Extension without change of a currently approved collection
No
Regular
12/06/2023
Requested
Previously Approved
36 Months From Approved
01/31/2024
313,994
299,266
1,117,570
1,166,694
121,016
122,066
10 CFR part 35, ââMedical Use of Byproduct Material,ââ contains NRCâs 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.
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
$87,000
No
No
No
No
No
No
No
Sarah Spence 301 415-7000
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.
NRC-2023-0065-0003_content.pdf
10 CFR 35, Medical Use of Byproduct Material