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
Final Suppporting Statement - 10 CFR Part 36 - 2011.doc	Supporting Statement A	Uploaded 2011-10-13	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: 201110-3150-004
Status: Historical Active	Previous ICR Reference No: 200804-3150-002
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: 12/27/2011
	Date Received in OIRA: 11/01/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. The following additional terms of clearance apply: (1) NRC will work directly with collection respondents to accurately assess the number of NRC licensees and Agreement State Licensees affected by this collection of information; and (2) NRC will update the burden hour and costs estimates as appropriate based on feedback from respondents.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved	12/31/2011
Responses	79	0	85
Time Burden (Hours)	32,690	0	35,008
Cost Burden (Dollars)	3,298	0	3,549

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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:
	76 FR 39132	07/05/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 60557	09/29/2011
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	79	85	0	0	-6	0
Annual Time Burden (Hours)	32,690	35,008	0	0	-2,318	0
Annual Cost Burden (Dollars)	3,298	3,549	0	0	-251	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 decreased by 2,318 hours from 35,008 to 32,690 hours because of a decrease of 5 irradiator licenses from both NRC and Agreement State licensees from 75 to 70. The previous OMB Supporting Statement for 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators" (3150-0158), which was developed in 2008, used various assumptions to arrive at an approximate total of 75 Agreement State and NRC licensees in this category (60 Agreement State licensees and 15 NRC licensees). When these numbers were formulated, the Agreement States had about four times as many nuclear materials licensees of all types as the NRC; i.e., the ratio of Agreement State licensees to NRC licensees was about 4:1. Since then, two states that were formerly under NRC jurisdiction (Pennsylvania and Virginia) have become Agreement States, thereby taking a large number of licensees from NRC jurisdiction to Agreement State jurisdiction. Thus, the ratio of Agreement State licensees to NRC licensees (of all types) is now about 6:1. When the previous 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 10 licensees in the irradiator category; i.e., five (5) of the licensees had been transferred to Agreement State jurisdiction. By using the new ratio of 6:1, staff calculated that the Agreement States continued to have about 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 70. The NRC did not have, in 2008, an exact count of the number of Agreement State licensees; nor does it have such a count now, in 2011. 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. The cost estimates have changed since the last clearance, as a result of an increase in the fee rate per hour from $258 to $259/hour.

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Annual Cost to Federal Government: $37,296

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: 11/01/2011

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