Federal Register / Vol. 75, No. 202 / Wednesday, October 20, 2010 / Notices 64749 

the Environmental Report submitted by 

NextEra Energy Duane Arnold, LLC 

(formerly known as FPL Energy Duane 

Arnold, LLC (FPL–DA)); (3) consultation 

with Federal, State, and local agencies; 

(4) the staff’s own independent review; 

and (5) the staff’s consideration of 

public comments. The recommendation 

of the staff is that the NRC determines 

that the adverse environmental impacts 

of license renewal for DAEC are not 

great enough to deny the option of 

license renewal for energy-planning 

decision-makers. 

The final Supplement 42 to the GEIS 

is publicly available at the NRC Public 

Document Room, located at One White 

Flint North, 11555 Rockville Pike, 

Rockville, Maryland, 20852, or from the 

NRC’s Agencywide Documents Access 

and Management System (ADAMS). The 

ADAMS Public Electronic Reading 

Room is accessible at http:// 

www.nrc.gov/reading-rm/adams.html. 

The accession number for the final 

Supplement 42 to the GEIS is 

ML102790308. Persons who do not have 

access to ADAMS, or who encounter 

problems in accessing the documents 

located in ADAMS, should contact the 

NRC’s Public Document Room 

Reference staff by telephone at 1–800– 

397–4209, or 301–415–4737 or by e-mail 

at PDR.Resource@nrc.gov. In addition, 

the Hiawatha Public Library, located at 

150 West Willman Street, Hiawatha, 

Iowa, has agreed to make the final 

supplement to the GEIS available for 

public inspection. 

For Further Information Contact: Mr. 

Jeremy J. Susco, Projects Branch 1, 

Division of License Renewal, Office of 

Nuclear Reactor Regulation, U.S. 

Nuclear Regulatory Commission, Mail 

Stop O–11F1, Washington, DC, 20555– 

0001. Mr. Susco may be contacted at 1– 

800–368–5642, extension 2927 or via email at Jeremy.Susco@nrc.gov. 

Dated at Rockville, Maryland, this 13th day 

of October, 2010. 

For the Nuclear Regulatory Commission. 

Bo Pham, 

Chief, Project Branch 1, Division of License 

Renewal, Office of Nuclear Reactor 

Regulation. 

[FR Doc. 2010–26396 Filed 10–19–10; 8:45 am] 

BILLING CODE 7509–01–P 

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. 

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 

Carol.Gallagher@nrc.gov. 

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 

pdr.resource@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Ashley Cockerham, Office of Federal 

and State Materials and Environmental 

Management Programs, telephone 240– 

888–7129, e-mail, 

ashley.cockerham@nrc.gov. 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
64750 Federal Register / Vol. 75, No. 202 / Wednesday, October 20, 2010 / Notices 

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/esubmittals.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 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 202 / Wednesday, October 20, 2010 / Notices 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] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[Docket Nos. STN 50–456, STN 50–457, STN 

50–454, and STN 50–455; NRC–2010–0329] 

Braidwood Station, Units 1 and 2 and 

Byron Station, Unit Nos. 1 and 2; 

Notice of Withdrawal of Application for 

Amendment to Facility Operating 

License 

The U.S. Nuclear Regulatory 

Commission (the Commission) has 

granted the request of Exelon 

Generation Company, LLC (the licensee) 

to withdraw its March 26, 2009, 

application for proposed amendments to 

Facility Operating License Nos. NPF–72 

and NPF–77 for Braidwood Station, 

Units 1 and 2, respectively, located in 

Will County, Illinois, and to Facility 

Operating License Nos. NPF–37 and 

NPF–66 for Byron Station, Unit Nos. 1 

and 2, respectively, located in Ogle 

County, Illinois. 

The proposed amendment would 

have revised the fire protection program 

to eliminate the requirement for the 

backup manual carbon dioxide fire 

suppression system in the upper cable 

spreading rooms. 

The Commission had previously 

issued a Notice of Consideration of 

Issuance of Amendment published in 

the Federal Register on May 19, 2009 

(74 FR 23445). However, by letter dated 

September 20, 2010, the licensee 

withdrew the proposed change. 

For further details with respect to this 

action, see the application for 

amendment dated March 26, 2009, as 

supplemented by letters dated 

September 10, 2009, March 15, and May 

27, 2010, and the licensee’s letter dated 

September 20, 2010, which withdrew 

the application for license amendment. 

Documents may be examined, and/or 

copied for a fee, at the NRC’s Public 


emcdonald on DSK2BSOYB1PROD with NOTICES