NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information

Forms and Documents

Document Name	Status
2015-15391.pdf Supplementary Document	2015-06-23
Rev FINAL SUPPORTING STATEMENT Iodine 131 Sept 18 2015 highlight HOWE.docx Supporting Statement A	2015-10-01

IC Document Collections

IC ID	Document Title	Status
217195	NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information	New

ICR Details

OMB Control No: 3150-0229	ICR Reference No: 201506-3150-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: NRC	Agency Tracking No:
Title: NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/01/2015
	Date Received in OIRA: 07/01/2015
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2018	36 Months From Approved
Responses	1,180	0	0
Time Burden (Hours)	458	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The NRC is requesting a one-time information collection that will be solicited in an FRN. The FRN will have specific I-131 patient release questions associated with: (1) Existing Web sites that the responders believe provide access to clear and consistent patient information about I-131 treatment processes and procedures; (2) information the responders believe represent best practices used in making informed decisions on releasing I 131 patients and stand alone or supplemental voluntary patient/licensee guidance acknowledgment forms, if available; (3) an existing set of guidelines that the responder developed or received that provides instructions to released patients; and (4) an existing guidance brochure that the responder believes would be acceptable for nationwide distribution. The responses will form the basis for patient release guidance products developed in response to the NRC's April 28, 2014, Staff Requirements-COMAMM–14– 0001/COMWDM–14–0001-"Background and Proposed Direction to NRC Staff to Verify Assumptions Made Concerning Patient Release Guidance." The Commission, based on information from patients and patient advocacy groups, questioned the availability of clear, consistent, patient friendly and timely patient release information and directed the staff to work with a wide variety of stakeholders when developing new guidance products. This information collection effort was developed to gain input from as many stakeholders as possible. The NRC solicitation in the Federal Register is to obtain existing information from a variety of stakeholders.

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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:
	80 FR 11471	03/03/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 35990	06/23/2015
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 Request for Sodium Iodide I-131 Treatment and Patient Release Information

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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	1,180	0	0	1,180	0	0
Annual Time Burden (Hours)	458	0	0	458	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The Nuclear Regulatory Commission is requesting a one-time information collection solicited by a FRN that will include specific sodium iodide I-131 patient release questions associated with four topics. NRC expects responders will spend 457.5 hours responding. Information obtained from the responses will form the basis for patient release guidance products developed in response to the NRC's April 28, 2014 the Staff Requirements – COMAMM-14-0001/COMWDM-14-0001 – "Background and Proposed Direction to the NRC Staff to Verify Assumptions Made Concerning Patient Release Guidance."

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Annual Cost to Federal Government: $127,503

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: 07/01/2015

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