[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Rules and Regulations]
[Page 32759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14853]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Rules
and Regulations
[[Page 32759]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 32, and 35
[NRC-2014-0030]
RIN 3150-AI63
Medical Use of Byproduct Material--Medical Event; Definitions and
Training and Experience
AGENCY: Nuclear Regulatory Commission.
ACTION: Final guidance; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
final guidance document entitled, ``Final Guidance for the Rule
`Medical Use of Byproduct Material--Medical Events Definitions,
Training and Experience, and Clarifying Amendments.' '' This guidance
document addresses implementation of the NRC's final rule amending its
medical use of byproduct material regulations which is being published
concurrently in Separate Part IV of this issue of the Federal Register.
DATES: The guidance document is available on July 16, 2018.
ADDRESSES: Please refer to Docket ID NRC-2014-0030 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly-available information related to this document
using any of the following methods:
Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2014-0030. 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.
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
final guidance document is available in ADAMS under Accession No.
ML18176A377.
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.
FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-5441; email: [email protected].
SUPPLEMENTARY INFORMATION: The NRC published the draft guidance
document in the Federal Register on July 21, 2014 (79 FR 42224). The
NRC received seven comments on the draft guidance. The NRC's response
to the public comments received can be found in the fourth section of
the final guidance. The guidance document is for use by applicants,
licensees, Agreement States, and the NRC staff. This guidance document
(ADAMS Accession No. ML18176A377) has four parts: the first two are
revisions to existing information in the NUREG-1556, ``Consolidated
Guidance About Materials Licenses,'' series of volumes for medical uses
(Volume 9) and commercial nuclear pharmacies (Volume 13); the third
part is a series of questions and answers to assist applicants and
licensees in understanding and implementing the new regulatory changes;
and the fourth is the comments received on the proposed guidance during
the public comment period, and the NRC's responses. The current NUREG-
1556 documents provide guidance to applicants for the completion and
submission of materials license applications to the NRC. The documents
also include model procedures that an applicant may consider when
developing its radiation safety program. The guidance document can be
found on the NRC's Medical Uses Licensee Toolkit website (http://www.nrc.gov/materials/miau/med-use-toolkit.html).
The NRC is publishing concurrently with this guidance document the
final rule, ``Medical Use of Byproduct Material--Medical Event
Definitions, Training and Experience, and Clarifying Amendments'' (RIN
3150-AI63, NRC-2008-0175) in Separate Part IV of this issue of the
Federal Register. In conjunction with the final rule, the NRC developed
this final guidance document which provides guidance to licensees and
applicants for implementing the revisions in the final rule.
Dated at Rockville, Maryland, this 3rd day of July 2018.
For the Nuclear Regulatory Commission.
Daniel S. Collins,
Director, Division of Materials Safety, Security, State, and Tribal
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2018-14853 Filed 7-13-18; 8:45 am]
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