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
Reginfo record details
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