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, ‘‘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.
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