2015-15391. Information Collection: NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of submission to the Office of Management and Budget; request for comment.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a proposed collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC Request for Sodium Iodide I-131 Treatment and Patient Release Practices.”

DATES:

Submit comments by July 23, 2015.

ADDRESSES:

Submit comments directly to the OMB reviewer at: Vlad Dorjets, Desk Officer, Office of Information and Regulatory Affairs, (3150-XXXX), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: [phone], email: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Tremaine Donnell, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC 2015-0020 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC 2015-0020. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC 2015-0020 on this Web site.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [e-mail]. The supporting statement and Patient Release Federal Register Notice (FRN) Soliciting Information is available in ADAMS under Accession No. ML15134A123.
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, Tremaine Donnell, Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; email: [e-mail].

B. Submitting Comments

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

II. Background

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC recently submitted a proposed collection of information to OMB for review entitled, “NRC Request for Sodium Iodide I-131 Treatment and Patient Release Practices.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The NRC published an FRN with a 60-day comment period on this information collection on March 3, 2015; 80 FR 11471, entitled “NRC Request for Sodium Iodide I-131 Treatment and Patient Release Practices.”

1. The title of the information collection: “NRC Request for Sodium Iodide I-131 Treatment and Patient Release Practices.”

2. OMB approval number: An OMB control number has not yet been assigned to this proposed information collection.

3. Type of submission: New.

4. The form number if applicable: Not Applicable.

5. How often the collection is required or requested: Once.

6. Who will be required or asked to respond: Medical professional organizations, physicians, patients, patient advocacy groups, NRC and Agreement State medical use licensees, Agreement States, and other interested individuals who use, receive, license or have interest in the use of I-131 sodium iodide (hereafter referred to as “I-131”) for the treatment of thyroid conditions.

7. The estimated number of annual responses: A one-time collection estimated to have 1,180 responses (620 medical community + 560 patients).

8. The estimated number of annual respondents: 1,180 respondents (620 medical community + 560 patients).

9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 457.5 hours (255 medical community + 202.5 patients).

10. 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.

Dated at Rockville, Maryland, this 18th day of June, 2015.

For the Nuclear Regulatory Commission.

Tremaine Donnell,

NRC Clearance Officer, Office of Information Services.