Information Collection: NRC Form 398, “Personal Qualification Statement-Licensee”
| Published date | 15 February 2019 |
| Record Number | 2019-02459 |
| Section | Notices |
| Court | Nuclear Regulatory Commission |
4545
Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
between medical devices and systems
enabled, new models for monitoring,
device interaction, and control—
including the development of closed
loop, autonomous and semiautonomous
systems—can be realized. These new
models will provide greater support for
patient safety, decrease medical errors,
reduce provider burden, reduce practice
variability across healthcare facilities/
geographic areas and, ultimately, will
enhance medical care quality and
outcomes.
Future Vision: When people with
serious injuries or illness are
hospitalized medical device additions
and changes are automatically recorded
with no deficit in patient safety, loss in
data fidelity, or data security as the
patient transitions across the continuum
of care. Additional medical devices can
be added or removed as the patient’s
status changes and details of these
changes, calibration of the instruments,
and each equipment’s unique device
identifier [UDI] and configuration
settings are recorded and synchronized.
If a piece of equipment breaks, it can be
switched seamlessly with a device from
another vendor. Data and settings from
patient medical devices, such as insulin
pumps, are identified, integrated, and
time synchronized, and select data are
included in the electronic health record.
As autonomous capabilities are added,
real-time care is logged, and supervisory
control established to ensure the
provision of real-time patient
monitoring and support. When
providers are not available, or have
competing demands, medical devices
will function in a closed loop,
autonomous manner with appropriate
safety and control measures to stabilize
the patient. Data will flow through
changes in equipment that occur in
moves from the emergency room, to the
operating room, to the intensive care
unit, to a rehabilitation facility, and
finally to the home. This will allow for
data and metadata to flow even as
changes in equipment are mapped to
individual patient needs and
environment. Each change in equipment
configuration will be noted in the
supervisory system/medical record and
in the metadata (e.g., the UDI) generated
by the device. The resulting patient
record from these systems will include
device data, metadata, and care
documentation. These patient records
can be stored and analyzed using
medical black box recorder-equivalents
to assess adverse events or examine
unexpected positive outcomes. This will
also improve the consistency and
quality of care; create real-time
automated care systems; create a
learning health system.
These types of records and the real-
time systems interactions they enable
are widely used or are being actively
developed in other industries, such as
the industrial controls and autonomous
systems in the automotive, aviation, and
energy sectors. That is not the case for
healthcare. While there are many factors
that may inhibit real-time interaction in
a medical setting, interoperability
solutions that are relevant for healthcare
and patient safety need to be developed.
Seamlessly flowing, interoperable data
from medical devices and systems,
when utilized effectively, could
significantly enhance patient outcomes,
identify and reduce errors, enhance the
efficiency of care delivery, reduce
development times and costs, improve
standardization/consistency of care
delivery, and decrease healthcare
provider burnout.
Next Steps: The Government
anticipates hosting a conference in June/
July 2019 to allow for additional
engagement. The results of the
conference discussion, in addition to
the written responses to this RFI, will be
used to determine next steps in
addressing federal efforts in
interoperability of data, platforms, and
medical devices. This RFI is solely
issued to engage with interested parties
to inform the Government on
developing a strategy for medical
device, data, and platform
interoperability. The Government will
not reimburse costs associated with
participating in the conference. The
Government may contact respondents
regarding their submissions, such as to
ask questions, to learn more, or to notify
them of further developments related to
the effort.
Submitted by the National Science
Foundation in support of the
Networking and Information
Technology Research and Development
(NITRD) National Coordination Office
(NCO) on February 11, 2019.
Suzanne H. Plimpton,
Reports Clearance Officer, National Science
Foundation.
[FR Doc. 2019–02519 Filed 2–14–19; 8:45 am]
BILLING CODE 7555–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2018–0119]
Information Collection: NRC Form 398,
‘‘Personal Qualification Statement—
Licensee’’
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 request for renewal of an
existing collection of information to the
Office of Management and Budget
(OMB) for review. The information
collection is entitled, ‘‘NRC Form 398,
‘‘Personal Qualification Statement—
Licensee.’’
DATES
: Submit comments by March 18,
2019.
ADDRESSES
: Submit comments directly
to the OMB reviewer at: OMB Office of
Information and Regulatory Affairs
(3150–0090), Attn: Desk Officer for the
Nuclear Regulatory Commission, 725
17th Street NW, Washington, DC 20503;
email: oira_submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT
:
David Cullison, NRC Clearance Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
INFOCOLLECTS.Resource@nrc.gov.
SUPPLEMENTARY INFORMATION
:
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID: NRC–2018–
0119 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 Website: Go to
http://www.regulations.gov and search
for Docket ID NRC–2018–0119. A copy
of the collection of information and
related instructions may be obtained
without charge by accessing Docket ID
NRC–2018–0119 on this website.
•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
‘‘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–
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Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
415–4737, or by email to pdr.resource@
nrc.gov. A copy of the collection of
information and related instructions
may be obtained without charge by
accessing ADAMS Package Accession
No. ML18166A095. The supporting
statement and NRC Form 398 are
available in ADAMS under
ML18166A123 and ML18166A129.
•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, David Cullison,
Office of the Chief Information Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
INFOCOLLECTS.Resource@NRC.GOV.
B. Submitting Comments
The NRC cautions you not to include
identifying or contact information in
comment submissions that you do not
want to be publicly disclosed in your
comment submission. All comment
submissions are posted at http://
www.regulations.gov and entered into
ADAMS. Comment submissions are not
routinely edited to remove identifying
or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the OMB, 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 comment submissions are not
routinely edited to remove such
information before making the comment
submissions available to the public or
entering the comment 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 request for renewal of an
existing collection of information to
OMB for review entitled, ‘‘NRC Form
398, ‘‘Personal Qualification
Statement—Licensee.’’ 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 a Federal
Register notice with a 60-day comment
period on this information collection on
October 10, 2018, 83 FR 50970.
1. The title of the information
collection: NRC Form 398, ‘‘Personal
Qualification Statement—Licensee.’’
2. OMB approval number: 3150–0090.
3. Type of submission: Extension.
4. The form number if applicable:
NRC Form 398.
5. How often the collection is
required or requested: Upon application
for an initial or upgrade operator license
and every six years for the renewal of
operator or senior operator licenses.
6. Who will be required or asked to
respond: Facility licensees who are
tasked with certifying that the
applicants and renewal operators are
qualified to be licensed as reactor
operators and senior reactor operators.
7. The estimated number of annual
responses: 1,074.
8. The estimated number of annual
respondents: 1,074.
9. An estimate of the total number of
hours needed annually to comply with
the information collection requirement
or request: 5,711.
10. Abstract: NRC Form 398 is used to
transmit detailed information required
to be submitted to the NRC by a facility
licensee on each applicant applying for
new and upgraded licenses or license
renewals to operate the controls at a
nuclear reactor facility. This
information is used to determine that
each applicant or renewal operator
seeking a license or renewal of a license
is qualified to be issued a license and
that the licensed operator would not be
expected to cause operational errors and
endanger public health and safety.
Dated at Rockville, Maryland, this 11th day
of February 2019.
For the Nuclear Regulatory Commission.
Kristen E. Benney,
Acting NRC Clearance Officer, Office of the
Chief Information Officer.
[FR Doc. 2019–02459 Filed 2–14–19; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2019–0021]
Information Collection: Invoice
Submissions by Contractors for NRC
Contracts/Invoices
AGENCY
: Nuclear Regulatory
Commission.
ACTION
: Renewal of existing information
collection; request for comment.
SUMMARY
: The U.S. Nuclear Regulatory
Commission (NRC) invites public
comment on the renewal of Office of
Management and Budget (OMB)
approval for an existing collection of
information. The information collection
is entitled, ‘‘Invoice Submissions by
Contractors for NRC Contracts/
Invoices.’’
DATES
: Submit comments by April 16,
2019. Comments received after this date
will be considered if it is practical to do
so, but the Commission is able to ensure
consideration only for comments
received on or before this date.
ADDRESSES
: You may submit comments
by any of the following methods:
•Federal Rulemaking Website: Go to
http://www.regulations.gov and search
for Docket ID NRC–2019–0021. Address
questions about docket IDs in
Regulations.gov to Krupskaya Castellon;
telephone: 301–287–9221; email:
Krupskaya.Castellon@nrc.gov. For
technical questions, contact the
individual listed in the
FOR FURTHER
INFORMATION CONTACT
section of this
document.
•Mail comments to: David Cullison,
Office of the Chief Information Officer,
Mail Stop: O–1 F21, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001.
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION
section of
this document.
FOR FURTHER INFORMATION CONTACT
:
David Cullison, Office of the Chief
Information Officer, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001; telephone: 301–415–
2084; email: Infocollects.Resource@
nrc.gov.
SUPPLEMENTARY INFORMATION
:
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2019–
0021 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 Website: Go to
http://www.regulations.gov and search
for Docket ID NRC–2019–0021. A copy
of the collection of information and
related instructions may be obtained
without charge by accessing Docket ID
NRC–2019–0021 on this website.
•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
‘‘Begin Web-based ADAMS Search.’’ For
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