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
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Download: ML18302A095 (3)

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54380 Federal Register/Vol. 83, No. 209/Monday, October 29, 2018/Notices revised to address the comments received.

III. Finding of No Significant Impact Based on its review of the proposed action, as documented in the EA, the NRC staff concludes that the renewal of

License SUC-1591 with an expanded

scope of authorized activities will not

have a significant effect on the quality

of the human environment. Therefore, the NRC staff has determined not to

prepare an EIS for the proposed action

and that, pursuant to 10 CFR 51.32, a

finding of no significant impact is

appropriate.

Dated at Rockville, Maryland, on October 23, 2018.

For the Nuclear Regulatory Commission.

Brian W. Smith, Acting Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office

of Nuclear Material Safety and Safeguards.

[FR Doc. 2018-23509 Filed 10-26-18; 8:45 am]

BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION

[NRC-2018-0230]

Training and Experience Requirements

for Different Categories of

Radiopharmaceuticals AGENCY: Nuclear Regulatory Commission.

ACTION: Training and experience requirements; request for comment.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is requesting

comments on its training and

experience (T&E) requirements.

Specifically, the NRC would like input

on whether it should establish tailored

T&E requirements for different

categories of radiopharmaceuticals for

which a written directive is required in

accordance with its regulations. The

input will be used to determine whether

significant regulatory changes to the

NRC's T&E requirements for authorized

users (AUs) are warranted.

DATES: Submit comments by January 29, 2019. Comments received after this date

will be considered if it is practical to do

so, but the NRC is only able to ensure

consideration for comments received on

or before this date.

ADDRESSES: You may submit comments by any of the following methods:

• Federal Rulemaking Website:

Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230. Address

questions about Docket IDs in

Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email:

Jennifer.Borges@nrc.gov. For technical

questions, contact the individual listed

in the FORFURTHERINFORMATION CONTACT section of this document.

• Mail comments to:

May Ma, Office of Administration, Mail Stop: TWFN

A60M, U.S. Nuclear Regulatory

Commission, Washington, DC 20555-

0001. For additional direction on obtaining information and submitting comments, see Obtaining Information and

Submitting Comments in the SUPPLEMENTARYINFORMATION section of this document. FORFURTHERINFORMATIONCONTACT

Sarah Lopas, Office of Nuclear Material

Safety and Safeguards, U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-

6360, email:

Sarah.Lopas@nrc.gov. SUPPLEMENTARYINFORMATION

I. Obtaining Information and

Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2018-0230 when contacting the NRC about the availability of information for this

action. You may obtain publicly-

available information related to this

action by any of the following methods:

• Federal Rulemaking Website:

Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the

ADAMS Public Documents collection at

http://www.nrc.gov/reading-rm/

adams.html. To begin the search, select

Begin Web-based ADAMS Search. For

problems with ADAMS, please contact

the NRC's Public Document Room (PDR)

reference staff at 1-800-397-4209, 301-

415-4737, or by email to pdr.resource@

nrc.gov. The ADAMS accession number

for each document referenced is

provided the first time that it is

mentioned in the SUPPLEMENTARY INFORMATION section. *NRC's PDR:

You may examine and purchase copies of public documents at

the NRC's PDR, Room O1-F21, One

White Flint North, 11555 Rockville

Pike, Rockville, Maryland 20852.

B. Submitting Comments Please include Docket ID NRC-2018-0230 in your comment submission. The NRC cautions you not to include

identifying or contact information in

comment submissions that you do not

want to be publicly disclosed in your

comment submission. All comment

submissions are posted at http://

www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying

or contact information.

If you are requesting or aggregating comments from other persons for

submission to the NRC, then you should

inform those persons not to include

identifying or contact information that

they do not want to be publicly

disclosed in their comment submission.

Your request should state that the NRC

does not routinely edit comment

submissions to remove such information

before making the comment

submissions available to the public or

entering the comment into ADAMS.

II. Background On August 17, 2017, the Commission issued a staff requirements memorandum (SRM), SRM-M170817 (ADAMS Accession No. ML17229B284),

approving the final rule revising parts

30, 32, and 35 of title 10 of the Code of Federal Regulations (10 CFR), Medical

Use of Byproduct Material-Medical

Event Definitions, Training and

Experience, and Clarifying

Amendments, and directing the staff to

evaluate (1) whether it makes sense to

establish tailored T&E requirements for

different categories of

radiopharmaceuticals, (2) how those

categories should be determined (such

as by risks posed by groups of

radionuclides or by delivery method),

(3) what the appropriate T&E

requirements would be for each

category, and (4) whether those

requirements should be based on hours

of T&E or focused more on competency.

In response to the SRM, the NRC staff

documented its initial results, status, and next steps related to this evaluation

in SECY-18-0084, Staff Evaluation of

Training and Experience Requirements

for Administering Different Categories

of Radiopharmaceuticals in Response to

SRM-M170817 (ADAMS Accession No. ML18135A276). In SECY-18-0084, the staff concluded that additional

outreach with the medical community is

needed to determine whether and how

to tailor the T&E requirements to

establish a limited AU status, the

specific T&E requirements that should

apply, how the T&E requirements

should be met (e.g., hours of training, demonstration of competency), and

whether a competency-based approach

makes sense for the T&E requirements

for all the medical uses authorized

under 10 CFR 35.300, Use of unsealed

byproduct material for which a written

directive is required.

The NRC is interested in obtaining input from as many stakeholders as

possible, including members of the

Advisory Committee on the Medical VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00073Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1 54381 Federal Register/Vol. 83, No. 209/Monday, October 29, 2018/Notices Uses of Isotopes, professional organizations, physicians, patients, patient advocacy groups, licensees, Agreement States, and other interested

individuals. The focus of this request is

to gather information that will permit

the NRC staff to determine whether

changes to the T&E requirements are

warranted for different categories of

radiopharmaceuticals for physicians

seeking AU status for the medical use of

specific categories of

radiopharmaceuticals requiring a

written directive under 10 CFR 35.300.

During the comment period between October 29, 2018 and January 29, 2019, the NRC will hold four public meetings

that will discuss the information being

requested and to accept comments on

the docket. All four public meetings will

be available for remote participation by

moderated bridge line and webinar, and

two of the four meetings will be open

for in-person attendance at NRC's

headquarters in Rockville, Maryland.

The public meetings are scheduled for November 14, 2018 (webinar-only);

December 11, 2018 (webinar and in-

person attendance); January 10, 2019 (webinar and in-person attendance); and

January 22, 2019 (webinar-only). The

public meetings will be noticed on the

NRC's public meeting website at least 10

calendar days before the meeting.

Members of the public should monitor

the NRC's public meeting website at

https://www.nrc.gov/pmns/mtg.

The NRC will also post the meeting notices

on the Federal Rulemaking website at

https://www.regulations.gov/

under Docket ID NRC-2018-0230.

The NRC may post additional materials related to this document, including public comments, on the

Federal Rulemaking website. The

Federal Rulemaking website allows you

to receive alerts when changes or

additions occur in a docket folder. To

subscribe: (1) Navigate to the docket

folder NRC-2018-0230; (2) click the

Sign up for Email Alerts link; and (3)

enter your email address and select how

frequently you would like to receive

emails (daily, weekly, or monthly).

III. Specific Requests for Comments

A. Tailored Training & Experience Requirements The NRC is requesting comments on whether it should establish tailored T&E

requirements for different categories of

radiopharmaceuticals for physicians

seeking AU status for the medical use of

specific categories of

radiopharmaceuticals requiring a

written directive under 10 CFR 35.300

(i.e., a limited AU status). This would be for physicians seeking AU status via the alternate non-board certified pathway, and for physicians certified by a

medical specialty board that is not

currently recognized by the NRC under

10 CFR 35.390, 35.392, 35.394, or

35.396 (Unsealed Byproduct Material-

Written Directive Required).

1. Are the current pathways for obtaining AU status reasonable and

accessible? Provide a rationale for your

answer. 2. Are the current pathways for obtaining AU status adequate for

protecting public health and safety?

Provide a rationale for your answer.

3. Should the NRC develop a new tailored T&E pathway for these

physicians? If so, what would be the

appropriate way to categorize

radiopharmaceuticals for tailored T&E requirements? If not, explain why the

regulations should remain unchanged.

[Some options to categorize

radiopharmaceuticals include

radiopharmaceuticals with similar

delivery methods (oral, parenteral);

same type of radiation characteristics or

emission (alpha, beta, gamma, low-

energy photon); similar preparation

method (patient-ready doses); or a

combination thereof (e.g.,

radiopharmaceuticals containing alpha-

and beta-emitting radioisotopes that are

administered intravenously and are

prepared as patient-ready doses).]

4. Should the fundamental T&E required of physicians seeking limited

AU status need to have the same

fundamental T&E required of physicians

seeking full AU status for all oral and

parenteral administrations under 10

CFR 35.300?

5. How should the requirements for this fundamental T&E be structured for

a specific category of

radiopharmaceuticals?

a. Describe what the requirements should include:

i. Classroom and laboratory training-What topics need to be covered in this

training requirement? How many hours

of classroom and laboratory training

should be required? Provide the basis

for the number of hours. If not hours, explain how this training should be

quantified. [

Note: The topics currently required in the regulations to be

included in the classroom and

laboratory training and work experience

are listed in 10 CFR 35.390, 35.392, 35.394, and 35.396.]

ii. Work experience-What should the work experience requirement involve?

How many hours of work experience

should be required and what is the

minimum number of patient or human

research subject administrations that an

individual must perform? Provide the

basis for the number of hours and administrations. What should be the

qualifications of the supervising

individual?

iii. Competency-How should competency be evaluated? Should a

written and/or practical examination by

an independent examining committee

be administered? Provide a rationale for

your answer.

b. Should a preceptor attestation be required for the fundamental T&E?

Provide a rationale for your answer.

c. Should the radiopharmaceutical manufacturer be able to provide the

preceptor attestation? Provide a rational

for your answer.

d. Who should establish and administer the curriculum and

examination? Provide specific group(s).

[Some options are: NRC, medical

specialty boards, medical professional

societies, educational professional

groups, and NRC in collaboration with

any or more of the aforementioned

groups.] e. Should AU competency be periodically assessed? If so, how should

it be assessed, how often, and by whom?

B. NRC's Recognition of Medical Specialty Boards The NRC is requesting comments on its recognition of medical specialty

boards. The NRC's procedures for

recognizing medical specialty boards are

located on the Medical Uses Licensee

Toolkit website (https://www.nrc.gov/

materials/miau/med-use-toolkit/certif-

process-boards.html

). The NRC staff

periodically reviews information to

determine a board's continued

eligibility for recognition.

1. What boards other than those already recognized by the NRC (American Board of Nuclear Medicine

[ABNM], American Board of Radiology

[ABR], American Osteopathic Board of

Radiology [AOBR], Certification Board

of Nuclear Endocrinology [CBNE]) could

be considered for recognition for

medical uses under 10 CFR 35.300?

2. Are the current NRC medical specialty board recognition criteria

sufficient? If not, what additional

criteria should the NRC use?

C. Patient Access The NRC is requesting comments on whether there is a shortage in the number of AUs for 10 CFR 35.300.

1. Is there a shortage in the number of AUs for medical uses under 10 CFR

35.300? If so, is the shortage associated

with the use of a specific

radiopharmaceutical? Explain how.

2. Are there certain geographic areas with an inadequate number of AUs?

Identify these areas. VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00074Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1 54382 Federal Register/Vol. 83, No. 209/Monday, October 29, 2018/Notices

3. Do current NRC regulations on AU T&E requirements unnecessarily limit patient access to procedures involving

radiopharmaceuticals? Explain how.

4. Do current NRC regulations on AU T&E requirements unnecessarily limit

research and development in nuclear

medicine? Explain how.

D. Other Suggested Changes to the T&E Regulations In 2002, the NRC revised its regulatory framework for medical use.

The goal was to focus the NRC's

regulations on those medical procedures

that pose the highest risk to workers, the

general public, patients, and human

research subjects and to structure the

regulations to be more risk-informed

and more performance-based. The 2002

rule reduced the unnecessary regulatory

burden by either reducing or

eliminating the prescriptiveness of some

regulations. Instead, the rule provided

for a performance-based approach that

relied on the training and experience of

the AUs, authorized nuclear

pharmacists, and radiation safety

officers. The NRC is requesting

comments on whether there are any

other changes to the T&E regulations in

10 CFR part 35 that should be

considered. Please discuss your

suggested changes.

1. Should the NRC regulate the T&E of physicians for medical uses?

2. Are there requirements in the NRC's T&E regulatory framework for

physicians that are non-safety related?

3. How can the NRC transform its regulatory approach for T&E while still

ensuring that adequate protection is

maintained for workers, the general

public, patients, and human research

subjects?

Dated at Rockville, Maryland, this 23rd day of October 2018.

For the Nuclear Regulatory Commission.

Daniel S. Collins, Director, Division of Materials Safety, Security, State, and Tribal Programs, Office

of Nuclear Material Safety and Safeguards.

[FR Doc. 2018-23521 Filed 10-26-18; 8:45 am]

BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION

[NRC-2018-0062]

Information Collection: Physical

Protection of Category 1 and Category

2 Quantities of Radioactive Material AGENCY: Nuclear Regulatory Commission.

ACTION: Renewal of existing information collection; request for comment.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) invites public

comment on the renewal of Office of

Management and Budget (OMB)

approval for an existing collection of

information. The information collection

is entitled, Physical Protection of

Category 1 and Category 2 Quantities of

Radioactive Material.

DATES: Submit comments by December 28, 2018. Comments received after this

date will be considered if it is practical

to do so, but the Commission is able to

ensure consideration only for comments

received on or before this date.

ADDRESSES: You may submit comments by any of the following methods:

• Federal Rulemaking Website:

Go to http://www.regulations.gov and search for Docket ID NRC-2018-0062. Address

questions about Docket IDs in

Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email:

Jennifer.Borges@nrc.gov.

For technical questions, contact the individual listed

in the FORFURTHERINFORMATION CONTACT section of this document.

• Mail comments to:

David Cullison, Office of the Chief Information Officer, Mail Stop: T-2 F43, U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001.

For additional direction on obtaining information and submitting comments, see Obtaining Information and

Submitting Comments in the SUPPLEMENTARYINFORMATION section of this document. FORFURTHERINFORMATIONCONTACT

David Cullison, Office of the Chief

Information Officer, U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-

2084; email:

INFOCOLLECTS.Resource@

nrc.gov. SUPPLEMENTARYINFORMATION

I. Obtaining Information and

Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2018-0062 when contacting the NRC about the availability of information for this

action. You may obtain publicly-

available information related to this

action by any of the following methods:

• Federal Rulemaking Website:

Go to http://www.regulations.gov and search for Docket ID NRC-2018-0062.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the

ADAMS Public Documents collection at

http://www.nrc.gov/reading-rm/

adams.html.

To begin the search, select

Begin Web-based ADAMS Search.

For problems with ADAMS, please contact

the NRC's Public Document Room (PDR)

reference staff at 1-800-397-4209, 301-

415-4737, or by email to pdr.resource@

nrc.gov. The supporting statement associated with the part 37 information

collections, the burden table, and the

NRC Form 755 are available in ADAMS

under Accession Nos. ML18172A301, ML18172A300, and ML18295A594.

• NRC's PDR:

You may examine and purchase copies of public documents at

the NRC's PDR, Room O1-F21, One

White Flint North, 11555 Rockville

Pike, Rockville, Maryland 20852.

• NRC's Clearance Officer:

A copy of the collection of information and related

instructions may be obtained without

charge by contacting the NRC's

Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone:

301-415-2084; email:

INFOCOLLECTS.Resource@nrc.gov.

B. Submitting Comments The NRC cautions you not to include identifying or contact information in comment submissions that you do not

want to be publicly disclosed in your

comment submission. All comment

submissions are posted at http://

www.regulations.gov and entered into ADAMS. Comment submissions are not

routinely edited to remove identifying

or contact information.

If you are requesting or aggregating comments from other persons for

submission to the OMB, then you

should inform those persons not to

include identifying or contact

information that they do not want to be

publicly disclosed in their comment

submission. Your request should state

that the NRC does not routinely edit

comment submissions to remove such

information before making the comment

submissions available to the public or

entering the comment submissions into

ADAMS. II. Background In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.

Chapter 35), the NRC is requesting

public comment on its intention to

request the OMB's approval for the

information collection summarized in

this section.

1. The title of the information collection:

10 CFR part 37, Physical Protection of Category 1 and Category 2

Quantities of Radioactive Material.

2. OMB approval number:

3150-0214.

3. Type of submission:

Revision.

4. The form number, if applicable:

NRC Form 755, Notification to the NRC VerDate Sep<11>2014 17:48 Oct 26, 2018Jkt 247001PO 00000Frm 00075Fmt 4703Sfmt 4703E:\FR\FM\29OCN1.SGM29OCN1 amozie on DSK3GDR082PROD with NOTICES1