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OMB Control No: 3150-0010	ICR Reference No: 201407-3150-004
Status: Historical Inactive	Previous ICR Reference No: 201402-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 11/04/2014
	Date Received in OIRA: 09/23/2014
Terms of Clearance: 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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	07/31/2017	08/31/2017
Responses	240,145	0	240,145
Time Burden (Hours)	1,066,031	0	1,066,031
Cost Burden (Dollars)	109,726	0	109,726

Abstract: 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).

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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