[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]
 BILLING CODE 7590-01-P