In accordance with 5 CFR 1320, the information collection is approved for three years.
Inventory as of this Action
Requested
Previously Approved
08/31/2019
36 Months From Approved
08/31/2016
3,937
0
4,789
164,608
0
164,540
2,289
0
2,784
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 is essentially unchanged from the previous reporting (i.e., the current estimated burden is 164,608 and the previous burden was 164,540); however, 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 recordkeepers by 5 from 22 to 17 and the corresponding burden by 1,350 hours from 5,940 to 4,590 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 recordkeepers by 3 from 6 to 3 and the corresponding burden by 300 hours from 600 to 300 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 recordkeepers by 15 from 68 to 53 and the corresponding burden by 628 hours from 3,299 to 2,671 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 32.51a(a)&(b), the estimated Hours Per Recordkeeper for was revised upward from 1.3 to 48.5 to bring the estimate in line with the estimated amount of time necessary to fulfill the requirement. The Number of Recordkeepers for the NRC licensees in this category decreased by 2 to 7 based on the current number of NRC licensees to which the requirement applies. These two factors resulted in a net increase in burden hours for these categories for NRC licensees of 328 from 12 to 340. In this category, for Agreement State licensees, the burden hours increased by 2,142 from 89 to 2,231.
e. For Section 32.72(a)(4), there was an increase in the number of recordkeepers by 8 from 334 to 342 and the corresponding burden by 3,120 hours from 130,260 to 133,380 hours. The current estimate is based on the number of NRC licensees to which the requirements in Section 32.72(a)(4) apply. An estimated ratio of 6.6 (A/S to NRC licensees) was used to estimate the burden for A/S licensees.
f. For Section 32.210, there was a decrease in the 1.) number of respondents by 128 from
360 to 232; 2.) number of responses by 140 from 720 to 580; and 3.) burden by 2,940 hours from 15,120 to 12,180 hours. The current estimate is based on the average number of 32.210 cases processed by the NRC from 2010 to 2015. A ratio of 4.8 (A/S 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 decreased from $274 to $268.
It should also be noted that the burden for various requirements on the labeling of products that were previously reported under Recordkeeping are now reported under Third-Party Disclosure because this category is more appropriate for these requirements [i.e., 32.15(d), 32.19(c), 32.19(d), 32.21a, 32.25(b), 32.29(b), 32.32(b), 32.51(a)(3)-(5), 32.51a(d), 32.54(a)&(b), 32.58, 32.61(d), 32.71(c), 32.71(d), 32.71(e), 32.72(a)(4), and 32.74(a)(3)].
$793,012
No
No
No
No
No
Uncollected
Eric Reber 301 415-5608
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 SS 10 CFR Part 32.doc
10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material