NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation

Forms and Documents

Document Name	Status
Form NRC Form 313 NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation Form	Modified
40-22 Final Rule SS for ROCIS.doc Supporting Statement A	2012-11-15

IC Document Collections

IC ID	Document Title	Status
33369	NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation Form	Modified

ICR Details

OMB Control No: 3150-0120	ICR Reference No: 201307-3150-004
Status: Historical Active	Previous ICR Reference No: 201202-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation
Type of Information Collection: Revision of a currently approved collection	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: 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	05/31/2013	05/31/2015
Responses	19,451	0	19,432
Time Burden (Hours)	83,776	0	83,558
Cost Burden (Dollars)	0	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 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 1-311 Name of Law: Atomic Energy Act
  

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
NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation	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	Application for Materials License ,   Medical Use Training and Experience and Preceptor Attestation ,   Radiation Safety Officer Training and Experience and Preceptor Attestation ,   Authorized Medical Physicist Training and Experience and Preceptor Attestation ,   Authorized Nuclear Pharmacist Training and Experience and Preceptor Attestation ,   Authorized User Training and Experience and Preceptor Attestation ,   Authorized User Training and Experience and Preceptor Attestation ,   Authorized User Training and Experience and Preceptor Attestation

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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	19,451	19,432	0	19	0	0
Annual Time Burden (Hours)	83,776	83,558	0	218	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: 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.

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Annual Cost to Federal Government: $2,801,823

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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