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
therefrom 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 overall burden has
increased by 7,193 hours from 1,066,031 hours (NRC Licensees
144,203 hrs. + Agreement States 921,826 hrs. + specialty certifying
entities 2 hrs.) to 1,073,224 hours (NRC Licensees 145,195 hrs. +
Agreement States 928,027 hrs. + specialty certifying entities 2
hrs.), the number of responses increased by 36,214 responses from
240,145 (32,466 NRC + 207,677 Agreement States + 2 specialty
certification entities) to: 276,359 ((NRC: 36,313 + 962 record
keepers = 37,275) + (Agreement States: 232,925 + 6,157 record
keepers + 2 specialty certification entity = 239,084)). The burden
calculations were affected by (1) a reduction in the number of NRC
medical use licensees and Agreement State licensees, (2) a shift in
the distribution of medical uses by the NRC licensees and the use
of materials within NRC license groups that may not reflect the
same distribution of Agreement State medical use licensees, (3) use
of the WBL data base which provides more detailed information for
some medical uses, but also consolidated multiple NRC licenses into
a single medical use license in the data base and (4) NRC observed
a number of shifts that reduced the burdens in many individual
burden estimates and a few key shifts from low frequency and low
burden uses to higher frequency leading to the total increased
burdens. The requirements for the reporting burden notifications
have been moved from the NRC and Agreement States reporting tables
(Table 1 and Table 4) to the third-party disclosure tables (Table 3
and Table 6). The NRC calculates the burden for Agreement State
medical use licensees based on the ratio of NRC licensees to
Agreement State licensees, and distribution of the types of medical
uses authorized by NRC medical use licensees. While the total
number of NRC and Agreement State licensees decreased from 2013 to
2016, the decrease in the number of Agreement State medical use
licensees may not have been proportional to the decrease in the
total number of NRC medical use licensees from 1,035 to 962. The
NRC estimates the number of NRC and Agreement State medical use
licensees decreased from 7,659 to 6,157. Further, the types of
medical uses retained by NRC licensees may not reflect the
Agreement State licensees’ distribution of these medical uses. The
NRC regional inspectors and license reviewers also observed a shift
in the uses of materials such as a marked reduction in generator
elution’s and hospitalization of patients and shifts from low
frequency and low burden uses to higher frequency and burden uses
such as the shift from manual brachytherapy to high dose rate
remote after loaders and other sophisticated therapy uses. In
addition, there was a decrease in the overall hourly fee rate from
$272/hr. to $265/hr.
$79,500
No
No
No
No
No
No
Uncollected
Donna Howe 301 415-7848
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-2017-0013-0003 30-day FRN (1).pdf
Copy of 12-21-DBH-Copy of Copy of Copy of Copy of Part 35 tables for final Dec 8 2016 cell AND cost fixed RENEWALshirley final(1).xlsx
Part 35 Final Supporting Statement from Draft PDF to word March 21 2017.docx
10 CFR 35, Medical Use of Byproduct Material