View Information Collection Request (ICR) Package

OMB Control No: 3150-0001	ICR Reference No: 201603-3150-003
Status: Historical Active	Previous ICR Reference No: 201302-3150-003
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 without change	Conclusion Date: 08/12/2016
	Date Received in OIRA: 03/31/2016
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	08/31/2019	36 Months From Approved	08/31/2016
Responses	3,937	0	4,789
Time Burden (Hours)	164,608	0	164,540
Cost Burden (Dollars)	2,289	0	2,784

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:
	80 FR 54596	09/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 18651	03/31/2016
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	3,937	4,789	-852
Annual Time Burden (Hours)	164,608	164,540	68
Annual Cost Burden (Dollars)	2,289	2,784	-495

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 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)].

Annual Cost to Federal Government: $793,012

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: Eric Reber 301 415-5608

View ICR - OIRA Conclusion