Part 32 of Title 10 of the Code of
Federal Regulations (10 CFR), establishes requirements for specific
licenses for the introduction of byproduct material into products
or materials and transfer of the products or materials to general
licensees, or persons exempt from licensing, medical use product
distributors to specific licensees, and those requesting a
certificate of registration for a sealed source and/or device. It
also prescribes requirements governing holders of the specific
licenses. Some of the requirements are for information which must
be submitted in an application for a certificate of registration
for a sealed source and/or device, records which must be kept,
reports which must be submitted, and information which must be
forwarded to general licensees and persons exempt from licensing.
As mentioned, 10 CFR part 32 also prescribes requirements for the
issuance of certificates of registration (concerning radiation
safety information about a product) to manufacturers or initial
transferors of sealed sources and devices. Submission or retention
of the information is mandatory for persons subject to the 10 CFR
part 32 requirements. The information is used by the NRC to make
licensing and other regulatory determinations concerning the use of
radioactive byproduct material in products and devices.
The overall burden has
decreased from the previous reporting (i.e., the previous estimated
burden was 164,608 and the current burden is 137,650); the various
elements that comprise this estimate have changed and the most
significant are noted here: a. For Section 32.29(b), there was a
decrease in the number of third-party disclosure recordkeepers by 3
from 17 to 14 and the corresponding burden by 810 hours from 4,590
to 3,780 hours. The current estimate is based on the number of NRC
licensees to which the requirements in this section apply. b. For
Section 32.32(b), there is a decrease in the number of third-party
disclosure recordkeepers by 1 from 3 to 2 and the corresponding
burden by 100 hours from 300 to 200 hours. The current estimate is
based on the number of NRC licensees to which the requirements in
this section apply. c. For Section 32.51(a)(3)-(5) and 32.51a(d),
there is a decrease in the number of third- party disclosure
recordkeepers by 7 from 53 to 46 and the corresponding burden by
440 hours from 2,671 to 2,231 hours. The current estimate is based
on the number of NRC licensees to which the requirements in this
section apply. A ratio of 6.6 (A/S to NRC licensees) was used to
estimate the burden for A/S licensees. d. For Section 32.72(a)(4),
there was a decrease in the number of respondents to this
third-party disclosure (labeling) requirement. The current estimate
is based on an updated number of active NRC licenses to which the
requirements in Section 32.72(a)(4) apply. The NRC staff queried
the Web-based Licensing system (WBL) to determine the number of
current NRC licensees. Data from the WBL indicates that since the
last renewal cycle, the number of licensees to whom this
requirement applies decreased from 45 licensees to 35 licensees.
Because obtaining and holding a license is a voluntary activity,
the number of licensees may fluctuate over time based on financial
and other business considerations that are not reported to, or
controlled by, the NRC. The NRC staff uses data on the number of
current licensees, in conjunction with any information available
regarding the current state of the industry and any available
projections, to estimate burden for the clearance period. An
estimated ratio of 6.6 (AS to NRC licensees) was used to estimate
the number of AS licensees; therefore, NRC staff estimated a total
of 231 Agreement State licensees subject to this requirement (35
NRC licensees x 6.6 = 231). As a result, the total number of
licensees since the last renewal decreased by 76 from 342 (45 NRC
licensees and 297 AS licensees) to 266 (35 NRC licensees and 231 AS
licenses). Because the burden associated with this labeling
requirement is relatively high (390 hours per respondent), the
corresponding burden decreased by 29,640 hours from 133,380 to
103,740 hours. e. For Section 32.210, there was an increase in the
1.) number of reporting respondents by 104 from 232 to 336; 2.)
number of responses by 260 from 580 to 840; and 3.) burden by 5,460
hours from 12,180 hours to 17,640. The current estimate is based on
the average number of 32.210 cases processed by the NRC from 2016
to 2018. A ratio of 4.8 (AS to NRC cases) was used to estimate the
burden for A/S licensees and registration certificate holders. It
should be noted that there was a change in the cost because the
hourly rate increased from $268 to $275.
$813,725
No
No
No
No
No
No
Uncollected
Lymari Sepulveda 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.
Form NRC Form 653, NRC 10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
Final Supporting Statement Part 32 REVISED 11-14.docx
10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material