In accordance with 5 CRF 1320, this information collection is preapproved for three years with the following terms of clearance: NRC upload the Federal Register citation information to this collection once the final rule is published.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
02/29/2016
05/31/2013
05/31/2015
19,451
0
19,432
83,776
0
83,558
0
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 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).
NRC Form 313A (ANP), NRC Form 313A (AUD), NRC Form 313A (AMP), NRC Form 313A (RSO), NRC Form 313A (AUT), NRC Form 313A (AUS), NRC Form 313A, NRC Form 313
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. To become specific licensees, they must submit an application (NRC Form 313, "Application for Materials License") to the NRC. An estimated 30 licensees (10 annually) would be required to submit NRC Form 313 as an application to become specific licensees in order to distribute source material products to persons for use under exemption. Of these 30 applicants, 18 applicants (approximately 6 annually) would also have to submit NRC Form 313 (or the Agreement State equivalent) for possession and use of source material instead of being able to continue to possess source material under a general license. This results in an additional burden of 218.4 burden hours.
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.
Form NRC Form 313 NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation
40-22 Final Rule SS for ROCIS.doc
NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation