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)
ICR 201307-3150-001 · OMB 3150-0215 · Historical Active
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)
New collection (Request for a new OMB Control Number)
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
02/29/2016
36 Months From Approved
137
0
0
281
0
0
15
0
0
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).
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.
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:
(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;
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.
40-22 Final Rule SS for ROCIS.doc
Burden for 10 CFR 40, Domestic Licensing of Byproduct Material