Source: https://www.law.cornell.edu/cfr/text/10/32.210
Timestamp: 2017-05-01 04:42:41
Document Index: 536235856

Matched Legal Cases: ['art 32', '§ 32', '§ 30', 'art 33', '§ 2014', '§ 2021', '§ 2021', '§ 2111', '§ 2201', '§ 2232', '§ 2233', '§ 5841', 'art 32', 'arts 20', 'arts 20', 'art 32', 'arts 1', 'arts 30', 'arts 30', 'arts 30', 'art 32', '§ 31', 'art 32', 'arts 20', 'arts 20', 'arts 30', 'arts 30']

10 CFR 32.210 - Registration of product information. | US Law | LII / Legal Information Institute
CFR › Title 10 › Chapter I › Part 32 › Subpart D › Section 32.210 10 CFR 32.210 - Registration of product information.
§ 32.210 Registration of product information.
(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration.
(b) The request for review must be sent to the NRC's Office of Nuclear Material Safety and Safeguards, ATTN: SSDR by an appropriate method listed in § 30.6(a) of this chapter.
(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.
(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the NRC formulates reasonable standards and criteria with the help of the manufacturer or distributor. The NRC shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. Subpart A of this part includes specific criteria that apply to certain exempt products and subpart B includes specific criteria applicable to certain generally licensed devices. Subpart C includes specific provisions that apply to certain specifically licensed items.
(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.
(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with - (1) The statements and representations, including quality control program, contained in the request; and
(2) The provisions of the registration certificate.
(g) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:
(1) Calibration and reference sources containing no more than:
(i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or
(ii) 0.37 MBq (10 µCi), for alpha emitting radionuclides; or
(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and
(i) The intended recipients are licensed under part 33 of this chapter or comparable provisions of an Agreement State; or
(ii) The recipients are authorized for research and development; or
(iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.
(h) After the certificate is issued, the Commission may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Commission will complete its evaluation in accordance with criteria specified in this section. The Commission may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested.
[ 52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995; 68 FR 58805, Oct. 10, 2003; 73 FR 5719, Jan. 31, 2008; 77 FR 43695, July 25, 2012]
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE§ 2014 - Definitions§ 2021 - Cooperation with States§ 2021b - Definitions§ 2111 - Domestic distribution§ 2201 - General duties of Commission§ 2232 - License applications§ 2233 - Terms of licenses§ 5841 - Establishment and transfers
Title 10 published on 04-Apr-2017 04:06The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR Part 32 after this date.2016-07-29; vol. 81 # 146 - Friday, July 29, 201681 FR 49863 - Rulemaking Activities Being Discontinued by the NRC
typeregulations.gov FR Doc.2016-17766 RIN3150-AH18 NRC-1999-0002, NRC-2001-0012, NRC-2002-0013, NRC-2006-0008, NRC-2008-0200, NRC-2009-0227, and NRC-20 NUCLEAR REGULATORY COMMISSION Rulemaking activities; discontinuation. Effective July 29, 2016, the rulemaking activities discussed in this document are discontinued. 10 CFR Parts 20, 26, 32, 40, 50, 53, 73, 74, and 150 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is discontinuing eight rulemaking activities. The purpose of this action is to inform members of the public that these rulemaking activities are being discontinued and to provide a brief discussion of the NRC&apos;s decision to discontinue them. These rulemaking activities will no longer be reported in the NRC&apos;s portion of the Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda).
2015-12-01; vol. 80 # 230 - Tuesday, December 1, 201580 FR 74974 - Miscellaneous Corrections
2015-09-30; vol. 80 # 189 - Wednesday, September 30, 201580 FR 58573 - Formatting and Non-Substantive Corrections to Authority Citations; Corrections
typeregulations.gov FR Doc.2015-24603 RIN3150-AJ61 NRC-2015-0122 NUCLEAR REGULATORY COMMISSION Correcting amendments. This rule is effective on September 30, 2015. 10 CFR Parts 20, 32, 54, 73, 95, and 110 SummaryThe U.S. Nuclear Regulatory Commission (NRC) published a final rule in the Federal Register on September 9, 2015, that amended its regulations to better adhere to the Office of Federal Register&apos;s (OFR) guidance for formatting authority citations. In addition, the final rule corrected typographical errors and made other non-substantive corrections to the NRC&apos;s authority citations. The final rule contained incorrect punctuation and spacing, one incorrect reference, and omitted two references. This document makes additional corrections to NRC&apos;s authority citations.
2015-07-30; vol. 80 # 146 - Thursday, July 30, 201580 FR 45413 - Commercial Distribution of Tritium Markers
typeregulations.gov FR Doc.2015-18630 RIN NRC-2013-0078 Docket No.s. PRM-32-8 NUCLEAR REGULATORY COMMISSION Petition for rulemaking; denial. The docket for the petition for rulemaking, PRM-32-8, is closed on July 30, 2015. 10 CFR Part 32 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking (PRM), dated December 2, 2011, which was filed with the NRC by Motti Slodowitz on behalf of CampCo (the petitioner) and supplemented with additional information on September 18, 2012. The petitioner requests the NRC to amend its regulations that govern the licensing of products containing byproduct material to allow the commercial distribution of tritium markers for use under an exemption from licensing requirements. The NRC is denying the petition because the petitioner fails to demonstrate that a specific exemption is warranted and that the existing regulatory framework for self-luminous products is insufficient.
2014-12-19; vol. 79 # 244 - Friday, December 19, 201479 FR 75735 - Organizational Changes and Conforming Amendments
typeregulations.gov FR Doc.2014-29664 RIN3150-AJ46 NRC-2014-0220 NUCLEAR REGULATORY COMMISSION Final rule. This final rule is effective on December 19, 2014. 10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to reflect internal organizational changes and conforming amendments. These changes include adding the address for a new NRC building at headquarters, removing references to several committees that no longer exist, adding the Computer Security Office, removing all references to the Office of Federal and State Materials and Environmental Management Programs because that office has merged with the Office of Nuclear Material Safety and Safeguards, and making conforming amendments throughout the regulations to reflect this office merger.
2014-09-22; vol. 79 # 183 - Monday, September 22, 201479 FR 56524 - Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments; Correction
typeregulations.gov FR Doc.2014-22522 RIN3150-AI63 NRC-2008-0175 NUCLEAR REGULATORY COMMISSION Proposed rule; correction. This correction is effective on September 22, 2014. Submit comments on the information collection aspects of the proposed rule by October 22, 2014. 10 CFR Parts 30, 32 and 35 SummaryThe U.S. Nuclear Regulatory Commission (NRC) published a proposed rule appearing in the Federal Register (FR) on July 21, 2014, to amend the NRC&apos;s regulations related to the medical use of byproduct material. The public comment period for the information collection aspects of the proposed rule was to have ended on August 20, 2014. However, the proposed rule inadvertently omitted the one-time implementation costs from the information collection burden estimate. This action sets out the corrected information collection burden estimate in its entirety and allows the public 30 days to comment from the date of publication of this action.
2014-07-21; vol. 79 # 139 - Monday, July 21, 201479 FR 42224 - Medical Use of Byproduct Material—Medical Event Definitions and Training and Experience
typeregulations.gov FR Doc.2014-16752 RIN3150-AI63 NRC-2014-0030 NUCLEAR REGULATORY COMMISSION Draft guidance; request for comment. Submit comments by November 18, 2014. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. 10 CFR Parts 30, 32 and 35 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guidance document entitled “Draft Guidance for the Proposed Rule `Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience, and Clarifying Amendments.&apos; ” This draft guidance document addresses implementation of the NRC&apos;s proposed rule amending its medical use of byproduct material regulations.
79 FR 42410 - Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments
typeregulations.gov FR Doc.2014-16753 RIN3150-AI63 NRC-2008-0175 NUCLEAR REGULATORY COMMISSION Proposed rule. Submit comments by November 18, 2014. Submit comments specific to the information collections aspects of this proposed rule by August 20, 2014. Comments received after these dates will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before these dates. 10 CFR Parts 30, 32, and 35 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations related to the medical use of byproduct material. In this action the NRC addresses three ongoing rulemaking projects and several other related topics. First, this rule proposes amendments to the reporting and notification requirements for a medical event for permanent implant brachytherapy. Second, the rule proposes changes to the training and experience (T&E) requirements for authorized users, medical physicists, Radiation Safety Officers, and nuclear pharmacists; to the requirements for measuring molybdenum (Mo) contamination and reporting of failed technetium and rubidium generators; and to allow Associate Radiation Safety Officers to be named on a medical license. Third, the rule proposes changes to address a request filed in a petition for rulemaking (PRM), PRM-35-20, to exempt certain board-certified individuals from certain T&E requirements (i.e., “grandfather” these individuals) so they may be identified on a license or permit for materials and uses that they performed on or before October 24, 2005, the expiration date of the prior T&E requirements.
2013-09-16; vol. 78 # 179 - Monday, September 16, 201378 FR 56839 - Compatibility of Generally Licensed and Exempt Devices
typeregulations.gov FR Doc.2013-22464 RIN Docket No.PRM-32-7 NRC-2012-0127 NUCLEAR REGULATORY COMMISSION Petition for rulemaking; denial. The docket for the petition for rulemaking, PRM-32-7, is closed on September 16, 2013. 10 CFR Part 32 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking (PRM), dated May 7, 2012, submitted by Mr. Sean Chapel (the petitioner) on behalf of the Association of Device Distributors and Manufacturers (ADDM). The petition was docketed by the NRC on May 24, 2012, and was assigned Docket No. PRM-32-7. The petitioner requested that the NRC create a new regulation for exempt devices similar to the NRC&apos;s regulations for generally licensed devices. The petitioner also requested that the NRC change the Agreement State compatibility designation of the regulations applicable to generally licensed devices that are specified in § 31.6 of Title 10 of the Code of Federal Regulations (10 CFR) from “C” to “B”. The NRC is denying the petition because the petitioner failed to present any significant new information or arguments that would support the requested changes, nor has he demonstrated a need for a new provision for exempt devices.
2013-07-11; vol. 78 # 133 - Thursday, July 11, 201378 FR 41720 - CampCo Petition to Allow Commercial Distribution of Tritium Markers
typeregulations.gov FR Doc.2013-16652 RIN PRM-32-8 NRC-2013-0078 NUCLEAR REGULATORY COMMISSION Petition for rulemaking; receipt and request for comment. Submit comments by September 24, 2013. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. 10 CFR Part 32 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is publishing for comment a petition for rulemaking (PRM) filed with the Commission by CampCo (the petitioner) on December 2, 2011, and supplemented on September 18, 2012. The petitioner requests that the NRC amend its regulations to allow the commercial distribution of tritium markers for use under exemption from licensing requirements.
2013-05-28; vol. 78 # 102 - Tuesday, May 28, 201378 FR - Physical Protection of Byproduct Material
typeregulations.gov FR Doc.C1-2013-05895 RIN3150-AI12 NRC-2008-0120 NRC-2010-0194 NUCLEAR REGULATORY COMMISSION 10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71, and 73 Summary
2013-03-19; vol. 78 # 53 - Tuesday, March 19, 201378 FR 16922 - Physical Protection of Byproduct Material
typeregulations.gov FR Doc.2013-05895 RIN3150-AI12 NRC-2008-0120 NRC-2010-0194 NUCLEAR REGULATORY COMMISSION Final rule. Effective Date: This final rule is effective on May 20, 2013. Compliance Date: Compliance with this final rule is required on March 19, 2014. 10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71, and 73 SummaryThe U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material. The NRC considers these quantities to be risk significant and, therefore, to warrant additional protection. Category 1 and category 2 thresholds are based on the quantities established by the International Atomic Energy Agency (IAEA) in its Code of Conduct on the Safety and Security of Radioactive Sources, which the NRC endorses. The objective of this final rule is to provide reasonable assurance of preventing the theft or diversion of category 1 and category 2 quantities of radioactive material. The regulations also include security requirements for the transportation of irradiated reactor fuel that weighs 100 grams or less in net weight of irradiated fuel. The final rule affects any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material, any licensee that transports these materials using ground transportation, and any licensee that transports small quantities of irradiated reactor fuel. The rule also considers a petition for rulemaking (PRM-71-13) submitted by the State of Washington that requested that the NRC adopt the use of global positioning satellite tracking as a national requirement for vehicles transporting highly radioactive mobile or portable radioactive devices.
2012-07-25; vol. 77 # 143 - Wednesday, July 25, 201277 FR 43544 - Implementation of Requirements for Distribution of Byproduct Material
typeregulations.gov FR Doc.2012-17710 RIN3150-AH91 NRC-2012-0074 NUCLEAR REGULATORY COMMISSION Interim guidance; request for comment. Submit comments by September 24, 2012. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date. 10 CFR Parts 30, 31, 32, 40, and 70 SummaryThe U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations to make requirements for distributors of byproduct material clearer, less prescriptive, and more risk-informed and up to date. The rulemaking also redefines some categories of devices to be used under exemption from licensing requirements, adds explicit provisions regarding the sealed source and device registration process, and adds flexibility to the licensing of users of sealed sources and devices. This action was primarily intended to make licensing processes more efficient and effective. These changes will affect manufacturers and distributors of sources and devices containing byproduct material and future users of some products currently used under a general or specific license. The NRC has prepared interim guidance to address implementation of the final regulations. This document announces the availability of the implementation guidance document for public comment.
77 FR 43666 - Requirements for Distribution of Byproduct Material
typeregulations.gov FR Doc.2012-17711 RIN3150-AH91 NRC-2008-0338 NUCLEAR REGULATORY COMMISSION Final rule. Effective Date: This final rule is effective on October 23, 2012. 10 CFR Parts 30, 31, 32, 40, and 70 SummaryThe U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations to make requirements for distributors of byproduct material clearer, less prescriptive, and more risk-informed and up to date. The Commission is also redefining categories of devices to be used under exemptions, adding explicit provisions regarding the sealed source and device registration process, and adding flexibility to the licensing of users of sealed sources and devices. This action is primarily intended to make licensing processes more efficient and effective. These changes will affect manufacturers and distributors of sources and devices containing byproduct material and future users of some products currently used under a general or specific license.
2012-07-06; vol. 77 # 130 - Friday, July 6, 201277 FR 39899 - Technical Corrections
typeregulations.gov FR Doc.2012-16176 RIN3150-AJ16 NRC-2012-0092 NUCLEAR REGULATORY COMMISSION Final rule. This rule is effective August 6, 2012. 10 CFR Chapter I SummaryThe U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations to make technical corrections, including updating the street address for its Region I office, correcting authority citations and typographical and spelling errors, and making other edits and conforming changes. This document is necessary to inform the public of these non-substantive changes to the NRC&apos;s regulations.
10 CFR 39.41 — Design and Performance Criteria for Sources.
10 CFR 30.22 — Certain Industrial Devices.
10 CFR 30.20 — Gas and Aerosol Detectors Containing Byproduct Material.
10 CFR 30.19 — Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147.
10 CFR 30.32 — Application for Specific Licenses.
10 CFR 30.38 — Application for Amendment of Licenses and Registration Certificates.