View Information Collection Request (ICR) Package

OMB Control No: 3150-0010	ICR Reference No: 202312-3150-001
Status: Active	Previous ICR Reference No: 202006-3150-004
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/06/2024
	Date Received in OIRA: 12/06/2023
Terms of Clearance: In accordance with 5 CFR 1320, this information collection is approved for three years. Prior to renewing this collection, the agency should proactively seek comments from no less than four (4) persons outside the agency who are familiar with this collection. The feedback should be related to the burden estimates, clarity and utility of the collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	313,994	0	299,266
Time Burden (Hours)	1,117,570	0	1,166,694
Cost Burden (Dollars)	121,016	0	122,066

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.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 50182	08/01/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 84835	12/06/2023
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
10 CFR 35, Medical Use of Byproduct Material

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	313,994	299,266	14,728
Annual Time Burden (Hours)	1,117,570	1,166,694	-49,124
Annual Cost Burden (Dollars)	121,016	122,066	-1,050

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 decreased from 1,166,695 hours to 1,117,570 hours, a decrease of 49,125 hours. 53,942 hours of this decrease is a decrease in recordkeeping burden. There was a 12,401-hour increase in third party disclosure burden. In previous clearances, the requirement to provide instructions to patients as part of the release criteria pursuant to 35.75(b) was included in the reporting burden. The current burden statement more accurately includes this burden as a third-party disclosure, resulting in an increase to the third-party disclosure burden. Additionally, the requirement limiting the aggregating of sealed sources in 35.65(b)(2) was included in the previous clearance. However, 35.65(b)(2) does not constitute a recordkeeping burden and has been removed from this clearance. The following table summarizes the changes: Part 35 Burden Totals Previous submission Current Request Change Reporting 69,391 61,807 (7,585) Recordkeeping 1,097,177 1,043,235 (53,942) 10 Third Party Disclosure 127 12,528 12,401 Total 1,166,695 1,117,570 (49,125) The number of estimated respondents increased slightly from 7,021 to 7,329. 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. Changes in industry are reflected in the distribution of specific license types and authorizations included in the data collected from WBL. The burden changes are in large part due to the change in the distribution of specific license types with different license types having different reporting and recordkeeping requirements. For example, the number of licensed HDR after loade units increased since the last clearance, signaling an ongoing increase in these types of activities and their associated reporting and recordkeeping burdens that is likely to continue over the next three years. 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 licensees 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, there were 7.5 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 7.2. 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. For example, before they became AS, the number of licensees subject to each requirement in 10 CFR Part 35 was known for licensees in Wyoming and Vermont, because they were regulated by the NRC and the NRC had their data in the webized licensing system. After these states became AS, the NRC did not have complete data on these licensees. Instead, NRC staff must estimate the number of licensees in WY and VT 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 s

Annual Cost to Federal Government: $87,000

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: Sarah Spence 301 415-7000

View ICR - OIRA Conclusion