Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51655 

No significant hazards consideration 

comments received: No. 

FirstEnergy Nuclear Operating 

Company, Docket No. 50–440, Perry 

Nuclear Power Plant (PNPP), Unit No. 1, 

Lake County, Ohio 

Date of amendment request: April 26, 

2017. 

Brief description of amendment: The 

amendment revised the PNPP 

Environmental Protection Plan 

(Nonradiological) to clarify and enhance 

wording, to remove duplicative or 

outdated program information, and to 

relieve the burden of submitting 

unnecessary or duplicative information 

to the NRC. 

Date of issuance: October 19, 2017. 

Effective date: As of the date of 

issuance and shall be implemented 

within 60 days of issuance. 

Amendment No.: 178. A publiclyavailable version is in ADAMS under 

Accession No. ML17257A098; 

documents related to this amendment 

are listed in the Safety Evaluation 

enclosed with the amendment. 

Facility Operating License No. NPF– 

58: Amendment revised the Facility 

Operating License. 

Date of initial notice in Federal 

Register: July 5, 2017 (82 FR 31097). 

The Commission’s related evaluation 

of the amendment is contained in a 

Safety Evaluation dated October 19, 

2017. 

No significant hazards consideration 

comments received: No. 

Florida Power & Light Company, et al., 

Docket Nos. 50–335 and 50–389, St. 

Lucie Plant, Unit Nos. 1 and 2, St. Lucie 

County, Florida 

Date of amendment request: May 2, 

2017. 

Brief description of amendments: The 

amendments revised the Renewed 

Facility Operating Licenses’ ‘‘Fire 

Protection’’ license conditions. The 

changes incorporated new references 

into these license conditions that 

approved a revision to plant 

modifications previously approved in 

the March 31, 2016, NRC issuance of 

National Fire Protection Association 

Standard 805 license amendments 

(ADAMS Accession No. ML15344A346). 

Date of issuance: October 23, 2017. 

Effective date: As of the date of 

issuance and shall be implemented 

within 60 days of issuance. 

Amendment Nos.: 242 (Unit No. 1) 

and 193 (Unit No. 2). A publiclyavailable version is in ADAMS under 

Accession No. ML17248A379; 

documents related to these amendments 

are listed in the Safety Evaluation 

enclosed with the amendments. 

Renewed Facility Operating License 

Nos. DPR–67 and NPF–16: Amendments 

revised the Renewed Facility Operating 

Licenses. 

Date of initial notice in Federal 

Register: July 5, 2017 (82 FR 31098). 

The Commission’s related evaluation 

of the amendments is contained in a 

Safety Evaluation dated October 23, 

2017. 

No significant hazards consideration 

comments received: No. 

NextEra Energy Duane Arnold, LLC, 

Docket No. 50–331, Duane Arnold 

Energy Center (DAEC), Linn County, 

Iowa 

Date of amendment request: March 

31, 2017. 

Brief description of amendment: The 

amendment revised the DAEC Plume 

Exposure Pathway Emergency Planning 

Zone (EPZ) in its Emergency 

Preparedness Plan. The DAEC 

Evacuation Time Estimates Study has 

also been revised to encompass the 

changes proposed to the DAEC Plume 

Exposure Pathway EPZ boundary. 

Date of issuance: October 18, 2017. 

Effective date: As of the date of 

issuance and shall be implemented 

within 180 days. 

Amendment No.: 301. A publiclyavailable version is in ADAMS under 

Accession No. ML17212A646; 

documents related to this amendment 

are listed in the Safety Evaluation 

enclosed with the amendment. 

Renewed Facility Operating License 

No. DPR–49: The amendment revised 

the Emergency Plan. 

Date of initial notice in Federal 

Register: June 6, 2017 (82 FR 26132). 

The Commission’s related evaluation 

of the amendment is contained in a 

Safety Evaluation dated October 18, 

2017. 

No significant hazards consideration 

comments received: No. 

Tennessee Valley Authority, Docket 

Nos. 50–390 and 50–391, Watts Bar 

Nuclear Plant, Units 1 and 2, Rhea 

County, Tennessee 

Date of amendment request: October 

20, 2016, as supplemented by letters 

dated May 5, 2017, and July 21, 2017. 

Brief description of amendments: The 

amendments revised Technical 

Specification 3.7.12, ‘‘Auxiliary 

Building Gas Treatment System 

(ABGTS),’’ to provide an action when 

both trains of the ABGTS are inoperable 

due to the auxiliary building secondary 

containment enclosure boundary being 

inoperable. 

Date of issuance: October 17, 2017. 

Effective date: As of the date of 

issuance and shall be implemented 

within 60 days of issuance. 

Amendment Nos.: 116 (Unit 1) and 16 

(Unit 2). A publicly-available version is 

in ADAMS under Accession No. 

ML17236A057; documents related to 

these amendments are listed in the 

Safety Evaluation enclosed with the 

amendments. 

Facility Operating License Nos. NPF– 

90 and NPF–96: Amendments revised 

the Facility Operating Licenses and 

Technical Specifications. 

Date of initial notice in Federal 

Register: February 28, 2017 (82 FR 

12137). The supplemental letters dated 

May 5, 2017, and July 21, 2017, 

provided additional information that 

clarified the application, did not expand 

the scope of the application as originally 

noticed, and did not change the NRC 

staff’s original proposed no significant 

hazards consideration determination as 

published in the Federal Register. 

The Commission’s related evaluation 

of the amendments is contained in a 

Safety Evaluation dated October 17, 

2017. 

No significant hazards consideration 

comments received: No. 

For the Nuclear Regulatory Commission. 

Anne T. Boland, 

Director, Division of Operating Reactor 

Licensing, Office of Nuclear Reactor 

Regulation. 

[FR Doc. 2017–23749 Filed 11–6–17; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2017–0215] 

Yttrium-90 Microsphere Brachytherapy 

Sources and Devices TheraSphere®

and SIR-Spheres®

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Draft guidance; request for 

comment. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is revising its 

licensing guidance for licenses 

authorizing the use of Yttrium-90 (Y–90) 

Microsphere Brachytherapy Sources and 

Devices TheraSphere® and SIRSpheres®. The NRC is requesting public 

comment on the draft revision of the 

licensing guidance (Rev. 10). The 

document has been revised to 

significantly update the criteria for 

training and experience, medical event 

reporting, inventory requirement 

specifications, and waste disposal 

issues. The revised guidance document 


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51656 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 

also provides new information regarding 

cremation and autopsy. This guidance is 

intended for use by NRC applicants, 

NRC licensees, and the NRC staff. 

DATES: Submit comments by January 8, 

2018. Comments received after this date 

will be considered if it is practical to do 

so, but the NRC is only able to ensure 

consideration of comments received on 

or before this date. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2017–0215. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–415–3463; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• Mail comments to: May Ma, Office 

of Administration, Mail Stop: OWFN–2– 

A13, 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 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Dimmick, Office of Nuclear Material 

Safety and Safeguards; U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001; telephone: 301–415– 

0694; email: Lisa.Dimmick@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and 

Submitting Comments 

A. Obtaining Information 

Please refer to Docket ID NRC–2017– 

0215 when contacting the NRC about 

the availability of information regarding 

this action. You may obtain publiclyavailable information related to this 

action by the following methods: 

• Federal Rulemaking Web site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2017–0215. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publiclyavailable documents online in the 

ADAMS Public Documents collection at 

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

adams.html. To begin the search, select 

‘‘ADAMS Public Documents’’ and then 

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 draft 

Y–90 Microsphere Brachytherapy 

Sources and Devices Licensing 

Guidance, Revision 10, is available in 

ADAMS under Accession No. 

ML17107A375. 

• 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. 

The draft Y–90 Microsphere 

Brachytherapy Sources and Devices 

Licensing Guidance, Revision 10, is also 

available on the NRC’s public Web site 

on the ‘‘Medical Uses Licensee Toolkit’’ 

page at https://www.nrc.gov/materials/ 

miau/med-use-toolkit.html. 

B. Submitting Comments 

Please include Docket ID NRC–2017– 

0215 in your comment submission. 

The NRC cautions you not to include 

identifying or contact information that 

you do not want publicly disclosed in 

your comment submission. The NRC 

will post all comment submissions at 

http://www.regulations.gov as well as 

enter the comment submissions into 

ADAMS. The NRC does not routinely 

edit comment submissions 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 submissions into 

ADAMS. 

II. Background 

The NRC is requesting public 

comment on the draft licensing 

guidance entitled ‘‘Yttrium-90 

Microsphere Brachytherapy Sources and 

Devices TheraSphere® and SIRSpheres® Licensing Guidance.’’ This 

draft would be revision 10 to this 

licensing guidance. The licensing 

guidance provides medical use 

applicants with an acceptable means of 

satisfying the requirements for a license 

for the use of TheraSphere® and SIRSpheres® and is not intended to be the 

only means of satisfying the 

requirements for a license. The licensing 

guidance provides the NRC with a set of 

standard criteria for evaluating a license 

application, although an applicant may 

submit alternative information and 

commitments for review by the NRC 

staff to make a licensing determination 

unless the information is specifically 

required by regulation. This guidance 

will also be available for voluntary use 

by Agreement States. 

The licensing guidance for Y–90 

microsphere brachytherapy was initially 

published in October 2002 and 

subsequently revised in 2004, 2007, 

2008, 2011, 2012, and 2016. Following 

years of using the current licensing 

guidance, the NRC staff, stakeholders, 

and the Advisory Committee on the 

Medical Uses of Isotopes (ACMUI) have 

identified numerous issues that need to 

be addressed. A working group 

comprised of Agreement State 

representatives and NRC staff was 

formed to address identified issues. The 

document has been revised to 

significantly update the criteria for 

training and experience, medical event 

reporting, inventory requirement 

specifications, and waste disposal 

issues. The revised guidance document 

also provides new information regarding 

cremation and autopsy. 

As described in the draft licensing 

guidance, the NRC is recommending 

removal of the alternate, manufacturer 

provided clinical training pathway to 

complete the training and experience 

criteria listed in Section B of the 

training and experience section of the 

licensing guidance. During an ACMUI 

meeting on October 7, 2016 

(ML16357A688), the ACMUI 

recommended that the NRC leave this 

alternate pathway in the Y–90 

microsphere licensing guidance to allow 

access to Y–90 microsphere 

brachytherapy in areas where there may 

not already be approved AUs to 

supervise new physicians. However, 

after licensing Y–90 microspheres under 

10 CFR 35.1000 for over 10 years, there 

should be substantial facilities and AUs 

available to offer training for Y–90 

microspheres, similar to other 

therapeutic modalities, and therefore 

this pathway should be removed to 

bring Y–90 microsphere brachytherapy 

training and experience (T&E) in line 

with other T&E requirements in 10 CFR 

part 35. 

The manufacturers stated, during the 

same ACMUI meeting, that training 

under the supervision of a manufacturer 

representative should remain as a T&E 

pathway because their representatives 

are highly knowledgeable about their 

devices. The NRC agrees with the 

manufacturers that the individual who 

provides the training in the operation of 

the device should be knowledgeable 

about the device, and this could include 

a manufacturer representative as well as 

the licensees’ personnel. The proposed 

licensing guidance still requires the 

physician to receive training on the 

operation of the device. However, the 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51657 

clinical experience a physician received 

during the 3 patient cases should 

include more than operation of the 

device. At a minimum, the clinical 

experience should also include 

evaluation of dose and activity of Y–90 

microspheres to be administered to each 

treatment site, calculating and 

measuring the activity and safely 

preparing the Y–90 microspheres to be 

delivered, using administrative controls 

to prevent a medical event, and 

following up and reviewing each 

patient’s case history. During the 

ACMUI meeting, the ACMUI 

recommended that this type of training 

be provided by someone with defined 

medical experience, but left it up to the 

NRC to decide what medical experience 

would be necessary. As this T&E is 

specific to patient care and patient 

follow-up, the proposed licensing 

guidance recommends this type of 

training be provided by an AU for each 

type of Y–90 microsphere for which the 

individual is seeking AU status, similar 

to how other modalities are regulated in 

10 CFR part 35. Additionally, changing 

the criteria would not preclude the 

manufacturer representatives from 

providing training, as is normally done 

for other therapies. 

III. Request for Comments 

The NRC is requesting comments on 

the proposed licensing guidance, 

entitled, ‘‘Yttrium-90 Microsphere 

Brachytherapy Sources and Devices 

TheraSphere® and SIR-Spheres®

Licensing Guidance, Revision 10.’’ 

While the NRC is requesting comments 

on the entirety of the proposed 

guidance, the NRC is specifically 

seeking comments on several sections. 

(1) Recommended Minimum Clinical 

Experience: Due to the complexity of 

delivery of Y–90 microspheres, the 

licensing guidance historically and 

currently recommends that a 

prospective AU demonstrate he or she 

has clinical experience with the device. 

The current recommendation is that 3 

patient cases for each type of 

microsphere should be completed for 

each prospective authorized user prior 

to approval. This recommendation is 

similar to requirements in other therapy 

modalities, such as section 35.390 of 

title 10 of the Code of Federal 

Regulations (10 CFR). The NRC is 

seeking specific comments on whether 3 

patient cases provide adequate clinical 

experience for a physician to gain AU 

status for Y–90 microspheres. 

(2) Adding Authorization for Other 

Microsphere Type: The NRC is seeking 

comments to determine additional 

training needed when an AU who is 

already authorized to use one type of 

microsphere requests authorization for 

use of another type of microsphere. For 

instance, are 3 additional cases for the 

other type of microsphere necessary for 

the AU to gain the knowledge to safely 

administer the new microsphere, or 

should the number of cases be left to the 

discretion of the supervising AU? 

(3) Written Attestation from Preceptor: 

Historically, the NRC has not required a 

written attestation, signed by a 

preceptor AU, because there was not a 

sufficient number of AUs to supervise 

the training and sign the written 

attestation. However, given that the NRC 

and Agreement States have licensed Y– 

90 microsphere brachytherapy AUs for 

over 10 years, the NRC is seeking 

comments to determine if there is 

anything unique about Y–90 

microsphere brachytherapy compared to 

other types of manual brachytherapy 

that would obviate the need for a 

written attestation. 

(4) Clinical Experience under the 

Supervision of a Manufacturer 

Representative: The proposed licensing 

guidance removes the alternate 

pathway, which allows an individual to 

become an AU for Y–90 microsphere 

brachytherapy prior to completing any 

patient cases if the applicant commits 

that the first three patient cases 

completed by that AU will be hands-on 

and supervised in the physical presence 

of a manufacturer representative. This 

alternate pathway remained in the 

licensing guidance for several years 

because there were a limited number of 

AUs who were authorized for each type 

of Y–90 microsphere, which made it 

difficult for physicians who were 

seeking authorization to complete the 

necessary clinical experience described 

in Section B under the supervision of 

another AU already authorized for the 

use of Y–90 microspheres. The NRC is 

seeking comments on whether 

completing the recommended clinical 

experience under the supervision of 

AU(s) authorized for the type of 

microsphere for which the new 

physician is seeking authorization still 

presents an undue burden on 

physicians. Further, the NRC is seeking 

comments on whether any unique 

characteristics of Y–90 microsphere 

brachytherapy warrant continuation of 

this alternate training pathway. 

Additionally, the NRC is seeking 

comments on whether finding licensed 

facilities at which the physicians could 

complete this clinical experience would 

be difficult. 

(5) Timeliness for Completion of InVivo Cases: The NRC is seeking 

comments on whether the proposed one 

in-vivo case prior to treating patients 

would be appropriate if 6 months has 

passed to ensure recentness of training 

or whether this proposal could 

potentially lower licensee’s safety 

standards for the patients being treated. 

(6) Medical Event Definition: The NRC 

is seeking comments on the definition of 

medical events (ME) for Y–90 

microspheres as provided in the 

proposed guidance. A primary purpose 

of ME reporting is to identify the cause 

of the event in order to correct them and 

prevent their recurrence. In the last 2 

years there have been several MEs 

reported where the administration of the 

Y–90 results in dose or activity to the 

lobe opposite the lobe documented in 

the written directive. The working 

group was informed that in some 

instances, the AU may determine in the 

interventional radiology suite that they 

may be unable to deliver the amount of 

Y–90 microspheres to the intended lobe, 

but still wish to perform the treatment 

knowing some dose or activity may go 

to the lobe opposite the lobe 

documented in the written directive. 

The NRC is seeking specific comments 

on whether the delivery of Y–90 

microspheres can be controlled to a 

specific lobe or location as described in 

the written directive and, if not, 

whether flexibility in the written 

directive is necessary to avoid reporting 

of events that cannot be controlled using 

the current technology. If flexibility is 

necessary, the NRC is seeking comments 

on whether the use of dose or activity 

ranges in the written directive or an 

ability to change the written directive in 

the interventional radiology suite prior 

to administering the Y–90 microspheres 

would be adequate. This type of 

revision could be made verbally by the 

AU, as long as the revision is 

documented in writing and signed by 

the AU within 24 hours of providing the 

revision verbally, consistent with other 

uses in 10 CFR part 35. 

Dated at Rockville, Maryland, this 1st day 

of November, 2017. 

For the U.S. Nuclear Regulatory 

Commission. 

Daniel S. Collins, 

Director, Division of Material Safety, State, 

Tribal and Rulemaking Programs, Office of 

Nuclear Material Safety and Safeguards. 

[FR Doc. 2017–24129 Filed 11–6–17; 8:45 am] 

BILLING CODE 7590–01–P 


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