10 CFR 35, Medical Use of Byproduct Material

ICR 201807-3150-002

OMB: 3150-0010

Federal Form Document

IC Document Collections
IC ID
Document
Title
Status
42721
Modified
ICR Details
3150-0010 201807-3150-002
Active 201706-3150-001
NRC
10 CFR 35, Medical Use of Byproduct Material
Revision of a currently approved collection   No
Regular
Approved without change 07/18/2018
Retrieve Notice of Action (NOA) 07/18/2018
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
07/31/2020 08/31/2020 08/31/2020
284,249 0 276,359
1,104,583 0 1,073,224
110,480 0 106,974

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).

PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act
  
None

3150-AI63 Final or interim final rulemaking 83 FR 33046 07/16/2018

No

1
IC Title Form No. Form Name
10 CFR 35, Medical Use of Byproduct Material

  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
Yes
Changing Regulations
No
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

$479,500
No
    No
    No
No
No
No
Uncollected
Torre Taylor 301 415-7900 [email protected]

  No

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.
11/21/2017


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