[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Pages 48783-48784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23041]




Draft Regulatory Guide: Issuance, Availability

AGENCY: Nuclear Regulatory Commission.

[[Page 48784]]

ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, 


FOR FURTHER INFORMATION CONTACT: Jack Foster, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone: (301) 415-6250 or e-
mail to [email protected].


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 
[email protected].
    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 
[email protected].
    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/doc-collections/. Electronic copies are also available in 
ADAMS (http://www.nrc.gov/reading-rm/adams.html), under Accession No. 
    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 [email protected].
    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]