View Information Collection Request (ICR) Package
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View ICR - Agency Submission
OMB Control No:
ICR Reference No:
202604-3150-023
Status:
Received in OIRA
Previous ICR Reference No:
Agency/Subagency:
NRC
Agency Tracking No:
W2-4
Title:
Information collections contained in Reducing Barriers to Medical Use Licensing proposed rule (10 CFR Part 35, Nuclear Materials Events Database, and NRC Form 313 series)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
05/01/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
1
0
Time Burden (Hours)
1
0
Cost Burden (Dollars)
18
0
Abstract:
The NRC is proposing to amend its regulations to reduce barriers to medical use licensing. This proposed rule would reduce overly prescriptive requirements, increase regulatory flexibility, and modernize radiation safety practices for the medical use of byproduct material. It also would enable more efficient and predictable licensing for emerging medical technologies and reduce unnecessary burden associated with training and experience requirements for medical authorized users. This effort is consistent with, and implements, the direction in Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” which directs the NRC to conduct a comprehensive review and revision of its regulations. This proposed rule addresses a wide range of topics, including the following areas that result in new or revised recordkeeping and reporting requirements involving: • Research applications, • Applications, • Temporary RSOs, • Instrument calibrations, • Medical events, • Dose to an embryo/fetus or a nursing child, • Generator elutions, • Radiation Safety Committees, • Mobile medical services, • Radiation safety, • Continuing education, • Decay-in-storage, • Permissible concentrations for generator-produced radionuclides, • Microsource brachytherapy, and • Safety precautions for patients not eligible for release.
Authorizing Statute(s):
PL:
Pub.L. 83 - 103 1-291
Name of Law: Atomic Energy ACt
EO: EO 14300 Name/Subject of EO: Ordering the Reform of the Nuclear Regulatory Commission
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
3150-AL50
Proposed rulemaking
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Information collections contained in Reducing Barriers to Medical Use Licensing proposed rule (10 CFR Part 35, Nuclear Materials Events Database, and NRC Form 313 series)
NRC 313A(AUD), NRC 313A (AUM), NRC 313A (RSO), NRC 313A (AUT), NRC 313A (AUS), NRC 313A (AMP), NRC 313A(ANP)
NRC Form 313A (AUD) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION , NRC 313A (AUM) AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION , NRC 313A (RSO)-RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION , NRC Form 313A(ANP)- AUTHORIZED NUCLEAR PHARMACIST TRAINING, EXPERIENCE, AND PRECEPTOR ATTESTATION , NRC Form 313A (AUS)- AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION , NRC Form 313A (AMP)-AUTHORIZED MEDICAL PHYSICIST OR OPHTHALMIC PHYSICIST, TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION , NRC Form 313A (AUT)- AUTHORIZED USER TRAINING, EXPERIENCE AND PRECEPTOR ATTESTATION
ICR Summary of Burden
Total Request
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
1
0
0
1
0
0
Annual Time Burden (Hours)
1
0
0
1
0
0
Annual Cost Burden (Dollars)
18
0
0
18
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 NRC is amending its regulations to reduce barriers to medical use licensing, which would reduce respondent burden by an estimated -13,280 hours annually. Specifically, this proposed rule would reduce overly prescriptive requirements, increase regulatory flexibility, and modernize radiation safety practices for the medical use of byproduct material. It would also enable more efficient and predictable licensing for emerging medical technologies by reducing reliance on Subpart K licensing and reduce unnecessary burden associated with training and experience requirements for medical authorized users. This effort is consistent with, and implements, the direction in Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission,” which directs the NRC to conduct a comprehensive review and revision of its regulations.
Annual Cost to Federal Government:
$0
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?
No
Agency Contact:
Irene Wu 301 415-1951 irene.wu@nrc.gov
Common Form ICR:
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:
(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:
05/01/2026
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