ML18302A095

Federal Register Notice 83 Fr 54380 Training and Experience Requirements for Different Categories of Radiopharmaceuticals

ML18302A095
Person / Time
Issue date:	10/29/2018
From:	Sarah Lopas NRC/NMSS/DMSST/MSEB
To:
Lopas S
References
Download: ML18302A095 (3)

Text

54380 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices revised to address the comments Jennifer.Borges@nrc.gov. For technical ADAMS. Comment submissions are not received. questions, contact the individual listed routinely edited to remove identifying in the FOR FURTHER INFORMATION or contact information.

III. Finding of No Significant Impact If you are requesting or aggregating CONTACT section of this document.

Based on its review of the proposed

• Mail comments to: May Ma, Office comments from other persons for action, as documented in the EA, the of Administration, Mail Stop: TWFN submission to the NRC, then you should NRC staff concludes that the renewal of A60M, U.S. Nuclear Regulatory inform those persons not to include License SUC-1591 with an expanded Commission, Washington, DC 20555- identifying or contact information that scope of authorized activities will not 0001. they do not want to be publicly have a significant effect on the quality For additional direction on obtaining disclosed in their comment submission.

of the human environment. Therefore, information and submitting comments, Your request should state that the NRC the NRC staff has determined not to see Obtaining Information and does not routinely edit comment prepare an EIS for the proposed action Submitting Comments in the submissions to remove such information and that, pursuant to 10 CFR 51.32, a SUPPLEMENTARY INFORMATION section of before making the comment finding of no significant impact is this document. submissions available to the public or appropriate. FOR FURTHER INFORMATION CONTACT: entering the comment into ADAMS.

Dated at Rockville, Maryland, on October Sarah Lopas, Office of Nuclear Material II. Background 23, 2018. Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, On August 17, 2017, the Commission For the Nuclear Regulatory Commission. issued a staff requirements Brian W. Smith, DC 20555-0001; telephone: 301-415-memorandum (SRM), SRM-M170817 Acting Director, Division of Fuel Cycle Safety, 6360, email: Sarah.Lopas@nrc.gov.

(ADAMS Accession No. ML17229B284),

Safeguards and Environmental Review, Office SUPPLEMENTARY INFORMATION:

approving the final rule revising parts of Nuclear Material Safety and Safeguards. 30, 32, and 35 of title 10 of the Code of I. Obtaining Information and

[FR Doc. 2018-23509 Filed 10-26-18; 8:45 am] Federal Regulations (10 CFR), Medical Submitting Comments BILLING CODE 7590-01-P Use of Byproduct MaterialMedical A. Obtaining Information Event Definitions, Training and Please refer to Docket ID NRC-2018- Experience, and Clarifying NUCLEAR REGULATORY 0230 when contacting the NRC about Amendments, and directing the staff to COMMISSION the availability of information for this evaluate (1) whether it makes sense to

[NRC-2018-0230] action. You may obtain publicly- establish tailored T&E requirements for available information related to this different categories of Training and Experience Requirements action by any of the following methods: radiopharmaceuticals, (2) how those for Different Categories of

• Federal Rulemaking Website: Go to categories should be determined (such Radiopharmaceuticals http://www.regulations.gov and search as by risks posed by groups of for Docket ID NRC-2018-0230. radionuclides or by delivery method),

AGENCY: Nuclear Regulatory

• NRCs Agencywide Documents (3) what the appropriate T&E Commission. Access and Management System requirements would be for each ACTION: Training and experience (ADAMS): You may obtain publicly- category, and (4) whether those requirements; request for comment. available documents online in the requirements should be based on hours ADAMS Public Documents collection at of T&E or focused more on competency.

SUMMARY

The U.S. Nuclear Regulatory http://www.nrc.gov/reading-rm/ In response to the SRM, the NRC staff Commission (NRC) is requesting adams.html. To begin the search, select documented its initial results, status, comments on its training and Begin Web-based ADAMS Search. For and next steps related to this evaluation experience (T&E) requirements. in SECY-18-0084, Staff Evaluation of problems with ADAMS, please contact Specifically, the NRC would like input Training and Experience Requirements the NRCs Public Document Room (PDR) on whether it should establish tailored for Administering Different Categories reference staff at 1-800-397-4209, 301-T&E requirements for different of Radiopharmaceuticals in Response to 415-4737, or by email to pdr.resource@

categories of radiopharmaceuticals for SRM-M170817 (ADAMS Accession nrc.gov. The ADAMS accession number which a written directive is required in No. ML18135A276). In SECY-18-0084, for each document referenced is accordance with its regulations. The the staff concluded that additional provided the first time that it is input will be used to determine whether outreach with the medical community is mentioned in the SUPPLEMENTARY significant regulatory changes to the needed to determine whether and how INFORMATION section.

NRCs T&E requirements for authorized

• NRCs PDR: You may examine and to tailor the T&E requirements to users (AUs) are warranted. establish a limited AU status, the purchase copies of public documents at DATES: Submit comments by January 29, the NRCs PDR, Room O1-F21, One specific T&E requirements that should 2019. Comments received after this date White Flint North, 11555 Rockville apply, how the T&E requirements will be considered if it is practical to do Pike, Rockville, Maryland 20852. should be met (e.g., hours of training, so, but the NRC is only able to ensure demonstration of competency), and consideration for comments received on B. Submitting Comments whether a competency-based approach or before this date. Please include Docket ID NRC-2018- makes sense for the T&E requirements ADDRESSES: You may submit comments 0230 in your comment submission. The for all the medical uses authorized amozie on DSK3GDR082PROD with NOTICES1 by any of the following methods: NRC cautions you not to include under 10 CFR 35.300, Use of unsealed

• Federal Rulemaking Website: Go to identifying or contact information in byproduct material for which a written http://www.regulations.gov and search comment submissions that you do not directive is required.

for Docket ID NRC-2018-0230. Address want to be publicly disclosed in your The NRC is interested in obtaining questions about Docket IDs in comment submission. All comment input from as many stakeholders as Regulations.gov to Jennifer Borges; submissions are posted at http:// possible, including members of the telephone: 301-287-9127; email: www.regulations.gov and entered into Advisory Committee on the Medical VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1

Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices 54381 Uses of Isotopes, professional alternate non-board certified pathway, administrations. What should be the organizations, physicians, patients, and for physicians certified by a qualifications of the supervising patient advocacy groups, licensees, medical specialty board that is not individual?

Agreement States, and other interested currently recognized by the NRC under iii. CompetencyHow should individuals. The focus of this request is 10 CFR 35.390, 35.392, 35.394, or competency be evaluated? Should a to gather information that will permit 35.396 (Unsealed Byproduct Material written and/or practical examination by the NRC staff to determine whether Written Directive Required). an independent examining committee changes to the T&E requirements are 1. Are the current pathways for be administered? Provide a rationale for warranted for different categories of obtaining AU status reasonable and your answer.

radiopharmaceuticals for physicians accessible? Provide a rationale for your b. Should a preceptor attestation be seeking AU status for the medical use of answer. required for the fundamental T&E?

specific categories of 2. Are the current pathways for Provide a rationale for your answer.

radiopharmaceuticals requiring a obtaining AU status adequate for c. Should the radiopharmaceutical written directive under 10 CFR 35.300. protecting public health and safety? manufacturer be able to provide the During the comment period between Provide a rationale for your answer. preceptor attestation? Provide a rational October 29, 2018 and January 29, 2019, 3. Should the NRC develop a new for your answer.

the NRC will hold four public meetings tailored T&E pathway for these

d. Who should establish and that will discuss the information being physicians? If so, what would be the administer the curriculum and requested and to accept comments on appropriate way to categorize radiopharmaceuticals for tailored T&E examination? Provide specific group(s).

the docket. All four public meetings will [Some options are: NRC, medical be available for remote participation by requirements? If not, explain why the regulations should remain unchanged. specialty boards, medical professional moderated bridge line and webinar, and societies, educational professional two of the four meetings will be open [Some options to categorize radiopharmaceuticals include groups, and NRC in collaboration with for in-person attendance at NRCs any or more of the aforementioned headquarters in Rockville, Maryland. radiopharmaceuticals with similar delivery methods (oral, parenteral); groups.]

The public meetings are scheduled for e. Should AU competency be November 14, 2018 (webinar-only); same type of radiation characteristics or emission (alpha, beta, gamma, low- periodically assessed? If so, how should December 11, 2018 (webinar and in- it be assessed, how often, and by whom?

person attendance); January 10, 2019 energy photon); similar preparation (webinar and in-person attendance); and method (patient-ready doses); or a B. NRCs Recognition of Medical January 22, 2019 (webinar-only). The combination thereof (e.g., Specialty Boards public meetings will be noticed on the radiopharmaceuticals containing alpha-The NRC is requesting comments on NRCs public meeting website at least 10 and beta-emitting radioisotopes that are its recognition of medical specialty calendar days before the meeting. administered intravenously and are boards. The NRCs procedures for Members of the public should monitor prepared as patient-ready doses).]

4. Should the fundamental T&E recognizing medical specialty boards are the NRCs public meeting website at located on the Medical Uses Licensee https://www.nrc.gov/pmns/mtg. The required of physicians seeking limited AU status need to have the same Toolkit website (https://www.nrc.gov/

NRC will also post the meeting notices materials/miau/med-use-toolkit/certif-on the Federal Rulemaking website at fundamental T&E required of physicians seeking full AU status for all oral and process-boards.html). The NRC staff https://www.regulations.gov/ under periodically reviews information to Docket ID NRC-2018-0230. parenteral administrations under 10 CFR 35.300? determine a boards continued The NRC may post additional eligibility for recognition.

materials related to this document, 5. How should the requirements for this fundamental T&E be structured for 1. What boards other than those including public comments, on the already recognized by the NRC Federal Rulemaking website. The a specific category of radiopharmaceuticals? (American Board of Nuclear Medicine Federal Rulemaking website allows you [ABNM], American Board of Radiology

a. Describe what the requirements to receive alerts when changes or [ABR], American Osteopathic Board of should include:

additions occur in a docket folder. To i. Classroom and laboratory training Radiology [AOBR], Certification Board subscribe: (1) Navigate to the docket What topics need to be covered in this of Nuclear Endocrinology [CBNE]) could folder NRC-2018-0230; (2) click the training requirement? How many hours be considered for recognition for Sign up for Email Alerts link; and (3) of classroom and laboratory training medical uses under 10 CFR 35.300?

enter your email address and select how should be required? Provide the basis 2. Are the current NRC medical frequently you would like to receive for the number of hours. If not hours, specialty board recognition criteria emails (daily, weekly, or monthly). explain how this training should be sufficient? If not, what additional III. Specific Requests for Comments quantified. [Note: The topics currently criteria should the NRC use?

required in the regulations to be C. Patient Access A. Tailored Training & Experience included in the classroom and Requirements laboratory training and work experience The NRC is requesting comments on The NRC is requesting comments on are listed in 10 CFR 35.390, 35.392, whether there is a shortage in the whether it should establish tailored T&E 35.394, and 35.396.] number of AUs for 10 CFR 35.300.

requirements for different categories of ii. Work experienceWhat should the 1. Is there a shortage in the number of amozie on DSK3GDR082PROD with NOTICES1 radiopharmaceuticals for physicians work experience requirement involve? AUs for medical uses under 10 CFR seeking AU status for the medical use of How many hours of work experience 35.300? If so, is the shortage associated specific categories of should be required and what is the with the use of a specific radiopharmaceuticals requiring a minimum number of patient or human radiopharmaceutical? Explain how.

written directive under 10 CFR 35.300 research subject administrations that an 2. Are there certain geographic areas (i.e., a limited AU status). This would be individual must perform? Provide the with an inadequate number of AUs?

for physicians seeking AU status via the basis for the number of hours and Identify these areas.

VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1

54382 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices

3. Do current NRC regulations on AU

SUMMARY

The U.S. Nuclear Regulatory problems with ADAMS, please contact T&E requirements unnecessarily limit Commission (NRC) invites public the NRCs Public Document Room (PDR) patient access to procedures involving comment on the renewal of Office of reference staff at 1-800-397-4209, 301-radiopharmaceuticals? Explain how. Management and Budget (OMB) 415-4737, or by email to pdr.resource@

4. Do current NRC regulations on AU approval for an existing collection of nrc.gov. The supporting statement T&E requirements unnecessarily limit information. The information collection associated with the part 37 information research and development in nuclear is entitled, Physical Protection of collections, the burden table, and the medicine? Explain how. Category 1 and Category 2 Quantities of NRC Form 755 are available in ADAMS D. Other Suggested Changes to the T&E Radioactive Material. under Accession Nos. ML18172A301, Regulations DATES: Submit comments by December ML18172A300, and ML18295A594.

28, 2018. Comments received after this

• NRCs PDR: You may examine and In 2002, the NRC revised its purchase copies of public documents at date will be considered if it is practical regulatory framework for medical use. the NRCs PDR, Room O1-F21, One to do so, but the Commission is able to The goal was to focus the NRCs White Flint North, 11555 Rockville ensure consideration only for comments regulations on those medical procedures Pike, Rockville, Maryland 20852.

received on or before this date.

that pose the highest risk to workers, the

• NRCs Clearance Officer: A copy of general public, patients, and human ADDRESSES: You may submit comments by any of the following methods: the collection of information and related research subjects and to structure the instructions may be obtained without regulations to be more risk-informed

• Federal Rulemaking Website: Go to http://www.regulations.gov and search charge by contacting the NRCs and more performance-based. The 2002 Clearance Officer, David Cullison, rule reduced the unnecessary regulatory for Docket ID NRC-2018-0062. Address questions about Docket IDs in Office of the Chief Information Officer, burden by either reducing or U.S. Nuclear Regulatory Commission, eliminating the prescriptiveness of some Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email: Washington, DC 20555-0001; telephone:

regulations. Instead, the rule provided 301-415-2084; email:

for a performance-based approach that Jennifer.Borges@nrc.gov. For technical questions, contact the individual listed INFOCOLLECTS.Resource@nrc.gov.

relied on the training and experience of the AUs, authorized nuclear in the FOR FURTHER INFORMATION B. Submitting Comments pharmacists, and radiation safety CONTACT section of this document.

• Mail comments to: David Cullison, The NRC cautions you not to include officers. The NRC is requesting identifying or contact information in comments on whether there are any Office of the Chief Information Officer, Mail Stop: T-2 F43, U.S. Nuclear comment submissions that you do not other changes to the T&E regulations in want to be publicly disclosed in your 10 CFR part 35 that should be Regulatory Commission, Washington, DC 20555-0001. comment submission. All comment considered. Please discuss your submissions are posted at http://

suggested changes. For additional direction on obtaining information and submitting comments, www.regulations.gov and entered into

1. Should the NRC regulate the T&E ADAMS. Comment submissions are not of physicians for medical uses? see Obtaining Information and Submitting Comments in the routinely edited to remove identifying

2. Are there requirements in the SUPPLEMENTARY INFORMATION section of or contact information.

NRCs T&E regulatory framework for this document. If you are requesting or aggregating physicians that are non-safety related?

3. How can the NRC transform its comments from other persons for FOR FURTHER INFORMATION CONTACT:

regulatory approach for T&E while still submission to the OMB, then you David Cullison, Office of the Chief ensuring that adequate protection is should inform those persons not to Information Officer, U.S. Nuclear maintained for workers, the general include identifying or contact Regulatory Commission, Washington, public, patients, and human research information that they do not want to be DC 20555-0001; telephone: 301-415-subjects? publicly disclosed in their comment 2084; email: INFOCOLLECTS.Resource@

submission. Your request should state Dated at Rockville, Maryland, this 23rd day nrc.gov.

that the NRC does not routinely edit of October 2018. SUPPLEMENTARY INFORMATION: comment submissions to remove such For the Nuclear Regulatory Commission. information before making the comment I. Obtaining Information and Daniel S. Collins, submissions available to the public or Submitting Comments Director, Division of Materials Safety, entering the comment submissions into Security, State, and Tribal Programs, Office A. Obtaining Information ADAMS.

of Nuclear Material Safety and Safeguards.

Please refer to Docket ID NRC-2018- II. Background

[FR Doc. 2018-23521 Filed 10-26-18; 8:45 am] 0062 when contacting the NRC about BILLING CODE 7590-01-P the availability of information for this In accordance with the Paperwork action. You may obtain publicly- Reduction Act of 1995 (44 U.S.C.

available information related to this Chapter 35), the NRC is requesting NUCLEAR REGULATORY action by any of the following methods: public comment on its intention to COMMISSION

• Federal Rulemaking Website: Go to request the OMBs approval for the

[NRC-2018-0062] http://www.regulations.gov and search information collection summarized in for Docket ID NRC-2018-0062. this section.

Information Collection: Physical

• NRCs Agencywide Documents 1. The title of the information amozie on DSK3GDR082PROD with NOTICES1 Protection of Category 1 and Category Access and Management System collection: 10 CFR part 37, Physical 2 Quantities of Radioactive Material (ADAMS): You may obtain publicly- Protection of Category 1 and Category 2 available documents online in the Quantities of Radioactive Material.

AGENCY: Nuclear Regulatory Commission. ADAMS Public Documents collection at 2. OMB approval number: 3150-0214.

http://www.nrc.gov/reading-rm/ 3. Type of submission: Revision.

ACTION: Renewal of existing information adams.html. To begin the search, select 4. The form number, if applicable:

collection; request for comment.

Begin Web-based ADAMS Search. For NRC Form 755, Notification to the NRC VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1