In accordance with 5 CFR 1320, OMB is withholding approval at this time. The agency shall examine public comment in response to the proposed rulemaking and will include in the supporting statement of the next ICR--to be submitted to OMB at the final rule stage--a description of how the agency has responded to any public comments on the ICR, including comments on maximizing the practical utility of the collection and minimizing the burden.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
07/31/2017
07/31/2017
08/31/2017
240,145
0
240,145
1,066,031
0
1,066,031
109,726
0
109,726
PROPOSED RULE: 10 CFR PARTS 30, 32, and 35, MEDICAL USE OF BYPRODUCT MATERIAL, MEDICAL EVENT DEFINITIONS, TRAINING AND EXPERIENCE, AND CLARIFYING AMENDMENTS
The 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 ME for permanent implant brachytherapy. Second, the rule proposes changes to the T&E requirements for AUs, medical physicists, RSOs, and nuclear 101 pharmacists; changes to the requirements for measuring Mo contaminations and reporting of failed Tc and Rb generators; and changes that would allow ARSOs to be named on a medical license, as well as other clarifying and conforming amendments. Third, the NRC is considering a request filed in a petition for rulemaking (PRM-35-20) to "grandfather" certain board-certified individuals.
NOTE: This rule affects three clearances: 10 CFR 30 (3150-0017), 10 CFR 35 (3150-0010), and NRC Form 313 (3150-0120).
The proposed amendments to 10 CFR Parts 30 and 35 that affect the burden and/or cost for complying with the regulations constitute the elements of a safety program the NRC considers essential to provide a risk-informed, performance-based approach for regulating the medical use of byproduct material. This proposed rule would reduce the potential unwarranted radiation exposure to patients, provide greater flexibility to licensees, reduce the paperwork burden for licensees, and clarify current regulations.
The proposed rule would increase burden by 33,038 hours (10 CFR Part 30: 4,670.5 hours, 10 CFR Part 35: 33,551.58 hours, NRC Form 313: -5,183.75 hours). The proposed amendments to 10 CFR Parts 30 and 35 that affect the burden and/or cost for complying with the regulations constitute the elements of a safety program the NRC considers essential to provide a risk-informed, performance-based approach for regulating the medical use of byproduct material. This proposed rule would reduce the potential unwarranted radiation exposure to patients, provide greater flexibility to licensees, reduce the paperwork burden for licensees, and clarify current regulations.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Part_35_proposed_rule_SS_in_ROCIS_(2)[1][1].docx
Copy of Part 35 proposed rule FINAL in ROCIS.xlsx
Draft Regulatory Analysis for Proposed Rule, 10 CFR Part 35, Medical Use of Byproduct Materials.pdf
10 CFR 35, Medical Use of Byproduct Material