E9-23041. Draft Regulatory Guide: Issuance, Availability

AGENCY:

Nuclear Regulatory Commission.

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: [phone] or e-mail to [e-mail].

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 [e-mail].

3. Fax comments to: Rulemaking and Directives Branch, Office of Administration, U.S. Nuclear Regulatory Commission at [phone]. Requests for technical information about DG-6007 may be directed to the NRC contact, Jack Foster at [phone] or e-mail to [e-mail].

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. 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 [phone] or [phone], by fax at [phone], and by e-mail to [e-mail].

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.