(6) as paragraph (b)(7);

(c)

Revise newly redesignated paragraph (b)(7);

(d)

Add new paragraph (b)(6);

(e)

Redesignate the introductory text of paragraph (c) as paragraph (c)(1); and (f)

Redesignate paragraph (c)(1) as paragraph (c)(2) to read as follows:

(b) * *

(5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; (6) For permanent implant brachytherapy:

(i) Before implantation: the treatment site, the radionuclide, and the total source strength; and (ii) After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, 180 NAC 07-019.02 - 03 7-019.02 * * * *

(D)

For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or (E) For permanent implant brachytherapy:

(i) Before implantation: The treatment site, the radionuclide, and the total source strength; and (ii) After implantation but before the patient leaves the post-treatment recovery area:

The treatment site, the number of sources implanted, the total source strength implanted, and date; or (F) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

(i) Before implantation: treatment site, the radionuclide, and dose; and (ii) After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time, (or the total dose); and the date.

7-019.03 * * * *

(A) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an

14 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska the total source strength implanted, and the date; or (7) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

(i) Before implantation: the treatment site, radionuclide, and dose; and (ii) After implantation but before completion of the procedure: the radionuclide; treatment site; number of sources; total source strength and exposure time (or the total dose);

and date.

(c)(1) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

(2) If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised existing written directive will be acceptable.,

provided that The oral revision is must be documented as soon as possible in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

15 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska written directive must be signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

§ 35.41 Procedures for administration s requiring a written directive H&S In § 35.41, revise paragraphs (b)(3) and (b)(4) and add new paragraphs (b)(5) and (b)(6) to read as follows:

(b) * * *

(3) Checking both manual and computer-generated dose calculations; (4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §§ 35.600 or 35.1000; (5) Determining if a medical event, as defined in § 35.3045, has occurred; and (6) Determining, for permanent implant brachytherapy, within 60 calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

180 NAC 07-020.02 7-020.02 * * * *

(E) Determining if a misadministration, as defined in 180 NAC 7-115, has occurred; and (F) Determining, for permanent implant brachytherapy, within sixty calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

16 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer B

Revise § 35.50 to read as follows:

Except as provided in § 35.57, the licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer or an individual assigned duties and tasks as an Associate Radiation Safety Officer as provided in § 35.24 to be an individual who (a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (d) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRCs Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1)(i) Hold a bachelors or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science; (ii) Have 5 or more years of professional experience in health physics (graduate training may be 180 NAC 07-022.01-05 7-022. TRAINING FOR RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER. Other than provided in 180 NAC 7-026, the licensee must require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer as provided in 180 NAC 7-015 to meet the following requirements.

7-022.01 CERTIFIED INDIVIDUAL. The individual is must be certified by a specialty board whose certification process has been recognized by the Department, an Agreement State or the U.S. Nuclear Regulatory Commission (NRC) and who meets the requirements in 180 NAC 7-022.02(B) and 7-022.04. (The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State are posted on the U.S. Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website).

7-022.02 STRUCTURED EDUCATIONAL PROGRAM COMPLETION. The individual must:

(A) Have completed a structured educational program consisting of both:

17 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics; and (iii) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or (2)(i) Hold a masters or doctors degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; (ii) Have 2 years of full-time practical training and/or supervised experience in medical physics (A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the Commission or an Agreement State; or (B) In clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in

§§ 35.57, 35.290, or 35.390; and (i) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:

(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Radiation biology; and (5) Radiation dosimetry; and (ii) One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a U.S. Nuclear Regulatory Commission (NRC) or an Agreement State license or permit issued by a U.S. Nuclear Regulatory Commission (NRC) master material licensee that authorizes similar type or types of use or uses of radioactive material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on a U.S. Nuclear Regulatory Commission (NRC) or an Agreement State license or permit issued by a U.S. Nuclear Regulatory Commission (NRC) master material licensee. The full-time radiation safety experience must involvinge the following:

(1) Shipping, receiving, and performing related radiation surveys;

18 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or (b)(1) Has completed a structured educational program consisting of both:

(i) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas-(A) Radiation physics and instrumentation; (B) Radiation protection; (C) Mathematics pertaining to the use and measurement of radioactivity; (D) Radiation biology; and (E) Radiation dosimetry; and (ii) One year of full-time radiation safety experience under the supervision of the individual identified as the Radiation Safety Officer on a Commission or an Agreement State license or permit issued by a Commission master material licensee that authorizes similar type(s) of use(s) of byproduct material. An Associate Radiation Safety Officer may provide supervision for those areas for which (2) Using and performing checks for proper operation of dose calibrators instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (3) Securing and controlling radioactive material; (4) Using administrative controls to avoid mistakes in the administration of radioactive material; (5) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (6) Using emergency procedures to control radioactive material; and (7) Disposing of radioactive material; or and (B) Obtain a written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer, who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation must state that the individual has satisfactorily completed the requirements in 180 NAC 7-022.02(B) and in 180 NAC 7-022.01(A)(i) and (ii) or 180 NAC 7-022.01(B)(i) and (ii), or 180 NAC 7-022.02(A) or 180 NAC 7-022.03 and is able

19 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska the Associate Radiation Safety Officer is authorized on a Commission or an Agreement State license or permit issued by a Commission master material licensee. The full-time radiation safety experience must involve the following (A) Shipping, receiving, and performing related radiation surveys; (B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (C) Securing and controlling byproduct material; (D) Using administrative controls to avoid mistakes in the administration of byproduct material; (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (F) Using emergency procedures to control byproduct material; and (G) Disposing of byproduct material; and (2) This individual must obtain a written attestation, signed by a preceptor Radiation Safety Officer or Associate Radiation Safety Officer who has experience with the to independently fulfill the radiation safety related duties as a radiation safety officer or as an associate radiation safety officer for medical use license; or 7-022.03 MEDICAL PHYSICIST, AUTHORIZED

USER, AUTHORIZED MEDICAL PHYSICIST OR AUTHORIZED NUCLEAR PHARMACIST. An The individual who is a must:

(A) Be a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Department, the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State in 180 NAC 7-023.01 and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as radiation safety officer or an associate radiation safety officer, and who meets the requirement in 180 NAC 7-022.02(B) and 7-022.04; or (B) Be an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensees a Commission or an Agreement State license, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State licensee of broad scope, or a permit issued by a Commission master material license broad scope permittee, has experience with the radiation

20 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska radiation safety aspects of similar types of use of byproduct material for which the individual is seeking approval as a Radiation Safety Officer or an Associate Radiation Safety Officer. The written attestation must state that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (d) of this section, and is able to independently fulfill the radiation safety related duties as a Radiation Safety Officer or as an Associate Radiation Safety Officer for a medical use license; or (c)(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State under §35.51(a),

has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as Radiation Safety Officer or an Associate Radiation Safety Officer, and meets the requirements in paragraph (d) of this section; or (2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a Commission or an Agreement State license, a permit issued by a safety aspects of similar types of use of radioactive material for which the individual has Radiation Safety Officer responsibilities licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer, and meets the requirements in 180 NAC 7-022.04; and or (C) Have experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material license. The individual must also meet the requirements in 180 NAC 7-022.04.

7-022.04 TRAINING FOR TYPES OF USE FOR WHICH A LICENSEE SEEKS APPROVAL. An individual who has training in the radiation safety, regulatory issues and emergency procedures for the types of use for which a licensee seeks approval.

This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, an associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user as appropriate, who is authorized for the type or types of use for which the licensee is seeking approval.

21 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Commission master material licensee, a permit issued by a Commission or an Agreement State licensee of broad scope, or a permit issued by a Commission master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of byproduct material for which the licensee seeks the approval of the individual as the Radiation Safety Officer or Associate Radiation Safety Officer, and meets the requirements in paragraph (d) of this section; or (3) Has experience with the radiation safety aspects of the types of use of byproduct material for which the individual is seeking simultaneous approval both as the Radiation Safety Officer and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material license. The individual must also meet the requirements in paragraph (d) of this section.

(d) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement

22 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska may be satisfied by completing training that is supervised by a Radiation Safety Officer, an Associate Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

§ 35.51 Training for an authorized medical physicist.

B In § 35.51, revise the introductory text of paragraph (a), and revise paragraphs (a)(2)(i) and (b)(2) to read as follows:

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (c) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(2) 180 NAC 07-023.01,.03 7-023.01 CERTIFICATION. An individual who is certified by a specialty board whose certification process has been recognized by the Department, the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State and who meets the requirements of 180 NAC 7-023.03 and 7-023.04. (The names of board certifications which have been recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (NRC) will be are posted on the NRCs web page (NRC)s Medical Uses Licensee Toolkit website.)

To have its certification process recognized, a specialty board must require all candidates for certification to:

7-023.01 * * * *

(B) Have two years of full-time practical training or supervision experience in medical physics:

(i) Under the supervision of a medical physicist who is certified in medical

23 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized under this section by the Commission or an Agreement State; or (b)

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (c) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in §§ 35.51, 35.57, or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

physics by a specialty board whose certification process has been recognized under this section by the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC); or 7-023.03 WRITTEN ATTESTATION.

Has obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-023.01(A) and (B), or 180 NAC 7-023.02(A) and 180 NAC 7-023.04, and has achieved a level of competency sufficient to function independently is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in 180 NAC 7-023, 7-026 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

§ 35.55 Training for an authorized B

In § 35.55, revise the introductory text of paragraph (a) and revise 180 NAC 07-024.01,.03 7-024.01 CERTIFICATION. Is certified by a specialty board whose certification process has

24 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska nuclear pharmacist.

paragraph (b)(2) to read as follows:

(a) Is certified by a specialty board whose certification process has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(b)

(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

been recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (NRC) who meets the requirements of 180 NAC 7-024.03. (The names of the board certifications which have been recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (NRC) will be are posted on the U.S. Nuclear Regulatory Commission (NRC)

Medical Uses Licensee Toolkit website.) To have its certification process recognized, a specialty board must require all candidates for certification to:

7-024.03 WRITTEN ATTESTATION. Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements of 180 NAC 7-024.01(A)(B), and (C) or 7-024.02 and has achieved a level of competency sufficient to function independently is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

§ 35.57 Training for experienced Radiation Safety

Officer, B

Except for In § 35.57:

(a) Revise paragraphs (a)(1),

(b)(1), (b)(2) and (b)(3);

(b) Add new paragraphs (a)(2),

(a)(3), (b)(2)(i),(ii)(iii) and (iv); and 180 NAC 07-026.01,.03 7-026.01 LICENSE OR PERMIT. An individual identified as on a U.S. Nuclear Regulatory Commission (NRC) or an Agreement State license or a permit issued by a U.S. Nuclear Regulatory Commission (NRC) or an

25 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

D:

35.57(a

)(4)

(c) Redesignate (a)(4);

to read as follows:

(a)(1) An individual identified on a Commission or an Agreement State license or a permit issued by a Commission or an Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as a Radiation Safety Officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before January 14, 2019 need not comply with the training requirements of §§ 35.50, 35.51, or 35.55, respectively, except the Radiation Safety Officers and authorized medical physicists identified in this paragraph must meet the training requirements in § 35.50(d) or § 35.51(c), as appropriate, for any material or uses for which they were not authorized prior to this date.

(2) Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board of Nuclear Medicine; American Board of Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as a radiation safety officer, a teletherapy or medical physicist, or a nuclear pharmacist or a authorized medial physicist, or a authorized nuclear pharmacist on a

U.S.

Nuclear Regulatory Commission, an Agreement State, or a Department license or on a permit issued by a U.S. Nuclear Regulatory Commission or Agreement State or a Department broad scope licensee or master material license permit or by a master material licensee permittee of broad scope that authorizes medical use or practice of nuclear pharmacy, before July 11, 2009 need not comply with the training requirements of 180 NAC 7-022 through 7-024. an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before the effective date of these regulations need not comply with the training requirements of 180 NAC 7-022 through 7-024, respectively, other than the radiation safety officers and authorized medical physicists identified in this paragraph must meet the training requirements in 180 NAC 7-022 or 7-023 as appropriate, for any material or uses for which they were not authorized prior to this date.

7-026.02 CERTIFICATION. Any individual certified by the American Board of Health Physics in Comprehensive Health Physics; American Board of Radiology; American Board

26 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of § 35.50 to be identified as a Radiation Safety Officer or as an Associate Radiation Safety Officer on a Commission or an Agreement State license or Commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.

(3) Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist of Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical Physics in radiation oncology physics; Royal College of Physicians and Surgeons of Canada in nuclear medicine; American Osteopathic Board of Radiology; or American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, need not comply with the training requirements of 180 NAC 7-022 to be identified as a radiation safety officer or as an associate radiation safety officer on a U.S. Nuclear Regulatory Commission (NRC) or an Agreement State license or U.S. Nuclear Regulatory Commission (NRC) master material license permit for those materials and uses that these individuals performed on or before July 11, 2009.

7-026.03 PRIOR CERTIFICATION.

Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, or certified by the American Board of Medical Physics in radiation oncology physics, on or before July 11, 2009, need not comply with the training requirements for an authorized medical physicist described in 180 NAC 7-023, for those materials and uses that these individuals performed on or before July 11, 2009.

27 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska described in § 35.51, for those materials and uses that these individuals performed on or before October 24, 2005.

(4) A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of §§ 35.50, 35.51 or 35.55, respectively, when performing the same uses.

A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and during the time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for the purposes of this chapter.

(a)(4) dealing with accelerator-produced radioactive materials does not apply to Nebraska.

7-026.05 NOT IDENTIFIED AS AN AUTHORIZED USER. Physicians, dentists, or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, a permit issued by a U.S. Nuclear Regulatory Commission (NRC) master material licensee, a permit issued by a U.S. Nuclear Regulatory Commission (NRC) or an Agreement State broad scope licensee, or a permit issued by a U.S. Nuclear Regulatory Commission (NRC) master material license of broad scope on or before July 11, 2009, need not comply with the training requirements for those materials and uses that these individuals performed on or before July 11, 2009, as follows:

(A) For uses authorized under 180 NAC 7-041 or 7-044 or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before July 11, 2009, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic

28 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (b)(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued by a Commission master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of subparts D through H of this part.

(2) Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by the Commission or an Agreement State, a permit issued by a Commission master material licensee, a permit issued by a Commission or an Agreement State broad scope licensee, or a permit issued by a Commission master material license of broad scope on or before October 24, 2005, need not comply with the training Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine; (B) For uses authorized under 180 NAC 7-048, a physician who was certified on or before July 11, 2009, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the American Osteopathic Board of Radiology after 1984; (C) For uses authorized under 180 NAC 7-055 or 7-067, a physician who was certified on or before July 11, 2009, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and (D) For uses authorized under 180 NAC 7-065, a physician who was certified on or before July 11, 2009, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board

29 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska requirements of Subparts D through H of this part for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

(i) For uses authorized under §§ 35.100 or 35.200, or oral administration of sodium iodide I-131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology by the American Board of Radiology; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or American Osteopathic Board of Nuclear Medicine in nuclear medicine; (ii) For uses authorized under § 35.300, a physician who was certified on or before October 24, 2005, by the American Board of Nuclear Medicine; the American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or the of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

(b)(3) dealing with accelerator-produced radioactive materials does not apply to Nebraska.

30 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska American Osteopathic Board of Radiology after 1984; (iii) For uses authorized under §§ 35.400 or 35.600, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the American Board of Radiology; radiation oncology by the American Osteopathic Board of Radiology; radiology, with specialization in radiotherapy, as a British Fellow of the Faculty of Radiology or Fellow of the Royal College of Radiology; or therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; and (iv) For uses authorized under § 35.500, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; nuclear medicine by the American Board of Nuclear Medicine; diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or nuclear medicine by the Royal College of Physicians and Surgeons of Canada.

(3) Physicians, dentists, or podiatrists who used only

31 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a Government agency or Federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC, need not comply with the training requirements of subparts D through H of this part when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for the purposes of this chapter.

§ 35.65 Authorization for calibration, transmission, and reference sources.

D In § 35.65, revised to read as follows:

(a) Any person authorized by § 35.11 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use:

180 NAC 07-32 N/A

32 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations; (2) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions; (3) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi);

(4) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCI) or 1000 times the quantities in appendix B of part 30 of this chapter; or (5) Technetium-99m in amounts as needed.

33 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (b) Byproduct material in sealed sources authorized by this provision shall not be:

(1) Used for medical use as defined in § 35.2 except in accordance with the requirements in § 35.500; or (2) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this section.

(c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in paragraphs (a) or (b) of this section need not list these sources on a specific medical use license.

§ 35.190 Training for

uptake, dilution, and excretion studies.

B In § 35.190, revise the introductory text of paragraph (a), revise paragraph (c)(2), and add new paragraphs (c)(2)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State.

The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.

180 NAC 07-043.01,.04 7-043.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by the Department, U.S. Nuclear Regulatory Commission or an Agreement State and who meets the requirements in 180 NAC 7-043.04.

(The names of board certifications which have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State will be are posted on the NRCs Web page U.S. Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website.) To have its certification process recognized, a specialty board must require all candidates for certification to:

34 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska To have its certification process recognized, a specialty board shall require all candidates for certification to:

(c)

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.100. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency 7-043.03 * * * *

(C) Has obtained written attestation signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-043, 7-047, or 7-051, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirement in 180 NAC 7-043.01, item 1 or 7-043.03, item 1 and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized in 180 NAC 7-041. that the individual has satisfactorily completed the requirement in 180 NAC 7-043.03 and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-041. The attestation must be obtained from either:

(i)

A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-043, 7-047, or 7-051, or equivalent Agreement State requirements; or (ii)

A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-043, 7-047, or 7-051, or equivalent

35 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (c)(1) of this section.

Agreement State requirements, and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-043.03 of this section.

§ 35.204 Permissible molybdenum-99, strontium-82, and strontium-85 concentration s

H&S In § 35.204, revise paragraph (b) and add new paragraph (e) to read as follows:

(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with paragraph (a) of this section.

(e) The licensee shall report any measurement that exceeds the limits in paragraph (a) of this section at the 180 NAC 07-045.02-.05 7-045.02 RADIONUCLIDE CONTAMINANT CONCENTRATION MEASUREMENT IN RADIOACTIVE DRUG PREPARATION. To demonstrate compliance with 180 NAC 7-045, the licensee preparing radioactive drugs from radionuclide generators must:

(A) Measure the concentration of radionuclide contaminant in the first each eluate after receipt of a molybdenum-99/technetium-99m generator; or (B) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.

7-045.05 REPORTING REQUIREMENT. A licensee must report immediately to the

36 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska time of generator elution, in accordance with § 35.3204.

Department according to 180 NAC 7-120 each occurrence of a concentration exceeding the limits specified in 180 NAC 7-045.01.

§ 35.290 Training for imaging and localization studies B

In § 35.290, revise the introductory text of paragraphs (a) and (c)(1)(ii), and paragraph (c)(2); and add new paragraphs (c)(2)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State.

The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.

To have its certification process recognized, a specialty board shall require all candidates for certification to:

(c)(1) *

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements. An authorized nuclear pharmacist who meets the requirements in § 35.55 or 180 NAC 07-047.01,.03,

.04 7-047.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC). The names of board certification which have been recognized by the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) will be are posted on the NRCs Web page U.S.

Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:

7-047.03, (A) * * * *

(ii) Work experience, under the supervision of an authorized user, who meets the requirements in 180 NAC 7-026, 7-047, or 7-051 and 7-047.03(A)(ii)(7) or equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State requirements involving;. An authorized nuclear pharmacist who meets the requirements in 180 NAC 7-024 or 7-026 may provide the supervised work experience for 180 NAC 7-

37 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 35.57 may provide the supervised work experience for paragraph (c)(1)(ii)(G) of this section. Work experience must involve (2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (c)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under §§ 35.100 and 35.200. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved 047.03(A)(ii)(7) of this section. Work experience must involve:

047.03 * * *

• 047.04 Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-047, or 7-051 and 7-047.03, item 1.b.(7) or equivalent U.S.

Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in 180 NAC 7-047.01, item 1 or 180 NAC 7-047.03, item 1 and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 180 NAC 7- 041 and 7-044.

(B) Obtained written attestation, that the individual has satisfactorily completed the requirements in 180 NAC 7-047.01 and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-041 and 7-044. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 180 NAC 7-

026, 7-047, or 7-051 and 7-047.03(A)(ii)(7),

or equivalent Agreement State requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the

38 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (c)(1) of this section.

residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-047, or 7-051 and 7-047.03(A)(ii)(7), or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-47.01 of this section.

§ 35.300 Use of unsealed byproduct material for which a written directive is required B

In § 35.300, revise the introductory text to read as follows:

A licensee may use any unsealed byproduct material identified in

§35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is 180 NAC 07-048 7-048. USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A

WRITTEN DIRECTIVE IS REQUIRED. A licensee may use any unsealed radioactive material for diagnostic or therapeutic medical use for which a written directive is required that has been identified in 180 NAC 7-051.02(A)(ii)(6) prepared for medical use and for which a written directive is required that is:

§ 35.390 Training for use of unsealed byproduct material for B

In § 35.390, revise the introductory text of paragraph (a), and revise paragraphs (b)(1)(ii)(G) and (b)(2);

and add new paragraphs (b)(2)(i) and (ii) to read as follows:

180 NAC 07-051.01-.03 051.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State, or the U.S.

Nuclear Regulatory Commission (NRC) who

39 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska which a written directive is required (a) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraphs (b)(1)(ii)(G) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRCs Medical Uses Licensee Toolkit Web page. To be recognized, a specialty board shall require all candidates for certification to:

(b)(1) *

(ii)

(G) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph.

Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under § 35.1000. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status meets the requirements in 180 NAC 7-051.02(A)(ii)(6) and 7-051.03.

(Specialty Boards whose certification process has been recognized by an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) are posted on the NRCs Web page Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website.) To be recognized, a specialty board must require all candidates for certification to:

051.02(A)(ii) * * * *

(6) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under 180 NAC 7-085. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

(a) * * * *

(b) * * * *

(c) Parenteral administration of any beta emitter or a

photonemitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or (d) Parenteral administration of any other radionuclide, for which a written

40 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (1) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131, for which a written directive is required; (2) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-1312; (3) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and (2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b)(1) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under § 35.300 for which the individual is requesting authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.390, or equivalent Agreement State requirements and has experience in administering dosages directive is required; and Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and 7-051.03 Has obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-051.01, item 1 and 7-051.02, item 1.b.(6) or 7-051.02, item 1 and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 180 NAC 7-048. The written attestation must be signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-051, or equivalent U.S.

Nuclear Regulatory Commission or Agreement State requirements.

The preceptor authorized user, who meets the requirement in 180 NAC 7-051.02 must have experience in administering dosages in the same dosage category or categories (that is, 180 NAC 7-051.02, item 1.b.(6)) as the individual requesting authorized user status.

(B) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-051.02 and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-048 for which the individual is

41 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska in the same dosage category or categories as the individual requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in § 35.57, 35.390, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraph (b)(1) of this section.

requesting authorized user status. The attestation must be obtained from either:

(i)

A preceptor authorized user who meets the requirements in 180 NAC 7-026 and 7-051, or equivalent Agreement State requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or (ii)

A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026 and 7-051, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user

status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the

42 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska American Osteopathic Association and must include training and experience specified in 180 NAC 7-051.02.

§ 35.392 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquere ls (33 millicuries)

B In § 35.392 revise paragraphs (a) and (c)(3); and add new paragraphs (c)(3)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (c)(2) of this section and whose certification process has been recognized by the Commission or an Agreement State.

The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.; or (c)(1) *

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal 180 NAC 07-052.01,.04 052.01 CERTIFICATION. Is certified by a medical specialty board whose certification process includes all of the requirements in 180 NAC 7-052.03(A) and (B) and whose certification has been recognized by the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC). The names of board certifications which have been recognized by an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) will be are posted on the NRCs Web page U.S.

Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website; or 052.03 * * * *

(C) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-052.03(A) and (B) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 180 NAC 7-048. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 180 NAC 7-

43 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements and has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or § 35.390(b)(1)(ii)(G)(2); or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State requirements, has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or § 35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of 026, 7-051, 7-052, 7-053, or equivalent Agreement State requirements and has experience in administering dosages as specified in 180 NAC 7-051.02(A)(ii)(6)(a) or (b); or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-051, 7-052, 7-053, or equivalent Agreement State requirements, has experience in administering dosages as specified in 180 NAC 7-051.02(A)(ii)(6)(a) or (b), and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-052.03.

7-052.04 Has obtained written attestation that the individual has satisfactorily completed the requirements in180 NAC 7-

44 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (c)(1) and (2) of this section.

052.03, item 1. and 2. and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under 180 NAC 7-048. The written attestation must be signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-051, 7-052, 7-053, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user, who meets the requirement in 180 NAC 7-051.02, must have experience in administering dosages as specified in 180 NAC 7-051.02, item 1.b.(6)(a) or (b).

§ 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquere ls (33 millicuries)

B In § 35.394, revise paragraphs (a) and (c)(3); and add new paragraphs (c)(3)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (c)(1) and (c)(2) of this section, and whose certification has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the 180 NAC 07-053.01,.04 053.01 CERTIFICATION. Is certified by a medical specialty board whose certification process includes all of the requirements in 180 NAC 7-053.03(A) and (B) and whose certification has been recognized the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC). The name of board certifications which have been recognized by an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) will be are posted on the NRCs Web page U.S.

Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website; or 053.03, (A), (B) * * *

• 45 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska NRCs Medical Uses Licensee Toolkit Web page.; or (c)(1) *

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under § 35.300. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.390, 35.394, or equivalent Agreement State requirements, and has experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2); or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.390, 35.394, or equivalent Agreement State requirements, has experience (C) Obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs 180 NAC 7-053.03(A) and (B), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 180 NAC 7-048. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 7-026, 7-051, 7-053, or equivalent Agreement State requirements, and has experience in administering dosages as specified in 7-051.02(A)(ii)(6)(b); or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 7-026, 7-051, 7-053, or equivalent Agreement State requirements, has experience in administering dosages as specified in 7-051.02(A)(ii)(6)(b), and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council

46 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska in administering dosages as specified in

§ 35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (c)(1) and (2) of this section.

for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 7-053.03(A) and (B).

§ 35.396 Training for the parenteral administration of unsealed byproduct material requiring a written directive B

In § 35.396 revise and redesignate paragraphs (a)(1), (a)(2), (a)(3),

(b)(1), (b)(2), (b)(2)(vi), and (b)(3);

and add new paragraphs (b)(3)(i) and (ii) to read as follows:

(a) Except as provided in § 35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who (1) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(3), or equivalent Agreement State requirements; or 180 NAC 07-054.04 7-054.04, (A), (B), ***

(C) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-054.02 or 7-054.03 of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-051, or 7-054, or equivalent Agreement State requirements. A preceptor authorized user who meets

47 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (2) Is an authorized user under §§ 35.490, 35.690, or equivalent Agreement State requirements, and who meets the requirements in paragraph (b) of this section; or (3) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under §§ 35.490 or 35.690, and who meets the requirements in paragraph (b) of this section.

(b) The physician (1) Has successfully completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training, applicable to parenteral administrations listed in § 35.390(b)(1)(ii)(G)(3). The training must include (i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Chemistry of byproduct material for medical use; and (v) Radiation biology; and (2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.390, 35.396, or equivalent Agreement State requirements, in the requirements in 180 NAC 7-051, or 7-054, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-051, or 7-054, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-54.04(A) and (B).

48 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska the parenteral administrations listed in § 35.390(b)(1)(ii)(G)(3). A supervising authorized user who meets the requirements in §§ 35.390, 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status.

The work experience must involve (i) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys; (ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters; (iii) Calculating, measuring, and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material; (v) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and (vi) Administering dosages to patients or human research subjects, that include at least three cases of

49 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska the parenteral administrations as specified in § 35.390(b)(1)(ii)(G)(3);

and (3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b)(1) and (2) of this section, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.390, 35.396, or equivalent Agreement State requirements. A preceptor authorized user who meets the requirements in § 35.390, 35.396, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.390,

50 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska 35.396, or equivalent Agreement State requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (2) of this section.

§ 35.400 Use of sources for manual brachytherap y

C In § 35.400 revise paragraphs (a) and (b) to read as follows:

A licensee must use only brachytherapy sources:

(a) Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used in 180 NAC 07-055.01-.02 7-055.01 As approved in the Sealed Source and Device Registry; or SEALED SOURCE AND DEVICE REGISTRY. Approved in the Sealed Source and Device Registry for manual brachytherapy medical use.

The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry, but must be used according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

51 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (b) In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

7-055.02 RESEARCH. For In research to deliver therapeutic doses for medical use in accordance with according to an active Investigational Device Exemption (IDE) application that has been accepted by the U.S.

Food and Drug Administration (FDA), provided the requirements of 180 NAC 7-021.01 are met.

§ 35.433 Strontium-90 sources for ophthalmic treatments B:

35.433(

a)

(The compat ibility categor y for 35.433(

a) has change d from H&S to B).

H&S:

35.433(

b),

(b)(1) and (b)(2)

In § 35.433, revise paragraph (a),

add new paragraphs (b), (b)(1) and (2), and redesignate paragraph (c) to read as follows:

(a) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in paragraph (b) of this section are performed by either:

(1) An authorized medical physicist; or (2) An individual who:

(i) is identified as an ophthalmic physicist on a specific medical use license issued by the Commission or an Agreement State; permit issued by a Commission or Agreement State broad scope medical use licensee; medical use permit issued by a Commission master material licensee; or permit issued by a 180 NAC 07-060.05,.07 7-060.05 Only an authorized medical physicist must calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined in accordance with 180 NAC 7-060.01, 7-060.02, or 7-060.03. STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS. This subsection addresses strontium-90 sources for ophthalmic treatments.

7-060.05(A)

INDIVIDUALS PERFORMING TREATMENTS. Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in 180 NAC 7-060.05(B) are performed by either:

(i) An authorized medical physicist; or (ii) An individual who:

(1) Is identified as an ophthalmic physicist on a specific medical use license issued by the Department, U.S.

Nuclear Regulatory Commission

52 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska D:

35.433(

c)

Commission master material licensee broad scope medical use permittee; and (ii) holds a masters or doctors degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and (iii) has successfully completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and (iv) Has documented training in:

(A) The creation, modification, and completion of written directives; (B) Procedures for administrations requiring a written directive; and (C) Performing the calibration measurements of brachytherapy sources as detailed in § 35.432.

(b) The individuals who are identified in paragraph (a) of this section must:

(1) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under § 35.432; and (2) Assist the licensee in developing, implementing, and maintaining written procedures to (NRC), or an Agreement State; permit issued by a Department, U.S. Nuclear Regulatory Commission (NRC), or Agreement State broad scope medical use licensee; medical use permit issued by a Commission master material licensee; or permit issued by a Commission master material licensee broad scope medical use permittee; and (2) Holds a master's or doctor's degree in

physics, medical

physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and (3) Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and (4) Has documented training in:

(a) The creation, modification, and completion of written directives; (b) Procedures for administrations requiring a written directive; and (5)

Is performing the calibration measurements of brachytherapy sources as detailed in 180 NAC 7-104.

7-060.05(B) WRITTEN PROCEDURES. The individuals who are identified in 180 NAC 060.05(A) must:

53 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in paragraph (a) of this section will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

(c) Licensees must retain a record of the activity of each strontium-90 source in accordance with § 35.2433.

(i) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 180 NAC 7-060; and (ii) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is according to the written directive. These procedures must include the frequencies that the individual meeting the requirements in 180 NAC 7-060.05(A) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were according to the written directives.

7-060.05(C) DECAY CALCULATION RECORD RETENTION. Licensees must retain a record of the activity of each strontium-90 source according to 180 NAC 7-105.

§ 35.490 Training for use of manual brachytherap y sources B

In § 35.490, revise the introductory text of paragraphs (a) and (b)(1)(ii), and paragraph (b)(3), and add new paragraphs (b)(3)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process 180 NAC 07-063.01,.03 7-063.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC). The names of board certifications which have been recognized an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) will be posed on the NRCs Web page are posted on

54 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska has been recognized by the Commission or an Agreement State.

The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.

To have its certification process recognized, a specialty board shall require all candidates for certification to:

(b)(1) *

(ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements, at a medical facility authorized to use byproduct materials under § 35.400, involving (3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under the U.S. Nuclear Regulatory Commission (NRC)s Medical Uses Licensee Toolkit website.

To have its certification process recognized, a specialty board must require all candidates for certification to:

7-063.02(A)(i) * * *

(ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-063 or equivalent U.S.

Nuclear Regulatory or Agreement State requirements at a medical institution facility authorized to use radioactive materials under 180 NAC 7-055, involving:

7-063.02(A)(B) * * *

(C) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-063.02(A) and (B) and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under 180 NAC 7-055. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-063, or equivalent Agreement State requirements; or

55 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§35.400. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.490, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in paragraphs (b)(1) and (b)(2) of this section.

(ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-063, or equivalent Agreement State requirements, and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-063.02(A) and (B).

7-063.03 Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-063, or equivalent U.S.

Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in 180 NAC 7-063.01, item 1 or 7-063.02, item 1 and 2 and has achieved a level of competency sufficient to independently

56 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska function as an authorized user of manual brachytherapy sources for the medical uses authorized under 180 NAC 7- 055.

§ 35.491 Training for ophthalmic use of strontium-90 B

In § 35.491, revise paragraph (b)(3) to read as follows:

(b)

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in

§§ 35.57, 35.490, 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (b)(2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

180 NAC 07-064.02,(C) 7-064.02(A)(B) * * *

(C) Has Obtained written attestation, signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-063 or 7-064 or equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State requirements, that the individual has satisfactorily completed the requirements in 180 NAC 7-064.01 and 7-064.02 and has achieved a level of competency sufficient to function is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

§ 35.500 Use of sealed sources and medical devices for diagnosis C

(The compat ibility categor y for 35.500(

a) was change d from

[C] to C)

In § 35.500 revise paragraph (a),

and add new paragraphs (b) and (c) to read as follows:

(a) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine.

The sealed sources may be used for diagnostic medical uses that are not 180 NAC 07-065 7-065.01 Approved in the U.S. Nuclear Regulatory Commissions Sealed Source and Device Registry; and SEALED SOURCES NOT IN MEDICAL DEVICES. A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used according to the radiation safety conditions

57 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

(b) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

(c) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

and limitations described in the Sealed Source and Device Registry.

7-065.02 Handled in accordance with the manufacturers radiation safety instructions.

MEDICAL DEVICES CONTAINING SEALED SOURCES. A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses.

The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry.

7-065.03 SEALED SOURCES AND DEVICES USED IN RESEARCH. Sealed sources and devices for diagnostic medical uses may be used in research according to an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration (FDA) provided the requirements of 180 NAC 7-021.01 are met.

§ 35.590 Training for use of sealed sources and medical B

In § 35.590 revise paragraph (a),

add new paragraph (b), and redesignate paragraphs (c) and (d) to read as follows:

180 NAC 07-066 7-066. TRAINING FOR USE OF SEALED SOURCES FOR DIAGNOSIS. Except Other than as provided in 180 NAC 7-026, the licensee must require the authorized user of a diagnostic

58 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska devices for diagnosis.

Except as provided in § 35.57, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized under § 35.500 to be a physician, dentist, or podiatrist who (a) Is certified by a specialty board whose certification process includes all of the requirements in paragraphs (c) and (d) of this section and whose certification has been recognized by the Commission or an Agreement State. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page; or (b) Is an authorized user for uses listed in § 35.200 or equivalent Agreement State requirements; or (c) Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include (1) Radiation physics and instrumentation; (2) Radiation protection; sealed source for use in a device authorized under 180 NAC 7-065 to be a physician, dentist or podiatrist who:

7-066.01 CERTIFICATION. Is certified by a specialty board whose certification process includes all of the requirements in 180 NAC 7-066.03 and 7-066.04 whose certification has been recognized by, an Agreement State or the U.S. Nuclear Regulatory Commission (NRC).

(The names of board certifications which have been recognized by an Agreement State or the U.S. Nuclear Regulatory Commission (NRC) will be are posted on the U.S. Nuclear Regulatory Commission (NRC)s Web page Medical Uses Licensee Toolkit website); or 7-066.02 The physician, dentist, or podiatrist:

1. Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device.

The training must include:

a. Radiation physics and instrumentation;

b. Radiation protection;

c. Mathematics pertaining to the use and measurement of radioactivity; and

d. Radiation biology; and AUTHORIZED USER. Is an authorized user for uses listed in 180 NAC 7-044, U.S. Nuclear

59 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; and (d) Has completed training in the use of the device for the uses requested.

Regulatory Commission (NRC), or equivalent Agreement State requirements; or 7-066.03 Has completed training in the use of the device for the uses requested.

CLASSROOM AND LABORATORY TRAINING. The physician, dentist, or podiatrist:

(A) Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:

(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and 066.04 DEVICE TRAINING. Has completed training in the use of the device for the uses requested.

§ 35.600 Use of a sealed source in a remote afterloader

unit, teletherapy unit, or gamma stereotactic radiosurgery unit C

In § 35.600 revise paragraphs (a) and (b) to read as follows:

(a) A licensee must only use sealed sources:

(1) Approved and as provided for in the Sealed Source and Device Registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery 180 NAC 07-067 7-067. USE OF A SEALED SOURCE IN A REMOTE AFTERLOADER

UNITS, TELETHERAPY

UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNIT. A licensee must use only sealed sources in photon-emitting remote afterloader units, or gamma stereotactic radiosurgery units for therapeutic medical uses as follows.

7-067.01 As approved in the U.S. Nuclear Regulatory Commission Sealed Source and

60 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska un to deliver therapeutic doses for medical uses: or (2) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of § 35.49(a) are met.

(b) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(1) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use.

These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (2) In research in accordance with an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of § 35.49(a) are met.

Device Registry; or APPROVED SEALED SOURCE. A licensee must only use sealed sources:

(A) As approved and as provided for in the U.S.

Nuclear Regulatory Commission (NRC)

Sealed Source and Device Registry; or (B) In research according to an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration (FDA) provided the requirements of 180 NAC 7-021.01 are met.

7-067.02 APPROVED DEVICES.

A licensee must only use devices:

(A) Approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry, but must be used according to radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (B) For In research in accordance with according to an active Investigational Device Exemption (IDE) application that has been accepted by the U.S. Food and Drug Administration (FDA) provided the requirements of 180 NAC 7-021.01 are met.

61 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska

§ 35.610 Safety procedures and instructions for remote afterloader

units, teletherapy units, and gamma stereotactic radiosurgery units H&S In § 35.610, add new paragraph (d)(1) and revise paragraphs (d) and (g) to read as follows:

(d)(1) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

(2) A licensee shall provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in (i) The procedures identified in paragraph (a)(4) of this section; and (ii) The operating procedures for the unit.

180 NAC 07-070.04 7-070.04 INSTRUCTION FREQUENCY. A licensee must provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in:

(A) The procedures identified in 180 NAC 7-070.01, item 4 Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training; and (B) The operating procedures for the unit.

Provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions must include:

(i) The procedures identified in 180 NAC 7-070.01(D); and (ii) The operating procedures for the unit.

7-070.06 RECORD RETENTION. A licensee must retain a record of individuals receiving

62 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (g) A licensee shall retain a copy of the procedures required by paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with § 35.2610.

instruction required by 180 NAC 7-070.04, according to 180 NAC 7-101.

§ 35.655(a

)

Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units H&S In § 35.655, revise the section heading and paragraph (a) to read as follows:

(a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

180 NAC 07-081.1 7-081.01 INSPECTION FREQUENCY.

A licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement to assure proper functioning of the source exposure mechanism and other safety components. or at The intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism. between each full inspection servicing must not to exceed five years for each teletherapy unit and must not exceed seven years for each gamma stereotactic radiosurgery unit.

§ 35.690 Training for use of remote afterloader

units, teletherapy units, and gamma stereotactic radiosurgery units B

In § 35.690, revise the introductory text of paragraphs (a) and (b)(1)(ii), and (b)(3), and add new paragraphs (b)(3)(i) and (ii) to read as follows:

(a) Is certified by a medical specialty board whose certification process has been recognized by the 180 NAC 07-084.01,.02 item 1 b,.03 7-084.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) and who meets the requirements of 180 NAC 7-084.03 and 7-084.04. The names of board certifications which have been recognized the Department, an Agreement State or the U.S.

Nuclear Regulatory Commission (NRC) will be

63 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska Commission or an Agreement State and who meets the requirements in paragraph (c) of this section. The names of board certifications that have been recognized by the Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit Web page.

To have its certification process recognized, a specialty board shall require all candidates for certification to:

(b)(1) *

(ii) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the supervision of an authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements, at a medical facility that is authorized to use byproduct materials in § 35.600, involving (3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (b)(1), (b)(2), and (c) of this section; and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting are posted on the U.S. Nuclear Regulatory Commission (NRC)s Web page Medical Uses Licensee Toolkit website. To be recognized, a specialty board must require all candidates for certification to:

7-084.02(A)(B) * * *

(C) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-084.02(A) and (B) and 7-087.03; and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-084, or equivalent Agreement State requirements for the type or types of therapeutic medical unit for which the individual is requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in 180 NAC 7-026, 7-084, or equivalent Agreement State

64 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska authorized user status. The attestation must be obtained from either:

(i) A preceptor authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or (ii) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in §§ 35.57, 35.690, or equivalent Agreement State requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must requirements, for the type or types of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director.

The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in 180 NAC 7-084.02(A) and (B).

7-084.03 Has obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-084.01, item 1 or 7-084.02, item 1 and 2, and 7-084.04 has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-084 or equivalent Agreement State or U.S. Nuclear Regulatory Commission requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status;

65 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska include training and experience specified in paragraphs (b)(1) and (b)(2) of this section.

and

§ 35.2024 Records of authority and responsibilitie s for radiation protection programs D

In § 35.2024, add new paragraph (c) to read as follows:

(c) For each Associate Radiation Safety Officer appointed under § 35.24(b), the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensees management.

180 NAC 07-086 N/A

§ 35.2310 Records of safety instruction D

Revise § 35.2310 to read as follows:

A licensee shall maintain a record of safety instructions required by §§ 35.310, 35.410, and the operational and safety instructions required by § 35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

180 NAC 07-101 N/A

§ 35.2655 Records of full-inspection servicing for D

In § 35.2655, revise the section heading and paragraph (a) to read as follows:

180 NAC 07-114 N/A

66 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska teletherapy and gamma stereotactic radiosurgery units (a)

A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by § 35.655 for the duration of the use of the unit.

§ 35.3045 Report and notification of a medical event C

In § 35.3045, revise paragraph (a) to read as follows:

(a) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which (1) The administration of byproduct material or radiation from byproduct material, except permanent implant brachytherapy, results in (i) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and (A) The total dose delivered differs from the prescribed dose by 20 percent or more; (B) The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls 180 NAC 07-115.01 7-115.01 MISADMINISTRATION REPORTING. Other than events that result from intervention by a patient or human research subject, a licensee must report any event as a misadministration in which the administration of radioactive material or radiation from radioactive material results in:

(A) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and either * * *

(B) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:

(i) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure; * *

• 67 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska outside the prescribed dosage range; or (C) The fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more.

(ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following (A) An administration of a wrong radioactive drug containing byproduct material or the wrong radionuclide for a brachytherapy procedure; (B) An administration of a radioactive drug containing byproduct material by the wrong route of administration; (C) An administration of a dose or dosage to the wrong individual or human research subject; (D) An administration of a dose or dosage delivered by the wrong mode of treatment; or (E) A leaking sealed source.

(iii) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

(A) 0.5 Sv (50 rem) or more the expected dose to that site from the (C) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

(i) 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given according to the written directive prepared or revised before administration; and (ii) Fifty percent or more the expected dose to that site from the procedure if the administration had been given according to the written directive prepared or revised before administration; or (D) For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material, excluding sources that were implanted in the correct site but migrated outside the treatment site, which results in:

(i) The total source strength administered differing by twenty percent or more from the total source strength documented in the post-implantation portion of the written directive; (ii) The total source strength administered outside of the treatment site exceeding twenty percent of the total source strength documented in the post-implantation portion of the written directive; or

68 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and (B) 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

(2) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in (i) The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive; (ii) The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; or (iii) An administration that includes any of the following:

(A) The wrong radionuclide; (iii) An administration that includes any of the following:

(a) The wrong radionuclide; (b) The wrong individual or human research subject; (c) Sealed source or sources implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (d) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

69 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (B) The wrong individual or human research subject; (C) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.

§ 35.3204 new Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentration s

C Add a new § 35.3204 to subpart M to read as follows:

(a) The licensee shall notify by telephone the NRC Operations Center and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in § 35.204(a) at the time of generator elution. The telephone report to the NRC must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

180 NAC 7-120.

7-120. REPORT AND NOTIFICATION FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS. This section addresses the report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

7-120.01 NOTIFICATION BY TELEPHONE WITHING SEVEN CALENDAR DAYS. The licensee must notify the Department and the distributor of the generator by telephone within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 180 NAC 7-045.01 at the time of generator elution. The telephone report to the Department must include the manufacturer, model number, and serial number or lot number of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients

70 NRC Section Title Cat.

Summary of Change to CFR NE Reference Nebraska (b) By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensees equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensees breakthrough determination; and the information in the telephone report as required by paragraph (a) of this section.

or human research subjects, when the distributor was notified, and the action taken.

7-120.02 SUBMISSION OF WRITTEN REPORT. The licensee must submit a written report to the Department within thirty calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by 180 NAC 7-120.01.