Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 48783 

upon demonstration by Mr. Poling of 

good cause. 

VI 

Any person adversely affected by this 

Confirmatory Order, other than Mr. 

Douglas Poling, may request a hearing 

within 20 days of the Order’s 

publication in the Federal Register. 

Where good cause is shown, 

consideration will be given to extending 

the time to request a hearing. A request 

for extension of time must be directed 

to the Director, Office of Enforcement, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555–0001, and 

include a statement of good cause for 

the extension. 

A request for a hearing must be filed 

in accordance with the NRC E-Filing 

rule, which the NRC promulgated in the 

August 28, 2007, Federal Register (72 

FR 49139). The E-Filing process requires 

participants to submit and serve 

documents over the Internet or, in some 

cases, to mail copies on electronic 

optical storage media. Participants may 

not submit paper copies of their filings 

unless they seek a waiver in accordance 

with the procedures described below. 

To comply with the procedural 

requirements associated with E-Filing, 

at least five days prior to the filing 

deadline the requestor must contact the 

Office of the Secretary by e-mail at 

hearingdocket@nrc.gov, or by calling 

(301) 415–1677, to request: (1) A digital 

ID certificate, which allows the 

participant (or its counsel or 

representative) to digitally sign 

documents and access the E-Submittal 

server for any NRC proceeding in which 

it is participating; and/or (2) creation of 

an electronic docket for the proceeding 

(even in instances when the requestor 

(or its counsel or representative) already 

holds an NRC-issued digital ID 

certificate). Each requestor will need to 

download the Workplace Forms 

ViewerTM to access the Electronic 

Information Exchange (EIE), a 

component of the E-Filing system. The 

Workplace Forms ViewerTM is free and 

is available at 

http://www.nrc.gov/site-help/esubmittals/install-viewer.html. 

Information about applying for a digital 

ID certificate also is available on NRC’s 

public Web site at http://www.nrc.gov/ 

site-help/e-submittals/applycertificates.html. 

Once a requestor has obtained a 

digital ID certificate, had a docket 

created, and downloaded the EIE 

viewer, it can then submit a request for 

a hearing through EIE. Submissions 

should be in Portable Document Format 

(PDF) in accordance with NRC guidance 

available on the NRC public Web site at 

http://www.nrc.gov/site-help/esubmittals.html. A filing is considered 

complete at the time the filer submits its 

document through EIE. To be timely, 

electronic filings must be submitted to 

the EIE system no later than 11:59 p.m. 

Eastern Time on the due date. Upon 

receipt of a transmission, the E-Filing 

system time-stamps the document and 

sends the submitter an e-mail notice 

confirming receipt of the document. The 

EIE system also distributes an e-mail 

notice that provides access to the 

document to the NRC Office of the 

General Counsel and any others who 

have advised the Office of the Secretary 

that they wish to participate in the 

proceeding, so that the filer need not 

serve the document on those 

participants separately. Therefore, any 

others who wish to participate in the 

proceeding (or their counsel or 

representative) must apply for and 

receive a digital ID certificate before a 

hearing request is filed so that they may 

obtain access to the document via the EFiling system. 

A person filing electronically using 

the agency’s adjudicatory E-Filing 

system may seek assistance through the 

‘‘Contact Us’’ link located on the NRC 

Web site at http://www.nrc.gov/sitehelp/e-submittals.html or by calling the 

NRC Meta-System Help Desk, which is 

available between 8 a.m. and 8 p.m., 

Eastern Time, Monday through Friday, 

excluding government holidays. The 

Meta-System Help Desk can be 

contacted by telephone at 1–866–672– 

7640 or by e-mail at 

MSHD.Resource@nrc.gov. 

Participants who believe that they 

have good cause for not submitting 

documents electronically must file a 

motion, in accordance with 10 CFR 

2.302(g), with their initial paper filing 

requesting authorization to continue to 

submit documents in paper format. 

Such filings must be submitted by: (1) 

First class mail addressed to the Office 

of the Secretary of the Commission, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, Attention: 

Rulemaking and Adjudications Staff; or 

(2) courier, express mail, or expedited 

delivery service to the Office of the 

Secretary, Sixteenth Floor, One White 

Flint North, 11555 Rockville, Pike, 

Rockville, Maryland, 20852, Attention: 

Rulemaking and Adjudications Staff. 

Participants filing a document in this 

manner are responsible for serving the 

document on all other participants. 

Filing is considered complete by firstclass mail as of the time of deposit in 

the mail, or by courier, express mail, or 

expedited delivery service upon 

depositing the document with the 

provider of the service. 

Documents submitted in adjudicatory 

proceedings will appear in NRC’s 

electronic hearing docket which is 

available to the public at http:// 

ehd.nrc.gov/EHD_Proceeding/home.asp, 

unless excluded pursuant to an order or 

policy of the Commission, an Atomic 

Safety and Licensing Board, or a 

Presiding Officer. Participants are 

requested not to include personal 

privacy information, such as social 

security numbers, home addresses, or 

home phone numbers in their filings. 

With respect to copyrighted works, 

except for limited excerpts that serve 

the purpose of the adjudicatory filings 

and would constitute a Fair Use 

application, participants are requested 

not to include copyrighted materials in 

their works. 

If a person other than Mr. Douglas 

Poling requests a hearing, that person 

shall set forth with particularity the 

manner in which his interest is 

adversely affected by this Order and 

shall address the criteria set forth in 10 

CFR 2.309(d) and (f). 

If the hearing is requested by a person 

whose interest is adversely affected, the 

Commission will issue an Order 

designating the time and place of any 

hearing. If a hearing is held, the issue to 

be considered at such hearing shall be 

whether this Confirmatory Order should 

be sustained. 

In the absence of any request for 

hearing, or written approval of an 

extension of time in which to request a 

hearing, the provisions specified in 

Section V above shall be final 20 days 

from the date this Order is published in 

the Federal Register without further 

order or proceedings. If an extension of 

time for requesting a hearing has been 

approved, the provisions specified in 

Section V shall be final when the 

extension expires, if a hearing request 

has not been received. A request for 

hearing shall not stay the immediate 

effectiveness of this order. 

Dated this 16th day of September 2009. 

For the U.S. Nuclear Regulatory 

Commission. 

Mark A. Satorius, 

Regional Administrator, Region III. 

[FR Doc. E9–23038 Filed 9–23–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0418] 

Draft Regulatory Guide: Issuance, 

Availability 

AGENCY: Nuclear Regulatory 

Commission. 


srobinson on DSKHWCL6B1PROD with NOTICES
48784 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices 

ACTION: Notice of Issuance and 

Availability of Draft Regulatory Guide, 

DG–6007. 

FOR FURTHER INFORMATION CONTACT: Jack 

Foster, U.S. Nuclear Regulatory 

Commission, Washington, DC 20555– 

0001, telephone: (301) 415–6250 or email to Jack.Foster@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The U.S. Nuclear Regulatory 

Commission (NRC) is issuing for public 

comment a draft guide in the agency’s 

‘‘Regulatory Guide’’ series. This series 

was developed to describe and make 

available to the public such information 

as methods that are acceptable to the 

NRC staff for implementing specific 

parts of the NRC’s regulations, 

techniques that the staff uses in 

evaluating specific problems or 

postulated accidents, and data that the 

staff needs in its review of applications 

for permits and licenses. 

The draft regulatory guide (DG), 

entitled, ‘‘Establishing Quality 

Assurance Programs for the 

Manufacture and Distribution of Sealed 

Sources and Devices Containing 

Byproduct Material,’’ is temporarily 

identified by its task number, DG–6007, 

which should be mentioned in all 

related correspondence. DG–6007 is a 

proposed Revision 1 of Regulatory 

Guide 6.9, dated February 1995. 

This regulatory guide directs the 

reader to the type of quality assurance 

(QA) and quality control (QC) program 

acceptable to the staff of the NRC during 

the review of an application to 

manufacture or distribute sealed sources 

and devices containing byproduct 

materials. 

Title 10 of the Code of Federal 

Regulations (10 CFR) Part 32, ‘‘Specific 

Domestic Licenses to Manufacture or 

Transfer Certain Items Containing 

Byproduct Material,’’ regulates the 

manufacture and distribution of sealed 

sources or devices containing byproduct 

material. Regulations in 10 CFR 

32.210(c) require the applicant or 

registrant to submit information about 

the QC program in sufficient detail to 

allow the NRC reviewers to ensure that 

the product is manufactured and 

distributed in a manner that is adequate 

to protect health and minimize danger 

to life and property. 

This regulatory guide endorses the 

methods and procedures for a QA/QC 

program described in Section 10.7, 

‘‘Quality Assurance and Quality 

Control’’ of NUREG–1556, Volume 3, 

‘‘Consolidated Guidance About 

Materials Licenses: Applications for 

Sealed Source and Device Evaluation 

and Registration,’’ issued April 2004, as 

a process that the NRC finds acceptable. 

As described in Volume 3 of NUREG– 

1556, the applicant must provide details 

of the QA program that ensure that the 

product is manufactured and distributed 

in accordance with the representations 

made in the application and the 

statements contained in the registration 

certificate for the product. 

II. Further Information 

The NRC staff is soliciting comments 

on DG–6007. Comments may be 

accompanied by relevant information or 

supporting data and should mention 

DG–6007 in the subject line. Comments 

submitted in writing or in electronic 

form will be made available to the 

public in their entirety through the 

NRC’s Agencywide Documents Access 

and Management System (ADAMS). 

Personal information will not be 

removed from your comments. You may 

submit comments by any of the 

following methods: 

1. Mail comments to: Rulemaking and 

Directives Branch, Mail Stop: TWB–05– 

B01M, Office of Administration, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001. 

2. Federal e-Rulemaking Portal: Go to 

http://www.regulations.gov and search 

for documents filed under Docket ID 

[NRC–2009–0418]. Address questions 

about NRC dockets to Carol Gallagher, 

301–492–3668; e-mail 

Carol.Gallagher@nrc.gov. 

3. Fax comments to: Rulemaking and 

Directives Branch, Office of 

Administration, U.S. Nuclear Regulatory 

Commission at (301) 492–3446. 

Requests for technical information about 

DG–6007 may be directed to the NRC 

contact, Jack Foster at (301) 415–6250 or 

e-mail to Jack.Foster@nrc.gov. 

Comments would be most helpful if 

received by November 21, 2009. 

Comments received after that date will 

be considered if it is practical to do so, 

but the NRC is able to ensure 

consideration only for comments 

received on or before this date. 

Although a time limit is given, 

comments and suggestions in 

connection with items for inclusion in 

guides currently being developed or 

improvements in all published guides 

are encouraged at any time. 

Electronic copies of DG–6007 are 

available through the NRC’s public Web 

site under Draft Regulatory Guides in 

the ‘‘Regulatory Guides’’ collection of 

the NRC’s Electronic Reading Room at 

http://www.nrc.gov/reading-rm/doccollections/. Electronic copies are also 

available in ADAMS (http:// 

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

under Accession No. ML091670485. 

In addition, regulatory guides are 

available for inspection at the NRC’s 

Public Document Room (PDR) located at 

11555 Rockville Pike, Rockville, 

Maryland. The PDR’s mailing address is 

USNRC PDR, Washington, DC 20555– 

0001. The PDR can also be reached by 

telephone at (301) 415–4737 or (800) 

397–4205, by fax at (301) 415–3548, and 

by e-mail to pdr.resource@nrc.gov. 

Regulatory guides are not 

copyrighted, and Commission approval 

is not required to reproduce them. 

Dated at Rockville, Maryland, this 17th day 

of September 2009. 

For the Nuclear Regulatory Commission. 

Andrea D. Valentin, 

Chief, Regulatory Guide Development Branch, 

Division of Engineering, Office of Nuclear 

Regulatory Research. 

[FR Doc. E9–23041 Filed 9–23–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0410; Docket No. 030–35904] 

Notice of Availability of Environmental 

Assessment and Finding of No 

Significant Impact for License 

Amendment to Byproduct Materials 

License No. 29–30707–01, for 

Termination of the License and 

Unrestricted Release of the Memory 

Pharmaceuticals Corporation Facility 

Located in Montvale, NJ 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Issuance of Environmental 

Assessment and Finding of No 

Significant Impact for License 

Amendment. 

FOR FURTHER INFORMATION CONTACT: 

Dennis Lawyer, Health Physicist, 

Commercial and R&D Branch, Division 

of Nuclear Materials Safety, Region I, 

475 Allendale Road, King of Prussia, 

Pennsylvania; telephone 610–337–5366; 

fax number 610–337–5269 or by e-mail: 

dennis.lawyer@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The U.S. Nuclear Regulatory 

Commission (NRC) is considering the 

issuance of a license amendment to 

Byproduct Materials License No. 29– 

30707–01. This license is held by 

Memory Pharmaceuticals Corporation 

(the Licensee) for its facility located at 

100 Philips Parkway in Montvale, New 

Jersey (the Facility). Issuance of the 

amendment would authorize release of 

the Facility for unrestricted use and 

termination of the NRC license. The 


srobinson on DSKHWCL6B1PROD with NOTICES