10 CFR Part 36 - Licenses and Radiation Safety Requirements for Irradiators

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
2014-24252.pdf	Supplementary Document	Uploaded 2014-10-14	Available
Final OMB Supporting Statement for 10 CFR 36.docx	Supporting Statement A	Uploaded 2014-10-14	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
33441	10 CFR Part 36 - Licenses and Radiation Safety Requirements for Irradiators		Modified

ICR Details

OMB Control No: 3150-0158	ICR Reference No: 201410-3150-004
Status: Historical Active	Previous ICR Reference No: 201110-3150-004
Agency/Subagency: NRC	Agency Tracking No:
Title: 10 CFR Part 36 - Licenses and Radiation Safety Requirements for Irradiators
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: 12/18/2014
	Date Received in OIRA: 10/15/2014
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	1,911	0	79
Time Burden (Hours)	34,048	0	32,690
Cost Burden (Dollars)	2,794	0	3,298

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Abstract: 10 CFR Part 36, contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials for a variety of purposes in research, industry, and other fields. The subparts cover specific requirements for obtaining a license or license exemption, design and performance criteria for irradiators; and radiation safety requirements for operating irradiators, including requirements for operator training, written operating and emergency procedures, personnel monitoring, radiation surveys, inspection, and maintenance. Part 36 also contains the recordkeeping and reporting requirements that are necessary to ensure that the irradiator is being safely operated so that it does not pose any danger to the health and safety of the general public and the irradiator employees.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 37780	07/02/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 61344	10/10/2014
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
10 CFR Part 36 - Licenses and Radiation Safety Requirements for Irradiators

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ICR Summary of Burden

table that charts list 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	1,911	79	0	0	1,832	0
Annual Time Burden (Hours)	34,048	32,690	0	0	1,358	0
Annual Cost Burden (Dollars)	2,794	3,298	0	0	-504	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 increased by 1,358 hours from 32,690 to 34,048 hours due to the correction and inclusion of third-party disclosure burden in this submission. The number of respondents has decreased from 70 to 56 due to a total decrease of 14 irradiator licenses from NRC and Agreement State licensees. The primary reason for the increase in the burden is the inclusion of burden for third-party disclosures, which was not included in the previous submission of this collection. The NRC is seeking to correct this omission in the current submission. The previous OMB Supporting Statement for 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators" (3150-0158), which was developed in 2011, used various assumptions to arrive at an approximate total of 70 Agreement State and NRC licensees in this category (60 Agreement State licensees and 10 NRC licensees). Thus, the ratio of Agreement State licensees to NRC licensees (of all types) is now about 6:1. When the circa-2008 OMB Supporting Statement was developed, NRC staff determined that the NRC had jurisdiction over 15 licensees in the irradiator licenses category. By using the ratio of 4:1, staff calculated that the Agreement States had about 60 licensees in this category (not an exact number; rather an approximation based on the use of the 4:1 ratio). Therefore the total of all Agreement State licensees and NRC licensees in this category was about 75. In the development of the current OMB Supporting Statement, NRC staff determined that the NRC had jurisdiction over 8 licensees in the irradiator category. By using the ratio of 6:1, staff calculated that the Agreement States licensees decreased to about 48 licensees, from 60 licensees in this category (again, an approximation based on the use of the new 6:1 ratio). Therefore the total of all Agreement State licensees and NRC licensees in this category was determined to be about 56. The NRC did not have, in 2011, an exact count of the number of Agreement State irradiator licensees; nor does it have such a count now, in 2014. Therefore, the apparent decrease in the total number of licensees is due to the methodology employed for the calculations, which necessarily involves estimates and approximations. Responses increased from 79 responses to 1,848 responses. The primary reason for the increase in the number of responses is the inclusion of third party disclosure requirements, which were not previously included. Previously, only the number of reporting responses plus the number of recordkeepers were counted in the number of responses. Because the current submission is based on third-party disclosures, the number of responses is based on the number of disclosures the licensees must make to their workers. Because of the large number of workers, this dramatically increased the number of responses. The current submission does not represent any changes in the requirements for licensees; rather, it represents two changes in the way that the NRC estimates the burden under this Part: the inclusion of Agreement State licensees and accounting for third-party disclosures. The cost estimates have changed since the last clearance, as a result of an increase in the fee rate per hour from $259 to $272/hour.

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Annual Cost to Federal Government: $34,816

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: 10/15/2014

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