10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Document Name	Status
10 CFR Part 35 Final Rule- Regulatory Analysis.pdf Supplementary Document	2017-11-20
OMB Tables for Part 35 final rule (2017).xlsx Supplementary Document	2017-11-16
Part 5 and 6 of final guidance sehnt to OMB for 2017 final Part 35 Rule.docx Supplementary Document	2017-11-16
Part 4 of final guidance sent to OMB for 2017 final Part 35 rule.docx Supplementary Document	2017-11-16
Part 3 of final guidance sent to OMB for 2017 final Part 35 Rule.docx Supplementary Document	2017-11-16
Part 2 of final guidance sent to OMB for 2017 final Part 35 Rule.pdf Supplementary Document	2017-11-16
Part 1 of the final guidance sent to OMB for the 2017 final Part 35 Rule .docx Supplementary Document	2017-11-16
10 CFR Part 30 32 35 supporting statement REVISED 5-30.docx Supporting Statement A	2018-05-30

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: 201807-3150-002
Status: Active	Previous ICR Reference No: 201706-3150-001
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: Approved without change	Conclusion Date: 07/18/2018
	Date Received in OIRA: 07/18/2018
Terms of Clearance: OMB notes that these revisions are required by a forthcoming final rule (RIN 3150-AI63) that has not yet published in the Federal Register. OMB preapproves the revised information collection, provided that there are no substantive changes in the published final rule relative to the draft final rule provided as a supplementary document in this package.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	08/31/2020	08/31/2020
Responses	284,249	0	276,359
Time Burden (Hours)	1,104,583	0	1,073,224
Cost Burden (Dollars)	110,480	0	106,974

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Abstract: FINAL RULE- 10 CFR PARTS 30, 32, and 35, MEDICAL USE OF BYPRODUCT MATERIAL, MEDICAL EVENT DEFINITIONS, TRAINING AND EXPERIENCE, AND CLARIFYING AMENDMENTS The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations related to the medical use of byproduct material. The final rule will amend the NRC regulations related to the medical use of byproduct material. This rule amends the reporting and notification requirements for a medical event (ME) for permanent implant brachytherapy. This rule also amends the training and experience (T&E) requirements to remove from multiple sections the requirement to obtain a written attestation for an individual who is certified by a specialty board whose certification process has been recognized by the NRC or an Agreement State; and 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). Additionally, this rule amends the requirements for measuring molybdenum contamination; adds a new requirement for the reporting of failed technetium and rubidium generators; and allows licensees to name associate radiation safety officers (ARSOs) on a medical license. 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	Final or interim final rulemaking	83 FR 33046	07/16/2018

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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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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	284,249	276,359	0	7,890	0	0
Annual Time Burden (Hours)	1,104,583	1,073,224	0	31,359	0	0
Annual Cost Burden (Dollars)	110,480	106,974	0	3,506	0	0

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 final rule will increase burden for Part 35 by 31,359. The amendments 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 final rule will reduce the potential unwarranted radiation exposure to patients, provide greater flexibility to licensees, reduce the paperwork burden for licensees, and clarify current regulations. See Supporting Statement attached

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Annual Cost to Federal Government: $479,500

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 11/21/2017

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