[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36127-36128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15868]
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NUCLEAR REGULATORY COMMISSION
[NRC-2019-0154]
Release of Patients Administered Radioactive Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Draft regulatory guide; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for
public comment draft regulatory guide (DG), DG-8057, ``Release of
Patients Administered Radioactive Material.'' This proposed guide,
Revision 1, provides licensees with more detailed instructions to
provide to patients
[[Page 36128]]
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, ``Dosages 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.
DATES: Submit comments by August 26, 2019. Comments received after this
date will be considered if it is practical to do so, but the NRC is
able to ensure consideration only for comments received on or before
this date. Although a time limit is given, comments and suggestions in
connection with the regulatory guides (RGs) currently being developed
or improvements in all published RGs are encouraged at any time.
ADDRESSES: You may submit comments by any of the following methods:
Federal rulemaking Website: Go to https://www.regulations.gov/ and search for Docket ID NRC-2019-0154. Address
questions about docket IDs in Regulations.gov to Jennifer Borges;
telephone: 301-287-9127; email: [email protected]. For
technical questions, contact the individuals listed in the FOR FURTHER
INFORMATION CONTACT section of this document.
Mail comments to: Office of Administration, Mail Stop:
TWFN-7A06, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, ATTN: Program Management, Announcements and Editing Staff.
For additional direction on accessing information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Vered Shaffer, telephone: 630-829-
9862, email: [email protected], and Harriet Karagiannis, telephone:
301-415-2493, email: [email protected]. Both are staff
members of the Office of Nuclear Regulatory Research, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
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, by any
of the following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov/ and search for Docket ID NRC-2019-0154.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://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
DG-8057 is available in ADAMS under Accession No. ML19108A463.
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-2019-0154 in your comment submission.
The NRC cautions you not to include identifying or contact information
that you do not want to be publicly disclosed in your comment
submission. The NRC posts all comment submissions at https://www.regulations.gov/ as well as entering 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 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. Additional Information
The NRC is issuing for public comment a DG in the NRC's
``Regulatory Guide'' series. This series was developed to describe and
make available to the public information regarding methods that are
acceptable to the NRC staff for implementing specific parts of the
NRC's regulations, techniques that the staff uses in evaluating
specific issues or postulated events, and data that the staff needs in
its review of applications for permits and licenses.
The DG, entitled, ``Release of Patients Administered Radioactive
Material,'' is temporarily identified by its task number, DG-8057. The
DG-8057 is proposed Revision 1 to RG 8.39
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, ``Dosages 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 meet the
NRC regulatory requirements.
III. Backfitting and Issue Finality
As discussed in the Implementation section of DG-8057, the NRC does
not intend or approve any imposition of the guidance in this draft
regulatory guide. Backfitting and issue finality considerations do not
apply to licensees or applicants when performing activities under part
35 of title 10 of the Code of Federal Regulations (CFR). Therefore, the
NRC has determined that its backfitting and issue finality regulations
would not apply to this draft regulatory guide, if ultimately issued as
Revision 1 to RG 8.39, because the draft regulatory guide does not
include any provisions within the scope of matters covered by the
backfitting provisions in 10 CFR parts 50, 70, 72, or 76 or the issue
finality provisions of 10 CFR part 52.
Dated at Rockville, Maryland, this 22nd day of July 2019.
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. 2019-15868 Filed 7-25-19; 8:45 am]
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