[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70843-70846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29027]


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NUCLEAR REGULATORY COMMISSION

[NRC-2015-0020]


Sodium Iodide-131 Patient Release Information Collection

AGENCY: Nuclear Regulatory Commission.

ACTION: Request for information.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is requesting 
information from the general public on a number of issues associated 
with medical treatment of patients with sodium iodide I-131 (hereafter 
referred to as I-131). Specifically, the NRC would like input on 
patient concerns about medical treatment involving the use of I-131, 
information that physicians use to make decisions on when it is safe to 
release I-131 patients based on radiation exposure concerns, radiation 
safety information used by I-131 patients after their release, and the 
availability of a radiation safety informational guidance brochure for 
I-131 patients that can be distributed nationwide. The information 
collected will be used to develop a Web site to provide patients with 
clear and consistent information about radioactive iodine treatments 
and to revise NRC patient release guidance.

DATES: Submit information and comments by February 16, 2016. 
Information and comments received after this date will be considered if 
it is practical to do so, but the NRC is able to assure consideration 
only for information and comments received on or before this date.

ADDRESSES: You may submit information and comments by any of the 
following methods (unless this document describes a different method 
for submitting information and comments on a specific subject):
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0020. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Mail information and comments to: Cindy Bladey, Office of 
Administration,

[[Page 70844]]

Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    For additional direction on obtaining and submitting information 
and comments, see ``Obtaining and Submitting Information and Comments'' 
in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Ph.D., Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001; telephone: 301-415-7848; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Obtaining and Submitting Information and 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.
     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 [email protected]. The 
ADAMS accession number for each document referenced (if it is available 
in ADAMS) is provided the first time that it is mentioned in the 
SUPPLEMENTARY INFORMATION section.
     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.

B. Submitting Information and Comments

    Please include Docket ID NRC-2015-0020 in your submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
submission. The NRC will post all submissions at http://www.regulations.gov as well as enter the submissions into ADAMS. The 
NRC does not routinely edit submissions to remove identifying or 
contact information.
    If you are requesting or aggregating information 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 submission. Your request should state that 
the NRC does not routinely edit submissions to remove such information 
before making the submissions available to the public or entering the 
submission into ADAMS.

II. Background

    In a March 10, 2014, memorandum to the Commission (COMAMM-14-0001/
COMWDM-14-0001, ``Background and Proposed Direction to NRC Staff to 
Verify Assumptions Made Concerning Patient Release Guidance'' (see 
http://www.nrc.gov/reading-rm/doc-collections/commission/comm-secy/2014/2014-0001comamm-0001-comwdm.pdf)), NRC Chairman MacFarlane and 
Commissioner Magwood brought into question whether patients receiving 
I-131 treatments are given consistent and useful information from 
medical facilities and whether patients can correctly follow those 
instructions. Anecdotal data from patients and patient advocacy groups 
indicated that while instructions are provided, the quality of the 
instructions varies significantly, and that some patients are provided 
with instructions that the patient and the medical facility know will 
be impractical to follow.
    In the Staff Requirements Memorandum to COMAMM-14-0001/COMWDM-14-
0001 (see http://www.nrc.gov/reading-rm/doc-collections/commission/comm-secy/2014/2014-0001comamm-0001-comwdmsrm.pdf), the Commission, 
among other things, directed the NRC staff to develop a Web site that 
provides patients with clear and concise information and links to 
relevant medical and patient advocacy Web sites about I-131 treatments, 
to revise NRC guidance to specify guidelines for patient instructions 
and information including a voluntary model patient/licensee 
acknowledgement form documenting the patient/licensee dialog leading to 
the licensee's decision of when to safely release the patient from its 
control based on radiation exposure concerns, and to develop a standard 
set of guidelines that licensees can use to provide instructions to 
released I-131 patients. The Commission also directed the NRC staff to 
consider whether the guidance information provided to the patients can 
be made into an NRC brochure, or whether a medical organization already 
has, or would produce, a brochure for nationwide distribution.
    The NRC is interested in obtaining input from as many stakeholders 
as possible, including the NRC's Advisory Committee on the Medical Use 
of Isotopes, professional organizations, physicians, patients, patient 
advocacy groups, licensees, Agreement States, and other interested 
individuals. The focus of this information gathering effort is to 
obtain: Information that patients believe will help them understand the 
I-131 treatment (also referred to as Radioactive Iodine (RAI)) 
procedures, the physician's or licensee's best practices when making 
informed decisions on releasing RAI treatment patients, and information 
provided to patients on how to reduce radiation doses to others. The 
NRC is also interested in learning if patient advocacy, medical 
professional organizations, licensees, or other individuals have 
brochures that already contain the information requested.

III. Requested Information and Comments

A. Web Site Information

    The NRC is considering establishing a Web site that provides 
potential patients with information on RAI treatment procedures so that 
patients will understand the reason for the procedures, the process, 
and how to reduce radiation exposure to others. Some of this is medical 
information that is outside the NRC's field of expertise. The NRC would 
like to be able to provide links to other sites providing this medical 
information. The NRC may develop the basic radiation safety information 
itself, but could provide links if established sites already have this 
information.
    The NRC is also seeking input from patients, patient advocacy 
groups, and other interested individuals to articulate concerns that 
may not be included in the topics identified in this section.
    If you have, or know of, a Web site that that can be used to 
explain the disease and treatment process, and addresses one or more of 
the following topics, please provide the link to the NRC.
     What is radioactivity?
     What is radioactive iodine (RAI)?
     RAI treatment:
     Any explanation of how radiation is used in the treatment 
should include clear information that the patient will receive 
radioactive material, emit radiation, retain radioactive material, and 
release radioactive material.


[[Page 70845]]

 Preparing for RAI treatment.
     What to expect before and after receiving the treatment.
     Side effects of RAI treatment.
     Basic radiation safety:
     Appropriate venues for recovery after release.
     Precautions to take after receiving treatment.
     Risks to others, to include risks to young children and 
pregnant women.
     Expected general behaviors after release.
    When identifying a Web site, indicate the topic it addresses and 
provide a link to that specific information on the topic.

B. Patient/Licensee Acknowledgement Form and Best Practices in Making 
Informed Decisions on Releasing Patients Treated With I-131 Based on 
Radiation Exposure Considerations

    The NRC is looking for best practices used by individual physicians 
and licensees that focus on enhancing the ability to make informed 
radiation safety decisions on the release of individual patients from 
their radiation safety control under the patient release criteria in 
the NRC's medical use regulations. The NRC expects the physician 
(licensee) to have a dialog with the patient that will ultimately lead 
to an informed decision on when the patient should be released from its 
radiation safety control based on radiation exposure considerations 
(this includes immediate or delayed release, in addition to 
hospitalization). The NRC is also interested in knowing whether a 
patient/licensee acknowledgment form documenting this dialog exists and 
is part of the physicians' best practices. The NRC believes this dialog 
would include some or all of the following:
     The patient's ability to understand the language of the 
physician (licensee) or need for an interpreter that understands the 
procedure.
     The need for a family member or another support person 
present to facilitate better retention of information.
     A discussion with the patient to determine suitability for 
release.
     Description of the patient's transportation from the 
medical facility to home.
     Discussion of the patient's normal daily behavior and 
patterns, including but not limited to:
     The patient's normal/routine social interactions.
     The patient's normal/routine working environment and 
tasks.
     The patient's normal/routine living arrangements.
     The planned changes to the patient's normal/routine 
behaviors during the treatment period (have friend or family member 
accompany the patient or spend time with patient, change in living 
arrangements, etc.).
     Financial considerations that will affect the patient's 
preference on early or delayed release.
     Discussion to evaluate patient's ability to understand and 
follow instructions.
     Discussion to evaluate of patient's willingness to follow 
instructions.
     Discussion to evaluate the level of disruption to patient 
routine lifestyle, if released, and the ability of the patient to make 
and follow the changes, if released.
    If you have a policy or procedure that provides you with the 
confidence that you are releasing the patient at the appropriate time, 
please describe your policy or provide your procedure. If the policy or 
procedure includes a patient/licensee acknowledgement form, or if you 
have a stand-alone form, documenting the patient/licensee discussion, 
please provide it. The policy, procedure, or form could include some of 
the topics listed but may include others. Indicate when this type of 
discussion with the patients takes place (e.g., when the patient is 
referred for the procedure, before administration, after 
administration, etc.). Does the timing of this discussion allow the 
patient enough time to make different living, working, or 
transportation arrangements or for the medical facility to make delayed 
release (may include hospitalization) arrangements? Please describe how 
your best practices are used in the decision making process.
    The NRC would also like input from the patient's or other 
interested individual's perspective of the optimal time for the 
discussion to take place so that both the patient and the medical 
facility have confidence the release decision is appropriate. How much 
time is needed to allow patients to make different living, working, 
transportation arrangements? The NRC is also seeking input from 
patients, patient advocacy groups, and other interested individuals to 
articulate other topics that should be included in the discussion.

C. Guidance for Released Patients

    The Commission directed the NRC staff to develop standardized 
guidance for licensees to provide to their patients that would help to 
reduce the variability of instructions provided to patients and 
eliminate some of the uncertainty regarding the type of information 
that is provided to the patient. While the NRC currently prefers to 
develop performance based guidance (articulating objectives but not 
telling licensees how to reach those objectives), prescriptive guidance 
(i.e., very detailed and specific) may be necessary to reduce 
uncertainty and provide confidence that regulatory requirements are 
met. If the standardized guidance is performance-based, it would need 
to provide individual patients with the ``tools'' needed to follow the 
objectives in the guidance and protect others.
    If you have guidance documents that you believe provide clear 
instructions to released patients, please provide a copy to the NRC. If 
your guidance includes topics not addressed below, indicate why you 
think each is an important topic to include. If it does not address one 
of the topics and you believe that topic is not needed, describe why it 
is not needed.
     What ``tools'' (or methods/means) can the patient use to 
protect others once released?
     Are both oral and written information presented in the 
patient's native language and presented in a manner understandable to 
both the patient and physician (licensee)?
     Does the medical facility/licensee have access to an 
interpreting service to make sure that oral and written information and 
instructions are understood?
     How are instructions personalized to the individual 
patient?
     Does the medical facility explain how to limit the 
exposures to others (especially to young children and pregnant women)?
     Arrangements for protecting others once arriving at home.
     Informed how long special care must be exercised.
     Are actions described that the patient can take to 
minimize the exposure of people both inside and outside the home?
     Do transportation instructions from the medical facility 
to home match the patient's plans?
     Are discussions held on managing biological wastes and 
trash in accordance with NRC, state, and local requirements?
     Are discussions held to identify whom to contact in the 
event that questions arise during the recovery period?
     Are discussions held on where to go for emergency care?
    The NRC is also seeking input from patients, patient advocacy 
groups, and other interested individuals to articulate topics that 
should be included in the instructions provided to released patients. 
Further, when do you want to be provided with these instructions? Are 
the instructions provided in a manner that is easy to understand and

[[Page 70846]]

follow? What would have made the instructions better?

D. Brochure for Nationwide Use

    The NRC is seeking identification of a brochure that you believe 
provides clear guidance on the release of patients treated with I-131. 
If you have or know of such a brochure please send the NRC a copy or a 
link to it. The intent is to identify a brochure that could be 
distributed nationwide.

IV. Paperwork Reduction Act Statement

    This information request contains information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). These information collections were approved 
by the Office of Management and Budget (OMB), OMB control number 3150-
0229, expiration date of October 31, 2018.
    The burden to the public for these information collections is 
estimated to average 0.25 to 0.50 hours per response, including time 
for reviewing instructions, searching existing data sources, gathering 
data, performing necessary analyses, and completing and reviewing the 
information collection. This information collection request only 
information already possessed by the responder and does not request the 
responder develop any new data.
    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

    Dated at Rockville, Maryland, this 5th day of November, 2015.

    For the Nuclear Regulatory Commission.
Christian E. Einberg,
Acting Deputy Director, Division of Material Safety, State, Tribal and 
Rulemaking Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2015-29027 Filed 11-13-15; 8:45 am]
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