[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
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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:
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#e6a58794898ac8a1878a8a87818e8394a6889485c8818990"><span class="__cf_email__" data-cfemail="abe8cad9c4c785eccac7c7caccc3ced9ebc5d9c885ccc4dd">[email protected]</span></a>. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
    <bullet> 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 <a href="/cdn-cgi/l/email-protection#ee9e8a9cc09c8b9d819b9c8d8bae809c8dc0898198"><span class="__cf_email__" data-cfemail="641400164a1601170b11160701240a16074a030b12">[email protected]</span></a>. The 
final guidance document is available in ADAMS under Accession No. 
ML18176A377.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#c783a8a9a9a6ea85a2b3afe98fa8b0a287a9b5a4e9a0a8b1"><span class="__cf_email__" data-cfemail="c084afaeaea1ed82a5b4a8ee88afb7a580aeb2a3eea7afb6">[email protected]</span></a>.

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]
 BILLING CODE 7590-01-P


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