10 CFR 35, Medical Use of Byproduct Material

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Part 35 renewal final SS.docx	Supporting Statement A	Uploaded 2020-06-30	Repair queued
Part 35 tables for final package.xlsx	Supplementary Document	Uploaded 2020-06-30	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
42721	10 CFR 35, Medical Use of Byproduct Material		Modified

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 202006-3150-004
Status: Received in OIRA	Previous ICR Reference No: 201807-3150-002
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR 35, Medical Use of Byproduct Material
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/08/2020

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	299,266	284,249
Time Burden (Hours)	1,166,694	1,104,583
Cost Burden (Dollars)	122,066	110,480

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Abstract: 10 CFR part 35, ‘‘Medical Use of Byproduct Material,’’ contains NRC’s requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. Part 35 contains mandatory requirements that apply to NRC licensees authorized to administer byproduct material or radiation to humans for medical use. These requirements also provide voluntary provisions for specialty boards to apply to have their certification processes recognized by the NRC so that their board certified individuals can use the certifications as proof of training and experience.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 11125	02/26/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 41070	07/08/2020
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	299,266	284,249	0	0	15,017	0
Annual Time Burden (Hours)	1,166,694	1,104,583	0	0	62,111	0
Annual Cost Burden (Dollars)	122,066	110,480	0	0	11,586	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The burden for Part 35 increased from 1,104,583 hours to 1,166,694 hours, an increase of 62,111 hours. 58,244 hours of this increase is an increase in recordkeeping burden. The number of estimated respondents decreased slightly from 7,121 to 7,021. Data on the number of NRC licensees is extracted from the Web-Based Licensing system (WBL). NRC staff queried the database to determine the total number of NRC licensees as well as the number of licensees holding licenses authorizing materials used for specific medical purposes. The data were used to estimate respondents on the NRC licensee burden tables. NRC staff anticipates that the number of licensees will remain stable over the course of the clearance period. The NRC does not have data on the number of licensee’s subject to Part 35 who operate in Agreement States; therefore, the number of these licensees must be estimated. Annually, the Agreement States provide the NRC with an estimate of the total number of radioactive materials licensees within their states. In the last survey, 7.2 times more licensees in Agreement States as there were in states regulated by the NRC. This is an increase from the previous renewal, in which the ratio was 6.4. Since the last renewal, Wyoming and Vermont became Agreement States (AS). There are now 39 AS compared to 37 in the last renewal. In states regulated by the NRC, data is available on both the number of licensees and the particular applications of the material for which they are licensed. As a result, the NRC can determine the specific requirements in the CFR and the specific information collections applicable to each of the licensees regulated by the agency. For AS, the NRC staff only knows the total number of licensees in each state - the specific applications of the material for they are licensed is unknown. As a result of the estimation method, the number of licensees in AS may show some variability over time, particularly when states newly join the AS program. Furthermore, when an NRC regulated state becomes an AS, the majority of them no longer report their licensing data in the NRC WBL system. Instead, NRC staff must estimate, the number of licensees in AS that are subject to each information collection requirement. Further, the method used to estimate respondents assumes that all types of licensees and applications of materials are equally distributed across states, and that the distribution is similar in Agreement States when compared to non-Agreement states. The NRC staff believes that the current method strikes the best balance between accuracy in estimation and burden upon licensees. The current estimation method is the most accurate available without burdening the AS with an annual, comprehensive survey of the specific types of licensees in each Agreement State. In addition, there was an increase in the overall hourly fee rate from $265/hr. to $278/hr.

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Annual Cost to Federal Government: $83,400

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

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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: 07/08/2020

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