[Federal Register Volume 75, Number 202 (Wednesday, October 20, 2010)]
[Notices]
[Pages 64749-64751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26391]


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NUCLEAR REGULATORY COMMISSION

[NRC-2010-0330]


Request for Comments on the Use of Electronic Signatures for NRC 
Documents Related to the Medical Use of Byproduct Material Maintained 
at Licensees' Facilities

AGENCY: Nuclear Regulatory Commission.

ACTION: Request for comment.

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SUMMARY: On February 17, 2009, President Obama signed the American 
Recovery and Reinvestment Act, and on March 23, 2010, he signed the 
Patient Protection and Affordable Care Act. Both statutes require a 
transition to the use of electronic medical records by 2014. The U.S. 
Nuclear Regulatory Commission (NRC) is seeking public comment on 
specific issues related to the use of electronic signatures on these 
documents and is seeking to receive feedback from stakeholders on 
additional concerns that may be raised by this practice.

DATES: Comments on the notice should be submitted by February 17, 2011. 
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 comments received on or before this date.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include Docket ID NRC-2010-0330 in the subject line of your 
comments. Comments submitted in writing or in electronic form will be 
posted on the NRC Web site and on the Federal rulemaking Web site 
Regulations.gov. Because your comments will not be edited to remove any 
identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed.
    The NRC requests that any party soliciting or aggregating comments 
received from other persons for submission to the NRC inform those 
persons that the NRC will not edit their comments to remove any 
identifying or contact information, and therefore, they should not 
include any information in their comments that they do not want 
publicly disclosed.
    Federal Rulemaking Web site: Go to http://www.regulations.gov and 
search for documents filed under Docket ID NRC-2010-0330. Address 
questions about NRC dockets to Carol Gallagher 301-492-3668; e-mail 
[email protected].
    Mail comments to: Cindy Bladey, Chief, Rules, Announcements and 
Directives Branch (RADB), Division of Administrative Services, Office 
of Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by fax to RADB at 301-492-
3446.
    You can access publicly available documents related to this notice 
using the following methods:
    NRC's Public Document Room (PDR): The public may examine and have 
publicly available documents copied for a fee at the NRC's PDR, Room O1 
F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland.
    NRC's Agencywide Documents Access and Management System (ADAMS): 
Publicly available documents created or received at the NRC are 
available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain 
entry into ADAMS, which provides text and image files of NRC's public 
documents. If you do not have access to ADAMS or if there are problems 
in accessing the documents located in ADAMS, contact the NRC's PDR 
reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 
[email protected].

FOR FURTHER INFORMATION CONTACT: Ashley Cockerham, Office of Federal 
and State Materials and Environmental Management Programs, telephone 
240-888-7129, e-mail, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In connection with the American Recovery and Reinvestment Act and 
the Patient Protection and Affordable Care Act, the NRC is soliciting 
early public input on issues associated with the use of electronic 
signatures on documents related to the medical use of byproduct 
material that are not submitted to the NRC but are maintained and 
inspected at the licensee's facility (i.e., written directives required 
by 10 Code of Federal Regulations (CFR) 35.40 and records for 
inspection required by 10 CFR part 35 subpart L). For medical use 
licensees, 10 CFR 35.5 permits the use of electronic media to produce 
and store records that are maintained and inspected at the licensee's 
site. NRC is aware that many medical licensees already develop and 
store certain documents in electronic form and may use electronic 
signatures for electronic documents that require signatures by specific 
individuals.

[[Page 64750]]

    NRC believes that electronic signatures should serve the same 
function as written signatures. They should uniquely identify the 
individual (the electronic equivalent of biometric information), 
provide authentication and non-repudiation, and assure data integrity. 
The individual providing the signature should know he/she is signing 
the document, and the signature process should be concise enough to 
assure the individual initiating the process is the same person 
concluding the process. An inspector must be able to see an electronic 
audit of the document and electronic signature process to assure the 
completeness and accuracy of the document. Licensees, certificate 
holders or other regulated individuals may use digital certificates for 
digitally signing electronic documents, but NRC will accept other means 
of obtaining the performance criteria described.
    The NRC is conducting enhanced public participatory activities to 
solicit early and active public input on major issues associated with 
electronic signatures on written directives. As a first step, the NRC 
has prepared an issues paper which describes issues related to 
electronic signatures on written directives required by 10 CFR 35.40. 
The intent of this paper is to solicit input regarding these issues. 
The issues paper is contained in Section III of this document. The NRC 
will use its rulemaking Web site to make the issues paper available to 
the public and to solicit public comments.

II. Request for Comments and Plans for Public Meetings

    The NRC is soliciting comments on the items presented in the issues 
paper in Section III of this document as well as soliciting input on 
any additional potential concerns that stakeholders may have with the 
use of electronic signatures on documents related to the medical use of 
byproduct material which are maintained at the licensee's facility 
(e.g., concerns with electronic storage; identification; reliability of 
this practice). Comments may be submitted as indicated under the 
ADDRESSES heading in this document. In addition to providing an 
opportunity for written comments, the NRC is considering holding 
facilitated public meetings to discuss this issue. If NRC staff 
determines that public meetings are necessary to allow for additional 
stakeholder feedback, these meetings will be announced in the Federal 
Register on a future date. The issues paper in Section III of this 
document provides background and topics of discussion on the major 
issues that would be the subject of the potential public meetings. The 
written public comment period will extend until after the last public 
meeting is held.
    The Commission believes that stakeholders' comments will help to 
determine the potential impact of these proposed changes and will 
assist the NRC in developing a risk-informed, preferred option for 
acceptable forms of electronic signatures for those documents that must 
be retained for inspection in accordance with current NRC regulations. 
Staff will consider future actions based on the comments received in 
response to this document.

III. Issues Paper on the Use of Electronic Signatures for Written 
Directives

Introduction

    Section A of this Issues Paper describes some general 
considerations regarding the use of electronic signatures at NRC-
licensed medical use facilities. Section B of the paper discusses the 
major issues that need to be addressed before commencing any regulatory 
activities related to the use of electronic signatures.
A. Background
    On February 17, 2009, President Obama signed the American Recovery 
and Reinvestment Act, and on March 23, 2010, he signed the Patient 
Protection and Affordable Care Act. Both Acts require a transition to 
the use of electronic medical records by 2014. Many medical facilities 
have already started the transition from paper records to electronic 
systems or are currently using electronic systems exclusively. NRC is 
seeking comments on acceptable forms of electronic signatures for 
documents that must be retained for inspection in accordance with 
current NRC regulations (i.e. 10 CFR 35.40 and 10 CFR part 35 subpart 
L).
    10 CFR 35.5 permits medical use licensees to store required records 
in electronic media provided the electronic media has the capability 
for producing legible, accurate, and complete records during the 
required retention period. Also, records such as letters, drawings, and 
specifications stored in electronic media must include all pertinent 
information such as stamps, initials, and signatures. Licensees must 
maintain adequate safeguards against tampering with and loss of 
records. The information that is required in each record is described 
in other sections of the regulations.
    Because the system that generates the electronic document must have 
functions that provide a legible document for the records retention 
period, the document must be readable in the future, even if the 
technology used to develop the document becomes outdated. Because the 
record must be complete for the records retention period, any 
electronic attachments, figures, drawings, stamps, signatures, etc., 
that are required to be part of the record must electronically be part 
of the record and remain part of the record. Because the record must be 
accurate for the records retention period, there must be a means of 
verifying the date of finalized electronic attachments, figures, 
drawings, stamps, signatures, etc., that are required to be part of the 
electronic record, the date the record itself was finalized, the date 
the electronic signature was affixed. There must also be a means of 
identifying the individual who affixed the signature and a method of 
verifying version control to identify dates of subsequent changes to 
the final record along with the names of individuals who have made 
these changes.
    Because these electronic documents are internal licensee records 
that are not submitted to the agency, the criteria for electronic 
submissions described in NRC's Electronic Submittals Web site at http://www.nrc.gov/site-help/e-submittals.html do not apply. The Web site 
addresses the use of digital certificates for digitally signing 
electronic submissions pertaining to licensing actions, associated 
hearings, and other regulatory matters. With regard to electronic 
signatures on internal licensee records, licensees may chose to use 
digital certificates and digital signatures to affix electronic 
signatures to electronic records; however, they are not required to do 
so.
    The NRC understands that there is no single accepted national 
standard for electronic signatures; however, several principles have 
been considered by NRC staff. Generally, when signing a paper document, 
the individual knows he/she is signing it, the physical signature 
provides biometric information that can be used to identify the person 
and provide the basis for authentication and non-repudiation. 
Generally, signing a completed document also functions to confirm the 
integrity of the document and prevent changes that would compromise 
``data integrity'' in its broadest meaning.
    The processes used to generate an electronic document and 
individual's electronic signature should satisfy the same functions 
provided by a written signature on a paper document. They should 
uniquely identify the individual (the electronic equivalent of 
biometric information), provide authentication and non-repudiation, and 
assure data

[[Page 64751]]

integrity. The individual providing the signature should know that he/
she is signing the document, and the signature process should be 
concise enough to assure that the individual initiating the process is 
the same person concluding the process. Systems that produce electronic 
records should have provisions that inform individuals electronically 
signing the document that they are entering their signatures. This 
process should be separate from the act of opening the document because 
most records required by NRC are produced by other individuals and may 
be produced and revised over an unspecified time.
    The signature process should be such that it is uniquely tied to 
the individual whose signature is required and the period that the 
signature process is open should be short enough to assure that the 
individual starting the process is the individual completing the 
process. If the signature is required to demonstrate review of specific 
information, then completion of the electronic signature should also 
block alteration of that information. Subsequent changes to the 
information should require a new electronic signature and not overwrite 
previous versions of the signed document. If the document must be dated 
and signed to meet the regulations, the electronic signature process 
should also affix the date and time to each electronic signature.
    Because these electronic records are kept at the facility and not 
sent to the NRC they have to be electronically inspected at the 
facility. Printing an electronic record with an electronic signature 
would not constitute a complete and accurate record because critical 
electronic information associated with the electronic record would not 
be available for inspection.
B. Issues for Discussion
    The following is a listing of issues regarding the use of 
electronic signatures on documents related to the medical use of 
byproduct material. Each issue is followed by one or more questions 
about existing practices related to standards, authentication, non-
repudiation, data integrity, records inspection, and improvements to 
software. The questions listed below are not meant to be a complete or 
final list of issues to be considered but are provided to initiate 
comments. Stakeholders are requested to comment on and recommend 
additions, deletions, or modifications to the issues listed below; and 
propose considerations for implementation of electronic signatures 
regarding each issue, as appropriate. These issues, and other relevant 
and substantial issues identified by commenters, will serve as the 
basis of discussion at the public meetings, if these meetings are 
scheduled in the future. Public feedback will also be used in 
developing options for implementation.

Issue No. 1--Standards

    Q1.1 What standards for electronic signatures in medical records 
are in use or under development?
    Q1.2 How do these standards address the principles of 
authentication, non-repudiation, data integrity, and access for 
inspection, as described in Issues No. 2 through 5, below?
    Q1.3 Do these standards consider any additional key principles?

Issue No. 2--Authentication

    Q2.1 For software applications currently in use, how does the 
licensee assure that the signature process is uniquely tied to the 
individual whose signature is required?

Issue No. 3--Non-Repudiation

    Q3.1 For software applications currently in use, what provisions 
does the licensee use to inform persons electronically signing 
documents that they are entering their signature?

Issue No. 4--Data Integrity

    Q4.1 For software applications currently in use, how does the 
licensee assure that the document being electronically signed cannot be 
changed after it is signed?
    Q4.2 For software applications currently in use, how does the 
licensee assure that subsequent changes to the electronically signed 
document require a new electronic signature and cannot overwrite 
previous versions of the signed document?
    Q4.3 For software applications currently in use, how does the 
licensee assure that the electronic signature process affixes the date 
and time to each electronic signature?

Issue No. 5--Records Inspection

    Q5.1 For software applications currently in use, how does the 
licensee assure that electronically signed documents and all revisions 
to the electronically signed documents are accessible for inspection?
    Q5.2 For software applications currently in use, how does the 
licensee assure that electronically signed documents and all revisions 
to the electronically signed documents are retained for 3 years?

Issue No. 6--Need for Improvements to Current Commercially-Available 
Software Applications

    Q6.1 Are any improvements needed for current commercially-available 
software applications to adequately meet existing standards and 
principles?

    Dated at Rockville, Maryland, this 14th day of Oct. 2010.

    For the Nuclear Regulatory Commission.
Christian Einberg,
Acting Deputy Director, Licensing and Inspection Support Directorate, 
Division of Materials Safety and State Agreements, Office of Federal 
and State Materials, and Environmental Management Programs.
[FR Doc. 2010-26391 Filed 10-19-10; 8:45 am]
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