§ 35.14 - Notifications.

§ 35.14 Notifications.

Cross Reference

Link to an amendment published at 83 FR 33103, July 16, 2018.

(a) A licensee shall provide the Commission a , 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

the written attestation(s), signed by a preceptor, the

, 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 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

, and

for each individual

no later than 30 days after the date that the

whom the licensee permits

the individual

to work

as an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist,

under

§ 35.13(b). For individuals permitted to work under § 35.13(b)(4), within the same 30-day time frame, the licensee shall also provide, as appropriate, verification of completion of;

(1) Any additional case experience required in § 35.390(b)(1)(ii)(G) for an authorized user under § 35.300;

(2) Any additional training required in § 35.690(c) for an authorized user under § 35.600; and

(3) Any additional training required in § 35.51(c) for an authorized medical physicist.

(b)

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, or 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 authorized user or 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 in accordance with § 35.24(c). ;

(3) The licensee's mailing address changes;

(4) The licensee's 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; or

(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.

(c) The licensee shall send the documents required in this section to the appropriate address identified in § 30.6 of this chapter.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 58805, Oct. 10, 2003; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007; 83 FR 33103, July 16, 2018]