View Information Collection Request (ICR) Package

OMB Control No: 3150-0001	ICR Reference No: 202211-3150-008
Status: Active	Previous ICR Reference No: 201907-3150-006
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 without change	Conclusion Date: 04/09/2024
	Date Received in OIRA: 11/25/2022
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	04/30/2024
Responses	3,038	0	3,751
Time Burden (Hours)	109,510	0	137,650
Cost Burden (Dollars)	545,129	0	122

Abstract: Part 32 of title 10 of the Code of Federal Regulations (10 CFR), “Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material,” 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:
	87 FR 19535	04/04/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 72516	11/25/2022
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	3,038	3,751	-713
Annual Time Burden (Hours)	109,510	137,650	-28,140
Annual Cost Burden (Dollars)	545,129	122	545,007

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 by 28,140 hours (i.e., the previous estimated burden was 137,650 and the current burden is 109,510); 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 9 from 14 to 5 and the corresponding burden by 2,430 hours from 3,780 to 1,350 hours. The current estimate is based on the number of NRC licensees to which the requirements in this section apply. b. 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 35 licensees to 28 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 185 Agreement State licensees subject to this requirement (28 NRC licensees x 6.6 = 185). As a result, the total number of licensees since the last renewal decreased by 52 from 266 (35 NRC licensees and 231 AS licensees) to 213 (28 NRC licensees and 185 AS licenses). Because the burden associated with this labeling requirement is relatively high (390 hours per respondent), the corresponding burden decreased by 31,590 hours from 103,740 to 72,150 hours. c. For Section 32.210, there was a decrease in the 1.) number of reporting respondents by 101 from 336 to 235; 2.) number of responses by 252 from 840 to 588; and 3.) burden by 5,302.5 hours from 17,640 hours to 12,337.5. The current estimate is based on the average number of 32.210 cases processed by the NRC from 2019 to 2021. . A ratio of 4.8 (rather than 6.6) Agreement State Respondents to NRC Respondents was used to more accurately estimate the number of respondents with regard to 10 CFR 32.210 in Agreement States. It should be noted that there was a change in the cost because the hourly rate increased from $275 to $288.

Annual Cost to Federal Government: $651,744

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? No

Agency Contact: Brenda Sida 301 415-7000

View ICR - OIRA Conclusion