[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19514-19515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07307]
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NUCLEAR REGULATORY COMMISSION
[NRC-2019-0154]
Release of Patients Administered Radioactive Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Regulatory guide; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing
Revision 1 to Regulatory Guide (RG) 8.39, ``Release of Patients
Administered Radioactive Material.'' This RG (Revision 1) provides
licensees with more detailed instructions to provide to patients before
and after they have been administered radioactive material than was in
Revision 0. In addition, the guide includes a new section on ``Death of
a Patient Following Radiopharmaceutical or Implants Administrations,''
as well as requirements for recordkeeping. Also, Table 3, ``Activities
of Radiopharmaceuticals That Require Instructions and Records When
Administered to Patients Who Are Breastfeeding an Infant or Child,''
has been revised.
DATES: Revision 1 to RG 8.39 is available on April 7, 2020.
ADDRESSES: Please refer to Docket ID NRC-2019-0154 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly-available information related to this document,
using the following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0154. Address
questions about NRC docket IDs in Regulations.gov to Jennifer Borges,
telephone: 301-287-9127; email: [email protected]. For technical
questions, contact the individual listed in the FOR FURTHER INFORMATION
CONTACT section of this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Document collection at https://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 [email protected]. The ADAMS accession number for each
document referenced in this notice (if that document is available in
ADAMS) is provided the first time that a document is referenced.
Revision 1 to RG 8.39 may be found in ADAMS under Accession No.
ML19232A081.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One
[[Page 19515]]
White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Regulatory guides are not copyrighted, and NRC approval is not
required to reproduce them.
FOR FURTHER INFORMATION CONTACT: Vered Shaffer, Office of Nuclear
Regulatory Research, telephone: 630-829-9862, email:
[email protected], U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Discussion
The NRC is issuing a revision to an existing guide in the NRC's
``Regulatory Guide'' series. This series was developed to describe and
make available to the public information regarding methods and
techniques that the NRC staff uses in evaluating specific issues or
postulated events, and data that the NRC staff needs in its review of
applications for permits and licenses.
RG 8.39 described methods that are acceptable to the NRC staff for
implementing specific parts of the NRC's regulations. Specifically, the
RG provides licensees with instructions for patients before and after
they receive medical procedures involving the administration of
radioactive material, as well as requirements for recordkeeping. The RG
also lists activities and dose rates that may be used by licensees for
the release of patients in order to meet NRC regulatory requirements.
This revision of the guide (Revision 1) provides licensees with
more detailed instructions to provide to patients before and after they
have been administered radioactive material than was in Revision 0. In
addition, the guide includes a new section on ``Death of a Patient
Following Radiopharmaceutical or Implants Administrations,'' as well as
additional guidance for requirements for recordkeeping. Also, Table 3,
``Activities of Radiopharmaceuticals that Require Instructions and
Records when Administered to Patients who are Breastfeeding an Infant
or Child,'' has been revised to provide information for the recommended
duration of interruption of breastfeeding to ensure that the dose to an
infant or child meets the NRC's regulatory requirements.
II. Additional Information
Proposed revision 1 of RG 8.39 was issued with a temporary
identification of Draft Regulatory Guide, (DG)-8057. The NRC published
a notice of the availability of DG-8057 in the Federal Register on July
29, 2019 (84 FR 36127) for a 30-day public comment period. The public
comment period was extended for another 30 days (84 FR 39383; August 9,
2019). The public comment period closed on September 26, 2019. Public
comments on DG-8057 and the staff responses to the public comments are
available under ADAMS under Accession No. ML19353B203.
III. Congressional Review Act
This RG is a rule as defined in the Congressional Review Act (5
U.S.C. 801-808). However, the Office of Management and Budget has not
found it to be a major rule as defined in the Congressional Review Act.
IV. Backfitting, Forward Fitting, and Issue Finality
Revision 1 of RG 8.39 does not constitute backfitting as defined in
title 10 of the Code of Federal Regulations (10 CFR) section 50.109,
``Backfitting'' and as described in NRC Management Directive (MD) 8.4,
``Management of Backfitting, Forward Fitting, Issue Finality, and
Information Requests'' (ADAMS Accession No. ML18093B087); affect the
issue finality of any approval issued under 10 CFR part 52, ``Licenses,
Certifications, and Approvals for Nuclear Power Plants;'' or constitute
forward fitting as that term is defined and described in MD 8.4. 10 CFR
part 35, ``Medical Use of Byproduct Material,'' does not include
backfitting or issue finality provisions and the forward fitting policy
in MD 8.4 does not apply to these licensees. In addition, licensees
will not be required to comply with the positions set forth in this RG.
Dated: April 2, 2020.
For the Nuclear Regulatory Commission.
Thomas H. Boyce,
Chief, Regulatory Guidance and Generic Issues Branch, Division of
Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2020-07307 Filed 4-6-20; 8:45 am]
BILLING CODE 7590-01-P