View Information Collection Request (ICR) Package

OMB Control No: 3150-0001	ICR Reference No: 201907-3150-006
Status: Historical Active	Previous ICR Reference No: 201603-3150-003
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/21/2019
	Date Received in OIRA: 07/18/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	11/30/2019
Responses	3,751	0	3,937
Time Burden (Hours)	137,650	0	164,608
Cost Burden (Dollars)	122	0	2,289

Abstract: 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.

Authorizing Statute(s): PL: Pub.L. 83 - 703 1-311 Name of Law: Atomic Energy Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 12643	04/02/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 33982	07/16/2019
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material	NRC Form 653, NRC Form 653A, NRC Form 653B

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	3,751	3,937	-186
Annual Time Burden (Hours)	137,650	164,608	-26,958
Annual Cost Burden (Dollars)	122	2,289	-2,167

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

Annual Cost to Federal Government: $813,725

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Lymari Sepulveda 301 415-7000

View ICR - OIRA Conclusion