82 FR 51655 - Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®
NUCLEAR REGULATORY COMMISSION Federal Register Volume 82, Issue 214 (November 7, 2017)
Federal Register Volume 82, Issue 214 (November 7, 2017)
| Page Range | 51655-51657 | |
| FR Document | 2017-24129 |
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)] [Notices] [Pages 51655-51657] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24129] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [NRC-2017-0215] Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] and SIR-Spheres[supreg] 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 ACTION: Draft guidance; request for comment.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[supreg] and SIR-Spheres[supreg]. 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 [[Page 51656]] 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: [email protected]. 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: [email protected]. 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 publicly-available 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 publicly-available 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 [email protected]. 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[supreg] and SIR-Spheres[supreg] 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[supreg] and SIR-Spheres[supreg] 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 [[Page 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[supreg] and SIR-Spheres[supreg] 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 In-Vivo 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
![Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51655
No significant hazards consideration Renewed Facility Operating License Effective date: As of the date of
comments received: No. Nos. DPR–67 and NPF–16: Amendments issuance and shall be implemented
revised the Renewed Facility Operating within 60 days of issuance.
FirstEnergy Nuclear Operating Licenses. Amendment Nos.: 116 (Unit 1) and 16
Company, Docket No. 50–440, Perry Date of initial notice in Federal (Unit 2). A publicly-available version is
Nuclear Power Plant (PNPP), Unit No. 1, Register: July 5, 2017 (82 FR 31098). in ADAMS under Accession No.
Lake County, Ohio The Commission’s related evaluation ML17236A057; documents related to
Date of amendment request: April 26, of the amendments is contained in a these amendments are listed in the
2017. Safety Evaluation dated October 23, Safety Evaluation enclosed with the
Brief description of amendment: The 2017. amendments.
amendment revised the PNPP No significant hazards consideration Facility Operating License Nos. NPF–
Environmental Protection Plan comments received: No. 90 and NPF–96: Amendments revised
(Nonradiological) to clarify and enhance the Facility Operating Licenses and
wording, to remove duplicative or NextEra Energy Duane Arnold, LLC, Technical Specifications.
outdated program information, and to Docket No. 50–331, Duane Arnold Date of initial notice in Federal
relieve the burden of submitting Energy Center (DAEC), Linn County, Register: February 28, 2017 (82 FR
unnecessary or duplicative information Iowa 12137). The supplemental letters dated
to the NRC. Date of amendment request: March May 5, 2017, and July 21, 2017,
Date of issuance: October 19, 2017. provided additional information that
Effective date: As of the date of 31, 2017.
clarified the application, did not expand
issuance and shall be implemented Brief description of amendment: The
the scope of the application as originally
within 60 days of issuance. amendment revised the DAEC Plume
noticed, and did not change the NRC
Amendment No.: 178. A publicly- Exposure Pathway Emergency Planning
staff’s original proposed no significant
available version is in ADAMS under Zone (EPZ) in its Emergency
hazards consideration determination as
Accession No. ML17257A098; Preparedness Plan. The DAEC
published in the Federal Register.
documents related to this amendment Evacuation Time Estimates Study has
The Commission’s related evaluation
are listed in the Safety Evaluation also been revised to encompass the
of the amendments is contained in a
enclosed with the amendment. changes proposed to the DAEC Plume
Safety Evaluation dated October 17,
Facility Operating License No. NPF– Exposure Pathway EPZ boundary.
2017.
58: Amendment revised the Facility Date of issuance: October 18, 2017.
No significant hazards consideration
Operating License. Effective date: As of the date of comments received: No.
Date of initial notice in Federal issuance and shall be implemented
Register: July 5, 2017 (82 FR 31097). within 180 days. For the Nuclear Regulatory Commission.
The Commission’s related evaluation Amendment No.: 301. A publicly- Anne T. Boland,
of the amendment is contained in a available version is in ADAMS under Director, Division of Operating Reactor
Safety Evaluation dated October 19, Accession No. ML17212A646; Licensing, Office of Nuclear Reactor
2017. documents related to this amendment Regulation.
No significant hazards consideration are listed in the Safety Evaluation [FR Doc. 2017–23749 Filed 11–6–17; 8:45 am]
comments received: No. enclosed with the amendment. BILLING CODE 7590–01–P
Florida Power & Light Company, et al., Renewed Facility Operating License
Docket Nos. 50–335 and 50–389, St. No. DPR–49: The amendment revised
the Emergency Plan. NUCLEAR REGULATORY
Lucie Plant, Unit Nos. 1 and 2, St. Lucie COMMISSION
County, Florida Date of initial notice in Federal
Register: June 6, 2017 (82 FR 26132). [NRC–2017–0215]
Date of amendment request: May 2, The Commission’s related evaluation
2017. of the amendment is contained in a Yttrium-90 Microsphere Brachytherapy
Brief description of amendments: The Safety Evaluation dated October 18, Sources and Devices TheraSphere®
amendments revised the Renewed 2017. and SIR-Spheres®
Facility Operating Licenses’ ‘‘Fire
No significant hazards consideration AGENCY: Nuclear Regulatory
Protection’’ license conditions. The
comments received: No. Commission.
changes incorporated new references
into these license conditions that Tennessee Valley Authority, Docket ACTION: Draft guidance; request for
approved a revision to plant Nos. 50–390 and 50–391, Watts Bar comment.
modifications previously approved in Nuclear Plant, Units 1 and 2, Rhea
the March 31, 2016, NRC issuance of County, Tennessee SUMMARY: The U.S. Nuclear Regulatory
National Fire Protection Association Commission (NRC) is revising its
Standard 805 license amendments Date of amendment request: October licensing guidance for licenses
(ADAMS Accession No. ML15344A346). 20, 2016, as supplemented by letters authorizing the use of Yttrium-90 (Y–90)
Date of issuance: October 23, 2017. dated May 5, 2017, and July 21, 2017. Microsphere Brachytherapy Sources and
Effective date: As of the date of Brief description of amendments: The Devices TheraSphere® and SIR-
issuance and shall be implemented amendments revised Technical Spheres®. The NRC is requesting public
within 60 days of issuance. Specification 3.7.12, ‘‘Auxiliary comment on the draft revision of the
ethrower on DSK3G9T082PROD with NOTICES
Amendment Nos.: 242 (Unit No. 1) Building Gas Treatment System licensing guidance (Rev. 10). The
and 193 (Unit No. 2). A publicly- (ABGTS),’’ to provide an action when document has been revised to
available version is in ADAMS under both trains of the ABGTS are inoperable significantly update the criteria for
Accession No. ML17248A379; due to the auxiliary building secondary training and experience, medical event
documents related to these amendments containment enclosure boundary being reporting, inventory requirement
are listed in the Safety Evaluation inoperable. specifications, and waste disposal
enclosed with the amendments. Date of issuance: October 17, 2017. issues. The revised guidance document
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![Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51657
clinical experience a physician received microsphere requests authorization for passed to ensure recentness of training
during the 3 patient cases should use of another type of microsphere. For or whether this proposal could
include more than operation of the instance, are 3 additional cases for the potentially lower licensee’s safety
device. At a minimum, the clinical other type of microsphere necessary for standards for the patients being treated.
experience should also include the AU to gain the knowledge to safely
(6) Medical Event Definition: The NRC
evaluation of dose and activity of Y–90 administer the new microsphere, or
is seeking comments on the definition of
microspheres to be administered to each should the number of cases be left to the
treatment site, calculating and discretion of the supervising AU? medical events (ME) for Y–90
measuring the activity and safely (3) Written Attestation from Preceptor: microspheres as provided in the
preparing the Y–90 microspheres to be Historically, the NRC has not required a proposed guidance. A primary purpose
delivered, using administrative controls written attestation, signed by a of ME reporting is to identify the cause
to prevent a medical event, and preceptor AU, because there was not a of the event in order to correct them and
following up and reviewing each sufficient number of AUs to supervise prevent their recurrence. In the last 2
patient’s case history. During the the training and sign the written years there have been several MEs
ACMUI meeting, the ACMUI attestation. However, given that the NRC reported where the administration of the
recommended that this type of training and Agreement States have licensed Y– Y–90 results in dose or activity to the
be provided by someone with defined 90 microsphere brachytherapy AUs for lobe opposite the lobe documented in
medical experience, but left it up to the over 10 years, the NRC is seeking the written directive. The working
NRC to decide what medical experience comments to determine if there is group was informed that in some
would be necessary. As this T&E is anything unique about Y–90 instances, the AU may determine in the
specific to patient care and patient microsphere brachytherapy compared to interventional radiology suite that they
follow-up, the proposed licensing other types of manual brachytherapy may be unable to deliver the amount of
guidance recommends this type of that would obviate the need for a Y–90 microspheres to the intended lobe,
training be provided by an AU for each written attestation.
but still wish to perform the treatment
type of Y–90 microsphere for which the (4) Clinical Experience under the
Supervision of a Manufacturer knowing some dose or activity may go
individual is seeking AU status, similar
Representative: The proposed licensing to the lobe opposite the lobe
to how other modalities are regulated in
guidance removes the alternate documented in the written directive.
10 CFR part 35. Additionally, changing
the criteria would not preclude the pathway, which allows an individual to The NRC is seeking specific comments
manufacturer representatives from become an AU for Y–90 microsphere on whether the delivery of Y–90
providing training, as is normally done brachytherapy prior to completing any microspheres can be controlled to a
for other therapies. patient cases if the applicant commits specific lobe or location as described in
that the first three patient cases the written directive and, if not,
III. Request for Comments completed by that AU will be hands-on whether flexibility in the written
The NRC is requesting comments on and supervised in the physical presence directive is necessary to avoid reporting
the proposed licensing guidance, of a manufacturer representative. This of events that cannot be controlled using
entitled, ‘‘Yttrium-90 Microsphere alternate pathway remained in the the current technology. If flexibility is
Brachytherapy Sources and Devices licensing guidance for several years necessary, the NRC is seeking comments
TheraSphere® and SIR-Spheres® because there were a limited number of on whether the use of dose or activity
Licensing Guidance, Revision 10.’’ AUs who were authorized for each type ranges in the written directive or an
While the NRC is requesting comments of Y–90 microsphere, which made it ability to change the written directive in
on the entirety of the proposed difficult for physicians who were the interventional radiology suite prior
guidance, the NRC is specifically seeking authorization to complete the to administering the Y–90 microspheres
seeking comments on several sections. necessary clinical experience described
(1) Recommended Minimum Clinical would be adequate. This type of
in Section B under the supervision of
Experience: Due to the complexity of revision could be made verbally by the
another AU already authorized for the
delivery of Y–90 microspheres, the use of Y–90 microspheres. The NRC is AU, as long as the revision is
licensing guidance historically and seeking comments on whether documented in writing and signed by
currently recommends that a completing the recommended clinical the AU within 24 hours of providing the
prospective AU demonstrate he or she experience under the supervision of revision verbally, consistent with other
has clinical experience with the device. AU(s) authorized for the type of uses in 10 CFR part 35.
The current recommendation is that 3 microsphere for which the new Dated at Rockville, Maryland, this 1st day
patient cases for each type of physician is seeking authorization still of November, 2017.
microsphere should be completed for presents an undue burden on For the U.S. Nuclear Regulatory
each prospective authorized user prior physicians. Further, the NRC is seeking Commission.
to approval. This recommendation is comments on whether any unique
Daniel S. Collins,
similar to requirements in other therapy characteristics of Y–90 microsphere
modalities, such as section 35.390 of brachytherapy warrant continuation of Director, Division of Material Safety, State,
title 10 of the Code of Federal this alternate training pathway. Tribal and Rulemaking Programs, Office of
Regulations (10 CFR). The NRC is Additionally, the NRC is seeking Nuclear Material Safety and Safeguards.
seeking specific comments on whether 3 comments on whether finding licensed [FR Doc. 2017–24129 Filed 11–6–17; 8:45 am]
patient cases provide adequate clinical facilities at which the physicians could BILLING CODE 7590–01–P
ethrower on DSK3G9T082PROD with NOTICES
experience for a physician to gain AU complete this clinical experience would
status for Y–90 microspheres. be difficult.
(2) Adding Authorization for Other (5) Timeliness for Completion of In-
Microsphere Type: The NRC is seeking Vivo Cases: The NRC is seeking
comments to determine additional comments on whether the proposed one
training needed when an AU who is in-vivo case prior to treating patients
already authorized to use one type of would be appropriate if 6 months has
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Document Created: 2018-10-25 10:27:23
Document Modified: 2018-10-25 10:27:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Draft guidance; request for comment. | |
| 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. | |
| Contact | Lisa Dimmick, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0694; email: [email protected] | |
| FR Citation | 82 FR 51655 |
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