10 C.F.R. Subpart A—General Information
Title 10 - Energy
This part contains the requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, others in this chapter. The requirements and provisions of parts 19, 20, 21, 30, 71, 170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted. Address of use means the building or buildings that are identified on the license and where byproduct material may be received, prepared, used, or stored. Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended. Area of use means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing byproduct material. Authorized medical physicist means an individual who— (1) Meets the requirements in §§35.51(a) and 35.59; or (2) Is identified as an authorized medical physicist or teletherapy physicist on— (i) A specific medical use license issued by the Commission or Agreement State; (ii) A medical use permit issued by a Commission master material licensee; (iii) A permit issued by a Commission or Agreement State broad scope medical use licensee; or (iv) A permit issued by a Commission master material license broad scope medical use permittee. Authorized nuclear pharmacist means a pharmacist who— (1) Meets the requirements in §§35.55(a) and 35.59; or (2) Is identified as an authorized nuclear pharmacist on— (i) A specific license issued by the Commission or Agreement State that authorizes medical use or the practice of nuclear pharmacy; (ii) A permit issued by a Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy; (iii) A permit issued by a Commission or Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or (iv) A permit issued by a Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or (3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or (4) Is designated as an authorized nuclear pharmacist in accordance with §32.72(b)(4). Authorized user means a physician, dentist, or podiatrist who— (1) 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), or 35.690(a); or (2) Is identified as an authorized user on— (i) A Commission or Agreement State license that authorizes the medical use of byproduct material; (ii) A permit issued by a Commission master material licensee that is authorized to permit the medical use of byproduct material; (iii) A permit issued by a Commission or Agreement State specific licensee of broad scope that is authorized to permit the medical use of byproduct material; or (iv) A permit issued by a Commission master material license broad scope permittee that is authorized to permit the medical use of byproduct material. Brachytherapy means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application. Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters. Client's address means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with §35.80. Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. Dentist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry. High dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed. Low dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed. Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates. Manual brachytherapy, as used in this part, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume. Medical event means an event that meets the criteria in §35.3045(a) or (b). Medical institution means an organization in which more than one medical discipline is practiced. Medical use means the intentional internal or external administration of byproduct material or the radiation from byproduct material to patients or human research subjects under the supervision of an authorized user. Medium dose-rate remote afterloader, as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed. Mobile medical service means the transportation of byproduct material to and its medical use at the client's address. Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions. Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration. Pharmacist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy. Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine. Podiatrist means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry. Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer. Prescribed dosage means the specified activity or range of activity of unsealed byproduct material as documented— (1) In a written directive; or (2) In accordance with the directions of the authorized user for procedures performed pursuant to §§35.100 and 35.200. Prescribed dose means— (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; (2) For teletherapy, the total dose and dose per fraction as documented in the written directive; (3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive. Pulsed dose-rate remote afterloader, as used in this part, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the “high dose-rate” range, but— (1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and (2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour. Radiation Safety Officer means an individual who— (1) Meets the requirements in §§35.50(a) or (c)(1) and 35.59; or (2) Is identified as a Radiation Safety Officer on— (i) A specific medical use license issued by the Commission or Agreement State; or (ii) A medical use permit issued by a Commission master material licensee. Sealed source means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material. Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product. Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume. Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training. Teletherapy, as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject. Temporary job site means a location where mobile medical services are conducted other than those location(s) of use authorized on the license. Therapeutic dosage means a dosage of unsealed byproduct material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment. Therapeutic dose means a radiation dose delivered from a source containing byproduct material to a patient or human research subject for palliative or curative treatment. Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive. Type of use means use of byproduct material under §§35.100, 35.200, 35.300, 35.400, 35.500, 35.600, or 35.1000. Unit dosage means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared. Written directive means an authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific patient or human research subject, as specified in §35.40. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 69 FR 55737, Sept. 16, 2004; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006] Each record required by this part must be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. (a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license for the uses authorized on its license. (b) If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research— (1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and (2) Obtain “informed consent,” as defined and described in the Federal Policy, from the human research subject. (c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its NRC medical use license. The amendment request must include a written commitment that the licensee will, before conducting research— (1) Obtain review and approval of the research from an “Institutional Review Board,” as defined and described in the Federal Policy; and (2) Obtain “informed consent”, as defined and described in the Federal Policy, from the human research subject. (d) Nothing in this section relieves licensees from complying with the other requirements in this part. [67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002] Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs or devices. (a) The Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements in this part under control number 3150–0010. (b) The approved information collection requirements contained in this part appear in §§35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 35.655, 35.690, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047 and 35.3067. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and the control numbers under which they are approved are as follows: (1) In §35.12, NRC Form 313, including NRC Form 313A, which licensees may use to provide supplemental information, is approved under control number 3150–0120. (2) [Reserved] [67 FR 20370, Apr. 24, 2002, as amended at 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006] (a)–(c) [Reserved] (d) If a license condition exempted a licensee from a provision of Part 35 on October 24, 2002, then the license condition continues to exempt the licensee from the requirements in the corresponding provision of §§35.1–35.4002. (e) When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern. (f) A licensee shall continue to comply with any license condition that requires it to implement procedures required by §§35.610, 35.642, 35.643, and 35.645 until there is a license amendment or renewal that modifies the license condition. [67 FR 20370, Apr. 24, 2002, as amended at 69 FR 55737, Sept. 16, 2004; 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006] (a) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer byproduct material for medical use only in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraphs (b)(1) or (b)(2) of this section. (b) A specific license is not needed for an individual who— (1) Receives, possesses, uses, or transfers byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in §35.27, unless prohibited by license condition; or (2) Prepares unsealed byproduct material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in §35.27, unless prohibited by license condition. (a) An application must be signed by the applicant's or licensee's management. (b) An application for a license for medical use of byproduct material as described in §§35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must be made by— (1) Filing an original and one copy of NRC Form 313, “Application for Material License,” that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, authorized user(s), authorized medical physicist(s), and authorized nuclear pharmacist(s); and (2) Submitting procedures required by §§35.610, 35.642, 35.643, and 35.645, as applicable. (c) A request for a license amendment or renewal must be made by— (1) Submitting an original and one copy of either— (i) NRC Form 313, “Application for Material License”; or (ii) A letter requesting the amendment or renewal; and (2) Submitting procedures required by §§35.610, 35.642, 35.643, and 35.645, as applicable. (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 information regarding any radiation safety aspects of the medical use of the material that is not addressed in Subparts A through C of this part. (1) The applicant shall also provide 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. (2) The applicant or licensee shall also provide any other information requested by the Commission in its review of the application. (e) An applicant that satisfies the requirements specified in §33.13 of this chapter may apply for a Type A specific license of broad scope. [67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002] A licensee shall apply for and must receive a license amendment— (a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but that is not authorized on the licensee's current license issued under this part; (b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist 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 the requirements in §§35.51(a) and (c) and 35.59; (4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist— (i) On a Commission or Agreement State license or other equivalent permit or license recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy; (ii) On a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; (iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or (iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists. (c) Before it changes Radiation Safety Officers, except as provided in §35.24(c); (d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license; (e) Before it adds to or changes the areas of use identified in the application or on the license, except for areas of use where byproduct material is used only in accordance with either §35.100 or §35.200; (f) Before it changes the address(es) of use identified in the application or on the license; and (g) Before it revises procedures required by §§35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety. [67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006] (a) A licensee shall provide the Commission a copy of the board certification and the written attestation(s), signed by a preceptor, 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, or the permit issued by a Commission master material license broad scope permittee for each individual no later than 30 days after the date that 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) 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 authorized medical 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. (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] A licensee possessing a Type A specific license of broad scope for medical use, issued under Part 33 of this chapter, is exempt from— (a) The provisions of §35.12(d) regarding the need to file an amendment to the license for medical use of byproduct material, as described in §35.1000; (b) The provisions of §35.13(b); (c) The provisions of §35.13(e) regarding additions to or changes in the areas of use at the addresses identified in the application or on the license; (d) The provisions of §35.14(a); (e) The provisions of §35.14(b)(1) for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist; (f) The provisions of §35.14(b)(4) regarding additions to or changes in 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. (g) The provisions of §35.49(a). (a) The Commission shall issue a license for the medical use of byproduct material if— (1) The applicant has filed NRC Form 313 “Application for Material License” in accordance with the instructions in §35.12; (2) The applicant has paid any applicable fee as provided in Part 170 of this chapter; (3) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission in this Chapter for the protection of the public health and safety; and (4) The applicant meets the requirements of Part 30 of this chapter. (b) The Commission shall issue a license for mobile medical service if the applicant: (1) Meets the requirements in paragraph (a) of this section; and (2) Assures that individuals or human research subjects to whom unsealed byproduct material or radiation from implants containing byproduct material will be administered may be released following treatment in accordance with §35.75. The Commission may, upon application of any interested person or upon its own initiative, grant exemptions from the regulations in this part that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart A—General Information
§ 35.1 Purpose and scope.
§ 35.2 Definitions.
§ 35.5 Maintenance of records.
§ 35.6 Provisions for the protection of human research subjects.
§ 35.7 FDA, other Federal, and State requirements.
§ 35.8 Information collection requirements: OMB approval.
§ 35.10 Implementation.
§ 35.11 License required.
§ 35.12 Application for license, amendment, or renewal.
§ 35.13 License amendments.
§ 35.14 Notifications.
§ 35.15 Exemptions regarding Type A specific licenses of broad scope.
§ 35.18 License issuance.
§ 35.19 Specific exemptions.
