United States Nuclear Regulatory Commission - Protecting People and the Environment

Frequently Asked Questions About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35

NRC developed these questions and answers as guidance to illustrate issues that may arise in licensing under revised 10 CFR Part 35. The answers represent NRC staff positions only and do not constitute formal interpretations of the regulations recognized as binding on the Commission by 10 CFR 30.5. They are arranged under the following topics.

On this page:

Index to All Frequently Asked Questions Pages

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Acceptable Variation from Prescribed Dosage

a) Does the requirement for ±20% for dosage apply to both therapeutic and diagnostic dosages? [10 CFR 35.63] (Q&A ID 0802026a)

b) Can a dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range be used for medical purposes? [10 CFR 35.63] (Q&A ID 0802026b)

a) Yes. Under §35.63, that applies to all dosages of unsealed byproduct material for medical use, an authorized user (AU) may prescribe a dosage or a dosage range. The permitted variation for an administered dose from a prescribed dose is ±20%.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR §35.63, as published in the Federal Register on April 24, 2002.

b) Yes. A dosage that differs from the prescribed dosage by more than 20% or is outside of the prescribed dosage range can be used for medical purposes if the AU so directs. This effectively means that before administration of the dosage, the AU modifies the prescription from one prescribed dosage or dosage range to a revised prescribed dosage or a revised prescribed dosage range that encompasses the dosage to be administered.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.63, as published in the Federal Register on April 24, 2002.

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Acceptance Testing of Therapy-Related Computer Systems

Does the acceptance testing described in §35.457 or §35.657, for the treatment planning system of therapy-related computer systems, have to precede the use of the therapeutic equipment? The 2002 revised rule is not clear in this aspect. [10 CFR 35.10, 35.457, 35.657] (Q&A ID 1202010)

Yes. User acceptance testing of a product is conducted by an end-user (licensee) to determine its fitness for use in the given operational environment. This must be accomplished prior to the first operational use of the product. In addition, §35.10 requires a licensee to implement the provisions of Part 35 on or before October 24, 2002. Therefore, systems in use before October 24, 2002 that may have been tested prior to use must be tested again, following the requirements of §35.457 or §35.657, respectively, prior to use after October 24, 2002. If the initial acceptance testing fulfilled the requirements of §35.457 or §35.657, no additional acceptance testing is required.

Under §35.457or §35.657, are licensees required to have their computerized treatment systems functionally tested if their systems have been in service for a long time? [10 CFR 35.457, 35.657] (Q&A ID 0303013)

Yes. However, if the systems have been tested, when installed, or later, in accordance with published protocols currently accepted by nationally recognized bodies, and passed the testing, then the testing required in §35.457 or §35.657 has been satisfied and nothing further is required.

One example of a published protocol accepted by a nationally recognized body which may be used as guidance for testing therapy-related computer systems is Report Number 62 of the American Association of Physicists in Medicine (AAPM), §Quality Assurance for Clinical Radiotherapy Treatment Planning. This report can be found on the AAPM website at www.aapm.org.

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Accuracy of Unit Doses

If a unit dose is received from a nuclear pharmacy, and the licensee does not assay that unit dose (because it is not required to), but the dose was outside the ±20% of the prescription, would the licensee be cited? [10 CFR 35.63] (Q&A ID 0902014)

If the licensee was aware (for example, through the labeling, the procedure manual, or decay correction calculation) that the dosage differed from the prescribed dosage by more than 20% but administered it anyway, without being directed to do so by the authorized user, the licensee would be cited under § 35.63(d).

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Activity "Dosage" Measurements of Unsealed Byproduct Material for Medical Use

How long before an administration ("medical use") may a dosage determination be performed under §35.63(a)? [10 CFR 35.63] (Q&A ID 0103012)

The NRC does not have a prescriptive requirement for when dosage measurements must be performed prior to administration, but licensees must ensure that the administered dosage is within the prescribed range or within ±20 percent of the prescribed dosage, as applicable.

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Adoption of Specific Requirements by Agreement States

What specific requirements within the revised rule do Agreement States have to adopt, and how long do Agreement States have to adopt them? [N/A] (Q&A ID 0302003)

For purposes of compatibility or because of health and safety significance, certain requirements in the revised rule have to be adopted by Agreement States. The specific sections and their compatibility designations are listed in "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," of 10 CFR Part 35, as published in the Federal Register on April 24, 2002 (67 FR 20249). With the exception of the training and experience requirements, the deadline for Agreement States to adopt specific requirements within the revised rule was October 24, 2005, three years after the effective date of the 2002 revised Part 35 as published in the Federal Register on April 24, 2002.

Further amendments to Part 35 training and experience requirements, including recognition of specialty board certification processes and certain other conforming changes, became effective April 29, 2005, thirty days after the publication in the Federal Register on March 30, 2005 (70 FR 16336). The compatibility between NRC and the Agreement States for amended sections is unchanged. These training and experience requirements must be adopted by Agreement States by April 29, 2008, three years after the effective date of the 2005 amendments.

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Agreement State Compatibility

Is there a document that addresses the degree of compatibility for Agreement States that is required for various sections of the rule? [N/A] (Q&A ID 0103038)

Yes, Section X, "Issues of Compatibility for Agreement States", in the Supplemental Information section of the Final Rule, as published in the Federal Register on April 24, 2002, addresses the degree of compatibility for Agreement States that is required for various sections of the rule.

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Agreement State Compatibility for Training and Experience Requirements

Will Agreement States have a grace period to adopt the NRC's revised training and experience (T&E) requirements, after the revised T&E for the Rule is published? [N/A] (Q&A ID 0902008)

Yes, the Agreement States will have 3 years from April 29, 2005, the effective date of the 2005 final rule amending the Part 35 T&E requirements, to adopt compatible regulations.

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Agreement States Recognizing Specialty Boards

Can certifying specialty boards be recognized by an Agreement State? [N/A] (Q&A ID 0103040)

The NRC has in place procedures for recognizing certification processes of specialty boards. In accordance with these procedures, Agreement States may recognize the certification processes of specialty boards that meet requirements of rules compatible, under Compatibility Category B, with those in 10 CFR Part 35. The names of these board certification processes will be included in the listing of recognized board certification processes on the NRC's web site, with annotations indicating which Agreement States recognized the boards' certification processes, after the NRC is notified of the recognition.

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Amendments for New Modalities under §35.1000

If a licensee currently has approval for therapeutic medical uses and wants to add a newly- developed therapeutic modality, is a license amendment required? [10 CFR 33.11, 35.13(a), 35.15(a), 35.400, 35.600, 35.1000] (Q&A ID 0303012)

Yes, if the newly-developed modality is a type of use that is regulated under Part 35, but not specifically authorized on its license. If this is the case, before beginning use, the licensee must apply for and receive a license amendment under §35.1000 to add the new modality to the license. However, for Type A medical broad scope licensees that possess sufficient authorization for licensed material to cover the addition of the new modality, under §35.15(a), a license amendment will probably not be necessary. A medical broad scope licensee wishing to add a new modality should contact the NRC Regional Office for advice prior to submitting an amendment request.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.13, as published in the Federal Register on April 24, 2002.

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Application for License, Amendment, or Renewal -- Meaning of "Equipment"

a) In §35.12, what is the definition of "equipment"?

b) What equipment has to be specifically described? [10 CFR 35.12(b)] (Q&A ID 0802037)

a) For information on NRC's regulatory requirements on equipment for medical use licensees, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Sections 8.14 through 8.19. Equipment includes radiation monitoring instruments, dose calibrators, and other equipment used to measure dosages of unsealed byproduct material, dosimetry equipment, and other equipment, such as fume hoods.

b) Radiation monitoring instruments to be used have to be identified in applications.

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Applying for Use of Sealed Sources under §35.400

To apply for medical use under 10 CFR 35.400, how is the applicant to list the sealed sources for which approval is sought? [10 CFR 35.400] (Q&A ID 0303011)

For each type of sealed source requested for use under §35.400, the applicant should indicate the radionuclide, the manufacturer(s), the model number(s), and the maximum total activity of such sources on-site at any time. For each type of sealed source, the applicant should include all manufacturers and model numbers that may possibly be used in the future, in order to minimize the need for applications for license amendment(s) if the authorized user(s) wants to change model or vendor.

See NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.5, "Radioactive Material."

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Approval for AUs

If a physician is listed as an AU on an Agreement State (AS) license for a medical use, will the NRC accept that physician's training and experience (or authorization as an AU) as evidence that the physician may be listed as an AU for the same medical use on an NRC license? [10 CFR 35.13(b), 35.14(a), 35.15, 35.57, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 35.491, 35.590, 35.690] (Q&A ID 0301010)

Yes. If a physician is identified as an AU for a medical use on an AS license, the physician may be listed as an AU on an NRC license for the same medical use. See 10 CFR 35.13(b) and §35.57. Note that a license amendment is not needed to permit the physician to begin work as an AU under the NRC license. However, for licensees other than those possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), a copy of the AS license would have to be submitted to the NRC within 30 days. See 10 CFR 35.14(a).

Could a physician moving to a new facility, listed as an AU on an NRC or Agreement State (AS) license for a medical use (e.g., HDR) under a 'type of use' as defined in 10 CFR 35.2 (e.g., 10 CFR 35.600), be listed on an NRC license for a different medical use under the same type of use (e.g., Gamma Knife)? [10 CFR 35.390, 35.392, 35.394, 35.396, 35.690] (Q&A ID 0106001)

Only if the physician who is seeking to be listed as an AU for a different medical use under the same type of use complies with any additional case experience or training required as specified in the regulations for the medical use for which the physician is seeking recognition. The licensee would have to provide 1) a copy of the AS or NRC license and 2) verification of completion of the required additional case experience or training specified in 10 CFR 35.14(a).

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Approval for AUs -- Other Medical Uses

a) What are the training and experience (T&E) requirements for 10 CFR 35.1000?

b) Will a preceptor statement be required? [10 CFR 35.12, 35.1000] (Q&A ID 0902007)

Section 35.1000 does not include specific training and experience requirements for AUs of emerging technologies because training requirements necessary for the safe use of byproduct material in new technologies are not known in advance.

a) 10 CFR 35.12(b)(1) requires applicants to submit T&E information for individuals who are to serve as authorized user(s), authorized medical physicist(s), authorized nuclear pharmacist(s), and radiation safety officer(s) for the purpose(s) for which licensed material will be used, as specified in the application for license or amendment. NRC will be evaluating this information on a case-by-case basis to determine whether the T&E of the identified individuals is appropriate for the proposed use. NRC staff will look first to the T&E requirements in other sections of 10 CFR Part 35 for similarities to evaluate the sufficiency of T&E of individuals identified in the application. It is likely, except for unique circumstances, that the T&E requirements for individuals identified for a Subpart K (§35.1000) use will closely match the established T&E requirements in other sections of 10 CFR Part 35. Additionally, licensing guidance for 10 CFR 35.1000 uses that have already been identified is provided on the NRC Web site and addresses T&E requirements for each medical use.

b) Not specifically; however, NRC has established in its other training and experience requirements that a preceptor statement concerning the individuals completion of appropriate training and experience and ability to function independently is a necessary component for evaluating the individual's qualification. Individuals seeking AU recognition for new (i.e., not previously licensed) medical uses under 10 CFR 35.1000 should submit a written attestation from a person (or persons) knowledgeable about the radiation safety aspects of the new medical use and the associated equipment, if applicable. A preceptor statement should also be submitted for medical uses that are or have been licensed under 10 CFR 35.1000. In this case, the preceptor could be an AU for the same 10 CFR 35.1000 use.

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Approval for Authorized Medical Physicist, Authorized Nuclear Pharmacist, or Authorized User

Is NRC's approval required before an individual can begin duties as an AMP, ANP, or AU under an NRC license? [10 CFR 35.13(b), 35.14(a), 35.15, 35.59] (Q&A ID 0301001)

In accordance with 10 CFR 35.13(b), an individual can begin duties as long as one of the following three conditions applies:

  1. The individual

  2. (a) is certified by a specialty board recognized by NRC that is appropriate for his or her intended responsibilities under the license,

    (b) has a written attestation signed by a preceptor, and

    (c) has any additional training beyond the specialty board training, as specified in 10 CFR 35.14(a), §35.51(a), §35.390(a), or §35.690(a), as applicable

    Note that, for this condition, the individual's training and experience must have been obtained within the preceding seven years, or the individual must have had related continuing education and experience.

  3. The individual is similarly identified (i.e., as an AMP, ANP, or AU) on

  4. (a) a Commission or Agreement State (AS) medical use license or nuclear pharmacy license recognized by NRC, or

    (b) a permit issued by a Commission or AS licensee of broad scope, including medical use or nuclear pharmacy activities, or

    (c) a permit issued by a Commission master material licensee authorized for medical use or nuclear pharmacy activities.

  5. For ANPs, the individual is identified as an ANP by a commercial nuclear pharmacy licensee authorized to identify ANPs.

However, except for licensees possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), the licensee is required by §35.14(a) to provide to the Commission within 30 days of the individual beginning work for the licensee as an AMP, ANP, or AU a copy of 1) the relevant board certification, the preceptor written attestation, and documentation of additional training, if specified; 2) the license; or 3) the permit. For individuals identified on a license or permit, the new licensee is also required by 10 CFR 35.14(a) to provide verification of completion of any added case experience or training requirements in 1) §35.390(b)(1)(ii)(G) for an AU under §35.300, 2) §35.690(c) for an AU under §35.600, and 3) §35.51(c) for an AMP.

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Approval for Permanent or Temporary Radiation Safety Officer

Is NRC's approval required before an individual can begin duties as a permanent RSO for an existing license? [10 CFR 35.13(c), 35.14(b), 35.24(c), 35.24(d), 35.50, 35.59] (Q&A ID 0301002)

Yes. However, the licensee can appoint individuals as temporary RSOs under the license for up to 60 days each year without prior NRC approval. To be so appointed, an individual must either be qualified to be an RSO or be an AMP, ANP, or AU identified on the licensee's license and have experience with the radiation safety aspects of similar types(s) of use(s) of byproduct material for which the individual will have RSO responsibilities. If necessary for complete radiation safety coverage of activities conducted under the license, the licensee may simultaneously appoint more that one temporary RSO.

If the RSO named on the license has permanently discontinued performance of duties under the license or has a name change, the licensee must notify the NRC by letter no later than 30 days after such discontinuation of performance of duties or name change.

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Approval for RSOs

Can a licensee, if appropriate to its operations, appoint deputy radiation safety officers (RSOs) for particular medical uses? [10 CFR 35.12, 35.24] (Q&A ID 1002003)

Nothing in the regulations prohibits a licensee from appointing deputy RSOs; however, as provided in 10 CFR 35.24(b), at any given time, only one RSO can be designated by a licensee, and that individual must be identified on the license. A licensee can, through its appointed RSO (who has responsibility for implementing the licensee's radiation protection program), assign or delegate radiation safety program tasks and duties, but not responsibilities, associated with particular medical uses, as approved under its license, to individuals that can be designated in any way the licensee chooses, including as deputy RSOs. These individuals can, but need not, be authorized users in the particular medical uses. However, the single RSO identified on the license retains overall responsibility for implementing the total radiation protection program. Additionally, as necessary, the licensee may appoint a temporary RSO or temporary RSOs to perform the functions of an RSO, as provided for in 10 CFR 35.24(c) and §35.24(d).

See NUREG-1556, Vol. 9, Rev. 1, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.10, "Radiation Safety Officer (RSO)" and Appendix I.

If an individual is listed as the RSO on an AS license, will the NRC accept that individual as having adequate training and experience to be listed as a RSO on a NRC license? [10 CFR 35.2, 35.13(c), 35.50] (Q&A ID 0301011)

An individual who is listed as a Radiation Safety Officer (RSO) on an Agreement State (AS) medical use license may be approved as an RSO on an NRC medical use license for those uses for which he or she has been previously approved. The definition of RSO in 10 CFR 35.2 defines "Radiation Safety Officer" in pertinent part as an individual who is identified as a Radiation Safety Officer on a specific medical use license issued by an Agreement State. This provision allows an individual listed on an AS medical use license to be listed as an RSO on an NRC license. However, pursuant to 10 CFR 35.13(c), a license amendment is needed before the individual can begin work as the RSO for the licensee.

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Authorization for Manual Brachytherapy Seeds

Regarding sealed sources for manual brachytherapy, "seeds" do two different models, from two different manufacturers, have to be listed on an application for license or license amendment? [10 CFR 30.32(g), 32.210(c)] (Q&A ID 0303016)

Yes. Section 30.32(g) requires applicants to provide the manufacturer's name and model number for each sealed source requested for use or supply the information identified in §32.210(c).

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Authorization for Medical Research in Humans

a) In the model license in NUREG-1556, Vol. 9, Rev 1 for a medical licensee of limited scope, licensees may use any byproduct material permitted by §35.100, 200, and 300. What byproduct materials are "permitted" for research use? [10 CFR 32.72, 32.74, 35.2, 35.6, 35.100, 35.200, 35.300] (Q&A ID 1202019a)

b) In §35.100, 200, and 300, it appears that "permitted" research is restricted in the regulations for these parts to research that either has approval from a Radioactive Drug Research Committee (RDRC) or is conducted under an Investigational New Drug (IND) protocol (for §35.300, only an IND). Is this correct? [10 CFR 32.72, 35.100, 35.200, 35.300] (Q&A ID 1202019b)

a) Section 35.2 defines "medical use" as 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. Accordingly, each licensee authorized for medical use is authorized for medical research as long as the requirements of §35.6, "Provisions for the protection of human research subjects" are met.

Any byproduct material that meets §32.72 requirements for administration to humans or is contained in a sealed source meeting §32.74 regulatory requirements for application of radiation from such sources to humans can be used, by a licensee authorized for medical use, for research involving human subjects.

Other research not involving administration to humans, must be specifically requested and authorized on the license.

b) No. The authorizations in §35.100, 200, and 300 do not restrict research to RDRC-approved or IND protocols. Licensees conducting medical research in humans are not limited to use of byproduct materials prepared for use in research in accordance with a RDRC-approved application or an IND protocol accepted by the U.S. Food and Drug Administration (FDA). These authorizations permit licensees to use materials that are not obtained from a §32.72 licensee (radioactive drug manufacturer or commercial nuclear pharmacy) or prepared by the properly trained authorized user, as long as the radioactive drug was prepared in accordance with an RDRC-approved or IND protocol.

Byproduct materials obtained from manufacturers or preparers meeting the requirements listed in Sections 35.100(a) or (b), 35.200(a) or (b), and 35.300(a) or (b) may also be used for medical research in humans. For example, byproduct material obtained from a manufacturer licensed under §32.72 can be used in research.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.100, §35.200, and §35.300, as published in the Federal Register on April 24, 2002.

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Authorized Medical Physicists and Decay of Sr-90 Sources for Ophthalmic Treatments

When a licensee is authorized to perform ophthalmic treatments, is the licensee required to have an authorized medical physicist (AMP) listed on the license in order to meet the requirement in §35.433(a)? [10 CFR 35.13(b), 35.14, 35.433(a)] (Q&A ID 0103019)

Yes. 10 CFR 35.433(a) specifies that only an AMP shall calculate the activity of each Sr-90 source that is used to determine the treatment times for ophthalmic treatments. Therefore, the licensee must identify individual(s) to work as AMP(s) under the license. This identification must be made by amendment in accordance with §35.13(b), or if applicable, by notification in accordance with §35.14.

When the licensee applies for an amendment to add an AMP, the amended license will list the individual as an AMP when approved. If the licensee provides notification of a new AMP with the appropriate documentation, the AMP will be listed on the next license amendment or renewal.

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Authorized Nuclear Pharmacist as Radiation Safety Officer

Can an authorized nuclear pharmacist (ANP) identified on a license become the radiation safety officer (RSO) for that license? [10 CFR 35.13(c), 35.24(b), 35.50(c)(2),(d) and (e), 35.55] (Q&A ID 0301020)

Yes. However, the ANP, like the AU or authorized medical physicist (AMP), must have 1) experience with the radiation safety aspects of similar types of byproduct material for which the individual would have RSO responsibilities, 2) training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval, and 3) a preceptor RSO written attestation for this training that: (a) the individual is an ANP identified on the licensee's license; (b) the ANP has satisfactorily completed the training in (2); and (c) the AU has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee. Additionally, the ANP must agree, in writing, to be responsible for implementing the radiation protection program.

Further, the licensee must apply to NRC for an amendment, as required under 10 CFR 35.13(c), and submit the ANP's training and experience qualifications to serve as RSO.

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Authorized User as Radiation Safety Officer -- Qualifications

When can an AU be appointed as the RSO for a medical use license? [10 CFR 35.13(c), 35.24(b), 35.50] (Q&A ID 0802009)

An AU can be appointed as the RSO for a license if the AU (1) is identified as an AU in the license, (2) has experience with the radiation safety aspects of similar types of use of byproduct material for which the individual will have RSO responsibilities, (3) has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval, (4) has obtained written attestation, signed by a preceptor RSO, that: (a) the individual is an AU identified on the licensee's license; (b) the AU has satisfactorily completed the training in (3); and (c) the AU has achieved a level of radiation safety knowledge sufficient to function independently as an RSO for a medical use licensee. Additionally, the AU must agree, in writing to be responsible for implementing the radiation protection program.

Note that a license amendment is needed before the individual can begin work as the RSO for the license. See 10 CFR 35.13(c).

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Authorized User Work Experience and Clinical Experience for Multiple Therapeutic Devices

Can a physician be granted authorized user status for multiple therapeutic units (teletherapy units and/or remote afterloader units and/or gamma stereotactic radiosurgery units) based on completion of a single structured educational program? [10 CFR 35.13, 35.690] (Q&A ID 0301003)

Yes, if the program covers the requirements in 10 CFR 35.690.

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Beta-Emitting Remote Afterloaders

Does the new 10 CFR § 35.600 apply to beta-emitting remote afterloaders in addition to addressing photon-emitting afterloader units? [10 CFR 35.600, 35.1000] (Q&A ID 0301004)

No. Use of beta-emitting afterloader devices must be addressed under 10 CFR 35.1000.

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Calibration Measurements for Intravascular Brachytherapy Sources

According to the intravascular brachytherapy (IVB) licensing guidance, IVB source output/activity must be checked by the licensee using a dosimetry system described in 10 CFR 35.630.

a) Why does this measurement have to be done using dosimetry equipment having the same requirements as for measurements of high dose-rate remote afterloader sources?

b) Why can't the licensee rely on the source output/activity as measured by the manufacturer, as is permitted for manual brachytherapy sources? [10 CFR 35.2, 35.12(d), 35.432, 35.630, 35.633, 35.1000] (Q&A ID 0802050)

a) The measurement requirement in the IVB licensing guidance reflects the high dose rates from sources used in IVB. These dose rates exceed the threshold for classifying remote afterloader brachytherapy devices as high dose-rate type. NRC believes that for such high dose-rate sources, use of the dosimetry equipment described in § 35.630 is warranted, to ensure that the correct dose is administered to patients.

b) Use of manufacturer-supplied measurements is only permitted for low dose-rate remote afterloader units and for sources used for manual brachytherapy, when such measurements are made in accordance with the requirements in § 35.432 (for manual use sources) or § 35.633 (for low dose-rate remote afterloader units). As noted above, the dose rates from IVB sources exceed the limit for classification as low-dose rate sources.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432 and § 35.630, as published in the Federal Register on April 24, 2002.

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Calibration Measurements of Batched Brachytherapy Sources

If a licensee receives a "batch" of manual brachytherapy sources (e.g., iodine-125 seeds), does the licensee have to determine source output or activity of each brachytherapy source before the first medical use or can the licensee take a representative sample from the batch of seeds and use that output/activity for all of the seeds in the batch? [10 CFR 35.432] (Q&A ID 0301018)

The NRC does not preclude a sampling of short half-life sources when received in a large batch. The rule requires that the calibration be performed using published protocols accepted by nationally recognized bodies, such as the American Association of Physicists in Medicine (AAPM). Such protocols require calibration of varying percentages of samples of seeds, depending on whether the seeds are loose or in ribbons. If applicable, the licensee must ensure that the published protocol allows for sampling of sources that have not been previously calibrated.

To fulfill the calibration requirement, the licensee can also use calibration measurements provided by the source manufacturer or by a calibration laboratory accredited by AAPM, as long as the measurements are done in accordance with a published protocol accepted by a nationally recognized body and using appropriately calibrated equipment. However, NRC believes that it is good practice to verify the calibration provided by the manufacturer. Reference "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432, as published in the Federal Register on April 24, 2002.

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Calibration Measurements of Brachytherapy Sources

Provide guidance for the historic quality of calibrations for older brachytherapy sources to meet the new requirements in § 35.432. [10 CFR 35.432, 35.630(a)] (Q&A ID 0802042)

Under § 35.432(a), brachytherapy sources require calibration in a specific manner before first medical use on or after October 24, 2002. Pre-October 24, 2002 calibrations performed by the licensee, or others,* would have to have been done in accordance with all of the requirements in § 35.432(a) in order to be acceptable for source usage on or after October 24, 2002, the effective date of the Final Rule. Note that the required calibration measurements include determining source positioning accuracy within applicators.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432 and § 35.630, as published in the Federal Register on April 24, 2002.

*A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine as long as the measurements were made in accordance with § 35.432(a).

What explicitly is required for licensee calibration measurements of sources to be used for manual brachytherapy? [10 CFR 35.432, 35.630(a)] (Q&A ID 0802022)

The requirements for licensees doing calibration measurements of brachytherapy sources are contained in 10 CFR § 35.432. The licensee doing such measurements must (1) determine the source output or activity using a dosimetry system that meets the requirements of § 35.630(a) and (2) use a published protocol that is currently accepted by a nationally recognized body.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432, as published in the Federal Register on April 24, 2002.

Do licensees have to independently verify the output or activity of their brachytherapy sources (Cs-137, Ir-192, I-125, Pd-103) to make sure the information supplied by the manufacturers of these sources is correct? If so, do licensees have to verify each individual brachytherapy source or is an assay of, say, 10% good enough? [10 CFR 35.432, 35.630(a)] (Q&A ID 0802001)

For the first medical use of a brachytherapy source on or after October 24, 2002, licensees are not required to independently verify (determine) the source output or activity provided that the licensee is using measurements of source output or activity provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine and that the measurements were obtained using a published protocol currently accepted by a nationally recognized body.

With respect to the question regarding statistical sampling, see Q&A ID 0301018.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432, as published in the Federal Register on April 24, 2002.

I-125 implant seeds come to us from another licensee. We do not have the capability to assay these seeds before use, as described in § 35.432. Is this a violation? [10 CFR 35.432, 35.630(a)] (Q&A ID 0802013)

Generally, if you, as an NRC licensee, use these seeds without assaying them, it would be a violation. As written, the requirement is that each licensee must calibrate its brachytherapy sources before the first medical use at the licensee's facility unless the output or activity information used by the licensee was supplied by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM) and the measurements were made using a dosimetry system that meets the requirements of § 35.630(a) and following a published protocol currently accepted by nationally recognized bodies. Accordingly, calibrations of the seeds that are supplied to or done by the other licensee will not satisfy this requirement.

However, if the seeds were delivered to you from the other licensee as an unopened identified transshipment from the manufacturer or from an AAPM-accredited calibration laboratory who also supplied the activity information, this would be considered to be the same as if the seeds were directly shipped to you. A similar situation would exist if the seeds, as well as the corresponding measurements made by the supplying manufacturer or AAPM-accredited calibration laboratory, were shipped by a supplying licensee who, pursuant to authorization under its license, had established and implemented quality assurance procedures, geared to ensure that seeds supplied to it, with the corresponding measurements were directly transmitted to you.

In either of these cases, measurements made by the manufacturer or by the AAPM-accredited calibration laboratory in accordance with § 35.432(a) and provided to you could be used to satisfy the requirement.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432, as published in the Federal Register on April 24, 2002.

Can a licensee use a dose calibrator to meet the intent of §35.630 (Dosimetry equipment) to achieve compliance with §35.432 (Calibration measurements of brachytherapy sources)? [10 CFR 35.432, 35.630(a)] (Q&A ID 1202011)

Yes, as long as the various calibration conditions for the equipment specified in §35.630(a) are met.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.432, as published in the Federal Register on April 24, 2002.

If a Cesium-137 source calibration is performed by a manufacturer who uses a well ionization chamber and intercompares the source output directly to the same type of brachytherapy source that was calibrated by the National Institute of Standards and Technology, is anything further needed to meet the requirements of §35.432? [10 CFR 35.432, 35.630(a)] (Q&A ID 0103017)

A licensee is responsible for establishing that a manufacturer's source calibration was performed in accordance with the applicable provisions in the revised Part 35. If the licensee cannot reach a conclusion, then the source should be recalibrated. While the information provided in the question is not indicative of a problem, it is not sufficient to demonstrate full compliance.

However, the Radiological Physics Center of the University of Texas M.D. Anderson Cancer Center in Houston, TX, has reported that there is close agreement between manufacturer calibration results for Cs-137 brachytherapy sources and recent calibrations performed in accordance with the rule.

Accordingly, inspectors who find that licensees have manufacturers' calibration records, such as those in the question, for Cs-137 sources should not devote further inspection efforts in a review of the manufacturer's calibration procedures or equipment.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.432, as published in the Federal Register on April 24, 2002.

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Calibration Measurements of Manual Brachytherapy Sources

Who is to perform required calibrations of sources used for manual brachytherapy? [10 CFR 35.432] (Q&A ID 0103015)

Section 35.432 allows for these measurements to be provided by the source manufacturer or an American Association of Physicists in Medicine-accredited calibration laboratory, or to be performed by the licensee. The licensee is responsible for ensuring that the calibration requirements of §35.432 are met, regardless of who performs the measurements. For licensees who perform their own source calibrations, the rule does not specify a particular staff position among the licensee's staff who is to perform the calibrations.

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Calibration of "Dose Calibrators"

If a manufacturer's instructions for calibrating an instrument state that the person carrying out the calibration "should" do something, but not "shall" do something, what is the regulatory requirement? [10 CFR 35.60] (Q&A ID 0902012)

Section 35.60 permits calibration of instrumentation used to measure the activity of unsealed byproduct material to be done in accordance with the manufacturer's instructions (or in accordance with nationally recognized standards). If a step or procedure in the manufacturer's instructions for calibration is not identified as required, but is specified as optional, the licensee need not perform the step or procedure in order to have carried out a calibration meeting the requirement of § 35.60.

Under the revised rule, can I continue to calibrate dose calibrators following NRC's Regulatory Guide (RG) 10.8? [10 CFR 35.60] (Q&A ID 0103025)

No. Under 10 CFR 35.60, licensees must perform the required calibrations in accordance with nationally recognized standards or the manufacturer's instructions. RG 10.8 is not a nationally recognized standard or a manufacturer's instruction and may not be used. (Note also that RG 10.8 has been superceded by NUREG-1556, Vol.9, Rev. 1.)

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.60, as published in the Federal Register on April 24, 2002.

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Calibration of Instruments for Measuring Activity

For an instrument used to measure the activity of unsealed byproduct material, does the absence of manufacturer's instructions for calibration mean that calibration is not required? [10 CFR 35.60] (Q&A ID 1202026)

No. Section 35.60 requires calibration of such instrumentation in accordance with either the manufacturer's instructions or nationally recognized standards. Therefore, if the manufacturer did not provide calibration instructions, the licensee must calibrate the instrument in accordance with nationally recognized standards.

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Calibration of Therapy Units

With respect to the requirements for performing calibrations on therapy units (e.g., 10 CFR 35.632, etc.), the regulation states that the calibrations must be performed by an authorized medical physicist (AMP). In practice, the actual work is often performed under the supervision of the AMP. Will this continue to be an acceptable practice? [10 CFR 35.51, 35.632(f), 35.633(h), 35.635(f)] (Q&A ID 1002005)

No. In fact, the former Part 35 regulations required that full calibrations (and physical decay corrections) for teletherapy units be performed by an authorized medical (teletherapy) physicist. The requirement for full calibrations and physical decay corrections of teletherapy, remote afterloader, and gamma stereotactic radiosurgery units to be performed by an AMP is clearly stated in § 35.632(f), §35.633(h), and §35.635(f), respectively.

This requirement does not preclude an AMP from providing training and experience in therapy unit calibration to a medical physicist in training, under § 35.51, as long as the AMP is physically present during and directly involved in all required calibrations of such units.

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Changes in Authorization for High Dose-rate Remote Afterloading Brachytherapy Authorized Users and Authorized Medical Physicists

Personnel currently authorized for remote afterloader use on an existing license(s), both medical physicists and physicians, were previously authorized under §35.400 but, under the revised rule, this authorization changes to under §35.600. If an authorized individual is named on an existing license, does the licensee have to submit a license amendment request to the NRC for this change? [10 CFR 35.13] (Q&A ID 0103021)

A license amendment request is not required from the licensee. Under §35.13, a licensee does not need to apply for a license amendment before it permits an individual presently identified as an AMP or AU on an existing license to work. At the time of the next amendment or renewal of the license, the NRC will make the necessary changes to the license to clarify the device used and uses as described in the current rule.

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Change of Mailing Address

a) Is a license amendment request required for a change of [mailing] address? [10 CFR 35.13(f), 35.14(b)(2)] (Q&A ID 0103039a)

No. The licensee can use the notification process in §35.14 for a change in the licensee§s mailing address. However, a licensee must apply for and receive an amendment before it changes the address(es) of use identified in the application or on the license.

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Change of Licensee Name

b) Is a license amendment request required for a change in the company name? [10 CFR 30.34(b), 35.14(b)(3)] (Q&A ID 0103039b)

The licensee can use the notification process in §35.14 for a simple name change as long as the name change does not constitute a transfer of control of the license as described in 10 CFR 30.34(b). However, a licensee must apply for and receive a license amendment if the name change constitutes a transfer of control of the license.

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Clarification on the Definition of "Annual"

What is the policy on "annual?" For example, when is an action late? (+/- 25%, calendar year?) [10 CFR 35.61, 35.310, 35.410, 35.610, 36.2] (Q&A ID 1202005)

Use of the word "annual," as it appears in Part 35 is usually associated with the frequency with which a function must be performed. For example, §35.310 requires licensees to provide radiation safety instruction annually. While there is no definition of "annual" in Part 35, NRC staff looks to other Parts of 10 CFR in order to implement the requirements of Part 35. The staff uses the definition of "annual" as it appears in §36.2. The definition of "annual" in §36.2 is: 1) at intervals not to exceed 1 year or 2) once per year, at about the same time each year, plus or minus one (calendar) month.

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Classification and Uses of Sources and Devices

What FDA category are Novoste and any other beta-emitting intravascular brachytherapy (IVB) devices with cranks (remote or manual) under? Should the Sealed Source and Device (SS&D) Registry make a distinction?
[10 CFR 35.400, 35.500, 35.600, 35.1000] (Q&A ID 0103022)

FDA uses very broad classification categories, such as medical device, pharmaceutical, or biologic. Thus, under FDA's classification system, all sources and devices used to perform brachytherapy procedures would be classified as medical devices. Since October 24, 2002, all SS&D certificates classify sources and devices into §35.400, 35.500, 35.600, and 35.1000 uses. A supplement to the SS&D Registry does the same for Agreement State-generated certificates issued before October 24, 2002. All beta-emitting IVB sources are currently classified under §35.1000.

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Clinical Activities Credited Toward 700 Hour T&E Requirement

May clinical work experience that is not related to radiation safety, such as reviewing case histories or interpreting scans, be counted toward the 700 hour training and experience requirements in §35.290(c)(1) and §35.390(b)(1)? [10 CFR 35.290(c)(1), 35.390(b)(1)] (Q&A ID 0407001)

The regulatory requirements refer to two categories of training: (a) classroom and laboratory training, and (b) supervised work experience. All hours credited to "classroom and laboratory training" must relate directly to radiation safety and safe handling of byproduct material. The classroom and laboratory training may be obtained using a variety of instructional methods, as long it meets the specific clock hour requirements and the subject matter relates to radiation safety and safe handling of byproduct material for the uses for which authorization is being requested.

The supervised work experience for physicians must include, but is not limited to, the subject areas listed in the applicable training and experience requirements. The NRC recognizes that physicians in training may not dedicate all of their supervised work experience§ time specifically to the subject areas listed in the regulatory requirements (i.e., §35.290(c)(1)(ii) and §35.390(b)(1)(ii)) and will be attending to other clinical matters involving the medical use of the material (e.g., reviewing case histories or interpreting scans). Even though these clinical activities are not specifically required by the NRC, this type of supervised clinical experience may be credited toward the §work experience§ category to obtain the required total of 700 hours of T&E, but not to the §classroom and laboratory training§ category.

Refer to Supplementary Information, Section IV, §Summary of Public Comments and Responses to Comments,§ Part II, §General Issues,§ Issue 7, §Should the term "laboratory training§ be defined?" as published in the Federal Register on March 30, 2005, and Supplementary Information, Section III, "Summary of Public Comments and Responses to Comments," Part II, "General Issues," Item E, "Training and Experience," Issue 6, "How Long Should the Training Programs Be for Individuals Who Would Like To Become AUs Under "§35.190, 35.290, and 35.390?," as published in the Federal Register on April 24, 2002.

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Compliance With Conditions in Licenses Issued Under the Previous Rule

Some §35.100 and/or §35.200 use licensees have previously committed to using procedures from Regulatory Guide 10.8. Are such licensees required to comply with those procedures after October 24, 2002, the effective date of the new rule? [10 CFR 35.10, 35.13, 35.26, 35.2026] (Q&A ID 1202024)

No. Licensees are not required to comply with procedures in Regulatory Guide 10.8 that they previously committed to follow, when the procedures differ from a regulatory requirement in the revised regulations. 10 CFR 35.10(e) provides that when a written requirement in Part 35 differs from the requirement an existing license condition, the requirement in Part 35 will govern.

In addition, Section 35.26 allows licensees to alter their procedures covering these topics without NRC approval, as long as 1) the alterations do not require an amendment pursuant to §35.13,* 2) the revisions are in compliance with the regulations and the license, 3) the alterations are approved by both the Radiation Safety Officer and licensee management, and 4) affected individuals are instructed on the revisions before the changes are implemented.

The licensee must retain a record of each change, for 5 years, in accordance with §35.2026.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.10 and §35.26, as published in the Federal Register on April 24, 2002.

___________________
*Revision of procedures required by §35.610, 642, 643, and 645 require a license amendment, as stated in §35.13(g), if the revision reduces radiation safety. (The topics for these procedures were not included in the RG 10.8 model procedures.)

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Decay-In-Storage for Radioactive Wastes

Do the decay-in-storage provisions of §35.92 apply to radioactive wastes from in-vitro or animal use of byproduct material that the medical licensee may conduct? [10 CFR 20.2001, 31.11, 33.11, 35.92] (Q&A ID 0303004)

No. In-vitro or animal uses of byproduct material are regulated under 10 CFR Parts 31 and 33, and not under Part 35.

Part 20, Subpart K, provides general requirements for various waste disposal methods, including decay-in-storage. When appropriate for authorized non-medical uses, the license will be amended to include a standard condition to address the decay-in-storage disposal process requirements, under Part 20, for these uses.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.92, as published in the Federal Register on April 24, 2002.

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Decay of Sr-90 Sources for Ophthalmic Treatments

Will it be acceptable to NRC if an authorized medical physicist (AMP) develops an activity vs. time (decay) chart or table for a Sr-90 ophthalmic applicator that the licensee can use to determine patient treatment times? (This scenario would apply when the licensee does not have a full-time AMP on staff and relies on an AMP consultant.) [10 CFR 35.12, 35.400, 35.432, 35.433] (Q&A ID 0902005)

No. Section 35.433 requires that only an AMP calculate the activity of each Sr-90 source used for brachytherapy, with the decay based on the activity determined under § 35.432. The involvement of the AMP, whether a full-time associate or a consultant, is to include performing a periodic verification that the corrected activity is being applied correctly. The Supplementary Information clarifies that, given the risks associated with the use of strontium-90 and numerous misadministrations in this area, more prescriptive requirements are warranted to ensure that the activities of strontium-90 sources are correctly determined and applied.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments," and Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35," for 10 CFR 35.433, as published in the Federal Register on April 24, 2002.

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Decommissioning Financial Assurance -- Limited Specific Medical Use Licensees

In the model license in NUREG-1556, Vol. 9 for a medical licensee of limited scope, what is the purpose of License Condition 13, which restricts possession limits, to avoid the need for submitting a decommissioning financial assurance plan? [10 CFR 30.35, 35.100, 35.200] (Q&A ID 1202020)

The license condition enables NRC and the licensee to better define the scope of the licensee's program. The license condition places a limit on quantities that may be possessed in order to ensure compliance with 10 CFR 30.35, which establishes requirements for applicants to submit a decommissioning funding plan, without materially reducing licensee flexibility on use.

When the licensee requests the maximum amount to be possessed for § 35.100 and/or § 35.200 uses as "as needed," without putting limits on total activity or activity per nuclide, the NRC staff is unable to determine the scope of activities to be conducted under an NRC license, because there is no upper bound on quantities or number of radionuclides to be possessed and used.

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Definition for "Misadministration"

Is a definition for "misadministration" missing from the Final Rule? [10 CFR 35.2, 35.3045(a)] (Q&A ID 0802003)

No. The term "misadministration" does not appear in the Final Rule and, therefore, no definition is needed. The term "medical event" does appear and is defined.

For discussion of replacement of "misadministration" by "medical event" in the Final Rule, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.3045, as published in the Federal Register on April 24, 2002.

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Definition of Management

Will the NRC provide more guidance for the definition of "management" in the regulations?
[10 CFR 35.2, 35.12, 35.24, 35.26] (Q&A ID 0103028)

No. Section 35.2 defines "management" as 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. In addition, the responsibilities and duties of management are included in certain other regulations in Part 35; e.g., 35.12, 35.24 and 35.26.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.3, as published in the Federal Register on April 24, 2002.

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Definition of Written Directive, and Use of I-125

The definition of "written directive" in the 2002 revised Part 35 deleted the reference to quantities greater than 30 microcuries of I-125. Does the use of I-125 for diagnostic purposes require a written directive? The revised §35.40 (Written directive) does not mention I-125 either. [10 CFR 35.2, 35.40, 35.100, 35.200, 35.300] (Q&A ID 1202009)

Use of I-125 for diagnostic purposes [under §35.100 or §35.200], regardless of activity, does not require a written directive. However, use of I-125 for therapeutic purposes [under §35.300], regardless of activity, does require a written directive.

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Definitions -- Master Material License

Is it necessary to define "master material license" (MML) in 10 CFR Part 35? (Note that the definition of MML appears in NUREG-1556, Vol. 10, "Consolidated Guidance About Material Licenses: Program-Specific Guidance About Master Material Licenses.") [10 CFR 35.2] (Q&A ID 0902002)

No. Even though the term appears in the rule (e.g., in § 35.14), the term is not specific to medical use of byproduct material.

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Delegation of Supervisory Responsibilities

Can the authorized user (AU) delegate supervisory responsibilities to a chief technician who supervises others in specific tasks associated with using or preparing byproduct material? [10 CFR 35.27] (Q&A ID 0103043)

Only AUs and authorized nuclear pharmacists (ANPs) are authorized to use or prepare, respectively, byproduct material in the practice of medicine. However, it is frequently necessary for an AU or ANP to delegate specific tasks associated with the use or preparation of byproduct material in the practice of medicine to other individuals. Section 35.27 allows for this delegation of tasks as long as the individuals are properly supervised and instructed. The AUs and ANPs are best suited for determining tasks that supervised individuals can perform and the degree of supervision that each individual needs.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.27, as published in the Federal Register on April 24, 2002.

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Difference Between "Address of Use" and "Areas of Use"

For license amendment requests, what is the difference between "address of use identified in the application or on the license" [§35.13(f)] and "areas [locations] of use identified in the application or on the license" [§35.13(e)]? [10 CFR 35.2, 35.12, 35.13] (Q&A ID 1202029)

As defined in 10 CFR 35.2, the "address of use" is the building or buildings, identified on the license, at which byproduct material may be received, prepared, used, or stored. "Areas of use" means a portion of an address of use that has been designated for the purpose of receiving, preparing, using, or storing byproduct material. For example, if radioactive material is to be used at 123 Main Street in Rooms 2A, 7A, and 12A, the "address of use" is 123 Main Street, while the "areas of use" are Rooms 2A, 7A, and 12A. The "address of use" would be indicated on the facility diagram accompanying the application.

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Dosage Determination

Do the determination of dosages provisions of §35.63 apply only to dosages to be used for therapeutic purposes? [10 CFR35.63] (Q&A ID 0303005)

No. The provisions of §35.63 apply to both diagnostic and therapeutic applications of unsealed byproduct material for medical use.

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Dosage Determinations of Unsealed Byproduct Material for Medical Use Using Volumetric Measurement Techniques

When a unit dosage is manipulated in any way, it stops being considered a unit dosage. If I modify the volume of a unit dosage under the direction of an Authorized User and do not have a dose calibrator, can I use volumetric data/decay correction as an assay method? [10 CFR 35.63] (Q&A ID 1202045)

Yes, provided that the requirements of §35.63(c)(3) are met. In addition, you should confirm that your modification of the volume will not adversely impact the homogeneous distribution of the byproduct material throughout the volume dosage. For example, volume variation procedures that induce either plating out or precipitation of the byproduct material(s) would be disallowed.

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Dose Calibrator Uses Other than Dosage Assay of Unsealed Byproduct Material for Medical Use

Do dose calibrators used for purposes other than patient dosage assay need to be calibrated? [10 CFR 35.432, 35.630] (Q&A ID 1202032)

Yes - If used for other measurements required under Part 35, such as source activity measurements of manual brachytherapy sources. In this case, the dose calibrator would need to meet the requirements in §35.630(a).

No - If used for measurements not required under Part 35, such as verifying the activity of licensed material used for diagnostic imaging equipment calibration, and not required under other NRC regulations, then calibration of the dose calibrator is not required.

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Dose Limit for Visitors to Hospitalized Therapy Patients

a) Does §20.1301(c) allow a visitor to receive 500 mrem each time he or she visits a hospitalized therapy patient?

b) Does the 500 mrem apply per patient visited or 500 mrem per individual who visits the patient? [10 CFR 20.1301(c)] (Q&A ID 0802031)

a) No. The pre-authorized elevated limit of 500 mrem applies to the total dose accumulated by the visitor through visits (one or more) to a particular individual who cannot be released under § 35.75. The 500 mrem is the annual dose limit, with pre-authorization, for an individual member of the public from the licensed operations of a single medical use licensee.

b) The pre-authorized elevated limit of 500 mrem applies to the total dose accumulated by a visitor through visits (one or more) to a particular individual who cannot be released under § 35.75. If pre-authorized by the authorized user for the individual who cannot be released under § 35.75, multiple visitors to the individual could receive up to 500 mrem each through visits (one or more) to the individual.

Refer to "Supplementary Information," Section II, "Petitions for Rulemaking (PRM)" and Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 20.1301(c), as published in the Federal Register on April 24, 2002.

Does 10 CFR 20.1301(c) allow a visitor who is a minor to receive up to 500 mrem when visiting a hospitalized therapy patient? [10 CFR 20.1301(c)] (Q&A ID 0902001)

Yes. Any person, including a minor, who is permitted by the medical facility/licensee to visit the therapy patient can be allowed by the licensee to receive up to 500 mrem through such visitation, as long as the authorized user has determined before the visit that a dose not exceeding 500 mrem is appropriate.

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Effective Date for the Revised Rule

When did the revised rule become effective? [10 CFR 35.10, 35.50(a), 35.51(a), 35.55(a), 35.59, 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), 35.690(a), 35.900-35.981] (Q&A ID 0302001)

Revised Part 35 as published in the Federal Register on April 24, 2002 (67 FR 20249) became effective on October 24, 2002. Further amendments to Part 35 training and experience (T&E) requirements, including recognition of specialty board certification processes and certain other conforming changes, became effective April 29, 2005, thirty days after the publication in the Federal Register on March 30, 2005 (70 FR 16336). Until October 24, 2005, licensees had the option of meeting either the T&E requirements of Subpart J or Subparts B and D-H. Since October 24, 2005, licensees must meet the requirements in Subparts B and D-H of the 2005 current Part 35.

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Elimination of Radiation Safety Committee

If a licensee previously committed to having a Radiation Safety Committee (RSC) but no longer wants to use its RSC, and the Final Rule does not require a RSC for the licensee's facility, does the licensee need to request and receive an amendment to the license before implementing the change? [10 CFR 35.10(e), 35.13, 35.24(f), 35.26, 35.2026] (Q&A ID 0802015)

No. Regardless of when after October 24, 2002, the effective date of the Final Rule, the licensee decides to discontinue use of its RSC, it need not apply for an amendment to its license before implementing the change. However, such a change to the licensee's radiation protection program must be done in accordance with the requirements of § 35.26 and be documented, with retention of the record for five years, per § 35.2026.

If the licensee wished to discontinue use of its RSC before October 24, 2002, it could only do so if it implemented all provisions of the revised Part 35 that were applicable to its license. In this case, too, the change(s) to the licensee's radiation protection program must have been done in accordance with the requirements of § 35.26 and be documented.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.10, as published in the Federal Register on April 24, 2002.

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Emergency Response Equipment for Brachytherapy

What is the definition of "emergency response equipment" under 10 CFR 35.415? [10 CFR 35.415(b)] (Q&A ID 1002006)

Emergency response equipment is equipment to respond to a source (1) dislodged from the patient or (2) lodged within the patient following removal of the source applicators and may include shielded storage containers, remote handling tools and, as appropriate, supplies necessary to remove applicators or sources from the patient. The licensee has the flexibility to determine the type of emergency response equipment needed. Responders should also have ready access to an appropriate survey instrument, which is often needed for locating dislodged sources and/or for assessing doses to people from dislodged sources.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.415, as published in the Federal Register on April 24, 2002. Also see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Item 10, "Safety Procedures and Instructions."

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Exemptions for Type A Broad Scope Licensees

Are Type A broad scope licensees exempt from the requirement to submit an amendment request to use § 35.1000 material, even if they do not have an appropriate possession limit? [10 CFR 35.12(d), 35.15(a), 35.1000] (Q&A ID 0902009)

No. The Type A broad scope license must authorize the material, form, and amount required for conduct of the § 35.1000 medical use. If it does not, an amendment request must be submitted by the licensee and approved by the NRC before the use can begin.

See NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 1.2.2, "Specific License of Broad Scope."

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Exposure of Nursing Infants/Children

Does the Part 20 public dose limit apply to infants/children being breast-fed by patients receiving NRC-licensed radioactive material for medical purposes? [10 CFR 20.1003, 20.1301(c), 35.75(a)] (Q&A ID 0802006)

No. Public dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75.

A licensee may authorize the release from its control of any individual who has been administered radioactive material for medical purposes if the total effective dose equivalent (TEDE) to any other individual, including infants/children being breast-fed, from exposure to the released individual is not likely to exceed 0.5 rem. Additionally, if the TEDE could exceed 0.1 rem assuming there were no interruption of breast-feeding, the licensee must provide instructions to the patient in accordance with 10 CFR 35.75.

In the case of a breast-feeding mother not released from the licensee's control, the authorized user must determine, in advance of visits, that it is appropriate for visitors to receive in excess of 0.1 rem. Each visitor, including a nursing infant/child, shall not receive a radiation dose exceeding 0.5 rem.

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Facility Diagram Submission to NRC

Are licensees required to submit updated diagrams to the NRC when changes to or additions of areas of use under §35.100 and/or §35.200 occur? [10 CFR 35.12(b), 35.14(b), 35.100, 35.200] (Q&A ID 1202012)

Section 35.12(b)(1) requires that a licensee, in its original application, submit a facility diagram. Section 35.14(b)(4) requires a licensee to notify the NRC by letter no later than 30 days after changes to or additions to areas of use under §35.100 and/or §35.200 are made.

If the change/addition of areas of use does not result in a change in the diagram originally submitted under 35.12(b)(1), then the licensee does not need to submit another diagram. However, if the change/addition of areas of use does result in a change in the diagram originally submitted under 35.12(b)(1), then the licensee should submit an updated diagram.

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Funding Plans for Decommissioning - Limited Scope Medical Use Licenses

In the model license in NUREG-1556, Vol. 9, Rev 1 for a medical licensee of limited scope, what is the purpose of License Condition 13, that restricts possession limits to below the minimum limit in §30.35(d) for establishing decommissioning financial assurance? [10 CFR 30.35, 35.100, 35.200] (Q&A ID 1202020)

When the licensee requests "as needed" for the maximum amount to be possessed for §35.100 and/or 35.200 uses without putting limits on total activity or activity per nuclide, as is reflected in the sample license, the NRC staff is unable to determine the scope of activities to be conducted under an NRC license. If this request were approved without condition, there would be no upper bound on quantities or number of radionuclides to be possessed and used. The license condition enables NRC and the licensee to better define the scope of the licensee's program so that the licensee can provide the necessary amount of financial assurance for decommissioning as required by §30.35.

The license condition places a limit on quantities that may be possessed in order to ensure compliance with §30.35, without significantly reducing license flexibility on use.

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Gamma Knife Neurosurgeons as Authorized Users

Do neurosurgeons who are named on the license for gamma stereotactic radiosurgery (gamma knife) qualify as authorized users (AUs) with regard to the 10 CFR 35.615 requirement for an AU to be physically present throughout the entire patient treatment involving the unit? [10 CFR 35.2, 35.615(f), 35.690] (Q&A ID 0802021)

No. A neurosurgeon named on the license for gamma stereotactic radiosurgery (gamma knife) does not qualify as an authorized user and cannot meet the physical presence requirement of an AU unless that neurosurgeon meets the definition of an AU in 10 CFR 35.2 or the T&E requirements in 10 CFR 35.690. Note that with the 2002 addition of 10 CFR 35.615 to the regulations an authorized medical physicist is also required to be physically present during all gamma stereotactic radiosurgery patient treatments.

Note that an earlier license condition requiring a neurosurgeon to be physically present was superseded in the 2002 revision of 10 CFR Part 35 by the provisions of 10 CFR 35.615(f)(3), and neurosurgeons are no longer listed on the license.

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Generators and Mobile Medical Service Providers

Can mobile medical service providers transport and use radioisotope generators? [10 CFR 35.80] (Q&A ID 1002008)

Yes, if the authorization to possess and use generators is listed in the license issued to the mobile medical service.

See NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.36, "Mobile Medical Service," and Appendix V, "Guidance for Mobile Medical Services."

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"Grandfathering" Experienced Individuals

Will an experienced RSO, teletherapy or medical physicist, ANP, or AU need to comply with the training requirements in the current 2005 Part 35? [10 CFR 35.57, 35.59] (Q&A ID 0301022)

No. If the individual was listed on a license or permit on April 29, 2005, the individual is a "grandfathered" individual provided he/she performs only those medical activities for which he or she was authorized before the effective date of the "Medical Use of Byproduct Material - Specialty Boards; Final Rule, April 29, 2005".

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Grandfathering of Training and Experience as it Relates to Type(s) of Use

Under §35.57, would a presently-authorized medical physicist (AMP) or authorized user (AU) be grandfathered for all modalities in §35.600, even if the individual was only authorized for one or two of these modalities on the implementation date of the new rule? [10 CFR 35.57] (Q&A ID 0103020)

No. There would be no change in what the individual is authorized to do. For example, an individual currently recognized as a "teletherapy physicist" would be recognized as an AMP for teletherapy units under the revised Part 35. The same criteria would apply in determining if AUs have "deemed status" under the revised rule. They would continue to be recognized as AUs for the type(s) of use of byproduct material for which they had approval under the previous rule. An AMP or AU cannot be authorized for a type of use for which training and experience is inadequate or not documented.

Refer to "Supplementary Information," Section III, "Summary of Public Comments", Part II, "General Issues," Subpart E.2., "Training and Experience - Unsealed Byproduct Material," as published in the Federal Register on April 24, 2002.

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Grandfathering Older Computerized Treatment Planning Systems

Will "grandfathering" of older treatment planning systems and software be allowed under Sections 35.457 and 35.657? [10 CFR 35.457, 35.657] (Q&A ID 0303014)

No. The rule does not differentiate on the basis of "age" of computer based treatment planning systems in terms of either hardware or software. All treatment planning systems - new, old, or modified - must undergo acceptance testing prior to use, effective October 24, 2002. However, if the systems were tested, when installed, or later, in accordance with published protocols currently accepted by nationally recognized bodies, and passed the testing, then nothing further is needed.

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"Grandfathering" Recent AUs in 2005

If I received training and experience to qualify as an AU during the time between the publication in the Federal Register of the "Medical Use of Byproduct Material - Recognition of Specialty Boards; Final Rule (March 30, 2005)" and the April 29, 2005 effective date of the revised Part 35, am I "grandfathered" as an AU or do I need to obtain the training and experience specified in the 2005 current Part 35? [10 CFR 35.57] (Q&A ID 0301008)

You are grandfathered if you were identified on April 29, 2005, the effective date of the 2005 current Part 35, as an AU for medical use of byproduct material on a license issued by the Commission or an AS, a permit issued by a Commission master material licensee, a permit issued by a Commission or AS broad scope licensee, or a permit issued by a Commission master material license broad scope permittee, as long as you only perform those medical uses for which you were authorized on that date. If you were not identified as an AU on April 29, 2005, you must comply with the training requirements of Subparts D-H of the 2005 current Part 35 or, until October 24, 2005, the training requirements of Subpart J.

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Guidance Regarding Patients Who Are Breast-Feeding

Where can I find sample guidance for licensees regarding patients to whom unsealed byproduct material is administered and who are breast-feeding infants or children? [10 CFR 35.75] (Q&A ID 0802004)

NRC is preparing consolidated guidance about medical use licenses. It has been published in draft form and will be published as a final technical report on or before October 24, 2002, the effective date of the Final Rule. It is identified as NUREG-1556, Vol. 9, "Consolidated Guidance About Material Licenses: Program-Specific Guidance About Medical Use Licenses." The final version will include an informational Appendix U with guidance regarding patients who are breast-feeding infants or children.

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Human Research

Are requests to conduct human research treated as requests for a license amendment? [10 CFR 35.6] (Q&A ID 0103031a)

A licensee that intends to conduct research on human subjects must meet the requirements in §35.6(b) or receive a license amendment before conducting the research. As long as the conditions in §35.6(b) are met, it is not necessary for a medical licensee to apply for and receive an amendment to its NRC license prior to conducting research involving human subjects. A license amendment request is required if the licensee wishes to use a radionuclide or type of use that is not currently authorized on its license.

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Identification of Sealed Sources in Application and Licenses

When must an applicant provide the manufacturer and model number for a sealed source as part of a license application? If this information has been provided for a source, and acquisition of a similar source from another manufacturer is contemplated, must an application for an amendment be submitted? Is it sufficient to merely indicate on an application that sources to be used will be registered in the Sealed Source and Device Registry (SSDR)? [10 CFR 30.32(g), 30.210(c)] (Q&A ID 1202028)

Under provisions of §30.32(g), an applicant for a specific license to use byproduct material in the form of a sealed source or in a device that contains a sealed source must either (1) identify the source or device by manufacturer and model number as registered with the Commission under §32.210 or with an Agreement State; or (2) contain the information identified in §32.210(c). Thus, individuals contemplating use of sealed sources must apply for a license amendment and supply the manufacturer and model number. It is insufficient to indicate that a license is sought for use of sealed sources listed under the SSDR without providing this information.

Applicants should consider the potential for ordering similar sources from multiple vendors and request authorization to possess and use these sources, identifying the manufacturer(s) and model number(s). Following this procedure can help avoid situations where a licensee wishes to substitute a sealed source from an alternate supplier but does not have authorization under its license to possess and use a sealed source from an alternate manufacturer.

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Implementation of the 2002 Revised Part 35

Did the NRC expect all medical use licensees to formally request a license amendment once they had implemented the 2002 Revised Part 35, so the license document could be modified to incorporate the revised regulations? For example, if I had a high dose-rate remote afterloader unit (HDR) listed as a line item on my license, did I need to get an amendment of my license to delete the "line item" and add 10 CFR 35.600 and to designate 10 CFR 35.600 materials for those AU physicians authorized to use the HDR? [10 CFR 35.10] (Q&A ID 0301015)

No, the NRC did not expect licensees to formally request a license amendment when they implemented the 2002 Revised Part 35, as published in the Federal Register on April 24, 2002. If a licensee submitted an amendment request during the implementation phase, the six months following publication of the 2002 Revised Part 35, as published in the Federal Register on April 24, 2002, the licensee should have addressed whether or not it implemented the 2002 Revised Part 35. If it did, the license was modified in its entirety at that point to incorporate the revised regulations. However, following expiration of the implementation period, on October 24, 2002, every medical license is being modified, during the next licensing action, to reflect of the provisions of the 2002 revised Part 35, with one exception. The medical license will not include revisions relating to procedures required in the provisions of 10 CFR Subpart H until the next license renewal unless the licensee specifically requests the revisions by submitting procedures with the license amendment request. See sample licenses in Appendix C of NUREG-1556, Vol. 9, Revision 1, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses."

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Implementation of the Revised Rule: Complying with Existing License Conditions

Why didn't NRC include the provisions of Section 35.615, "Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units," in § 35.10(f), "Implementation" [of procedures]? [10 CFR 35.10, 35.615, 35.610, 35.642, 35.643, 35.645] (Q&A ID 0301023)

Unlike the sections specified in 10 CFR § 35.10(f), 10 CFR § 35.615 does not refer to written procedures.

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Inspection Review of § 20.1301(c) Decision Documentation

a) Will an inspector review a licensee's documentation associated with an authorized user (AU) under the license determining that a visitor (or visitors) to a hospitalized radiation therapy patient can receive up to 500 mrem during visitation? [10 CFR 20.1301(c), 35.75] (Q&A ID 0802024)

b) Can an AU issue a blanket order for visitors to patients who are held under § 35.75 to be permitted to receive up to 500 mrem through visitation? [10 CFR 20.1301(c), 35.75] (Q&A ID 0802029)

a) Not necessarily. As part of an inspector possibly verifying that visitor control is adequate to ensure compliance with the regulations for doses to members of the public, including visitors under 20.1301(c), the inspector may review a limited number of licensee records and interview AUs to verify that AUs did determine the appropriateness of the 500 mrem dose limit for some or all visitors to particular patients before visitations began.

Yes. Nothing in Part 20 or in Part 35 precludes the AU from determining that the higher dose limit for visitors should apply for all radiation therapy patients for which he or she has or will have AU responsibilities. Such a determination would be reflecting a determination by the AU, based on judgment, considering their condition, that all of the AU's radiation therapy patients would benefit from allowing visitors to these patients to receive doses up to 500 mrem.

b) Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 20.1301(c), as published in the Federal Register on April 24, 2002.

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Instruction for Users of Teletherapy Units for Non-Medical Purposes

Is the instruction specified in 10 CFR §35.610(d) required for users of teletherapy units for non-medical purposes? [10 CFR 35.610(d), 36.51] (Q&A ID 1002009)

Yes, but only if the unit is licensed under Part 35 for medical use. If the unit is not used for medical purposes at all, including not being used for medical research involving human subjects, and is not licensed under Part 35, then 10 CFR 36.51 and conditions of the license addressing training requirements would apply instead, and the instruction specified in 10 CFR 35.610(d) would not be required.

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Instructions for Written Directives for Tc-99m Users

Under §35.27, does a nuclear medicine technician who, under the supervision of an authorized user, only administers Tc-99m radiopharmaceuticals need instruction in the licensee§s written directive procedures? [10 CFR 35.27, 35.40] (Q&A ID 0103044)

If the licensee is authorized for §35.300 use, i.e., use of unsealed byproduct material for which a written directive is required, the licensee must have written directive procedures. Section 35.27(a)(1) requires that the licensee instruct the supervised individual (the nuclear medicine technician) in their application. If, however, the licensee is not authorized for use requiring written directives, then the licensee need not have written directive procedures, and the licensee need not instruct the supervised individual in use of written directives.

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Instrument Calibration Using Manufacturer's Instructions

For calibration, using the manufacturer's instructions, of an instrument for measuring activity of unsealed byproduct material, do the instructions have to be written? Can they be oral? Do they need to be "official"? [10 CFR 21.3, 21.21, 35.60] (Q&A ID 0802011)

Instrument calibration instructions received from a manufacturer do not have to be written; they can be transmitted orally. Regardless of whether the instructions are received in writing or orally, they can be considered "official" if they are received from an individual who is representing the manufacturer.

However, for assurance that instructions that are received orally are correctly interpreted and followed, particularly for future calibrations, the licensee should promptly commit the instructions to writing, to establish a "procedure," and ask the manufacturer that supplied the instructions to review the "procedure" for correctness.

Note that a prudent manufacturer would document its verbal instructions in writing (via procedure or via documentation of phone call). Also note that the manufacturer has reporting responsibilities under 10 CFR § 21.21 if inadequate or incorrect instrument calibration procedures are supplied and later require modification or revision to eliminate a substantial safety hazard, as defined in § 21.3.

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Intravascular Brachytherapy Device Use Under § 35.1000

For intravascular brachytherapy (IVB) device use under § 35.1000 that does not have a tie-down condition in the license (referring to the application and other documents submitted to NRC), what keeps the licensee from changing the use without notifying the NRC? [10 CFR 30.52, 35.7, 35.12(d), 35.13(a), 35.1000, 35.4001] (Q&A ID 0802045)

Applications for possession and use of IVB devices, licensed under § 35.1000, must include information as described in § 35.12(b) through (d) that would then be tied-down to (referenced as a condition in) the issued license. Thus, licenses for IVB use always have tie down conditions that include the purpose(s) for which use of the licensed material is authorized. Because IVB is regulated under § 35.1000 in the Final Rule, conditions in a license for IVB usage issued under the provisions of the version of Part 35 in effect until October 24, 2002, the effective date of the Final Rule, remain in effect following implementation of the Final Rule. Reference § 35.1000(b).

If a licensee did institute a change in usage of an IVB device regulated under § 35.1000 from that described in its NRC application, without notification of and approval from NRC, that action would be subject to inspection and enforcement under § 30.52 and § 35.4001, respectively, with citation for violation of § 35.13(a).

Medical use of an IVB device under § 35.1000 also requires investigator (authorized user) compliance with an active FDA-accepted Investigational Device Exemption (IDE) application. This requirement, too, prohibits changes in usage without notification of and approval from the relevant regulatory authority (FDA). This relates to licensee compliance with § 35.7, "FDA, other Federal, and State requirements."

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Iodine-131 Authorizations for Experienced Authorized Users

If an authorized user (AU) is presently authorized for use of §35.100 materials, I-131, and §35.200 materials, will that individual have to apply for a license amendment to update to the 2002 requirements for use of I-131? [10 CFR 35.392 ,35.394] (Q&A ID 0303010)

No. An AU who was authorized on a license to use I-131 prior to the effective date for the revised rule, October 24, 2002, may continue to perform those medical uses for which he or she was authorized. During the next revision of the license (amendment or renewal), the regional license reviewer will determine whether the authorization for the use of I-131 issued prior to October 24, 2002 required a written directive and if so, whether the AU administered less than or greater than 33 millicuries at a time. The license will be updated accordingly, to reflect the revised requirements.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for Part II E, "Training and Experience," as published in the Federal Register on April 24, 2002.

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Leak Test Procedures

Under the Final Rule, applicants for medical licenses no longer submit procedures for leak testing sealed sources. Will this licensing approach eventually be used for other types of material licensees, and will it be reflected in the NUREG-1556 series? [10 CFR 35.12] (Q&A ID 0802039)

Keeping risk in mind, the requirements for a license under Part 35 do not necessarily reflect guidance that applies to sealed sources used in other applications (e.g., industrial gauges, irradiators [Part 36], radiography [Part 34], well-logging [Part 39], etc.). This licensing approach for Part 35 is an example of performance-based regulation. Volumes in the NUREG-1556 series are reviewed periodically for, in part, establishment or maintenance of consistency, as appropriate.

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Leak Testing Iridium-192 (Ir-192) Sources

The Sealed Source and Device (SSD) Registry requires leak testing for iridium-192 seeds. For seeds of iridium-192 encased in nylon ribbon, what takes precedence: the regulations in Part 35 that exempt them from leak testing when encased in nylon ribbon or the SSD Registry that requires leak testing? [10 CFR 35.67(f)] (Q&A ID 0301017)

Leak testing is not required for iridium-192 seeds encased in nylon ribbon. However, § 35.67 requires iridium-192 seeds not encased in nylon ribbon and containing more than 3.7 MBq (100 uCi) to be leak tested.

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Leak Testing of Alpha Foil Sources

Are leak tests required for alpha foil sources? [10 CFR 35.2, 35.67] (Q&A ID 0902004)

Leak testing requirements for most sealed sources and plated sources are documented in the Sealed Source and Device Registry for the source. The Registry indicates whether the source needs to be leak tested and indicates the required leak test frequency. In addition, 10 CFR 35.67(f)(3) states that "sources containing 0.37 MBq (10 uCi) or less of alpha-emitting material" need not be leak tested.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.67 as published in the Federal Register on April 24, 2002.

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License Conditions versus Regulatory Requirements

If a license condition requires a licensee to use syringe shields, what happens under the revised Part 35? Will the licensee be required to keep the most restrictive requirement (still use syringe shields) or not? [10 CFR 20.1101, 35.10] (Q&A ID 1202006)

Under 10 CFR 35.10(e), when license conditions and the regulations of revised Part 35 differ, Part 35 regulations govern. However, §35.10(d) also provides that, if a license condition exempted a licensee from a provision of Part 35, the license condition continues to exempt the licensee from that requirement. Further, §35.10(f) mandates that a licensee must continue to comply with any license conditions requiring it to implement procedures required by §35.610, 642, 643, and 645 until there is a license amendment or renewal modifying these conditions.

Moreover, licensees are still obligated to comply with 10 CFR Part 20, including compliance with occupational dose limits. The use of syringe shields may help the licensee maintain occupational doses within the limits of Part 20.

In addition, when used to the extent practical, syringe shields will help achieve occupational doses that are as low as is reasonable achievable (ALARA) as required by §20.1101.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.10, as published in the Federal Register on April 24, 2002.

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Listing an Authorized Medical Physicist on a License

For what uses under Part 35 must a licensee have an authorized medical physicist (AMP) named on the license? [10 CFR, 35.433, 35.610, 35.615, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645] (Q&A ID 0103033)

An AMP(s) must be named on licenses authorizing the medical uses of strontium-90 ophthalmic applicators, teletherapy units, photon-emitting remote after loader units, and gamma stereotactic radiosurgery units.

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Loss of Control of Material; Departure of Patient Non-Releasable Under §35.75

a) If a non-releasable patient under §35.75 leaves on his or her own accord, would this be considered loss of control of material? [10 CFR 20.1002, 20.1802, 20.2202, 35.2, 35.75, 35.3045] (Q&A ID 1202001a)

b) If a non-releasable patient under §35.75 leaves on his or her own accord, would this be considered patient intervention? [10 CFR 20.1002, 20.1802, 20.2202, 35.2, 35.75, 35.3045] (Q&A ID 1202001b)

a) It depends. Under §20.1802, a licensee must control licensed material. Under §20.2202, a licensee must notify the NRC of events involving loss of control of licensed material that threaten to cause specified conditions. Under §20.1002, the dose limits in Part 20 do not apply to doses from individuals administered radioactive material and released under §35.75. However, if a patient not released under §35.75 leaves the facility on his or her own accord, then Part 20 applies and the licensee may be required to report the release under §20.2202.

The NRC recognizes that patients cannot be held against their will. The NRC would not penalize a licensee for the activities of a patient, if a patient were to leave "against medical advice."

However, the licensee has a responsibility to keep doses to members of the public from patients below 500 millirem (5 mSv) and should try every means available to have a patient that cannot be released under §35.75 remain hospitalized. When it is clear before treatment that a patient does not intend to be hospitalized, the licensee should consider the consequences and alternative treatments or actions.

Refer to Section III, "Public Comments on the Proposed Rule" for 10 CFR Part 20 and 35, as published in the Federal Register on January 29, 1997 (Vol. 62, No. 19, pp. 4120-4133).

b) Leaving the hospital while containing unsealed byproduct material or with radioactive sources securely in place is not considered patient intervention. The term "patient intervention" is defined in §35.2 as an action by a patient or human research subject such as dislodging or removing treatment devices or permanently terminating the administration, and refers to an exception to when an event must be reported as a medical event under §35.3045.

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Management Delegation of Authority to the RSO

Will the final consolidated guidance for medical licenses (NUREG-1556, Vol. 9) require a licensee to "commit" to management delegation of authority to the RSO? [10 CFR 35.24] (Q&A ID 0802035)

Section 35.24(e) requires that the licensee "establish the authority...of the Radiation Safety Officer in writing" and § 35.24(g) requires that the licensee "provide the Radiation Safety Officer sufficient authority...to...." It is not necessary for the licensee to submit this written authority to the NRC as part of the licensing process.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.24, as published in the Federal Register on April 24, 2002.

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Master Material Licensee Name Changes

Facilities of master material licensees (e.g., the Department of Veterans Affairs) are sometimes required to make certain name changes. Are license amendment requests required? [10 CFR 30.31, 35.13, 35.14] (Q&A ID 0103042)

Master material licensees (MMLs) are issued pursuant to 10 CFR Part 30. Only the MML medical use permittees are licensed pursuant to 10 CFR Part 35. If an MML medical use permittee has a simple name change, then the permittee may use the notification process in §35.14. However, if the name change results from a transfer of control of the license, the permit will need to be amended by the MML permit issuing authority.

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Management Delegation of Responsibility

To what extent can management responsibilities be delegated? [10 CFR 35.24, 35.26] (Q&A ID 0103032)

Licensee management has the ultimate responsibility for the radiation protection program. Management can delegate tasks or duties, but not the responsibility, to a management delegate. Therefore, management must approve, in writing, requests for a license application, renewal, or amendment before submittal to the Commission; any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist; and radiation protection program changes that do not require a license amendment and are permitted under §35.26.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.

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Maximum Activities for Broad Scope Medical Use Licensees

The model license in NUREG-1556, Vol. 9 for a medical licensee of broad scope lists, under 6A, "Any byproduct material with atomic numbers 1 through 83" and for possession limit, under 8A, lists "200 millicuries per radionuclide and 15 curies total." Why is there a "per radionuclide" limit and a "total activity" limit? Why not "as needed"? [10 CFR 30.33(a), 30.35, 30.71, 30.72, 35.18(a)] (Q&A ID 1202017)

The "as needed" possession limit is only used by NRC for byproduct material permitted by § 35.100 and § 35.200, for medical diagnostic use, based on knowledge of quantities typically involved in such operations. In addition to use for medical diagnosis, the broad scope authorization also includes byproduct material used for medical therapy and for medical research, so "per radionuclide" and "total" numeric possession limits apply and appear in the sample license.

Specifying a possession limit for each nuclide and a total possession limit, with specific nuclides listed that exceed the general per-nuclide limit, permits the NRC to review the true scope of the licensee's program while providing the licensee needed flexibility. Also, with an "as needed" possession limit, the NRC staff would be unable to assess licensee compliance with NRC requirements for providing a decommissioning funding plan and an emergency plan.

If the licensee requested "as needed" without putting limits on total activity and activity per nuclide, NRC staff would be unable to determine the scope of activities to be conducted under a license because there would be no upper bound on quantities or number of radionuclides to be possessed and used and because of a lack of information about intended operations under an NRC license. Therefore, NRC staff could not make the determinations required under 10 CFR 35.18(a)(3), to enable the Commission to find 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. [Similar requirements appear in 10 CFR 30.33(a)(2).]

The sample license entries reflect the possession limits requested in the sample application for the license (under § 33.12, § 33.16, or § 35.12) which is not shown, as well as information on the licensee's program, personnel, and facilities, as provided in the application. The entries also conform to the authorization format for all broad scope licenses, which always includes possession limits, regardless of type of use.

Note that the sample license also includes authorizations for particular radionuclides for medical diagnosis, therapy, and research in humans, as separate items with possession limits exceeding 200 millicuries. Examples are molybdenum-99 and technetium-99m, with possession limits of 10 curies each.

The model license in NUREG-1556, Vol. 9, Rev 1 for a medical licensee of broad scope lists, under 6A, "Any byproduct material with atomic numbers 1 through 83", and for possession limit, under 8A, lists "200 millicuries per radionuclide and 15 curies total". Why is there a "per radionuclide" limit and a "total activity" limit? Why not "as needed"? [10 CFR 30.32(i)(1), 30.33(a), 30.35(c), 30.35(d), 30.71, 30.72, 33.11(a), 33.12, 33.16, 35.12, 35.18(a)] (Q&A ID 1202017)

Specifying a possession limit for each nuclide and a total possession limit, permits the NRC to review the true scope of the licensee's program while providing the licensee with some flexibility.

If the licensee requested "as needed" without putting limits on total activity and activity per nuclide, NRC staff would be unable to determine the scope of activities to be conducted under a license because there would be no upper bound on quantities or number of radionuclides to be possessed and used, and there would be insufficient information about intended operations under an NRC license. Therefore, NRC staff could not determine, as specified in §35.18(a)(3), whether the applicant was equipped and committed to observe the safety standards established by the Commission for the protection of the public health and safety. NRC staff would also be unable to assess licensee compliance with §30.35 (c) and (d) and 30.32(i)(1) for providing a funding plan for decommissioning and an emergency plan.

The sample license entries reflect the possession limits requested in the sample application for the license (under §33.12, §33.16, or §35.12) which is not shown, as well as information on the licensee's program, personnel, and facilities, as provided in the application. The entries also conform to the authorization format for all broad scope licenses, which always includes use, based on knowledge of quantities typically involved in such operations. In addition to use for medical diagnosis, the broad scope authorization also includes byproduct material for medical therapy and for medical research, so "per radionuclide" and "total" possession limits apply, and appear in the sample license.

Note that the sample license also includes authorizations for particular radionuclides for medical diagnosis, therapy, and research in humans, as separate items with possession limits exceeding 200 millicuries. Examples are molybdenum-99 and technetium-99m, with possession limits of 10 curies each.

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Maximum Activities for § 35.300 Uses -- Limited Specific Medical Use License

The model license in NUREG-1556, Vol. 9 for a medical licensee of limited scope that does both diagnostic and therapeutic nuclear medicine includes a 900 mCi possession limit for "Any byproduct material permitted by 10 CFR 35.300." While this is more than the 200 mCi possession limit in the model license for a medical licensee of broad scope, it is still not enough for many practices. If the possession limit for § 35.100 and for § 35.200 applications is "as needed," why not for therapy as well? [10 CFR 30.33(a), 35.12, 35.300] (Q&A ID 1202018)

The "as needed" possession limit is only used by NRC for byproduct material permitted by § 35.100 and § 35.200, for medical diagnostic use, based on knowledge of quantities typically involved in such operations, so a numeric possession limit applies for § 35.300 uses, and appears in the sample license.

The licensee is asked to specify the amount of materials needed for § 35.300 uses because, typically, additional equipment and facilities are needed to safely handle materials used for such purposes, as compared with materials used for § 35.100 and § 35.200 purposes. Specification of the amount(s) assists the NRC license reviewer in evaluating the equipment, facilities, training, and experience needed by the licensee to ensure that the criterion in § 30.33(a) is met. In addition, with an "as needed" possession limit, the NRC staff would be unable to assess licensee compliance with NRC requirements for providing a decommissioning funding plan and an emergency plan.

The model license is a sample; the specification of a possession limit in the sample is not intended to imply an upper limit on possession for all entities licensed under § 35.300. Applicants may request other possession limits to meet their individual needs.

The model license in NUREG-1556, Vol. 9, Rev 1 for a medical licensee of limited scope that does both diagnostic and therapeutic nuclear medicine includes a 900 mCi possession limit for "Any byproduct material permitted by 10 CFR 35.300". While this is more than the 200 mCi possession limit in the model license for a medical licensee of broad scope, it is still not enough for many practices. If the possession limit for §35.100 and for §35.200 applications is "as needed", why not for therapy, as well? [10 CFR 35.12, 35.300] (Q&A ID 1202018)

The licensee is asked to specify the amount of materials needed for §35.300 uses because, typically, additional equipment and facilities are needed to safely handle materials used for such purposes, as compared with materials used for §35.100 and §35.200 purposes. Specification of the amount(s) assists the NRC license reviewer in evaluating the equipment and facilities, training and experience, and emergency plans needed by the licensee.

The model license is a sample. The specification of a possession limit in the sample is not intended to imply an upper limit on possession for all entities licensed under §35.300. Applicants may request other possession limits to meet their individual needs.

The sample license entry reflects the possession limit requested in the sample application for the license, under §35.12, which is not shown, as well as information on the licensee's program, personnel, facilities, as provided in the application. The entry also conforms to the authorization format for limited scope licenses for medical use for which written directives are required, which always include possession limits because of the greater risk associated with the byproduct materials employed, compared to those used for medical diagnostic purposes.

The "as needed" possession limit is only used by NRC for byproduct material permitted by §35.100 and §35.200, for medical diagnostic use, based on knowledge of quantities typically involved in such operations, so a possession limit applies only for §35.300 uses, and appears in the sample license.

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Meaning of "Physically Present"

When particular individuals are required to be "physically present" during various phases of several therapeutic medical uses, does NRC's meaning of "within hearing distance of normal voice" include through use of "walkie-talkies"? [10 CFR 35.615(f)] (Q&A ID 0802016)

No. Use of communication devices, including "walkie-talkies," would enable the identified individuals to be at a distance from the location of therapeutic medical use, and thus not "physically present" (i.e., "within hearing distance of normal voice"). However, use of communication devices, including "walkie-talkies," by identified individuals is permitted when the requirement is for the individual to be "immediately available" (i.e., "available on an on-call basis to respond to an emergency").

Refer to "Supplementary Information," Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR § 35.615, as published in the Federal Register on April 24, 2002.

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Medical Event and Patient Intervention

a) How does a licensee determine if an event is a "medical event" (which is reportable to NRC) or an event involving patient intervention (which is not reportable to NRC)?

b) What threshold is used to make that determination? [10 CFR 35.2, 35.3045] (Q&A ID 0902003)

a) "Patient intervention" is defined in § 35.2 as "actions by the patient or human research subject, whether intentional or unintentional..." and examples are provided in the definition, for guidance as to when patient intervention has occurred. Section 35.3045(b) indicates when the consequences of patient intervention are serious enough for the event to be reported as a "medical event."

b) Per § 35.3045(b), if intervention of a patient or human research subject in the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician, the event is reportable to NRC as a "medical event." Even though the threshold for reporting medical events is high, licensees are expected to continue to act reasonably, in accordance with prevailing standards of care, to prevent medical events caused by intervention of patients or human research subjects.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" and Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR 35.3045, as published in the Federal Register on April 24, 2002.

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Medical Events -- Definition

Do medical events only apply to uses of byproduct material that require a written directive? [10 CFR 35.2, 35.3045(a)] (Q&A ID 0802030)

No. "Medical event" means an event that meets the criteria in § 35.3045(a). However, because these reporting criteria include dose-based thresholds, it is unlikely that a medical event would be associated with a medical use that does not require a written directive.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.3045, as published in the Federal Register on April 24, 2002.

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Minimization of Contamination

What is an adequate response from an applicant on how contamination will be minimized in its facility? [10 CFR 20.1406] (Q&A ID 0802038)

For guidance on preparing such a response, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.27 (Guidance).

As stated in the Guidance, response from an applicant is not required under the following condition: the NRC will consider that the criteria in Section 8.27 have been met if the information provided in applicant's responses satisfy the criteria in Sections 8.14, 8.15, 8.20, 8.24, 8.26, and 8.28 on Facility and Equipment; Facility Diagram; Radiation Protection Program; Safety Program; and Waste Management.

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Mobile Medical Units and Unit Dose Radiopharmaceuticals

Does a mobile medical unit have to use a dose calibrator if using only unit doses? [10 CFR 35.63, 35.80] (Q&A ID 0902015)

No. For use of unit dosages, § 35.63 provides for determination of activity of each dosage by means other than direct measurement. Additionally, § 35.80 does not require a mobile medical service to determine the activity of each dosage by direct measurement.

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Molybdenum Break-Through Test Requirements for Nuclear Pharmacies

Do nuclear pharmacies need to comply with the molybdenum break-through tests requirements under §35.204? [10 CFR 30.34(g), 35.204(b)] (Q&A ID 1202002)

Yes, 10 CFR 30.34(g) requires each licensee preparing unsealed byproduct material for medical use from Tc-99m/Mo-99 generators to test the generator eluants for molybdenum break-through in accordance with §35.204.

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Multiple Medical Use Licenses

Our facility has separate licenses for nuclear medicine and brachytherapy, teletherapy, and gamma knife. Under the revised Part 35, can these licenses be combined into one? [10 CFR 35.12(b)] (Q&A ID 0301005)

Yes. Current licensees can request consolidation of existing separate medical use licenses. Reference "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.12, as published in the Federal Register on April 24, 2002. Also, note that a single, qualified RSO must be designated for the consolidated license.

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Multiple RSOs

Can a licensee appoint multiple RSOs to fill a permanent RSO position on a single license? [10 CFR 35.12(b)(1), 35.24(b)-(d), 35.50, 35.57(a)] (Q&A ID 0301016)

No. Part 35 does not allow licensees to have more than one permanent RSO on a license. The revised rule does allow licensees to name multiple temporary RSOs, if necessary.

Note that if an organization possesses more than one license, the RSO may differ for each license.

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"Name of Individual" in Record-Keeping Requirements

In the Part 35 record requirements, what does "name of the individual" mean? [10 CFR 35.2070] (Q&A ID 1202016)

"Name of Individual" means the entire name of the individual, NOT the individual's initials.

Refer to Supplementary Information, Section V, 'Summary of Changes Made Between the Current Part 35 and the Revised Part 35' for 10 CFR 35.2070, as published in the Federal Register on April 24, 2002.

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National Institute of Standards and Technology and National Bureau of Standards

Is the National Institute of Standards and Technology (NIST) the same organization as the National Bureau of Standards (NBS)? [10 CFR 35.630] (Q&A ID 0103016)

Yes. NBS was renamed to NIST in 1988. Up-to-date standards designated as "NBS" standards are thus accepted as "NIST" standards.

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Need for Named Authorized Medical Physicist for Use of Sr-90 Eye Applicators

If a licensee is approved for Sr-90 eye applicators, must an AMP be listed on the license? [10 CFR 35.12, 35.400, 35.433] (Q&A ID 0802014)

Yes. § 35.433 requires that an AMP calculate the activity of each Sr-90 source used for brachytherapy. § 35.12 requires that applications for a license, an amendment, or a renewal include the training and experience qualifications of the AMP(s) to be involved in medical use of byproduct material as described in § 35.400.

For a sample license, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Appendix F.

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New Authorized Nuclear Pharmacist

Will I need to get a license amendment before letting someone work as an ANP? [10 CFR 35.13, 35.14, 35.15, 35.55, 35.59] (Q&A ID 0301021)

Yes, except when one of the following three conditions applies: (1) The individual meets the board certification criteria and recentness of training requirements; (2) The individual is identified as an ANP on (a) a Commission or Agreement State medical use license or nuclear pharmacy license, (b) a permit issued by a Commission or Agreement State licensee of broad scope including medical use or nuclear pharmacy activities, or (c) a permit issued by a Commission master material licensee authorized for medical use or nuclear pharmacy activities; or (3) The individual is identified as an ANP by a commercial nuclear pharmacy authorized to identify ANPs.

However, like for the AU or AMP, except for licensees possessing a Type A specific license of broad scope for medical use (issued under 10 CFR Part 33), the licensee must provide to the Commission a copy of the relevant board certification and the written attestation(s) signed by a preceptor, license, or permit within 30 days of the individual beginning work for the licensee as an ANP. Note that, except for the written attestation(s) for board-certified ANPs, a requirement added in 2005, this is not a change from the rule in effect prior to the 2002 revision.

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Non-Commercial Transfer of Sealed Sources and Devices

Under §35.49(b), can NRC medical use licensees use sealed sources or devices non-commercially transferred from an Agreement State licensee? [10 CFR 35.49(b)] (Q&A ID 0103041)

No. The current regulation does not specifically include non-commercial transfers from Agreement State licensees. Presently, an NRC medical use licensee may only use sealed sources or devices obtained through non-commercial transfers if the transfers are from other NRC medical use licensees.

Non-commercial transfers from Agreement State medical use licensees may be requested by NRC medical use licensees, as exemptions for license amendments.

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Non-Routine Diagnostic Procedures

If a physician, not supervised by an authorized user (AU), requests a non-routine diagnostic study, does the licensee have to develop a written procedure for the study? [10 CFR 35.27] (Q&A ID 0303001)

Although the licensee does not have to develop a written procedure for the study, medical use has to be under the supervision of an authorized user (AU).

If the request is non-routine and not already included in the directions of an AU, either the AU has to administer the dosage or instruct the supervised individual in its administration.

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Notifications/Amendments

Are the notification requirements under 10 CFR 35.14 treated as requests for amendment of the license? [10 CFR 35.13, 35.14] (Q&A ID 0103031b)

If the licensee follows the requirements in §35.14 and the requested information is appropriate and complete, the action is not an amendment request; the changes noted will be incorporated into the license during the next licensing action (amendment or renewal). However, if the NRC's license reviewer determines that the information provided does not meet the requirements in §35.14, the licensee will be notified that an amendment request is needed.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.14, as published in the Federal Register on April 24, 2002.

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NRC Involvement When a Nuclear Pharmacy Distributes Unsealed Byproduct Material for Medical Use That Is Inconsistent with Prescriptions

What would the NRC's action be if a nuclear pharmacy distributed a "bad" batch of unsealed byproduct material for medical use to a licensee and did not notify the licensee of the problem?* An example might be mixing up the entire batches of Tc-99m with differing activities. [10 CFR 32.72, 35.3045] (Q&A ID 1202007)

In a situation when a nuclear pharmacy has distributed unsealed byproduct material to a medical use licensee that is not consistent with a prescription, the NRC would only become involved with the medical licensee if the administration of the "bad" unsealed byproduct material resulted in a medical event. In this scenario, the NRC would follow up with the licensee involved in the medical event and the nuclear pharmacy (if it was also an NRC licensee). The NRC would work in cooperation with the State radiation control agency if the nuclear pharmacy was located in an Agreement State.

In accordance with §32.72(a)(4)(i), nuclear pharmacies are required to label the transport shield of a radioactive drug for commercial distribution with, among other things, the name of the radioactive drug and the quantity of the radioactivity at a specified date and time.

Distributing a "bad" batch of Tc-99m, meaning having an incorrect activity at a specified date and time listed on the label, is in violation of NRC regulations. In this case, the licensee receiving that "bad" batch is not required to notify the NRC, although it may wish to discuss this issue with the nuclear pharmacy.


*There is no NRC requirement to report this occurrence to the licensee.

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NRC Notification of Retired Radiation Safety Officer

If the Radiation Safety Officer (RSO) continues an association with the licensee after retirement, is NRC notification required? Can the former RSO stay on the license as an Authorized User (AU)? [10 CFR 35.12, 35.13, 35.14, 35.59] (Q&A ID 0103026)

Since the RSO retired, he or she is presumably no longer performing the duties of the RSO under the license. Accordingly, §35.14(b)(1) requires notification to the NRC, by letter, no later than 30 days after retirement. If the former RSO was also listed on the license as an AU, he or she can continue in that capacity if the licensee so desires. Otherwise, the former RSO can function under the license as an AU if the individual satisfies the training and experience requirements appropriate to the intended medical use and recentness of training requirements, as long as the licensee provides notification under §35.14(a) or applies for, under §35.13(b), and receives a license amendment.

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NRC Notifications Review

Will the NRC be reviewing the appropriateness of notifications received from licensees for moving the locations of use, within previously-specified addresses of use, for stress studies, other diagnostic studies, and waste storage? [10 CFR 35.13, 35.14] (Q&A ID 0103029)

Yes. NRC will review notifications to ensure the information received meets the requirements of §35.14 and that license amendments are not necessary. If the information is incomplete, additional information will be requested. If NRC staff determines that the requirements for notification are not met, submission of an application for a license amendment may be necessary.

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NRC Recognition of Certification Boards -- American Board of Nuclear Cardiology

What types of authorized uses have been approved by the NRC for individuals certified by the American Board of Nuclear Cardiology (ABNC)? [10 CFR 35.100, 35.190, 35.200, 35.290] (Q&A ID 0802036)

Due to an administrative error NRC incorrectly identified the Certification Board of Nuclear Cardiology as the "American" Board of Nuclear Cardiology when the "Q & A's" were posted on the Web. The "Specialty Board(s) Certification Recognized by NRC Under 10 CFR Part 35 (Effective October 24, 2002)" Web page correctly identified the "Certification Board of Nuclear Cardiology" as the only specialty board recognized by NRC under 10 CFR Part 35, Subparts B, D, E, F, G, and H. There is no American Board of Nuclear Cardiology (ABNC). To add to the confusion, several nuclear cardiologists have incorrectly identified their certification as the "American Board of Nuclear Cardiology" or "Diplomats, Board of Nuclear Cardiology," when in fact the Certification Board of Nuclear Cardiology confirmed these individuals were certified by the "Certification Board of Nuclear Cardiology."

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NRC Recognition of Certification Boards -- Certification Board of Nuclear Cardiology

What types of authorized uses have been approved by the NRC for individuals certified by the Certification Board of Nuclear Cardiology (CBNC)? [10 CFR 35.100, 35.190, 35.200, 35.290] (Q&A ID 0802036)

The CBNC requested recognition under § 35.290 for § 35.200 materials only, and that is what was granted. Accordingly, a physician who is certified by the CBNC satisfies the training and experience requirements for an authorized user (AU) for use of § 35.200 materials. Note that an AU for use of § 35.200 materials also satisfies the training and experience requirements under § 35.190 for an AU for use of § 35.100 materials.

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NRC Review of Disposal Procedures

Do procedures have to be reviewed by NRC for Part 35 licensees who perform alternative types of disposal under §20.2002? (a) Incineration (b) Sewer (c) Other [10 CFR 20.2002, 20.2003, 20.2005] (Q&A ID 1202004)

(a) Incineration - (1) No, review is not required for licensed materials listed in §20.2005 (certain quantities of H-3 & C-14 in liquid scintillation medium and animal carcasses). (2) Yes, review is required for all other licensed materials, since licensees need approval pursuant to §20.2002, which requires that an applicant submit proposed procedures.

(b) Sewer - In general, review is not required for sewer disposal of medical waste generated, including excreta from individuals undergoing medical diagnosis or therapy with licensed material, under §20.2003(b). However, the licensee must ensure that all conditions in §20.2003 are satisfied.

(c) Yes, see (a)(2) above.

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Patient Intervention - Dose Limits

Two brachytherapy patients are sharing the same room (which is allowed under the revised Part 35). One patient removes the source(s), exposing other persons. What dose limits apply? [10 CFR 20.1301, 20.2203(a), 35.415(a), 30.3045(b)] (Q&A ID 1202013)

For this occurrence, the dose limit for all non-occupationally exposed persons, except the other brachytherapy patient sharing the room, is 100 mrem (1 mSv) in a year (the dose limit for members of the public), per §20.1301*, and if exceeded, is reportable under §20.2203(a). For either patient, the event, which resulted from intervention of a patient, is reportable as a medical event, per §35.3045, if the dose received from the removed source(s) results or will result in permanent functional damage to an organ or a physiological system of either patient, as determined by a physician.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.315, 35.415, and 35.3045, as published in the Federal Register on April 24, 2002.


*Visitors to either of the brachytherapy patients may be permitted to receive radiation doses up to 500 mrem (5 mSv) in a year from exposure to the patient being visited if deemed appropriate, prior to the visit or visits, by the authorized user involved in the patient's treatment(s).

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Patient treatment with radioactive iodine-release of patients

Why does NRC not require hospitalization of patients receiving therapeutic doses of radioactive iodine-131 (I-131)? [10 CFR 35.75(a)] (Q&A ID 0308001)

The NRC believes that its current release criterion is based on sound radiation protection principles, is sufficient to protect public health and safety, results in reduced health care costs, and allows patients to be in the comfort of their homes. Under the current regulations, a patient may be treated as an outpatient if the authorized user physician determines that the radiation dose to other individuals from the patient treated with I-131 is likely to be below a certain level, i.e., 5 millisieverts (500 millirem).

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Patient treatment with radioactive iodine - release of patients to location other than primary residence (RIS 2011-01)

Why is the NRC issuing RIS 2011-01?

The NRC is issuing this Regulatory Issues Summary (RIS) to inform its licensees and others of NRC's guidelines for the release of iodine-131 therapy patients to locations other than private residences.

Does the NRC believe that the current regulations in 10 CFR 35.75 are protective of public health and safety?

The NRC believes that radiation exposure to other individuals from released patients can be safely controlled by the current 10 CFR 35.75 patient release criteria, patient dose calculations, and by the adherence to patient release instructions. The NRC believes that the current patient release criteria appropriately balances public safety with patient access to medical treatment.

What has prompted the NRC to issue RIS 2011-01?

The NRC has been made aware of concerns regarding instances when patients who have been treated with radioactive iodine (I-131) are released to hotels or motels and this RIS provides further clarification of the NRC's guidelines in response to those concerns.

Do NRC regulations prohibit the release of I-131 radioactive patients to hotels or motels?

Although 10 CFR 35.75 does not expressly prohibit the release from the hospital of a patient who has been administered radioactive iodine to a location other than a private residence, the NRC strongly discourages this practice because it can result in radiation exposures to members of the public for which the licensee may not be able to fully assess compliance with NRC requirements, and may result in doses which are not as low as reasonably achievable.

Will release of I-131 radioactive patients to hotels or motels be a topic for NRC rulemaking?

The NRC has no plans to promulgate new rules for the release of patients from the hospital who have been administered radioactive iodine. The NRC believes current patient release criteria appropriately balances public safety with patient access to medical treatment.

Will the NRC generate specific guidance if the patient's post-release destination is a hotel/motel?

Guidance or instructions on how licensees should revise the standard patient release instructions if the patient's post-release destination is a hotel/motel will be provided in an update to NUREG-1556, Vol. 9 (Program-Specific Guidance About Medical Use Licenses), Appendix U (Release of Patients or Human Research Subjects Administered Radioactive Materials).

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Patient treatment with radioactive iodine-limited hospitalization of patients

Is NRC concerned that hospitals and insurance companies deny hospitalization for patients who do not wish to go home immediately after treatment, saying the NRC doesn't allow it? [10 CFR 35.75(a)] (Q&A ID 0308002)

The rule does not preclude hospitalization of these patients. The licensee has a responsibility to keep doses to members of the public from patients below 5 millisieverts (mSv) (500 millirem [mrem]). The authorized physician has the primary responsibility for the health and safety of his/her patients and, therefore, is the appropriate individual to make the determination as to whether the patient should be released, considering the patient's condition and the unique living situation of the patient and evaluating, on a case-by-case basis, the ability of a patient to comply with the dose limit of 5 mSv (500 mrem) to others.

The NRC does not have regulatory jurisdiction over the practices and policies of insurance companies. However, NRC does encourage continued communication between regulatory bodies and insurance companies to clarify this issue.

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Patient treatment with radioactive iodine-safety information for patients

Does NRC require medical licensees to give patients information about their radioactivity following treatment? [10 CFR 35.75(b)] (Q&A ID 0308003)

If the projected radiation dose to another individual from exposure to the released patient could exceed a specified value, 1 millisievert (mSv) (100 millirem [mrem]), NRC regulations require licensees to provide instructions, including written instructions, to the patient or the patient's family, to keep exposure to other individuals as low as possible.

The Society of Nuclear Medicine has prepared a pamphlet that includes special instructions for patients to reduce exposure to others. Many licensees provide this pamphlet to their patients, and many institutions have developed their own set of precautions which they provide to the patients, or to the patients' relatives, to minimize contamination and exposures to other individuals.

NRC's guidance documents also provide safety precautions to minimize exposure to others. See NUREG-1556, Vol. 9, Rev. 2, “Consolidated Guidance About Medical Use Licenses: Program-Specific Guidance About Medical Use Licenses,” Appendix U, which is available at the NRC public web site, www.nrc.gov.

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Patient treatment with radioactive iodine-verifying patient instruction

Does NRC make any effort to verify if medical licensees are giving patients proper information/education about what dangers they may or may not pose to others, and what precautions they should take? [10 CFR 35.75(b)] (Q&A ID 0308004)

Yes. Licensees are routinely inspected, and our inspectors, through interviews and observations and reviews of licensees§ procedures, verify that licensees are providing relevant information to the patients or their guardians. A special study in 2006-2007 focused on this issue and confirmed generally adequate practices by licensees; the results were published in The Journal of Nuclear Medicine, Vol. 48, No. 12, December, 2007.

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Patient treatment with radioactive iodine-required hospitalization of patients

Under what conditions would NRC regulations require hospitalization for radioactive iodine-131 patients? [10 CFR 35.75(a), 35.2075(a)] (Q&A ID 0308005)

Under current regulations, the authorized user physician makes an assessment of the individual patient, including anticipated living conditions, and determines whether the patient needs hospitalization or can be treated as an outpatient. The determination is based on projected radiation doses to other individuals. If the dose to another individual may exceed the 5 millisievert (500 millirem) regulatory limit, the patient cannot be released, i.e., treated as an outpatient, and must be hospitalized.

NRC regulations require licensees to keep a record of the basis for release of patients if the total effective dose equivalent is calculated by certain specified methods which are outside of the NRC's conservative default model procedures specified in NUREG-1556, Vol.9, Rev. 2, Appendix U, “Model Procedure for Release of Patients or Human Research Subjects Administered Radioactive Materials.”

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Patient treatment with radioactive iodine-clearance of radioiodine from patients

How fast does radioiodine clear from the body after administration? (Q&A ID 0308006)

The usual radioiodine used for patient therapeutic treatments is iodine-131 (I-131). The physical half-life of I-131, i.e., the time it takes to decay to half of its initial strength (or activity) is 8 days. However, when I-131 is administered to a patient, the amount of radioactivity in the patient also decreases due to biological elimination from the body, as well as by physical decay, so its effective half-life in the body is less than 8 days. While the effective half-life for I-131 in patients varies among individuals, depending on their medical conditions, for most cancer patients, most of the I-131 administered is excreted by the body in the first 2 days after treatment.

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Patient treatment with radioactive iodine-radiation exposure to other persons

Can a patient who has received radioiodine therapy actually "contaminate" someone else with radioactive iodine (e.g., through saliva or other bodily fluids, or bodily contact)? Or is there just an issue of external exposure of others to radiation from the patient, due to decay of the radioiodine within the patient? (Q&A ID 0308007)

Exposure to relatives, caregivers, and the public can occur in two ways: (1) external irradiation of persons in close proximity to the patient and (2) internal and external contamination of people who come into contact with the radioiodine excreted or exhaled by the patient. The patient's saliva, sweat, and other bodily fluids all contain some radioactivity. Most of the activity is excreted through the urine. However, by following simple instructions provided by the treating physician or his/her designee, the spread of contamination from the patient to other persons can be minimized.

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Patient treatment with radioactive iodine-patient instruction on avoiding §public places§

NRC's current guidance to medical licensees on instructions for patients being released from licensee control following administration of unsealed byproduct material or implants containing byproduct material includes recommending that released patients minimize being in "public places" for a period of time following release. What is the basis for this guidance on instructions? [10 CFR 35.75(b)] (Q&A ID 0308008)

The overall objective of minimizing released patient presence in “public places” for a specified period of time is to keep both external and internal radiation doses to others as low as reasonably achievable, by avoiding contact by the released patient with other individuals, especially infants and young children. Examples of “public places,” contained in the current guidance, include grocery stores, shopping centers, theaters, restaurants, sporting events, and public transportation vehicles. The guidance description of “public places” is not all-inclusive–portions of other places, such as schools and hotels, may also be considered to be accessible to the public, depending on the circumstances.

(See NUREG-1556, Vol. 9, Rev. 2, “Consolidated Guidance About Medical Use Licenses: Program-Specific Guidance About Medical Use Licenses,” Appendix U, which is available at the NRC public web site, www.nrc.gov.)

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Patient treatment with radioactive iodine-released patient contamination control

What information can a patient who has been treated with radioactive iodine and is to be released expect to receive about the control of radioactive contamination? [10 CFR 35.75(b)] (Q&A ID 0308009)

The instructions provided by the licensee on actions recommended to maintain doses to other individuals as low as is reasonably achievable should include measures to limit the transfer of radioactive contamination to others. Because such transfer can occur through direct contact with the released patient and also indirectly, through individuals' contact with contaminated objects and surfaces within the patient's living quarters or elsewhere, the instructions provided by the licensee should cover both pathways. Accordingly, the instructions should include limiting direct contact with others and measures to limit the contamination of objects and surfaces and the spread of contamination. The instructions should also take into account the environment to which the patient will be released.

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Physical Presence of AUs and AMPs During Byproduct Material Medical Use

Must an AU and/or AMP be physically present during procedures? [10 CFR 35.615 (f)(2), (3)] (Q&A ID 0301012)

Not in most cases. However, for high dose-rate remote afterloader units (HDRs), the AU and AMP must be physically present during the initiation of all patient treatments. In addition, the AMP and either the AU or a physician under the supervision of the AU and trained in the operation and emergency response for the unit must also be physically present during continuation of all patient treatments involving HDRs.

For gamma stereotactic radiosurgery units, the AU and AMP must be physically present throughout all patient treatments involving the units. "Physically present" means within hearing distance of normal voice. (Refer to "Supplementary Information," Section V, "Summary of Changes," for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.)

For medium dose-rate and pulsed dose-rate remote afterloaders, the AMP and either the AU or a physician under the supervision of the AU and trained in emergency response for the unit must be physically present during the initiation of all patient treatments and be immediately available during continuation of all patient treatments. "Immediately available" means available on an on-call basis (at minimum, available by telephone). (Refer to "Supplementary Information," Section V, "Summary of Changes," for 10 CFR 35.615, as published in the Federal Register on April 24, 2002.)

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Preparation of Radioactive Material for Medical Use Under an IND

Is there a conflict between Part 32 and Part 35 with regard to who may prepare radioactive material for medical use under an FDA-accepted Investigational New Drug (IND) protocol? [10 CFR 32.72, 35.100, 35.200, 35.300] (Q&A ID 0802025)

No. 10 CFR § 32.72 lists criteria for authorization of a license to manufacture, prepare, or transfer radioactive drugs for use by persons authorized pursuant to Part 35. However, § 35.100, 200, and 300 were specifically amended to allow a medical use licensee to receive radioactive drugs, for use in IND research protocols, that are prepared and distributed by NRC or Agreement State licensees who are not § 32.72 licensees.

Refer to "Supplementary Information," Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for 10 CFR § 35.100, § 35.200, and § 35.300; "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.100, § 35.200, and § 35.300, as published in the Federal Register on April 24, 2002.

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Prescribed Dosage Range

For the dosage determination provisions of §35.63, can the prescribed dosage range be broad enough to permit the use of a dosage that differs from the central value of the range by 30%? [10 CFR 35.63] (Q&A ID 0303006)

Yes. Under §35.63(d), the authorized user can prescribe any dosage range that he or she believes to be appropriate.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.

For a prescribed range of dosages, can the authorized user (AU) prescribe a "dosage plus or minus 'xx' percent"?[10 CFR 35.2, 35.40(c), 35.63, 35.3045(a)] (Q&A ID 0103030)

Yes. The AU can prescribe a dosage range, an exact dosage +/- "XX" percent, or he/she may specify an exact dosage and rely on the +/- 20 percent for permitted variation from the exact dosage specified in §35.63 and §35.3045(a). If the AU prescribes a dosage range, then the administered dosage must be within the stated range in order to be consistent with the prescription. Under 10 CFR 35.2, "Definitions" (for "prescribed dosage") and 10 CFR 35.40(c), for given types of usage, the AU is not precluded from changing the range at any time prior to administration of the dosage.

For a specific patient, however, whether or not a written directive is required under 10 CFR 35.40, once the dosage or dosage range is specified and the dosage administered, changes to the specified dosage or dosage range are not permitted.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.

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Program Changes from Existing License Tie-Down Conditions (referring to the application and other documents submitted to NRC plus specific requirements)

a) When a licensee transitions to the revised Part 35 and makes changes to survey frequencies or other radiation safety program elements previously required under a license condition or commitment, what records, if any, should the licensee prepare to document the transition? [10 CFR 35.26(a), 35.2026] (Q&A ID 0802049)

b) If a licensee is currently operating with specific tie-down conditions (standard license conditions that refers to the application and other documents submitted to NRC plus specific requirements for the medical usage), does the licensee need to request and receive an amendment to the license to change something in the tie-down conditions that is not a procedure that must be submitted to NRC under the revised Part 35? [10 CFR 35.10, 35.13(g), 35.26, 35.1000, 35.2026] (Q&A ID 0802044)

a) Transitioning to the revised Part 35 as described would involve changes to the radiation protection program. The requirements for carrying out such changes are contained in § 35.26.

The requirements for documentation of radiation protection program changes made in accordance with § 35.26(a) are contained in § 35.2026. The record must include a copy of the old and new procedures, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.26 and § 35.2026, as published in the Federal Register on April 24, 2002.

b) No. An amendment is not required as long as the program revision is in compliance with the regulations in the Final Rule [§ 35.10(e)]. However, for modalities to be regulated under § 35.1000, such as intravascular brachytherapy device usage, tie-down conditions remain in effect and cannot be changed by the licensee without NRC approval [§ 35.1000(b)].* Additionally, an amendment is not required for revisions of procedures that must be submitted to NRC as long as the revisions do not reduce radiation safety [§ 35.13(g)].

Note that changes to the licensee's radiation protection program must be done in accordance with the requirements of § 35.26 and be documented, with retention of the record for five years, per § 35.2026.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.10, § 35.13, and § 35.1000, as p


ublished in the Federal Register on April 24, 2002.

*Section 35.1000(b) requires written approval from the Commission for medical use that is not specifically addressed in Subparts D through H. The tie-down condition(s) of a license for a medical modality to be regulated under § 35.1000 are or reference the "specific conditions the Commission considers necessary for the medical use of the material." Accordingly, an amendment (i.e., written approval from the Commission) is required before the licensee can change something in the tie-down condition(s) relating to a § 35.1000 usage.

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Public Dose Limit for Visitors to Hospitalized Individuals

Has there been any change to the dose limit for members of the public who visit hospitalized individuals that cannot be released under §35.75? [10 CFR 20.1301(c), 35.75] (Q&A ID 1202023)

Yes. While the dose limit for routine visitations remains at the dose limit for individual members of the public in §20.1301 of 100 mrem (1 mSv) per year, a licensee may permit visitors to an individual that cannot be released under §35.75 to receive up to 500 mrem (5 mSv) in a year if the authorized user involved in the patient's treatment(s) has determined before the visit(s) that the increased dose limit is appropriate.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §20.1301, as published in the Federal Register on April 24, 2002.

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Published Protocols

What are the "published protocols currently accepted by nationally recognized bodies"? Where can I find them? [10 CFR 35.432(a), 35.457, 35.630(a), 35.632(d), 35.633(d), 35.635(d), 35.657 ] (Q&A ID 1202041)

The Supplementary Information for 10 CFR 35.432 defines "nationally recognized bodies" as official standards consensus bodies on the National Institute of Standards and Technology (NIST) website and professional organizations that develop protocols using a consensus process and multiple peer reviews. Examples of nationally recognized bodies include the American Association of Physicists in Medicine, the American College of Radiology, and the National Institute of Standards and Technology.

A fairly comprehensive listing of various published protocols can be found in Appendix AA of NUREG-1556, Vol. 9, Rev. 1, pages 6-9, published May 2005.

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Qualifications for Radiation Safety Officers

Does anyone who meets the requirements in §35.2, Definitions, meet the requirements to serve as Radiation Safety Officer (RSO)? [10 CFR 35.2, 35.50, 35.59] (Q&A ID 0103023)

Yes. Section 35.2 provides the definition of an RSO as an individual who meets the training and experience requirements in §§35.50(a) or (c) and 35.59. If an individual meets these requirements, an individual will be able to serve as RSO. However, the licensee would still have to apply for a license amendment request before it permits the individual to work under its license.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments," Part II, "General Issues," Subpart E, "Training and Experience," as published in the Federal Register on April 24, 2002.

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Quartering Patients Who Cannot Be Released Under § 35.75

Can a patient with a therapy implant be quartered in a room with a patient receiving I-131 therapy? [10 CFR 35.75, 35.315, 35.415] (Q&A ID 0802027)

No. However, two patients with therapy implants can be quartered together. Similarly, two patients receiving I-131 therapy can be quartered together.

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Radiation Safety Committee Delegated Authority

Can the licensee's chief executive officer delegate his or her authority (to manage, direct or administer the licensee§s activities) to a Radiation Safety Committee (RSC)? [10 CFR 35.24] (Q&A ID 0103037)

If an RSC is required under §35.24(f), its duty is to oversee all uses of byproduct material permitted by the licensee. However, licensee management has the ultimate responsibility for the radiation protection program. If the licensee is not required under §35.24(f) to create an RSC, but still decides to establish this committee, the RSC functions as management directs, and its duties are as assigned.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 14, 2002.

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Radiation Safety Committee Meeting Frequency

If a Radiation Safety Committee (RSC) is required, does the frequency of meetings of the RSC have to be established? ? [10 CFR 35.24] (Q&A ID 0103045)

The regulations require certain licensees to have radiation safety committees. However, the regulations do not include specific requirements for the frequency of RSC meetings.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.

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Radiation Safety Committee Meeting Requirements

If a Radiation Safety Committee (RSC) is required, do all designated members of the RSC have to be present to have a "meeting"? [10 CFR 35.24(f)] (Q&A ID 1202030)

No. 10 CFR 35.24(f) sets out the requirements for the RSC, should one be necessary. These requirements do not specify that all designated members of the RSC must be present. As explained in the Supplementary Information for this regulation, most of the prescriptive requirements and committee tasks formerly in Part 35 have been deleted from the current rule. Only the Committee membership is specified in §35.24(f).

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.

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Radiation Safety Officer Acting as Management

If the radiation safety officer (RSO) is placed in the management structure, are actions of the RSO considered actions of management? [10 CFR 35.2, 35.24] (Q&A ID 0103036)

Yes, if the RSO meets the criteria of §management§ as defined in the regulations by being any of the following: i) the chief executive officer; ii) the individual having the authority to manage, direct or administer the licensee§s activities; or iii) a delegate of either i or ii above. However, if the licensee has a radiation safety committee, the RSO is prohibited by §35.24(f) from serving as the management representative on the committee.

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Radiation Safety Officer "Grandfathering"

Would an individual be "grandfathered" if he/she stopped being a Radiation Safety Officer (RSO) in 2004?
[10 CFR 35.50, 35.57, 35.59] (Q&A ID 0103024)

If an individual is listed as RSO on the licensee's current license, notwithstanding the fact that he/she is no longer actively working as an RSO, the individual would be "grandfathered" and would not need to comply with the T&E requirements in §35.50. Note that §35.59 would continue to apply, and the T&E would have to have been obtained within seven years preceding the date of the application, or the individual must have had related continuing education and experience. Also note, with regard to an indiivdual's stopping work as an RSO in 2004, under section 35.14(b)(1), the licensee was required to provide letter notification to NRC within 30 days of an individual's (permanently) discontinuing performance of RSO duties under the license. However, if an individual is no longer listed on a current license, he/she would not be "grandfathered" and would have to meet the T&E requirements in §35.50, plus the recentness of training requirement in §35.59.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.50, as published in the Federal Register on April 24, 2002.

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Radiation Safety Officer's Written Acceptance of Duties and Responsibilities

Will an authorized user (AU)/licensee in a small medical office who wishes to be identified as the Radiation Safety Officer (RSO) for the license need to comply with §35.24(b), which requires an RSO to accept, in writing, the duties and responsibilities of the position, since he/she is the same person? [10 CFR 35.24(b)] (Q&A ID 1202022)

Yes. The individual is now going to be taking on the responsibilities of an RSO, and as such, must specifically comply with the regulatory requirements applicable to the position of RSO. The regulations assign to the position of the RSO rather than to another position, the responsibility for implementing the radiation program, and in connection with that responsibility, explicitly require that the RSO acknowledge in writing responsibility for the radiation protection program.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.24, as published in the Federal Register on April 24, 2002.

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Radiation Safety Procedures for Hospitalized Patients Released Under § 35.75

a) How should a hospital handle a patient who has been released under 10 CFR 35.75 but remains in the hospital for other reasons?

b) Is the hospital responsible for treating excreta from the patient as radioactive waste? [10 CFR 20.1003, 20.2003, 35.75] (Q&A ID 1002001)

a) If the "released" patient is not discharged from the hospital, the patient continues to represent a source of radiation exposure to others* and, for some treatments, potentially a source of radioactive contamination to the facility and persons in it. Licensees should consider the requirement regarding providing instructions on maintaining exposures ALARA in situations where the individual has been released under § 35.75 but remains hospitalized for other reasons; in this case the maximally exposed individual may be a member of the licensee's staff. Moreover, the basis for the "release" was a total effective dose to others, including hospital staff, patients, and visitors, not likely to exceed 500 mrem. Based on emerging conditions for the hospitalized patient, conditions that differ from those assumed in authorizing the "release" and that result in the possibility of the dose to someone exceeding 500 mrem, the hospital could reconsider the "release" status and consider revoking it, if warranted.

b) No. 10 CFR Section 20.2003(a) provides the regulatory framework for release of radioactive waste into the sanitary sewerage. However, 20.2003(b) specifically provides that excreta from individuals undergoing medical diagnosis or therapy with radioactive material is not subject to these requirements. Items contaminated with excreta from "released" patients should be handled in accordance with the hospital's procedures regarding non-"released" patients.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.75, as published in the Federal Register on April 24, 2002.
___________
*Exposure from such patients does not constitute occupational dose for employees of the hospital or public dose for others.

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Recalibration of Dose Calibrators

To be in compliance with the 2002 requirements, does a licensee have to recalibrate a dose calibrator that was in use prior to October 24, 2002? [10 CFR 35.60] (Q&A ID 0303015)

Not necessarily. If the dose calibrator was calibrated in compliance with the NRC requirements that were in effect prior to October 24, 2002,* and the licensee has continued to perform calibrations at the frequency specified in the prior rule, the requirements of the present §35.60, "Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material," would be satisfied, since the prior requirements aligned with ANSI N42.13-1986 (R1993), a current national consensus standard. Section 35.60 requires calibrations to be in accordance with nationally recognized standards or the manufacturers instructions.


*10 CFR 35.50, "Possession, use, calibration, and check of dose calibrators."

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Receipt of Material Delivered to a Mobile Medical Nuclear Licensee

For convenience of operation of a mobile nuclear medicine licensee, will the NRC approve an exemption to §35.80(b) to permit early morning receipt of short-term storage (less than 1 hour) of unsealed byproduct material for medical use in a non-licensee hospital's lab before licensee staff arrives on-site for shipment check-in and use? [10 CFR 35.80] (Q&A ID 0103018)

No. Licensee convenience is not considered adequate justification to issue an exemption. To institute this delivery and storage plan, either the receiving hospital should apply for a possession-only license or a staff member of the mobile nuclear medicine licensee should be at the client hospital at the time of delivery or the hospital's lab should be listed as a base location on the mobile nuclear medicine licensee's license.

Refer to "Supplementary Information," Sect on III, "Summary of Public Comments and Responses to Comments" for §35.80, as published in the Federal Register on April 24, 2002.

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Recency of Board Certification for Nuclear Cardiologists

When accepting a board-certified cardiologist for §35.200 use, how recently should he or she have been certified? NRC recognized the Certified Board of Nuclear Cardiology (CBNC), but only relatively recently. If the qualifications for certification were different several years ago, before NRC recognition, does NRC accept older certifications anyway? [10 CFR 35.59, 35.200, 35.290] (Q&A ID 1202008)

In general, if an individual became certified by the CBNC after the board's certification processes were recognized, his or her certification will be considered valid if it was granted during the time that the board's certification processes were recognized, even if the requirements at the time were different. In order to become an authorized user on a license, however, the individual will have to be currently certified and meet the recentness-of-training requirements of §35.59.

The CBNC was recognized under the regulations in Part 35 that became effective October 24, 2002 and was re-recognized under the revised training and experience regulations in Part 35 that became effective April 29, 2005. The 2002 regulations included the requirement that, in order to be recognized, a board's certification process had to require that the individual being certified obtain a preceptor statement. (The regulations were revised, effective April 29, 2005, so as to "decouple" this requirement from the criteria required for recognition, so as to place this requirement separately directly upon the applicant.) However, the predecessor organization to the CBNC, the Certification Council of Nuclear Cardiology (CCNC) did not include in its criteria for certification that an individual obtain a preceptor statement. Therefore, an applicant certified by the CCNC should submit a copy of the board certification plus the preceptor statement required by §35.290. The applicant will also have to satisfy the recentness-of-training requirements in §35.59.

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Recentness of Training and Experience

If you were qualified (training and experience) more than 7 years ago, what continuing education activities and experience are required in order to be identified as an authorized individual on a license? [10 CFR 35.59] (Q&A ID 0103034)

To determine compliance with §35.59, the NRC staff will consider whether the continuing education and experience would demonstrate competency in the topics specified in the applicable regulation [e.g., §35.190(c), §35.290(c), and §35.390(b)]. To support this determination, the licensee should submit information on prior qualifications and on the continuing education and experience obtained by the individual during the last 7 years, with preceptor statements, if available, for new training and experience, current level of competency specific to each of the topics in the applicable regulation. This information will be reviewed on a case-by-case basis, with input from the Advisory Committee for the Medical Use of Isotopes (ACMUI), as necessary.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.59, as published in the Federal Register on April 24, 2002.

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Recognition of Certification Specialty Boards

a) If an Agreement State (AS) recognizes a certification board that the NRC has not recognized, how will the NRC handle this?

b) Will the AS-recognized board be listed on the NRC Web site? [10 CFR 35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394, 35.490, 35.491, 35.590, 35.690] (Q&A ID 0902006)

a) For all training requirements in the Final Rule (radiation safety officers, authorized medical physicists, authorized nuclear pharmacists, authorized user physicians), the specialty certification board can be recognized by the NRC or by an AS; there is no requirement that a certification board be recognized by both NRC and one or more ASs. Moreover, the criteria for recognition of a specialty board appear in the section of the Final Rule appropriate to the specialty, so NRC and ASs will be utilizing the same criteria in considering applications from specialty boards for recognition, since AS training requirements must be essentially identical to those of the NRC. Therefore, NRC will accept certifications from boards recognized by ASs.

b) Yes, as are the NRC-recognized boards.

(Recognition of certification boards is discussed under paragraphs (a) and (b) of each of the subsections cited in the Rule Sections.)

Refer to "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," "Summary of NRC Rules With Compatibility or Health and Safety Designations Under the Revision of 10 CFR Parts 20, 32, and 35," as published in the Federal Register on April 24, 2002.

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Redistribution of Sealed Sources

Does §35.65(b) authorize medical use of sealed sources redistributed by Agreement State licensees? [10 CFR35.65(b)] (Q&A ID 0303002)

No. Currently, §35.65(b) does not specifically include sources redistributed by Agreement State licensees.

Use of sealed sources redistributed by Agreement State licensees may be requested by licensees as exemptions for license amendments.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.65, as published in the Federal Register on April 24, 2002.

Can sources redistributed under §35.65(b) for medical use be manufactured and initially distributed by an Agreement State licensee? [10 CFR 35.65(b)] (Q&A ID 0303003)

No. Currently, §35.65(b) does not specifically include sources manufactured and initially distributed by Agreement State licensees.

Use of sealed sources manufactured and initially distributed by Agreement State licensees and redistributed by an individual licensed by NRC, or an Agreement State [see Q&A #0303002], may be requested by medical licensees as exemptions for license amendments.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.65, as published in the Federal Register on April 24, 2002.

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Regulation for "New" Modalities

How does the NRC plan to communicate to broad scope licensees when a decision is made regarding regulation of a "new" medical use modality by a specific section of Part 35? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802034)

The Commission, with input from its Advisory Committee on the Medical Uses of Isotopes, as requested, will determine if a "new" medical use modality is truly a new technology and is covered by Subpart K, "Other Medical Uses of Byproduct Material or Radiation From Byproduct Material" or if the "new" technology is actually a type of use regulated under Subparts D through H.

When NRC decides that a "new" medical use modality is regulated under an existing Subpart (D through H) of Part 35, as opposed to it being regulated under § 35.1000 as an application that involves devices and procedures that differ from those for conventional medical usage, that decision will be made known to medical licensees, including broad scope licensees that are authorized for medical applications. This may be accomplished through issuance of a generic communication or through other appropriate mechanism(s), such as posting Regional Generic Technical Assistance Request (TAR) responses on the NRC Web site, notation in the SSDR, and/or a comment in the NMSS newletter.

Will Regions make final decisions on which sections of Part 35 that "new" medical use modalities will be regulated under? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802041)

The Commission, with input from its Advisory Committee on the Medical Uses of Isotopes, as requested, will determine if a "new" medical use modality is truly a new technology and is covered by Subpart K, "Other Medical Uses of Byproduct Material or Radiation from Byproduct Material" or if the "new" technology is actually a type of use regulated under Subparts D through H. The current expectation is that final determinations will be made at Headquarters, with consideration initiated through Technical Assistance Requests (TARs) from the Regions. This is the preferred approach to ensure uniformity of classification (drug vs. device) and regulatory treatment.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.12 and § 35.1000, as published in the Federal Register on April 24, 2002.

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Regulation of Attenuation Sources Used in Medicine

Which sections in Part 35 provide regulations for use of attenuation sources (e.g., Gd and Cs sources) in medicine? [10 CFR 35.65, 35.500, 35.590] (Q&A ID 0802033)

Section 35.65 authorizes the receipt, possession, and use of sealed sources of byproduct material for medical transmission and other purposes. The conditions that such sources must meet are listed in the section.

If the conditions of § 35.65 are not met, then Subpart G, "Sealed Sources for Diagnosis," provides those regulations applicable to attenuation sources used in medicine.

For information on use conditions approved for such sources, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments," Part II, "General Issues," Section F, "Global Changes in the Rule," Issue 1, "What Is the Sealed Source and Device Registry and How Do I Access the Registry?" as published in the Federal Register on April 24, 2002.

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Regulation of GliaSite

Under what section(s) of the Final Rule is use of the GliaSite§ Radiation Therapy System (RTS) regulated? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802018)

Use of the GliaSite® RTS is considered as an application that involves a device and procedures that differ from those for conventional sealed source therapeutic medical usage. As such, use of the GliaSite® RTS is presently to be regulated under 10 CFR § 35.1000, rather than under Subpart F (Manual Brachytherapy).

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.

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Regulation of Intravascular Brachytherapy

Under what section(s) of the Final Rule is intravascular brachytherapy (IVB) regulated? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802017)

IVB using beta emitters and IVB with devices using gamma emitters are both considered as applications that involve devices and procedures that differ from those for conventional sealed source therapeutic medical usage. As such, IVB is presently to be regulated under 10 CFR § 35.1000, rather than under Subpart F (Manual Brachytherapy) or Subpart H (Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units ).

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.

Under what section of the Final Rule is intravascular brachytherapy (IVB) using the Cordis device regulated? [10 CFR 35.12(d), 35.400, 35.600, 35.1000] (Q&A ID 0802023)

Use of the Cordis Checkmate® IVB device, which uses gamma-emitting radioactive sources, is considered as an application that involves devices and procedures that differ from those for conventional sealed source therapeutic medical usage. As such, IVB with devices using gamma emitters is presently to be regulated under 10 CFR § 35.1000, rather than under Subpart F or Subpart H.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.

If an Agreement State (AS) decides to add IVB to its regulations, what would the NRC compatibility category be, since the use of byproduct materials in IVB is not explicitly discussed in 10 CFR Part 35? [10 CFR 35.1000] (Q&A ID 0902010)

Presently, use of byproduct material in IVB is being licensed under 10 CFR 35.1000, rather than under Subpart F or Subpart H, of the Final Rule. The Agreement State Compatibility Category for § 35.1000 is "D," meaning the requirement does not need to be adopted by an Agreement State for purposes of compatibility. Until NRC issues a regulation with specific requirements for IVB and specifies a different compatibility category, compatibility of AS regulations for IVB with NRC regulations is not required.

Refer to "Supplementary Information," Section X, "Issues of Compatibility for Agreement States," as published in the Federal Register on April 24, 2002.

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Regulation of Low Dose Rate Remote Afterloader Therapy Units

What section of Part 35 applies to the use and calibration of Low Dose Rate (LDR) therapy devices? [10 CFR 35.2, 35.12(d), 35.600, 35.10006] (Q&A ID 0802043)

Subpart H, "Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units," governs, unless the device employs a remote beta-emitting radioisotope or is not remotely driven. In these cases, § 35.1000, "Other Medical Uses of Byproduct Material or Radiation From Byproduct Material," is the appropriate section for remote beta-emitting sources and 35.400 is the appropriate section for manual LDR sources.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.615, as published in the Federal Register on April 24, 2002.

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Regulation of "New" Medical Uses of Byproduct Material

Relatively new medical uses of byproduct material, such as monoclonal antibodies labeled with byproduct material, are not mentioned in NUREG-1556, Vol. 9, Rev 1. Will "new" medical uses of byproduct material for imaging and localization studies and/or for therapeutic uses be regulated as §35.100, 200, or 300 entities, rather than §35.1000? [10 CFR 35.100, 35.200, 35.300, 35.1000] (Q&A ID 1202021)

The scope of new 35.100 (Part 35 Subpart K) is intended to include all new medical uses of byproduct materials or radiation from byproduct material. The NRC, with input from its Advisory Committee on the Medical Uses of Isotopes, as requested, will determine if the technology truly is a new technology and should be licensed under Subpart K, or if it is actually a type of use regulated under the other subparts. When determining which section of Part 35 applies, the form, type of use, training and experience, and any other necessary information will be considered.

Byproduct materials will not be licensed under §35.1000 when other sections provide appropriate regulations for an intended medical use.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.1000, as published in the Federal Register on April 24, 2002.

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Regulation of "New" Medical Uses of Unsealed Byproduct Material

Relatively new medical uses of unsealed byproduct material, such as monoclonal antibodies labeled with byproduct material, are not mentioned in NUREG-1556, Vol 9. Will "new" medical uses of unsealed byproduct material for imaging and localization studies, and/or for therapeutic uses, be regulated as § 35.100, 200, or 300 entities, rather than under § 35.1000? [10 CFR 35.100 35.200 35.300, 35.1000] (Q&A ID 1202021)

While § 35.1000 is a new section, created to address "other" medical uses of byproduct material, the scope of this section includes medical uses of byproduct material that are not licensed under 10 CFR Subparts D through H. Thus, byproduct materials will not be licensed under § 35.1000 when other sections provide appropriate regulations for an intended medical use. This may be expected to be the case for most new medical uses of unsealed byproduct material for imaging and localization studies, and/or for therapeutic purposes. Monoclonal antibodies labeled with byproduct material will be regulated as § 35.200 or 300 entities based on their form (unsealed byproduct material) and use (medical).

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.

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Report of a Dose to an Embryo/Fetus

Assume that a dose received by an embryo/fetus for a medical use was not specifically approved in advance by the AU. Should the licensee treat the whole embryo/fetus as one organ and assess its dose equivalent (DE) or evaluate the DE for the maximally exposed organ or tissue of the embryo/fetus, to determine if the 50 mSv (5 rem) threshold for reporting and notification is exceeded? [10 CFR 20.1003, 35.3047] (Q&A ID 0301009a)

The licensee should evaluate the DE for the maximally exposed organ or tissue of the embryo/fetus, in determining if the 50 mSv (5 rem) threshold for reporting and notifications is exceeded. [This position is based on the definition of DE in Part 20, which applies to DEs specified in Part 35.] Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.3047, as published in the Federal Register on April 24, 2002.

In the example above, assume that a dose equivalent of 50 mSv (5 rem) to the embryo/fetus was approved by the authorized user before the dose was administered to a pregnant patient. Assume that after administration, the dose equivalent for the embryo/fetus was determined to be greater than 50 mSv (5 rem) Would this dose to the embryo/fetus require that the licensee report the event to NRC and make the notifications specified in 10 CFR § 35.3047? [10 CFR 35.3047] (Q&A ID 0301009b)

No. This would not be a reportable event because the AU made the assessment of the embryo/fetus dose equivalent and approved it, in advance of administering the dose to the pregnant patient. Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.3047, as published in the Federal Register on April 24, 2002.

(The discussion of this issue in the Supplementary Information emphasizes that only unintended exposures must be reported to the NRC. The Supplementary Information is written in terms of a licensee not needing to report a dose if the AU specifically approved, in advance, the "administration" of the resultant dose to the embryo/fetus, not in terms of whether the AU approved the magnitude of the resultant dose. As stated in the Supplementary Information, commenters noted that "the lack of adequate data makes it virtually impossible to accurately calculate radiation doses to an embryo/fetus at various gestational periods from radiopharmaceuticals." The accuracy of a dose assessment changes, and improves, post-administration, when uptake/localization information is available, compared to a pre-administration dose assessment, when these parameters for dose computation must be estimated. A modified embryo/fetus dose estimate post-administration is typical, rather than the exception.)

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Requirements for Use of Various Byproduct Materials

Does use of byproduct materials associated with FDA new drug applications (NDAs) and/or biologic license applications (BLAs) fall under NRC requirements for use of FDA investigational new drugs (INDs) and radioactive drug research committee (RDRC) byproduct materials or for byproduct materials in routine use? [10 CFR 35.6, 35.7, 35.100, 35.200, 35.300] (Q&A ID 0902016)

NRC's requirements are based on type of medical use, not type of byproduct material. The requirements are the same for use of byproduct materials associated with FDA IND applications and RDRC approvals and for byproduct materials in routine use. Note that licensees must also, as applicable, comply with the provisions of § 35.6, "Provisions for the protection of human research subjects" and § 35.7, "FDA, other Federal, and State requirements."

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.100, 35.200, 35.300, as published in the Federal Register on April 24, 2002.

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Review of Applications Under § 35.1000

How are applications under § 35.1000 for new modalities, i.e., for presently unknown processes and materials, to be reviewed? [10 CFR 35.12(d), 35.1000] (Q&A ID 0802019)

Each technology is to be evaluated on a case-by-case basis. This process is to include working with the ACMUI, the medical community, the public, and the developers of the new technology, as appropriate, to determine the specific risks associated with the technology and any additional regulatory requirements for the medical use of the technology.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.

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RSO Written Agreement to Implement Licensee's Radiation Protection Program

Does an individual who was appointed as RSO for a medical licensee before October 24, 2002, have to agree in writing to be responsible for implementing the licensee's radiation protection program? [10 CFR 35.24(b)] (Q&A ID 0802005)

No. Only an individual who assumed the duties of RSO after October 24, 2002, the effective date of the Final Rule, will be required to agree in writing that he or she is responsible for implementing the radiation safety program. The one exception would be for a licensee that notified NRC before October 24, 2002, that it was fully implementing the Final Rule and then appoints an RSO.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.24, as published in the Federal Register on April 24, 2002.

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Source Output Measurement - Published Protocols

Do we know of a "published protocol" under §35.432? Do Task Force Reports from the American Association of Physicists in Medicine (AAPM) qualify? [10 CFR 35.432] (Q&A ID 1202033)

10 CFR 35.432(a)(3) provides that the licensee must use published protocols accepted by nationally recognized bodies to meet the requirements of §35.432. The Supplementary Information defines "nationally recognized bodies" as official standards consensus bodies on the National Institute of Standards and Technology (NIST) website and professional organizations that develop protocols using a consensus process and multiple peer reviews, and AAPM is listed as an example of such a nationally recognized body. In fact, AAPM Task Group reports number 40 and 56 are cited in the Supplementary Information as the basis for the requirements in §35.432.

A fairly comprehensive listing of various published protocols can be found in Appendix AA, pages 6-9,of NUREG-1556, Vol.9, Rev. 1, published May 2005.

Refer to "Supplementary Information", Section V, "Summary of Changes Made Between the Current Part 35 and the Revised Part 35" for §35.432 as published in the Federal Register on April 24, 2002.

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Submission of Non-Required Procedures

What is the administrative process the Regions are expected to use when an applicant for a medical use license submits procedures that are not required for review? [10 CFR 35.12, 35.26] (Q&A ID 0802040)

Non-required procedures are not to be reviewed as part of the licensing process. Regions are expected to use the revised standard license condition for medical use licenses that refers to the application and other documents submitted to NRC. The condition requires a licensee to conduct its program in accordance with submitted information, except supplied procedures that are not required to be submitted in accordance with the regulations.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.12 and § 35.26, as published in the Federal Register on April 24, 2002.

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Submission of Shielding Calculations

Does the NRC require submission of shielding calculations for treatment rooms as part of the license application? [10 CFR 30.33(a), 35.18(a), 35.600] (Q&A ID 1202003)

While there is no "requirement" that shielding calculations be provided, in order to issue a license, the Commission must find that facilities are adequate to protect health and minimize danger to life or property as required under §30.33(a) and/or §35.18(a). For types of use permitted by §35.600, the shielding calculations for the facility are needed by the Commission to make this finding.

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Survey Instrument Calibration

Will licensees need multiple survey instruments to meet the ±20% requirement in 10 CFR 35.61(b), for accuracy of survey instrument response, if both high energy and low energy photon-emitting byproduct material is authorized? [10 CFR 35.61] (Q&A ID 1002004)

Compliance with § 35.61(b) should not result in multiple survey instruments being required if use of both high energy and low energy photon-emitting byproduct material is authorized. Survey instruments are commonly available for which the response, when acceptably calibrated with high energy photon-emitting byproduct material, should, without further instrument response adjustment, be within the ±20% acceptable range for calibration with low energy photon emitters, if such calibration is undertaken. If the response of a survey instrument to low energy photon emitters is determined to be, or is otherwise known to be, outside of the ±20 % range, response correction factors for photon energy can be employed for use of such an instrument in low energy fields, as long as the high energy photon source calibration of the instrument is acceptable.

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Survey Requirements

When and where are radiation and contamination surveys required for medical licensees? [10 CFR 20.1101, 20.1402, 20.1501, 35.70(a), 35.315(a)(4)] (Q&A ID 0301014)

The revised Part 35 has deleted most survey requirements that were previously specifically required. For example, 10 CFR § 35.70 no longer requires daily surveys of all areas where radiopharmaceuticals are routinely prepared for use or administered, weekly surveys of radiopharmaceutical storage or radiopharmaceutical waste storage areas, or weekly surveys for removable contamination. Also, the revised 10 CFR § 35.315 deletes the requirement to survey the radiopharmaceutical therapy patient's room and private sanitary facility for removable contamination before assigning another patient to the room.

Some survey requirements have been retained in the revised Part 35. For example, a) revised 10 CFR § 35.70 does require surveys at the end of each day in areas where unsealed byproduct material requiring a written directive is prepared for use or administered; b) 10 CFR 35.315 requires either monitoring material and items removed from the patient's room or handling the material and items as radioactive waste. Note that 10 CFR § 35.70(a) provides that the surveys to be performed under that provision are in addition to Part 20 survey requirements. Other survey requirements can be found in 10 CFR § 35.75 (possible surveys), § 35.92, § 35.315(a)(3), § 35.404, § 35.415, § 35.604, and § 35.652.

NRC requires that surveys be conducted to satisfy the requirements of 10 CFR § 20.1101 and § 20.1402. Licensees are required to show compliance with the public and occupational dose limits specified in Part 20 and, specifically, to develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed activities and sufficient to ensure compliance with the provisions of Part 20 [10 CFR § 20.1101(a)]. Section 20.1501 requires licensees to perform necessary and reasonable surveys to evaluate the magnitude and extent of radiation levels; concentrations or quantities of radioactive material; and the potential radiological hazards. In situations where radioactive material is used at levels that would not require surveys under 10 CFR § 20.1101, licensees should be aware that a survey may be required by 10 CFR § 20.1501. Radiological criteria for unrestricted use of sites are specified in 10 CFR § 20.1402.

For further information on NRC's regulatory requirements on surveys for medical use licensees, see NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses," Section 8.23, "Item 10: Area Surveys."

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Technologists Acting as Management

Can a nuclear medicine technologist be considered §management§? [10 CFR 35.2] (Q&A ID 0103035)

Yes, if the nuclear medicine technologist meets the criteria of §management§ defined in the regulations by being any of the following: i) the chief executive officer; ii) the individual having the authority to manage, direct or administer the licensee§s activities; or iii) a delegate of either i or ii above.

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Technologist as Radiation Safety Officer -- Qualifications

When can a technologist (for example, a nuclear medicine technologist) be appointed as the radiation safety officer (RSO) for a medical use license? [10 CFR 35.10, 35.24(b), 35.50] (Q&A ID 0802010)

A technologist can be an RSO if he or she successfully completes all of the training and experience requirements in 10 CFR 35.50 of the 2005 current Part 35, as published in the Federal Register on March 30, 2005 or, until October 24, 2005, in 10 CFR 35.900 and agrees, in writing, to be responsible for implementing the radiation protection program.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.50, as published in the Federal Register on April 24, 2002.

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Testing of Therapy-Related Computer Systems

What is the frequency requirement for testing therapy-related computer systems under 10 CFR 35.457 and under 10 CFR 35.657? [10 CFR 35.457, 35.657] (Q&A ID 1002007)

Sections 35.457 and 35.657 each require "acceptance testing on the treatment planning system" for therapy-related computer systems, "in accordance with published protocols accepted by nationally recognized bodies." Accordingly, the testing is to be done at acceptance, unless the published protocol being used requires follow-up testing at some frequency to complete the acceptance testing. Similarly, acceptance testing of the treatment planning system should typically be performed following modification of the treatment planning system of a therapy-related computer system.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR 35.457 and 35.657, as published in the Federal Register on April 24, 2002. Also refer to "Code of Practice for Brachytherapy Physics: Report of the AAPM Therapy Committee Task Group No. 56," Medical Physics 24(10): 1557-98 (October 1997).

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Therapy-Related Computer Systems

Will licensees be required to provide their procedures for acceptance testing on the treatment planning system of therapy-related computer systems on or before the implementation date of the rule, or will this acceptance testing be addressed during the inspection process? [10 CFR 35.457, 35.657] (Q&A ID 0301019)

Licensees are not required to submit to NRC the procedures used for acceptance testing of treatment planning systems. This item was subject to inspection after the revised rule became effective (October 24, 2002).

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Timing of Calibration for Brachytherapy Sources

Must brachytherapy sources that were calibrated before October 24, 2002, the effective date of the Final Rule, be calibrated again before first medical use on or after October 24, 2002? [10 CFR 35.432(a)] (Q&A ID 0802032)

Not necessarily. Under § 35.432(a), brachytherapy sources must be calibrated in a specific manner before first medical use on or after October 24, 2002. If the pre-October 24, 2002 calibration was done in accordance with § 35.432(a) requirements, recalibration of the sources before first medical use on or after October 24, 2002, is not required. Note that the required calibration measurements include determining source positioning accuracy within applicators.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.432, as published in the Federal Register on April 24, 2002.

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Training for Members of the Public

a) Must a licensee train members of the public who may receive up to 500 mrem from exposure to individuals administered radioactive material and released under § 35.75?

b) Must a licensee train members of the public who may receive up to 500 mrem from exposure to individuals administered radioactive material and not released under § 35.75? [10 CFR 19.12(a), 20.1301(a), 20.1301(c), 35.75(a)] (Q&A ID 0802007)

a) No. There is no regulatory requirement for the provision of training to members of the public receiving such exposure. Note that even though the dose to a person may exceed the Part 20 public dose limit (100 mrem in a year) through such exposure, public dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75. Also note that while there is a requirement in Part 19 for instruction of workers who may receive greater than 100 mrem occupational dose in a year, for this exposure, the limit does not apply, as occupational dose does not include dose received from exposure to individuals administered radioactive material and released under § 35.75.

b) No. NRC believes that licensees should have flexibility in determining how they will effectively limit radiation exposure of the visitors to levels that are as low as is reasonably achievable. Refer to "Supplementary Information," Section II, "Petitions for Rulemaking (PRM)" for PRM-20-24, as published in the Federal Register on April 24, 2002.

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Training Requirements for Ophthalmic Radiotherapy

What are the training and experience (T&E) requirements for authorized users (AUs) employing eye plaques, for therapeutic medical purposes, manufactured with byproduct material other than Sr-90? [10 CFR 35.490, 35.491] (Q&A ID 0802028)

The T&E requirements for most AUs employing manual brachytherapy sources are contained in § 35.490. The only exception in Part 35 is for authorized users of Sr-90 devices for ophthalmic radiotherapy. The T&E requirements for those AUs are in § 35.491. AUs employing eye plaques, for therapeutic medical purposes, manufactured with byproduct material other than Sr-90, have to meet the T&E requirements in § 35.490.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.491, as published in the Federal Register on April 24, 2002.

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Transfer of Medical Devices Between Medical Licensees

Can a licensee transfer a licensed medical device to another licensee for use? [10 CFR 30.3, 35.1, 35.49(b)] (Q&A ID 0303008)

Yes. Section 35.49(b) allows sealed sources or devices for medical use to be non-commercially transferred from a Part 35 licensee to another Part 35 licensee. Prior to transfer, the medical licensee receiving the sealed source or device must be authorized on its license to possess and use the device in accordance with applicable sections of Part 35 for which the sealed source or device will be used. See 10 CFR 30.3 and 35.1.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.49, as published in the Federal Register on April 24, 2002.

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Treatment Site -- Definition

Does NRC plan to provide guidance on the definition of "treatment site," as used in the requirements for written directives? [10 CFR 35.2, 35.40] (Q&A ID 0902011)

No. The definition in the Final Rule, "the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive," is self-explanatory. Any specific questions on the meaning or usage of this term can be submitted to the NRC.

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Unit Dosage Manipulation

Under §35.63, does changing the needle of a unit dosage or introducing a 3-way stopcock constitute a §manipulation§ of the unit dosage? [10 CFR 35.63] (Q&A ID 0303007)

If a unit dosage is changed or manipulated in any way, it is no longer considered to be a unit dosage and will need to be reassayed before it is administered. However, if changing the needle of a unit dosage or introducing a 3-way stopcock does not result in modification of the supplied volume of the unit dosage or adversely impact the homogeneous distribution of the byproduct material throughout the volume of the unit dosage, then such action is not a change or manipulation of the unit dosage.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for §35.63, as published in the Federal Register on April 24, 2002.

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Updating Existing Licenses to the 2002 Revised Part 35

When will existing licenses be updated to reflect the new use sections in the 2002 revised Part 35 (e.g., administrations of diagnostic unsealed licensed material with or without a written directive, remote afterloaders, and gamma stereotactic radiosurgery)? [10 CFR 35.10] (Q&A ID 0802046)

Every medical license is being modified during the next licensing action to reflect the provisions of the 2002 revised Part 35. Additionally, pursuant to 10 CFR 35.10(f), licensees must continue to implement procedures required by 10 CFR 35.610, §35.642, §35.643, and §35.645 until amendment or renewal modifies the license condition.

Reference Q&A ID O301015.

When and how will licenses be updated? [10 CFR 35.10] (Q&A ID 0802052)

If a licensee submitted an amendment request, renewal, or new application during the six month implementation phase of the 2002 revised Part 35, as published in the Federal Register on April 24, 2002, the licensee should have addressed whether or not it implemented the 2002 revised Part 35. If it did, the license was modified in its entirety or written at that point to incorporate the revised regulations.

Following expiration of the implementation period, on October 24, 2002, every medical license is being modified, during the next licensing action, to reflect the provisions of the revised Part 35 with one exception. Under NRC policy, the medical license will not include revisions relating to procedures required in the provisions of 10 CFR 35.610, §35.642, §35.643, and §35.645, as applicable, until the next license renewal unless the licensee specifically requests the revisions by submitting procedures with the license amendment request.

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Use of Sealed Sources for Medical Use as Approved

Is it the licensee's responsibility to ensure that sealed sources used for medical purposes are only used as approved in the Sealed Source and Device Registry (SSDR)? [10 CFR 33.11, 33.13, 33.17, 35.2, 35.49, 35.400, 35.500, 35.600] (Q&A ID 0802012)

Yes. The only exceptions are for sources used in research in accordance with an active Investigational Device Exemption application accepted by the FDA, provided the requirements of § 35.49(a), concerning suppliers for sealed sources for medical use, are met.

It is NRC's expectation that all sources currently approved for medical use will continue to be approved. NRC prepared an addendum to the SSDR to ensure this expectation is met. Going forward, NRC plans to issue guidance to SSD reviewers to ensure that the intended medical use for each medical use source is clearly identified in the SSDR, along with any applicable limitations on that use.

For a description of the SSDR, refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for Global Changes in the Rule, as published in the Federal Register on April 24, 2002. To access SSDR evaluations, refer to http://nrc-stp.ornl.gov/ssdr.html.

Note that Type A medical broad scope licensees are not licensed under § 35.400, § 35.500, or § 35.600. Accordingly, they are not limited to SSDR-indicated uses of sealed sources for medical purposes. Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.49, as published in the Federal Register on April 24, 2002.

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Using Amendment Requests to Meet Notification Requirements

If a licensee submits an amendment request to add a new Radiation Safety Officer (RSO), does this amendment request satisfy the notification requirement for announcing the departure of the previous RSO? [10 CFR 35.13, 35.14] (Q&A ID 0103027)

Yes, conditionally, the amendment request can satisfy the notification requirement. To do so, the amendment request must clearly reference the departure of the former RSO and clearly differentiate between the new RSO and the departing RSO. Also, the amendment request must be submitted within 30 days after the departing RSO discontinues performance of duties under the license.

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Validating Therapy-Related Computer Systems - Published Protocols

Section 35.657 of the revised Part 35 requires that "published protocols accepted by nationally recognized bodies" be used to validate therapy-related computer systems. Where can such protocols be found? [10 CFR 35.657] (Q&A ID 0103001)

A fairly comprehensive listing of various published protocols appears in Appendix AA of NUREG-1556, Vol. 9, Rev. 1., pages 6-9, published May 2005. One example of a published protocol accepted by a nationally recognized body which may be used to validate therapy-related computer systems, as required in §35.657 is Report Number 62 of the American Association of Physicists in Medicine (AAPM), "Quality Assurance for Clinical Radiotherapy Treatment Planning."

This report, among other AAPM-published protocols, can be found on the AAPM website at www.aapm.org. [This report does not appear in the list of protocols in Appendix AA of NUREG-1556, Vol. 9, Rev. 1.]

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Written Directive Requirements for Manual Low Dose-rate Remote Afterloading Brachytherapy Procedures

The provisions of §35.40(b)(6) appear to be specific to the use of brachytherapy seeds, but may not be as appropriate for other forms of brachytherapy. Does the NRC plan to address this issue? [10 CFR 35.40(b)(6), 35.3045] (Q&A ID 0103009)

The written directive requirements in this paragraph apply to all brachytherapy procedures except high dose-rate remote afterloading brachytherapy procedures. Note that the Commission has approved the revision of these written directive requirements, as they pertain to certain types of brachytherapy use, to reflect recommendations from the NRC's Advisory Committee on the Medical Uses of Isotopes.

NRC staff has been directed to proceed directly with the development of a proposed rule to modify both the written directive requirements in 10CFR 35.40(b)(6) and the medical event reporting requirements in 10CFR 35.3045 for permanent implant brachytherapy medical use, to convert from dose-based to activity-based.

Reference Staff Requirements Memorandum SRM-SECY-2005-0234, issued February 16, 2006 and available at www.nrc.gov.

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Written Procedures for Administrations Requiring a Written Directive

Define the meaning of "high level of assurance" under § 35.41. [10 CFR 35.40, 35.41] (Q&A ID 0802048)

Section 35.41(a) provides that for any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide "high confidence" that the patient or human research subject's identity is verified before each administration and each administration is in accordance with the written directive. While "high confidence" is not defined in the regulations, § 35.41(b) establishes the minimum items that must be addressed in the procedures to provide this level of confidence. Licensees have flexibility to include additional information that they consider necessary for a supervised individual to perform a procedure according to the directions of the authorized user.

Refer to "Supplementary Information," Section III, "Summary of Public Comments and Responses to Comments" for 10 CFR § 35.40 and § 35.41, as published in the Federal Register on April 24, 2002.

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Written Procedures -- Submission to NRC

What required written procedures must be submitted to NRC for review and approval? [10 CFR 20.1406, 35.12(b), 35.18(a)] (Q&A ID 0301006)

All procedures that must be submitted to NRC, with a license application or with an amendment application, involve therapeutic medical units (teletherapy units, remote afterloader brachytherapy units, gamma stereotactic radiosurgery units). The required procedures cover (1) response to abnormal occurrences with potential for unintended patient exposure and (2) steps to be followed when carrying out required periodic spot checks for medical therapeutic units as applicable.

Note that for all applications other than renewals, the applicant must also describe how facility design and procedures for operation will minimize, to the extent practicable, contamination and the generation of radioactive waste. Reference 10 CFR 20.1406.

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Page Last Reviewed/Updated Tuesday, December 11, 2012