Extension without change of a currently approved collection
No
Regular
07/08/2020
Requested
Previously Approved
36 Months From Approved
01/31/2021
299,266
284,249
1,166,694
1,104,583
122,066
110,480
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
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.
$83,400
No
No
No
No
No
No
No
Said Daibes-Figueroa 301
415-6865
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.
Part 35 renewal final SS.docx
Part 35 tables for final package.xlsx
10 CFR 35, Medical Use of Byproduct Material