10 CFR PARTS 30, 40, 70, 170, and 171, FINAL RULE. Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions. (BURDEN for 10 CFR 40)

Forms and Documents

Document Name	Status
40-22 Final Rule SS for ROCIS.doc Supporting Statement A	2012-11-15

IC Document Collections

IC ID	Document Title	Status
204822	Burden for 10 CFR 40, Domestic Licensing of Byproduct Material	New

ICR Details

OMB Control No: 3150-0215	ICR Reference No: 201307-3150-001
Status: Historical Active	Previous ICR Reference No: 201211-3150-005
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR PARTS 30, 40, 70, 170, and 171, FINAL RULE. Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions. (BURDEN for 10 CFR 40)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/02/2013
	Date Received in OIRA: 07/02/2013
Terms of Clearance: In accordance with 5 CRF 1320, this information collection is preapproved for three years with the following terms of clearance: 1) NRC should transfer the burden associated with this new collection to the existing 10 CFR Part 40 (3150-0020) collection upon that collection being extended and 2) that NRC upload the Federal Register citation information to this collection once the final rule is published.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved
Responses	137	0	0
Time Burden (Hours)	281	0	0
Cost Burden (Dollars)	15	0	0

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Abstract: FINAL RULE - 10 CFR PARTS 30, 40, 70, 170, and 171. DISTRIBUTION OF SOURCE MATERIAL TO EXEMPT PERSONS AND TO GENERAL LICENSEES AND REVISION OF GENERAL LICENSE AND EXEMPTIONS. The NRC is amending its regulations in 10 CFR Part 40 to establish new requirements for distributors of source material to persons exempt from the regulations or for use under a general license in § 40.22. In addition, the rule modifies the existing possession and use requirements for § 40.22 general licensees to align the requirements with current health and safety standards. Finally, the rule revises, clarifies, or deletes certain exemptions in § 40.13(c) to make the exemptions more risk informed. Conforming changes will be made to 10 CFR Parts 30, 70, 170 and 171. These changes would affect manufacturers and distributors of products and materials containing source material and future users of some products used under exemptions from licensing and under the § 40.22 general license. The changes result in an increase in burden under 10 CFR Parts 19, 20, and 40, as well as additional reporting burden on NRC Form 313, Application for Materials License. NOTE: This submission is a revision to 10 CFR Part 40 (3150-0020). The burden associated with this rule could not be submitted under Part 40 (3150-0020) because the information collection was up for renewal and ROCIS only allows one submission per clearance number at any given time. After receiving approval, the NRC will transfer the hours from this submission to 3150-0020 via nonsubstantive change request, and we will discontinue this new clearance number. NOTE: This rule affects four clearances: 10 CFR 40 (submitted as a request for a new clearance number), 10 CFR 19 (3150-0044), 10 CFR 20 (3150-0014), and NRC Form 313 (3150-0120).

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Authorizing Statute(s): PL: Pub.L. 83 - 703 68 STAT 919 Name of Law: Atomic Energy Act of 1954, as amended
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3150-AH15	Final or interim final rulemaking	78 FR 32310	05/29/2013

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Burden for 10 CFR 40, Domestic Licensing of Byproduct Material

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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	137	0	0	137	0	0
Annual Time Burden (Hours)	281	0	0	281	0	0
Annual Cost Burden (Dollars)	15	0	0	15	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: Currently, 10 CFR Part 40 does not include any requirement to report information about source material being distributed for use under the general license in Section 40.22 or under any exemption from licensing in Section 40.13. Because the NRC does not require the reporting of products and materials distributed for use under the general license or exemptions, the NRC cannot readily determine if the source material is being maintained in accordance with the regulatory requirements for those uses, or how or in what quantities the source material is being used. As a result, the NRC cannot fully assess the resultant risks to public health and safety. Because of the difficulty of collecting such information and its limited reliability, the NRC has concluded that new reporting requirements on the distribution of source material to Section 40.22 general licensees and persons exempt from licensing would significantly increase the NRC's ability to evaluate impacts and more efficiently and effectively protect public health and safety from the use of source material. The final rule adds a requirement in 10 CFR 40.13(c)(10) that requires persons who initially transfer products for use under a product exemption in 10 CFR 40.13(c) to obtain a specific license to be issued under 10 CFR 40.52. This means that those persons who previously operated as general licensees (and therefore did not have to submit an application to the NRC) and manufacture and initially distribute products for use under 10 CFR 40.13(c) must now be licensed as specific licensees.

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Annual Cost to Federal Government: $2,124

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

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Common Form ICR:  No

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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: 11/19/2012

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