2012-13620. Regulatory Guide 8.33, Quality Management Program

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Regulatory Guide; withdrawal.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC or Commission) is withdrawing Regulatory Guide (RG) 8.33, “Quality Management Program.” This guide provided guidance to ensure that the objectives of the former NRC “Quality Management Program” regulations were met. In this connection, the guide suggested policies and procedures to be used in complying with other specific NRC regulations. However, the requirement to establish a Quality Management Program was deleted from the regulations as part of an overall revision in 2002 of the “Medical Use of Byproduct Material” regulations. Therefore, the guidance provided in RG 8.33 is no longer accurate or current and is being withdrawn through this notice.

ADDRESSES:

Please refer to Docket ID NRC-2012-0126 when contacting the NRC about the availability of information regarding this document. You may access information related to this document, which the NRC possesses and are publicly-available, using the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2012-0126. Address questions about NRC dockets to Carol Gallagher; telephone: [phone]; email: [e-mail].
• NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly-available documents online in the NRC Library at http://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [e-mail].
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Mohammad Saba, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone] or email to [e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction

The NRC is withdrawing Regulatory Guide 8.33, “Quality Management Program,” published on November 4, 1991 (56 FR 56425). The guide provided guidance for licensees and applicants for developing policies and procedures for a quality management program acceptable to the NRC staff for complying with former Title 10 of the Code of Federal Regulations (10 CFR) Part 35, “Medical Use of Byproduct Material,” 10 CFR 35.32, “Quality Management Program.” However, the requirement that licensees must establish and maintain a Quality Management Program was deleted from the regulations on April 24, 2002 (see 67 FR 20370). Therefore, the guidance provided in RG 8.33 is neither necessary nor current. NUREG-1556, Volume 9, “Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses,” has since been published to provide guidance on topics related to the current regulations in 10 CFR Part 35. The guidance in NUREG-1556, Volume 9, will be revised in conjunction with the promulgation of a rule revising 10 CFR Part 35 that is currently being developed.

II. Further Information

The withdrawal of Regulatory Guide 8.33 does not alter any prior or existing licensing commitments or conditions based on their use. The guidance provided in these regulatory guides is neither necessary nor current. Regulatory guides may be withdrawn when their guidance is superseded by congressional action or no longer provides useful information.

Dated at Rockville, Maryland, this 24th day of May 2012.

For the Nuclear Regulatory Commission.

Harriet Karagiannis,

Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research.