10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material

Forms and Documents

Document Name	Status
Form NRC Form 653, 653A 10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material Form	Modified
2013-03722.pdf Supplementary Document	2013-02-19
Final Supporting Statement 3150-0001.docx Supporting Statement A	2013-02-19

IC Document Collections

IC ID	Document Title	Status
33107	10 CFR Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material Form	Modified

ICR Details

OMB Control No: 3150-0001	ICR Reference No: 201302-3150-003
Status: Historical Active	Previous ICR Reference No: 201209-3150-002
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: 05/01/2013
	Date Received in OIRA: 03/12/2013
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	05/31/2016	36 Months From Approved	06/30/2015
Responses	4,789	0	3,432
Time Burden (Hours)	164,540	0	167,461
Cost Burden (Dollars)	2,784	0	5,955

---

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:
	77 FR 69661	11/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 11686	02/19/2013
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, 653A, and 653B	Transfers of Industrial Devices Report

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4,789	3,432	0	0	1,357	0
Annual Time Burden (Hours)	164,540	167,461	0	0	-2,921	0
Annual Cost Burden (Dollars)	2,784	5,955	0	0	-3,171	0

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 2,921 hours from 167,461 to 164,540 hours due to the following: a. The estimated ratio of the number Agreement State licensees to NRC licensees increased from 3.6 to 6.6 to more accurately reflect current data in the License Tracking System and Agreement State data. The ratio change occurred, in part, as a result of New Jersey and Virginia becoming Agreement States; however, neither State assumed responsibility to perform implementation of 10 CFR 32.210, and therefore, this function remained with the NRC licensees. b. As of a result of the increased Agreement State licensee to NRC licensee ratio, the total number of recordkeepers has increased from 665 to 1,230. c. There is an increase in the number of respondents for Section 32.210 by 136 respondents from 224 to 360; the number of responses by 272 from 448 to 720 responses; and the burden by 5,712 hours from 9,408 to 15,120 hours. This increase is based on the current number of actions processed in the past 2 years and using an estimated ratio of 4.8, resulting in an overall burden increase for this section of an estimated 2,921 hours. There was a change in overall burden cost because the hourly rate increased from $238 to $274.

---

Annual Cost to Federal Government: $810,766

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

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/12/2013

---