10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Document Name	Status
Part_35_proposed_rule_SS_in_ROCIS_(2)[1][1].docx Supporting Statement A	2014-09-22
Copy of Part 35 proposed rule FINAL in ROCIS.xlsx Supplementary Document	2014-09-22
Draft Regulatory Analysis for Proposed Rule, 10 CFR Part 35, Medical Use of Byproduct Materials.pdf Supplementary Document	2014-07-28

IC Document Collections

IC ID	Document Title	Status
42721	10 CFR 35, Medical Use of Byproduct Material	Modified

ICR Details

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

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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).

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Authorizing Statute(s): PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3150-AI63	Proposed rulemaking	79 FR 42410	07/21/2014

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
10 CFR 35, Medical Use of Byproduct Material

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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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Annual Cost to Federal Government: $6,600

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/23/2014

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