80_FR_36110 80 FR 35990 - Information Collection: NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information

80 FR 35990 - Information Collection: NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range35990-35991
FR Document2015-15391

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.''

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015)
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35990-35991]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15391]


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NUCLEAR REGULATORY COMMISSION

[NRC-2015-0020]


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: 202-395-7315, email: Vladik_Dorjets@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT: Tremaine Donnell, NRC Clearance 
Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; 
telephone: 301-415-6258; email: INFOCOLLECTS.Resource@nrc.gov.

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 pdr.resource@nrc.gov. 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: 301-415-6258; email: 
INFOCOLLECTS.Resource@NRC.GOV.

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.

[[Page 35991]]

    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.
[FR Doc. 2015-15391 Filed 6-22-15; 8:45 am]
BILLING CODE 7590-01-P



                                                  35990                          Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices

                                                  Federal Register on October 22, 2003                    and Budget, Washington, DC 20503;                      submissions at http://
                                                  (68 FR 60422). The licensee affirmed the                telephone: 202–395–7315, email:                        www.regulations.gov as well as entering
                                                  applicability of the model NSHC                         Vladik_Dorjets@omb.eop.gov.                            the comment submissions into ADAMS.
                                                  determination in its application dated                  FOR FURTHER INFORMATION CONTACT:                       The NRC does not routinely edit
                                                  July 24, 2014.                                          Tremaine Donnell, NRC Clearance                        comment submissions to remove
                                                     Date of issuance: May 28, 2015.                      Officer, U.S. Nuclear Regulatory                       identifying or contact information.
                                                     Effective date: As of the date of                    Commission, Washington, DC 20555–                        If you are requesting or aggregating
                                                  issuance and shall be implemented                       0001; telephone: 301–415–6258; email:                  comments from other persons for
                                                  within 60 days of issuance.                             INFOCOLLECTS.Resource@nrc.gov.                         submission to the NRC, then you should
                                                     Amendment No.: 99. A publicly-
                                                                                                          SUPPLEMENTARY INFORMATION:                             inform those persons not to include
                                                  available version is in ADAMS under
                                                                                                                                                                 identifying or contact information that
                                                  Accession No. ML15092A761;                              I. Obtaining Information and
                                                  documents related to this amendment                                                                            they do not want to be publicly
                                                                                                          Submitting Comments                                    disclosed in their comment submission.
                                                  are listed in the Safety Evaluation
                                                  enclosed with the amendment.                            A. Obtaining Information                               Your request should state that the NRC
                                                     Facility Operating License No. NPF–                     Please refer to Docket ID NRC 2015–                 does not routinely edit comment
                                                  90: Amendment revised the Facility                      0020 when contacting the NRC about                     submissions to remove such information
                                                  Operating License and Technical                         the availability of information for this               before making the comment
                                                  Specifications.                                         action. You may obtain publicly-                       submissions available to the public or
                                                     Date of initial notice in Federal                    available information related to this                  entering the comment submissions into
                                                  Register: September 30, 2014 (79 FR                     action by any of the following methods:                ADAMS.
                                                  58827).                                                    • Federal Rulemaking Web site: Go to                II. Background
                                                     The Commission’s related evaluation                  http://www.regulations.gov and search
                                                  of the amendment is contained in a                      for Docket ID NRC 2015–0020. A copy                       Under the provisions of the
                                                  Safety Evaluation dated May 28, 2015.                   of the collection of information and                   Paperwork Reduction Act of 1995 (44
                                                     NSHC determination comments                          related instructions may be obtained                   U.S.C. chapter 35), the NRC recently
                                                  received: No.                                           without charge by accessing Docket ID                  submitted a proposed collection of
                                                    Dated at Rockville, Maryland, this 12th day           NRC 2015–0020 on this Web site.                        information to OMB for review entitled,
                                                  of June 2015.                                              • NRC’s Agencywide Documents                        ‘‘NRC Request for Sodium Iodide I–131
                                                    For the Nuclear Regulatory Commission.
                                                                                                          Access and Management System                           Treatment and Patient Release
                                                                                                          (ADAMS): You may obtain publicly-                      Practices.’’ The NRC hereby informs
                                                  A. Louise Lund,
                                                                                                          available documents online in the                      potential respondents that an agency
                                                  Acting Director, Division of Operating Reactor          ADAMS Public Documents collection at
                                                  Licensing, Office of Nuclear Reactor                                                                           may not conduct or sponsor, and that a
                                                  Regulation.
                                                                                                          http://www.nrc.gov/reading-rm/                         person is not required to respond to, a
                                                                                                          adams.html. To begin the search, select                collection of information unless it
                                                  [FR Doc. 2015–15275 Filed 6–22–15; 8:45 am]
                                                                                                          ‘‘ADAMS Public Documents’’ and then                    displays a currently valid OMB control
                                                  BILLING CODE 7590–01–P
                                                                                                          select ‘‘Begin Web-based ADAMS                         number.
                                                                                                          Search.’’ For problems with ADAMS,
                                                                                                          please contact the NRC’s Public                           The NRC published an FRN with a 60-
                                                  NUCLEAR REGULATORY                                                                                             day comment period on this information
                                                                                                          Document Room (PDR) reference staff at
                                                  COMMISSION                                                                                                     collection on March 3, 2015; 80 FR
                                                                                                          1–800–397–4209, 301–415–4737, or by
                                                  [NRC–2015–0020]                                         email to pdr.resource@nrc.gov. The                     11471, entitled ‘‘NRC Request for
                                                                                                          supporting statement and Patient                       Sodium Iodide I–131 Treatment and
                                                  Information Collection: NRC Request                     Release Federal Register Notice (FRN)                  Patient Release Practices.’’
                                                  for Sodium Iodide I–131 Treatment and                   Soliciting Information is available in                    1. The title of the information
                                                  Patient Release Information                             ADAMS under Accession No.                              collection: ‘‘NRC Request for Sodium
                                                  AGENCY:  Nuclear Regulatory                             ML15134A123.                                           Iodide I–131 Treatment and Patient
                                                  Commission.                                                • NRC’s PDR: You may examine and                    Release Practices.’’
                                                                                                          purchase copies of public documents at                    2. OMB approval number: An OMB
                                                  ACTION: Notice of submission to the
                                                                                                          the NRC’s PDR, Room O1–F21, One                        control number has not yet been
                                                  Office of Management and Budget;
                                                                                                          White Flint North, 11555 Rockville                     assigned to this proposed information
                                                  request for comment.
                                                                                                          Pike, Rockville, Maryland 20852.                       collection.
                                                  SUMMARY:    The U.S. Nuclear Regulatory                    • NRC’s Clearance Officer: A copy of
                                                                                                          the collection of information and related                 3. Type of submission: New.
                                                  Commission (NRC) has recently
                                                  submitted a proposed collection of                      instructions may be obtained without                      4. The form number if applicable: Not
                                                  information to the Office of                            charge by contacting the NRC’s                         Applicable.
                                                  Management and Budget (OMB) for                         Clearance Officer, Tremaine Donnell,
                                                                                                                                                                    5. How often the collection is required
                                                  review. The information collection is                   Office of Information Services, U.S.
                                                                                                                                                                 or requested: Once.
                                                  entitled, ‘‘NRC Request for Sodium                      Nuclear Regulatory Commission,
                                                                                                          Washington, DC 20555–0001; telephone:                     6. Who will be required or asked to
                                                  Iodide I–131 Treatment and Patient
                                                                                                          301–415–6258; email:                                   respond: Medical professional
                                                  Release Practices.’’
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                                                                                                          INFOCOLLECTS.Resource@NRC.GOV.                         organizations, physicians, patients,
                                                  DATES: Submit comments by July 23,                                                                             patient advocacy groups, NRC and
                                                  2015.                                                   B. Submitting Comments                                 Agreement State medical use licensees,
                                                  ADDRESSES:  Submit comments directly                      The NRC cautions you not to include                  Agreement States, and other interested
                                                  to the OMB reviewer at: Vlad Dorjets,                   identifying or contact information that                individuals who use, receive, license or
                                                  Desk Officer, Office of Information and                 you do not want to be publicly                         have interest in the use of I–131 sodium
                                                  Regulatory Affairs, (3150–XXXX),                        disclosed in your comment submission.                  iodide (hereafter referred to as ‘‘I–131’’)
                                                  NEOB–10202, Office of Management                        The NRC posts all comment                              for the treatment of thyroid conditions.


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                                                                                 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices                                           35991

                                                     7. The estimated number of annual                    NUCLEAR REGULATORY                                     available information related to this
                                                  responses: A one-time collection                        COMMISSION                                             action by any of the following methods:
                                                  estimated to have 1,180 responses (620                                                                            • Federal rulemaking Web site: Go to
                                                                                                          [NRC–2015–0147]
                                                  medical community + 560 patients).                                                                             http://www.regulations.gov and search
                                                     8. The estimated number of annual                    Information Collection: Environmental                  for Docket ID NRC–2015–0147.
                                                  respondents: 1,180 respondents (620                     Protection Regulations for Domestic                       • NRC’s Agencywide Documents
                                                  medical community + 560 patients).                      Licensing and Related Regulatory                       Access and Management System
                                                     9. An estimate of the total number of                Functions                                              (ADAMS): You may obtain publicly-
                                                  hours needed annually to comply with                    AGENCY:  Nuclear Regulatory                            available documents online in the
                                                  the information collection requirement                  Commission.                                            ADAMS Public Documents collection at
                                                  or request: 457.5 hours (255 medical                                                                           http://www.nrc.gov/reading-rm/
                                                                                                          ACTION: Renewal of existing information                adams.html. To begin the search, select
                                                  community + 202.5 patients).                            collection; request for comment.                       ‘‘ADAMS Public Documents’’ and then
                                                     10. Abstract: The NRC is requesting a                                                                       select ‘‘Begin Web-based ADAMS
                                                  one-time information collection that                    SUMMARY:   The U.S. Nuclear Regulatory
                                                                                                          Commission (NRC) invites public                        Search.’’ For problems with ADAMS,
                                                  will be solicited in an FRN. The FRN                                                                           please contact the NRC’s Public
                                                  will have specific I–131 patient release                comment on the renewal of Office of
                                                                                                          Management and Budget (OMB)                            Document Room (PDR) reference staff at
                                                  questions associated with: (1) Existing                                                                        1–800–397–4209, 301–415–4737, or by
                                                                                                          approval for an existing collection of
                                                  Web sites that the responders believe                                                                          email to pdr.resource@nrc.gov. The
                                                                                                          information. The information collection
                                                  provide access to clear and consistent                  is entitled, ‘‘Environmental Protection                supporting statement is available in
                                                  patient information about I–131                         Regulations for Domestic Licensing and                 ADAMS under Accession No.
                                                  treatment processes and procedures; (2)                 Related Regulatory Functions.’’                        ML15106A720.
                                                  information the responders believe                                                                                • NRC’s PDR: You may examine and
                                                                                                          DATES: Submit comments by August 24,
                                                  represent best practices used in making                                                                        purchase copies of public documents at
                                                                                                          2015. Comments received after this date
                                                  informed decisions on releasing I–131                   will be considered if it is practical to do            the NRC’s PDR, Room O1–F21, One
                                                  patients and stand alone or                             so, but the Commission is able to ensure               White Flint North, 11555 Rockville
                                                  supplemental voluntary patient/licensee                 consideration only for comments                        Pike, Rockville, Maryland 20852.
                                                  guidance acknowledgment forms, if                       received on or before this date.                          • NRC’s Clearance Officer: A copy of
                                                  available; (3) an existing set of                                                                              the collection of information and related
                                                                                                          ADDRESSES: You may submit comments
                                                  guidelines that the responder developed                 by any of the following methods:                       instructions may be obtained without
                                                  or received that provides instructions to                  • Federal Rulemaking Web site: Go to                charge by contacting NRC’s Clearance
                                                  released patients; and (4) an existing                  http://www.regulations.gov and search                  Officer, Tremaine Donnell, Office of
                                                  guidance brochure that the responder                    for Docket ID NRC–2015–0147. Address                   Information Services, U.S. Nuclear
                                                  believes would be acceptable for                        questions about NRC dockets to Carol                   Regulatory Commission, Washington,
                                                  nationwide distribution. The responses                  Gallagher; telephone: 301–287–3422;                    DC 20555–0001; telephone: 301–415–
                                                  will form the basis for patient release                 email: Carol.Gallagher@nrc.gov. For                    6258; email: INFOCOLLECTS.Resource@
                                                  guidance products developed in                          technical questions, contact the                       NRC.GOV.
                                                  response to the NRC’s April 28, 2014,                   individual listed in the FOR FURTHER                   B. Submitting Comments
                                                  Staff Requirements—COMAMM–14–                           INFORMATION CONTACT section of this
                                                  0001/COMWDM–14–0001—                                    document.                                                Please include Docket ID NRC–2015–
                                                  ‘‘Background and Proposed Direction to                     • Mail comments to: Tremaine                        0147 in your comment submission.
                                                  NRC Staff to Verify Assumptions Made                    Donnell, Office of Information Services,
                                                                                                                                                                   The NRC cautions you not to include
                                                  Concerning Patient Release Guidance.’’                  Mail Stop: T–5 F53, U.S. Nuclear
                                                                                                                                                                 identifying or contact information in
                                                  The Commission, based on information                    Regulatory Commission, Washington,
                                                                                                                                                                 comment submissions that you do not
                                                  from patients and patient advocacy                      DC 20555–0001.
                                                                                                                                                                 want to be publicly disclosed in your
                                                  groups, questioned the availability of                     For additional direction on obtaining
                                                                                                                                                                 comment submission. The NRC will
                                                  clear, consistent, patient friendly and                 information and submitting comments,
                                                                                                                                                                 post all comment submissions at
                                                  timely patient release information and                  see ‘‘Obtaining Information and
                                                                                                                                                                 http://www.regulations.gov as well as
                                                  directed the staff to work with a wide                  Submitting Comments’’ in the
                                                                                                                                                                 enter the comment submissions into
                                                  variety of stakeholders when developing                 SUPPLEMENTARY INFORMATION section of
                                                                                                                                                                 ADAMS, and the NRC does not
                                                  new guidance products. This                             this document.
                                                                                                                                                                 routinely edit comment submissions to
                                                  information collection effort was                       FOR FURTHER INFORMATION CONTACT:                       remove identifying or contact
                                                  developed to gain input from as many                    Tremaine Donnell, Office of Information                information.
                                                  stakeholders as possible. The NRC                       Services, U.S. Nuclear Regulatory
                                                                                                          Commission, Washington, DC 20555–                        If you are requesting or aggregating
                                                  solicitation in the Federal Register is to                                                                     comments from other persons for
                                                  obtain existing information from a                      0001; telephone: 301–415–6258; email:
                                                                                                          INFOCOLLECTS.Resource@NRC.GOV.                         submission to the NRC, then you should
                                                  variety of stakeholders.                                                                                       inform those persons not to include
                                                                                                          SUPPLEMENTARY INFORMATION:
                                                    Dated at Rockville, Maryland, this 18th day                                                                  identifying or contact information that
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  of June, 2015.                                          I. Obtaining Information and                           they do not want to be publicly
                                                    For the Nuclear Regulatory Commission.                Submitting Comments                                    disclosed in their comment submission.
                                                                                                                                                                 Your request should state that the NRC
                                                  Tremaine Donnell,                                       A. Obtaining Information                               does not routinely edit comment
                                                  NRC Clearance Officer, Office of Information              Please refer to Docket ID NRC–2015–                  submissions to remove such information
                                                  Services.                                               0147 when contacting the NRC about                     before making the comment
                                                  [FR Doc. 2015–15391 Filed 6–22–15; 8:45 am]             the availability of information for this               submissions available to the public or
                                                  BILLING CODE 7590–01–P                                  action. You may obtain publicly-                       entering the comment into ADAMS.


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Document Created: 2018-02-22 11:15:11
Document Modified: 2018-02-22 11:15:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of submission to the Office of Management and Budget; request for comment.
DatesSubmit comments by July 23, 2015.
ContactTremaine Donnell, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6258; email: [email protected]
FR Citation80 FR 35990 

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