Medical Use of Byproduct Material-Medical Event; Definitions and Training and Experience, 32759 [2018-14853]

Download as PDF 32759 Rules and Regulations Federal Register Vol. 83, No. 136 Monday, July 16, 2018 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. 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 Nuclear Regulatory Commission. ACTION: Final guidance; issuance. AGENCY: 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: Carol.Gallagher@nrc.gov. 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 publiclyavailable documents online in the ADAMS Public Documents collection at sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:38 Jul 13, 2018 Jkt 244001 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 pdr.resource@nrc.gov. 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: DonnaBeth.Howe@nrc.gov. 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). PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA–2015–0310; Special Conditions No. 25–732–SC] Special Conditions: Gulfstream Aerospace Corporation Model GVII– G500 Series Airplanes; Flight Envelope Protection—High Incidence Protection System Federal Aviation Administration (FAA), DOT. ACTION: Final special conditions. AGENCY: These special conditions are issued for the Gulfstream Aerospace Corporation (Gulfstream) Model GVII– G500 series airplanes. This airplane will have a novel or unusual design feature when compared to the state of technology and design envisioned in the airworthiness standards for transport category airplanes. This design feature is a high incidence protection system that limits the angle of attack at which the airplane can be flown during normal low speed operation. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level SUMMARY: E:\FR\FM\16JYR1.SGM 16JYR1

Agencies

[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]



========================================================================
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. 

========================================================================


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.

-----------------------------------------------------------------------

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]
 BILLING CODE 7590-01-P